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D003863: Depression

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (162)


Name (Synonyms) Correlation
drug3218 Survey Wiki 0.22
drug547 CHAMindWell Wiki 0.12
drug469 Blood for research purposes Wiki 0.12
Name (Synonyms) Correlation
drug1179 Entrée: Interpersonal skills Wiki 0.12
drug1655 Internet Cognitive Behavioral Therapy plus CHAMindWell Wiki 0.12
drug401 Beck Depression Inventory (BDI) Wiki 0.12
drug2019 Minimal Attention Control Intervention Wiki 0.12
drug2640 Psychoeducation Wiki 0.12
drug3449 Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki 0.12
drug3249 TAPE-Software Wiki 0.12
drug929 Cross-sectional study investigating the association of NPIs with mental health Wiki 0.12
drug3763 e-Psychotherapy Wiki 0.12
drug1104 EPDS (Edinburgh Postnatal Depression Scale) Wiki 0.12
drug167 Aerobic Exercises Wiki 0.12
drug3309 Test for SARS-CoV-2 Wiki 0.12
drug2116 Nasopharyngeal, oropharyngeal, or saliva swab Wiki 0.12
drug3604 Web-based psychosocial peer-to-peer support Wiki 0.12
drug560 COMPASS Wiki 0.12
drug403 Behavioral Activation SSI Wiki 0.12
drug3404 Training video on anxiety, fear and loneliness in the COVID-19 environment. Wiki 0.12
drug1849 Low-Intensity Psychosocial Interventions through Telemental health Wiki 0.12
drug3963 psycho-education video Wiki 0.12
drug3718 care modalities Wiki 0.12
drug2627 Prosocial acts Wiki 0.12
drug3135 Standard charity resources Wiki 0.12
drug909 Covid ICU containment measures Wiki 0.12
drug451 Biosensor Wiki 0.12
drug3244 T89 capsule Wiki 0.12
drug3350 Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki 0.12
drug3326 The standard Macintosh laryngoscope Wiki 0.12
drug3499 Use of social media during COVID-19 Wiki 0.12
drug2631 Prospective study across two time-points examining the impact of viral mitigation protocols on mental health Wiki 0.12
drug511 Brief Behavioral Activation with Mental Imagery Wiki 0.12
drug3238 Systemic indirect endovenous ozone therapy Wiki 0.12
drug3965 psychological assessment Wiki 0.12
drug1370 Growth Mindset SSI Wiki 0.12
drug3272 Tears swab Wiki 0.12
drug3392 Tracheostomy Wiki 0.12
drug3068 Slef questionnaires fulfilment Wiki 0.12
drug3318 Text material for psychoeducation and audio for relaxation techniques Wiki 0.12
drug3325 The psychosocial effects of COVID-19 pandemic on dental professionals Wiki 0.12
drug3311 TestNPass Wiki 0.12
drug3351 Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28 Wiki 0.12
drug1934 Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores Wiki 0.12
drug635 COVID-surgRES questionaire Wiki 0.12
drug404 Behavioral: OCAT Wiki 0.12
drug3307 Test Group: experimental - UVC Therapy applied Wiki 0.12
drug3381 Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses) Wiki 0.12
drug4046 test Wiki 0.12
drug3340 Therapist Guided E-Therapy Wiki 0.12
drug3072 Social media & news consumption Wiki 0.12
drug1151 Emotion Regulation Training via Telehealth Wiki 0.12
drug3347 Thoracic CT Scan Wiki 0.12
drug3220 Survey Group Wiki 0.12
drug3380 Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 Wiki 0.12
drug514 Brief Skills for Safer Living Wiki 0.12
drug3495 Uniform random message delivery Wiki 0.12
drug1319 GAD-7 (General Anxiety Disorder) scale Wiki 0.12
drug3290 Telephone survey Wiki 0.12
drug2755 Reading a Book Wiki 0.12
drug2961 Sampler skills Wiki 0.12
drug4004 self-care tools Wiki 0.12
drug3352 Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki 0.12
drug3294 Telepsychoeducation with personalized videos Wiki 0.12
drug1177 Entrée: Behavioral skills Wiki 0.12
drug2772 Registery Data Collection Wiki 0.12
drug3251 TCC-COVID mHealth solution Wiki 0.12
drug3455 Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki 0.12
drug461 Blood collection Wiki 0.12
drug429 Biobehavioral Tele-rehabilitation Sessions Wiki 0.12
drug3335 Therapeutic Plasma Exchange (TPE) Wiki 0.12
drug1178 Entrée: Cognitive skills Wiki 0.12
drug3175 State-trait anxiety inventory scale Wiki 0.12
drug923 Crisis intervention therapy Wiki 0.12
drug3399 Training clinicians in basic critical care and the management of severe COVID-19 cases Wiki 0.12
drug293 Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery Wiki 0.12
drug3295 Telepsychoeducation without personalized videos Wiki 0.12
drug3207 Supportive Therapy SSI Wiki 0.12
drug3396 Traditional Chinese Medicine Prescription Wiki 0.12
drug3462 Two doses of placebo at the schedule of day 0, 14 #middle-dose group# Wiki 0.12
drug2273 Online Intervention Mental Health COVID-19 Wiki 0.12
drug3322 The Vie Scope laryngoscope Wiki 0.12
drug3393 Tracheostomy with aerosol box in COVID-19 positive patients Wiki 0.12
drug3848 lay telephone coaching Wiki 0.12
drug2935 STI-5656 Wiki 0.12
drug3329 The study does not required Wiki 0.12
drug4013 service of questionnaire Wiki 0.12
drug3280 Teleconsultation either by phone or by computer consultation Wiki 0.12
drug3463 Two doses of placebo at the schedule of day 0, 28(high-dose group) Wiki 0.12
drug49 38 questions questionnaire Wiki 0.12
drug1790 Limbix Spark Wiki 0.12
drug3355 Three doses of placebo at the schedule of day 0, 14, 28(high-dose group) Wiki 0.12
drug770 Clinical interview Wiki 0.12
drug3464 Two doses of placebo at the schedule of day 0, 28(middle-dose group) Wiki 0.12
drug2009 Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell Wiki 0.12
drug3267 Taking biological samples Wiki 0.12
drug3520 VR for psychoeducation and relaxation Wiki 0.12
drug3222 Survey and Questionnaire Wiki 0.12
drug3353 Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group# Wiki 0.12
drug3402 Training of youth, community health assistants and community health workers. Wiki 0.12
drug1662 Intervention Wiki 0.12
drug3302 Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care. Wiki 0.12
drug3348 Thorax CT Wiki 0.12
drug3252 TCM prescriptions Wiki 0.12
drug3461 Two doses of placebo at the schedule of day 0, 14 #High-dose group# Wiki 0.12
drug3617 WofB Wiki 0.12
drug2981 Self Study Wiki 0.12
drug3412 Transfusion of COVID-19 convalescent plasma Wiki 0.12
drug3450 Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki 0.12
drug2985 Self-Help Therapy Wiki 0.12
drug3049 Simha Kriya Wiki 0.12
drug2363 Pandemic control measures Wiki 0.12
drug467 Blood for anti-drug antibody (ADA) Wiki 0.12
drug3338 Therapeutic plasma exchange Wiki 0.12
drug1666 Intervention group CoronaCope Wiki 0.12
drug3400 Training for Awareness, Resilience, and Action (TARA) Wiki 0.12
drug3314 Testing for SARS-CoV-2 Wiki 0.12
drug2779 Reinforcement learning message delivery Wiki 0.12
drug927 Cross-sectional observational study Wiki 0.12
drug3297 Telerehabilitation-Based Wiki 0.12
drug280 Ashmolean Website Wiki 0.12
drug3261 TOF protocol Wiki 0.12
drug515 Brief cognitive behavioral therapy Wiki 0.12
drug3025 Serology test follow-up Wiki 0.12
drug2337 PHQ-9 (Patient Health Questionnaire) Depression Scale Wiki 0.12
drug3354 Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group# Wiki 0.12
drug3319 Thalidomide Wiki 0.12
drug2989 Self-focused acts Wiki 0.12
drug3456 Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki 0.12
drug2093 NT-I7 Wiki 0.12
drug3401 Training load Wiki 0.12
drug1101 EMDR Wiki 0.12
drug3321 The PREPARE program Wiki 0.12
drug3281 Telehealth Wiki 0.12
drug3748 covid-19 positive pregnant women Wiki 0.12
drug3324 The demographic, clinical, laboratory, and instrumental data Wiki 0.12
drug1124 Edinburgh Postnatal Depression Scale (EDPS) Wiki 0.12
drug3549 Video-Based Wiki 0.12
drug468 Blood for pharmacokinetic samples Wiki 0.12
drug406 Behaviour Change Technique Intervention to Improve Quality of Life Wiki 0.12
drug405 Behavioral: OCAT-sham Wiki 0.12
drug2714 RECHARGE Wiki 0.12
drug425 Bicalutamide 150 Mg Oral Tablet Wiki 0.09
drug577 COVID Convalescent Plasma Wiki 0.09
drug1908 MagPro X100 Stimulator, B70 Fluid-Cooled Coil Wiki 0.09
drug407 Bemiparin Wiki 0.09
drug621 COVID-19 patients Wiki 0.09
drug600 COVID-19 RT-PCR Wiki 0.07
drug466 Blood draw Wiki 0.07
drug3632 Yoga Wiki 0.07
drug3296 Telerehabilitation Wiki 0.06
drug2276 Online Survey Wiki 0.06
drug2284 Online survey Wiki 0.06
drug2951 Saliva collection Wiki 0.05
drug2685 Questionnaire Wiki 0.04
drug391 Baricitinib Wiki 0.04
drug672 Camostat Mesilate Wiki 0.04
drug1000 Dexamethasone Wiki 0.04
drug3943 placebo Wiki 0.03
drug2448 Placebo Wiki 0.02
drug2782 Remdesivir Wiki 0.02
drug3375 Tocilizumab Wiki 0.02

Correlated MeSH Terms (17)


Name (Synonyms) Correlation
D003866 Depressive Disorder NIH 0.51
D019052 Depression, Postpartum NIH 0.28
D001008 Anxiety Disorders NIH 0.18
Name (Synonyms) Correlation
D059020 Suicidal Ideation NIH 0.12
D013405 Suicide NIH 0.09
D001714 Bipolar Disorder NIH 0.09
D000077062 Burnout, Psychological NIH 0.09
D002055 Burnout, Professional NIH 0.08
D040921 Stress Disorders, Traumatic NIH 0.07
D007319 Sleep Initiation and Maintenance Disorders NIH 0.07
D013313 Stress Disorders, Post-Traumatic NIH 0.07
D013315 Stress, Psychological NIH 0.07
D020920 Dyssomnias NIH 0.05
D020447 Parasomnias NIH 0.04
D020521 Stroke NIH 0.03
D016638 Critical Illness NIH 0.02
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0000716 Depressivity HPO 0.51
HP:0100754 Mania HPO 0.09
HP:0100785 Insomnia HPO 0.07
Name (Synonyms) Correlation
HP:0001297 Stroke HPO 0.03

Clinical Trials

Navigate: Correlations   HPO

There are 65 clinical trials


1 Getting it Right: Towards Responsible Social Media Use During a Pandemic

The investigators plan to conduct a cross-sectional survey to examine how social media use during COVID-19 relates to: (1) information management, (2) assessment of the situation, and (3) affect.

NCT04305574
Conditions
  1. Coronavirus
  2. Depression
  3. Anxiety
  4. Stress
Interventions
  1. Behavioral: Use of social media during COVID-19
MeSH:Depression

Primary Outcomes

Description: 21-item validated scale assessing symptoms of depression, anxiety, and stress (DASS-21): Min score = 0, Max score = 21; higher score indicates a worse outcome

Measure: Depression, Anxiety and Stress Scale

Time: Single measurement (upon study enrolment)

Other Outcomes

Description: 3 items on fear of the situation, confidence the government can manage the situation, and assessed chance of being infected (each rated using 4-point scales: min = 1, max = 4; higher scores indicate increased confidence / likelihood / fear)

Measure: Assessment of COVID-19 situation

Time: Single measurement (upon study enrolment)

Description: Participants' self-report of their familiarity (yes/no) and belief of specific (yes/no), and whether they shared these on social media (yes/no)

Measure: Familiarity and trust in COVID-related rumours

Time: Single measurement (upon study enrolment)
2 The Mental Health Status of the General Population During the COVID-19 Pandemic and Its Association With Adherence to Government-initiated Non-pharmacological Epidemiological Interventions (NPI's)

This study seeks to investigate the levels of common psychopathology symptoms (i.e., depression and generalized anxiety) in a general population during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also seeks to examine the predictors of generalized anxiety and depressive symptoms, as well as predictors of adherence rates to government-initiated non-pharmacological epidemiological interventions (NPI's). The aim of the project is to: - Inform the policymakers, the general public, scientists, and health practitioners about the psychological associations of the COVID-19-related government-initiated measures. - Provide a foundation for policymakers and health-care professionals to employ interventions that protect the general public against possibly increased psychological stressors, suffering and dysfunction during society's handling of the pandemic. - Help policymakers better understand the associations of demographic variables and psychological symptoms with adherence, providing an initial understanding of adherence rates, which may be used to help society fight against the COVID-19-virus from an epidemiological perspective by promoting factors that increase adherence.

NCT04356365
Conditions
  1. Depression
  2. Generalized Anxiety
  3. Adherence to Non-pharmacological Epidemiological Interventions (NPIs)
Interventions
  1. Other: Cross-sectional study investigating the association of NPIs with mental health
MeSH:Depression

Primary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (non-pharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Higher scores indicate greater anxiety severity, and scores that are above the cut-off of 10 are considered to be in the clinical range (Spitzer et al., 2006). Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (non-pharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Description: Measures of adherence to all eight non-pharmacological interventions (NPIs) employed against COVID-19 is measured, with each item being on a five-point Likert scale (0-4).

Measure: Measures of adherence

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (non-pharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway
3 Mental Health of Urban Mothers (MUM) Study: A Multi-center Randomized Controlled Trial

Mental health disorders are common during pregnancy and the postnatal period, and can have serious adverse effects on the well-being of woman and child. Every tenth woman has depressive symptoms and 5% suffer major depression during pregnancy. The consequences for global mental health due to the novel coronavirus disease, COVID-19, are likely to be significant and may have long-term impact on the global burden of disease. Pregnant women may be particularly vulnerable due to partial immune suppression. Besides physical vulnerability, the women could be at increased risk of mental health problems, such as anxiety, depression, and post-traumatic stress disorder (PTSD), due to social distancing leading to less support from the family and friends, and in some cases, partners not being allowed to be present during prenatal visits, labor and delivery. Furthermore, many pregnant women may feel insecure and worried about the effect of COVID-19 on their unborn child, if the women get infected during pregnancy. Today, young urban women are used to utilizing internet services frequently and efficiently. Therefore, providing mental health support to pregnant women via web-based support may be effective in ameliorating their anxiety/depression and reduce the risk of serious mental health disorders leading to improved maternal and perinatal outcomes.

NCT04363177
Conditions
  1. Perinatal Depression
  2. COVID19
  3. Anxiety
  4. PTSD
  5. Pregnancy Related
Interventions
  1. Behavioral: Web-based psychosocial peer-to-peer support
MeSH:Depression

Primary Outcomes

Description: To investigate the impact of a web-based psychosocial intervention on Edinburgh Postnatal Depression Scale (EPDS) in urban women living in Hong Kong and Shanghainese women. Scores of EPDS range from min = 0 to max=30. The higher the score, the more depressed a woman is.

Measure: Edinburgh Postnatal Depression Scale (EPDS)

Time: 4-6 weeks postpartum

Secondary Outcomes

Description: Correlation between mental health status (EPDS, GAD7, IES-R) and COVID-19 pandemic among pregnant women. GAD 7 Generalized anxiety questionnaire IES-R Impact Event Scale to assess Post traumatic stress Disorder (PTSD) COVID-19 questionnaire

Measure: Mental health status and COVID-19

Time: 4-6 weeks postpartum

Description: Impact of web-based psychosocial intervention on mental health and pregnancy outcomes among women from different socio-economic and cultural environments. Socio-economic information gained by sociodemographic questions.

Measure: Socio-economic status (education level, income, marital status, profession, nationality)

Time: 4-6 weeks postpartum

Description: Relationship between mental health status of pregnant women and rates of elective cesarean section (CS) on maternal request.

Measure: Elective CS

Time: 4-6 weeks postpartum
4 Loneliness During the Non-pharmacological Epidemiological Interventions for the COVID-19 Pandemic in Norway: Risk Factors and Associations With Psychopathology

The present study of loneliness during the COVID-19-related NPIs is part of a larger project aiming to investigate psychological reactions and symptoms associated with the current and ongoing governmental initiatives in place in Norway. The results will lead to a better understanding of the psychological effects on quarantine on the population and consequently will be relevant for the development of tailored prevention and intervention programs fit for pandemic crises. Objectives Investigate the levels of loneliness in a general population during the strict social distancing government-initiated non-pharmacological interventions (NPIs) for the COVID-19 pandemic. Investigate risk and resilience factors for loneliness and the associations between loneliness and psychopathology symptoms during the NPIs. Aims Inform the general public, policy makers, scientists, and health practitioners about the associations of the NPIs with the mental health problem of loneliness and its potential effect on psychopathology. Provide a foundation for policymakers and health-care professionals to employ interventions that protect the general public against increased psychological suffering and dysfunction during society's handling of pandemics.

NCT04365881
Conditions
  1. Loneliness, Worry, Rumination, Health Anxiety, Depression, Anxiety
Interventions
  1. Other: Cross-sectional observational study
MeSH:Depression

Primary Outcomes

Description: The UCLA Loneliness Scale-8 (ULS-8) measures the frequency and intensity of aspects of the lonely experience, using a 1 (never) to 4 (always) Likert-type scale. A composite score was computed by summing the items after reverse coding when appropriate, such that higher scores indicate greater loneliness. In terms of symptoms, validated measures routinely used in clinical practice to screen symptom-levels suggestive of psychiatric diagnosis were utilized.

Measure: UCLA Loneliness Scale-8 (ULS-8)

Time: From March31st 2020 to April 7th 2020

Description: The Patient Health Questionnaire-9 (PHQ-9)16 consists of nine items covering the DSM-IV criteria for major depression scored on a four-point Likert-scale (0-3), with scores ranging from 0 to 27. High scores on the PHQ-9 reveal greater depression severity and scores above 10 are considered as the cut-off indicative of a depressive diagnosis with a sensitivity and specificity of 88%.16 The PHQ-9 has revealed good psychometric properties, as demonstrated by Kroenke et al. (2001).

Measure: Patient Health Questionnaire-9 (PHQ-9)

Time: From March31st 2020 to April 7th 2020

Description: The Generalized Anxiety Disorder-7 (GAD-7)17 consists of seven items covering the DSM-IV criteria for GAD on a four-point Likert scale (0-3) with scores ranging from 0 to 21. Higher scores reveal greater GAD symptoms, and scores above 10 are considered as the cut-off indicative of a GAD-diagnosis with a specificity of 82% and sensitivity of 89%.17 The GAD-7 has revealed construct validity and reliability (Kroenke, Spitzer, Williams, Monahan & Löwe, 2007; Löwe et al., 2008).

Measure: Generalized Anxiety Disorder-7 (GAD-7)

Time: From March31st 2020 to April 7th 2020
5 Psychological Impact of the Lockdown on Patients Giving Birth During the COVID-19 Epidemic

The COVID-19 epidemic has a major impact on the organization of hospital structures as a whole. Regarding the functioning of the Maternities, it was decided by the three Maternities of AP-HP. Sorbonne University of the Pitié-Salpêtrière, Trousseau and Tenon sites, from March 20, 2020 to no longer authorize visits during the stay of mothers following childbirth. This prohibition has also been extended to spouses. This measure was guided by a concern to protect both the patients, their newborn and the entire staff of the aftermath. The period surrounding a birth is a period of strong emotional impact with an incidence of postpartum depression estimated at 15% in the general population (1). The separation of women from their spouses during this period could expose them to greater psychological vulnerability. In addition, when they return home, the patients will be isolated from their relatives due to the quarantine, which is an additional risk factor for postpartum depression. The teams of the three maternity units of AP-HP. Sorbonne University have organized themselves to be able to respond to situations of mental vulnerability during their stay with the intervention of maternity psychologists and psychiatrists and child psychiatrists as is done in the treatment usual charge. In addition, anticipating situations of greater vulnerability linked to the health crisis, the Maternity teams decided to set up a follow-up of patients after their return home through a telephone interview with psychologists or student psychologists in Master at D10 - D12 and 6-8 weeks postpartum in order to identify patients at increased risk of postpartum depression and to set up appropriate management if necessary for these patients. We therefore propose through this project to describe the consequences of this separation from the spouse during the postpartum stay and then with the family after returning home within the context of quarantine by assessing the incidence of post-partum depression during this sanitary crisis. A telephone interview of all the patients will be proposed on D10 - D12 and at 6-8 weeks postpartum using specific questionnaire to calculate a score of depression. This early identification will allow the establishment of an adapted psychological follow-up.

NCT04366817
Conditions
  1. Post Partum Depression
Interventions
  1. Behavioral: psychological assessment
MeSH:Depression, Postpartum Depression

Primary Outcomes

Description: assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemic

Measure: Proportion of patients with postpartum depression defined by an EPDS score >12

Time: Between week 6 and week 8

Description: assess the emotional impact of women's separation from their partners following childbirth and then their family isolation when they return home in the context of the health crisis linked to the COVID-19 epidemic

Measure: Proportion of patients with postpartum depression defined by an EPDS score >12

Time: Between day 10 and day 12

Secondary Outcomes

Measure: Socio-demographic data

Time: Between day 1 and day 5

Measure: Occurrence of a maternal or fetal pathology in a previous pregnancy

Time: Between day 1 and day 5

Measure: Pregnant maternal pathology (hypertension, diabetes, threat of premature delivery)

Time: Between day 1 and day 5

Description: as above, maternal psychological history as vulnerability factor included : history of perinatal loss, IMG, history of post partum depression.

Measure: Presence of psycological maternal risk factor

Time: Between day 1 and day 5

Measure: Dyadic adjustment scale 16 (DAS-16)

Time: Between day 10 and day 12 and at between week 6 and week 8

Measure: Perinatal post traumatic stress disorder questionnaire (PPQ scale)

Time: Between day 10 and day 12

Measure: Mother to infant bonding scale (MIBS) autoquestionnaire

Time: Between day 10 and day 12 and at between week 6 and week 8

Description: Participants will be asked open-ended questions about their post-partum experience in the context of COVID-19 epidemic lockdown. The interviews will be transcribed and tagged with codes which have been extracted from the data. As more data is collected codes can be regrouped into concepts and then categories. These categories are the basis of the "theory model" that emerge from the narrative of the patients. The verbatim of the interview will be analyzed using NVIVO software which allows a grounded theory approach. Using software package as Nvivo (Hutchison, 2010) with automatic analysis of the verbatim to extract codes and concepts provides a transparent account of the data and enhance study validity. Verbatim are download in the software, that extract repeated lexical fields the categories from the mother's narrative. As this is a qualitative study, there are no expected outcomes. Outcomes will be determined by the themes that arise from the post-partum interview process.

Measure: Measure Qualitative Interviews by Grounded theory

Time: Week 14
6 Getting it Right: Towards Responsible Social Media Use During a Pandemic (COVID-19)

In this protocol, we seek to examine the role of social media in information spread during a pandemic. As there have been few pandemics in the last decade (coinciding with the rise of social media), its use in this context remains understudied. This study hence intends to: (1) characterize the nature of social media use, (2) understand the impact of social media use, and (3) understand how to communicate accurate information.

NCT04367363
Conditions
  1. Coronavirus
  2. Depression
  3. Anxiety
  4. Stress
Interventions
  1. Behavioral: Social media & news consumption
MeSH:Depression

Primary Outcomes

Description: 21-item validated scale assessing symptoms of depression, anxiety and stress (DASS-21): Min score = 0, Max score = 21; higher score indicates a worse outcome.

Measure: Change in DASS scores across 7 days

Time: Twice: once during initial enrollment, and then 8 days after

Description: 1 item each day on fear specifically of the COVID-19 situation (measured on a 4 point scale: min = 1, max = 4; higher scores indicating greater fear about the outbreak).

Measure: Changes in fear with regards the COVID-19 situation across 1 week

Time: 1 week, starting from date after initial DASS survey completion

Description: 1 item each day on how much they thought about the outbreak that day (measured on a 5 point scale: min = 1, max = 5; higher scores indicating more thinking about the outbreak).

Measure: Changes in amount of thinking about the COVID-19 situation across 1 week

Time: 1 week, starting from date after initial DASS survey completion
7 The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19: Validation of a New Online Treatment

Attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and empirical research. Former research in the lab of the investigators has shown positive effects of an interactive attention control/interpretation training, in which participants learned to unscramble scrambled sentences ("life is my a party mess") in a positive way ("my life is a party") by getting eye-tracking feedback about attention for positive ("party") vs. negative information ("mess"). After the training, participants could better reinterpret negative photos in a positive way. Attention- and cognitive control mechanisms prior to negative stressors (proactive control) and after negative stressors (reactive control) seem to play a role in this. Moreover, research has shown that low perceived control and negative expectations about future emotion regulation skills results in lower proactive control and a higher need of reactive control. Based on this, the assumption can be made that the effects of attention control training - targeting reactive control - could benefit from adding techniques that affect proactive control (e.g. psycho-education). In the present study this is investigated by testing a new two weeks attention control training to see if this has a positive effect on stress related complaints, depressive symptoms and emotion regulation. Given that the current COVID-19 pandemic is perceived as very stressful by a lot of people, the training could help here. Participants between 18 to 65 years of age are recruited during this corona crisis. The attention control training is a new smartphone based application. Participants have to unscramble scrambled sentences into grammatically correct sentences. In the training condition, participants are asked to unscramble the scrambled sentences in a positive way. By swiping, participants can see part of the sentences. This gives the investigators an image about the processing of the sentences. This procedure allows to measure how long participants attend to positive and negative words. In the training condition participants get feedback about the duration they process positive and negative words. In the control group participants unscramble the sentences as fast as possible without feedback on emotional attention. Participants only get feedback about the speed at which sentences are unscrambled. Before and after the 10 training sessions, attention of the participants is measured to see the effects of the training. Questionnaires on depressive and anxiety complaints, emotion regulation strategies, well-being and stress are administered before and after the training. There is also a follow-up measure 2 months after the training. Both groups (training and control) watch a psycho-education video before the start of the training.

NCT04367636
Conditions
  1. Rumination
  2. Anxiety
  3. Stress
  4. Depressive Symptoms
Interventions
  1. Behavioral: Behavioral: OCAT-sham
  2. Behavioral: Behavioral: OCAT
  3. Other: psycho-education video
MeSH:Depression

Primary Outcomes

Description: Measured by Mood and Anxiety Symptom Questionnaire (MASQ-30). It measures the dimensions of Clark and Watson's tripartite model, covering both shared and distinct symptoms of depression and anxiety. It has three sub-scales: Negative Affect (NA), associated with both depression and anxiety; lack of Positive Affect (PA), associated with depressive moods; and Somatic Arousal (SA), associated with anxiety. Scores are ranging from 10 to 50, with higher scores indicating more severe psychopathology.

Measure: Changes in depression-, anxiety- and psychosomatic stress symptoms

Time: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

Secondary Outcomes

Description: Measured by Rumination Response Scale (RRS). This 22-item questionnaire provides a total rumination score (range: 22 - 88), as well as Brooding and Reflection sub-scale scores (range: 5 - 20). Brooding is characterized by a passive style of moody pondering. Higher scores indicate a worse outcome.

Measure: Changes in rumination.

Time: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

Description: Measured by the Cognitive Emotion Regulation Questionnaire (CERQ). Which measures different emotion regulation strategies. This questionnaire has 9 sub-scales: self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive reappraisal, acceptance and planning. Each sub-scale has a scoring range between 4 and 20. A higher score represents a greater frequency of engaging in that emotion regulation strategy.

Measure: Changes in cognitive emotion regulation strategies.

Time: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

Description: Measured by a baseline measure in our OCAT app and measure of the end of the training period.

Measure: Changes in emotional attention

Time: pre-test (before starting the training), post-test (immediately after the training)

Other Outcomes

Description: Measured by the COVID questionnaire (designed by the researchers).

Measure: How variables related to COVID-19 and the quarantine affect the life of participants

Time: pre-test (before starting the training)

Description: Measured by Center for Epidemiological Studies - Depression (CES-D), which has 20 items. A higher score represents more depressive feelings (range: 0 - 60).

Measure: Changes in depressive complaints

Time: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

Description: Measured by the Generalized Anxiety Disorder 7 item scale (GAD-7). Scores may vary from 0 to >15. A higher score represents more symptoms of anxiety.

Measure: Changes in symptoms of anxiety

Time: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

Description: Measured by the Warwick-Edinburgh Mental Well-being Scales (WE-MWB). This 14-item scale indexes positive aspects of mental health. Scores may vary between 14 and 70. A higher score represents a more positive mental health.

Measure: Changes in well-being

Time: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

Description: Measured by a Visual Analogue Stress Scale, is scored from 1 (not at all) - 10 (a lot).

Measure: Changes in perceived stress

Time: pre-test (before starting the training), post-test (immediately after the training), follow-up (two months after the training)

Description: Measured by the Credibility/Expectancy Questionnaire (CEQ). It measures participants' credibility and expectancy of the training. In the credibility scale the items are rated on 9- point scales ranging from 1 (Not at all logical/useful/confident) to 9 (Very logical/effective/confident). This leads to a total score on this scale between 3 and 27. In the expectancy scale the same 9-point scale is used and an 11-point scale (from 0% to 100%). Responses are standardized to get the total expectancy score. Higher scores represent higher credibility and expectancy.

Measure: Treatment Credibility and Expectancy

Time: post-test (immediately after the training)

Description: A question was added to determine how pleasant the training is perceived by the participants. It is scored on a scale from 0 to 10 where 0 stands for "very unpleasant" and 10 stands for "very pleasant".

Measure: Perceived pleasantness of the training

Time: post-test (immediately after the training)
8 Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression

Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health. The women's satisfaction degree in front of childbirth is an important factor associated with postnatal depression since women unsatisfied of their childbirth and/or women with a complicated childbirth are more encline to suffer from postnatal depression. It is likely that the actual context of Covid 19 pandemia and the change in obstetrical cares organization may have a negative impact on women's satisfaction about their childbirth and so a negative impact on the risk of postnatal depression.

NCT04368208
Conditions
  1. Postnatal Depression
Interventions
  1. Other: Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery
MeSH:Depression, Postpartum Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: proportion of women with an Edinburgh score higher than 12 between 4 and 6 weeks postpartum

Measure: Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia

Time: 4-6 weeks postpartum

Secondary Outcomes

Description: Existence of an association with postnatal depression and these factors: socio demographic women's characteristics, modalities of pregnancy management, satisfaction and experience about delivery, postnatal pelvic floor disorders, self rated health for the woman and the child, modalities of delivery, prenatal anxiety

Measure: Report factors associated with postnatal depression between 4 of 6 weeks during the covid 19 pandemia

Time: 4-6 weeks postpartum

Description: Scale from 0 to 10 of satisfaction ; answers to the WOMBLSQ4 questionnaire about childbirth experience and satisfaction

Measure: Describe the experience and the satisfaction about delivery during the covid 19 pandemia

Time: within the week after delivery
9 Prevalence Of Anxiety And Depression During COVID-19

1. To understand the prevalence of symptoms of Depression and Anxiety in general population during COVID-19 in India 2. To understand correlation between COVID-19 related factors and mental health symptomology in the general population in India Hypothesis: There is likelihood of significant symptoms of depression and anxiety among general population in India during the current COVID-19 outbreak. Procedure: The participants would be selected with their informed consent. The objective of the study would be clearly written on Page 1 of the survey. The test would be administered electronically by all the participants individually only when consented to the study. The data collected will be kept strictly confidential and the identity of the participants will not be disclosed at any point of the research Measures: 1. Demographic Information Demographic variables included Gender, Age, Place of Stay, Marital Status, Highest Level ofEducation, current living arrangement (e.g. staying alone or with family) and Occupation. It further includesregular employment status and current employment status(e.g, Work from home, temporary leave, termination etc) 2. History of illness (Present or past) History of physical ailment specified (diabetes, hypertension, heart ailment or being on any steroid or any other chronic ailment) Previous history of H1N1/ Influenza like illness 3. COVID-19 Information This section includes time spent focusing on COVID related information, current stressors with respect to COVID-19 and coping mechanisms used. This further includesinformation on resources available to participants near their place of stay and information of any known diagnosed case of COVID-19. 4. Standardized Scales to be used Generalized Anxiety Disorder Scale (GAD-7); Patient Health Questionnaire (PHQ-9) Powered by

NCT04369300
Conditions
  1. COVID-19
Interventions
  1. Behavioral: Registery Data Collection
MeSH:Depression

Primary Outcomes

Description: To understand the prevalence (magnitude) of depression and anxiety of general adult population during COVID-19 using Generalized Anxiety Disorder Scale (GAD-7)

Measure: Prevalence (magnitude) of anxiety of general adult population during COVID-19

Time: 1 YEAR

Description: To understand the prevalence (magnitude) of depression and anxiety of general adult population during COVID-19 using Patient Health Questionnaire (PHQ-9).

Measure: prevalence (magnitude) of depression and anxiety of general adult population during COVID 19

Time: 1 Year
10 Nursing Perspective on Burnout and Medical Errors in the Intensive Care Unit of an Exclusively Covid-19 Hospital: the Malaysian Experience

The investigators plan to perform an observational study to evaluate the prevalence of burnout, depression and medical errors in a designated exclusive Covid-19 patients hospital in Malaysia, during the Covid-19 pandemic. In addition, the relationship between burnout and depression with medical errors will be assessed. The population studied will be the nurses working in the Intensive Care Unit, who are at higher risk due to the nature of their work at the frontlines of the pandemic.

NCT04371302
Conditions
  1. Burnout, Professional
  2. Medical Errors
  3. Depression
Interventions
  1. Diagnostic Test: Questionnaire
MeSH:Burnout, Professional Depression Burnout, Psychological

Primary Outcomes

Description: Prevalence of burnout risk

Measure: Prevalence of burnout among ICU nurses during Covid-19

Time: 2 months

Description: Prevalence of depression risk

Measure: Prevalence of depression among ICU nurses during Covid-19

Time: 2 months

Description: Prevalence of self perceived medical errors

Measure: Prevalence of self-perceived medical errors among ICU nurses during Covid-19

Time: 2 months

Description: To find out if there exists a relationship between burnout, depression and medical errors

Measure: Association of burnout, depression and medical errors among anaesthesiology clinicians during Covid-19

Time: 2 months
11 Level and Predictors of Trauma-symptoms Among Health Workers and Public Service Providers During the COVID-19 Outbreak

The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also aims to investigate predictors of trauma-symptoms.

NCT04374097
Conditions
  1. Post Traumatic Stress Disorder
  2. Anxiety
  3. Depression
MeSH:Depression Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: PCL-5 is 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.

Measure: PTSD Checklist for DSM-5 (PCL-5)

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Secondary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27.

Measure: Patient Health Questionnaire 9 (PHQ-9)

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21.

Measure: The Generalized Anxiety Disorder 7 (GAD-7)

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway]

Description: Symptoms of health anxiety was measured with two items from the validated Health Anxiety Inventory (HAI), one item measuring specific fear of being infected by coronavirus, and an item measuring fear of dying by the coronavirus. All items used a Likert scale from 0-3, and the new total score of health anxiety had a range from 0-12.

Measure: Health anxiety

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway
12 Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population : PsyConfPop

Quarantine is an unpleasant experience : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. It may lead to negative mental health consequences and thus the emergence of anxiety and depressive symptoms. From March 17th, 2020 to May 11th 2002, the French government has implemented national containment measures due to the Covid-19 epidemic. Although there are data on the psychological impact and experience of quarantine measures in people who have been infected or suspected of being carriers of certain pathogens (e.g. Ebola), there are no data on such impact in the French population and quarantines lasting longer than 21 days. Investigators therefore propose to conduct a human and social sciences study in order to better understand the current situation

NCT04374643
Conditions
  1. Depression
  2. COVID 19
Interventions
  1. Other: Slef questionnaires fulfilment
MeSH:Depression

Primary Outcomes

Description: depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)

Measure: Depressive Symptomatology

Time: during confinement

Secondary Outcomes

Description: depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)

Measure: Depressive Symptomatology

Time: post-confinement : 15 days, 3 months, 6 months

Other Outcomes

Description: Psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)

Measure: Psychological pain

Time: during confinement

Description: quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)

Measure: sleep

Time: during confinement

Description: quality of sleep assessed with Insomnia Seveity Index (ISI Insomnia Severity Scale ; higher score, more insomnia -> min : 0 max : 28)

Measure: sleep

Time: post-confinement (15 days, 3 months, 6 months)

Description: anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)

Measure: anxiety

Time: during confinement

Description: anxiety intensity assessed by Generalized Anxieety Disorder (GAD 7 Generalized Anxiety Disorder higher score, more anxious -> min : 0 max : 21)

Measure: anxiety

Time: post-confinement (15 days, 3 months, 6 months)

Description: psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)

Measure: psychological pain

Time: post-confinement (15 days, 3 months, 6 months)

Description: psychological pain : likert scale (higher score, more psychological pain-> min : 0 max : 10)

Measure: physical pain

Time: during confinement

Description: psychological pain : likert scale higher score, more psychological pain-> min : 0 max : 10)

Measure: physical pain

Time: post-confinement (15 days, 3 months, 6 months)

Description: staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)

Measure: anger

Time: during confinement

Description: staxi state scale (STAXI ; State and Trait Anger Expression Inventory : higher score, more anger -> min : 0 max : 50)

Measure: anger

Time: post-confinement (15 days, 3 months, 6 months)

Description: Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45) )

Measure: Stressful Event Impact

Time: during confinement

Description: Assessed by the Stressful Event Impact Scale - Horowitz (HOROWITZ higher score, more traumatizes -> min : 0 max : 45)

Measure: Stressful Event Impact

Time: post-confinement (15 days, 3 months, 6 months)

Description: Number of patients declaring an increase of psychotropic drug use

Measure: Use of psychotropic drugs

Time: during confinement

Description: Number of patients declaring an increase of psychotropic drug use

Measure: Use of psychotropic drugs

Time: post-confinement (15 days, 3 months, 6 months)

Description: Number of patients declaring an increase of tobacco consumption

Measure: Tobacco consumption

Time: during confinement

Description: Number of patients declaring an increase of tobacco consumption

Measure: Tobacco consumption

Time: post-confinement (15 days, 3 months, 6 months)

Description: Number of patients declaring an increase of alcohol consumption

Measure: alcohol consumption

Time: post-confinement (15 days, 3 months, 6 months)

Description: Number of patients declaring an increase of alcohol consumption

Measure: alcohol consumption

Time: confinement

Description: Number of patients declaring an increase of illicit substances consumption

Measure: Illicit substances consumption

Time: confinement

Description: Number of patients declaring an increase of illicit substances consumption

Measure: Illicit substances consumption

Time: post-confinement (15 days, 3 months, 6 months)

Description: Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24

Measure: orientation of life

Time: confinement

Description: Life Orinetation Test Revised (LOT-R questionnaire): higher score, more optimistic --> min : 0 max : 24

Measure: orientation of life

Time: post-confinement (15 days, 3 months, 6 months)
13 Parenting in a Pandemic: Parental Stress During the COVID-19 and Its Association With Depression and Anxiety

This study seeks to investigate the levels of parental stress across different demographic subgroups in the general parental population during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also seeks to examine the predictors of parental stress rates related to these non-pharmacological interventions (NPI's). In addition, the research will investigate the association between parental stress associated and psychopathology symptoms (i.e., depression and generalized anxiety). The aim of the project is to: - Inform the policymakers, the general public, scientists, and health practitioners about the psychological associations of the COVID-19-related government-initiated measures on parental stress, with special focus on the school and kindergarten lockdowns. - Provide a foundation for policymakers and health-care professionals to employ interventions that protect families against possibly increased psychological stressors. - Help policymakers and healthcare professionals to better understand the association of demographic variables and other predictors on parental stress and parent-child dysfunction, which information necessary for evaluating the psychological impact of NPIs on parental stress and thus the framework under which decisions about school/kindergarten lockdowns are made.

NCT04377074
Conditions
  1. Parental Stress
  2. Depression
  3. Anxiety
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary Outcomes

Description: Three items from the Danish Parental Stress Scale (PSS) was selected, which intends to be a short measure of perceived stress resulting from being a parent (Pontoppidan et al., 2018). The scale consists of nine items measuring parental stress where each is measured on a five-point Likert scale (1-5), with the scores ranging from 3 to 15. Higher scores indicate higher parental stress. The following three were chosen in this large-scale investigation: 1) I feel overwhelmed by the responsibility of being a parent. 2) The major source of stress in my life is my child(ren), and 3) It is difficult to balance different responsibilities because of my child(ren) (Pontoppidan et al., 2018).

Measure: Measure of parental stress

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Higher scores indicate greater anxiety severity, and scores that are above the cutoff of 10 are considered to be in the clinical range (Spitzer et al., 2006). Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway
14 Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey

The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.

NCT04377412
Conditions
  1. Anxiety
  2. Depression
  3. Pregnancy Related
Interventions
  1. Other: Pandemic control measures
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary Outcomes

Description: Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points

Measure: Anxiety

Time: 4 months

Description: Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points

Measure: Depression

Time: 4 months
15 Efficacy of Therapist Guided e-Therapy Versus Self-Help Therapy on Psychological Distress Among Individuals in Oman During COVID-19 Pandemic: An Open-Label 12 - Weeks Randomized Controlled Trail

Background: COVID-19 (Corona Virus Disease 2019) is a virulent infectious disease with an incubation period ranging between 2-14 days. This highly contagious disease is caused by Sars-Cov-2 (Severe Acute Respiratory Syndrome Coronavirus 2). The number of people infected by COVID-19 has increased exponentially since January as a result of traveling and contact with COVID-19 infected individual. Initially, the seriousness of COVID-19 was not gauged properly until World Health Organization classified it as Pandemic type infectious disease and rapidly made plans actions to fight against it on 20 January, 2020. The uncertainty and low predictability of COVID-19 not only threaten people's physical health, but also affect people's mental health, especially in terms of emotions and cognition. As consequence of public emergency, with its economic health and social impacts, psychological repercussions among people are inevitable at the short and long term. Importance and justify the study: This study will assess the effectiveness of e therapy in treating anxiety and depression during a pandemic. This would be a novel way of providing therapy during crises Hypothesis: We hypothesize that compared to self-help email delivered therapy, the therapist guided e-Therapy is more efficacious in reducing the level of psychosocial stress among distressed individuals in Oman during COVID19. Objective: The aim of this study is to assess the efficacy of six weeks therapist guided e-Therapy versus Self-help e-mail delivered therapy on Psychological distress among random sample of individuals live in Oman during COVID 19 pandemic. This study will recruit 60 participants from a list respondents to public survey who reported high levels of depression and anxiety, and randomize them to either therapist guided e-psychotherapy(intervention) or (control) self-help arms. Participants in the intervention arm will receive six sessions of therapist guided e therapy as described in the study schedule. Participants in the control arm will receive self-help psychotherapy contents similar to the intervention arm as detailed in the study schedule. Throughout the study, outcome and safety assessments will be conducted.

NCT04378257
Conditions
  1. Depressive Symptoms
  2. Generalized Anxiety
Interventions
  1. Behavioral: Therapist Guided E-Therapy
  2. Behavioral: Self-Help Therapy
MeSH:Depression

Primary Outcomes

Description: Depressive symptoms will be measured with the Patient Health Questionnaire-9 (PHQ-9) instrument. The PHQ-9 is a nine item survey to assess depressive symptoms over the previous 2 weeks. The patient may answer "not at all" (scored as a 0) , "several days" (scored as a 1), "more than half the days" (scored as a 2), or "nearly every day" (scored as a 3) for each item. The range in total scores is from 0 (no depressive symptoms or best outcome) to 27 (severe depressive symptoms or worst outcome). The primary out come measure is to calculate the change in the mean scores of PHQ-9 from baseline to the end of the study between the intervention and the control.

Measure: Change in Depressive symptoms measured by Patient Health Questionnaire-9

Time: 6-12 weeks

Description: The Generalized Anxiety Disorder 7-item scale is a 7- item self-report measure of generalized anxiety. Participants rate the frequency with which they experience anxiety-related symptoms on a scale of 0 (Not at all) to 3 (Nearly every day). Total scores range from 0-21 with higher scores indicating greater anxiety symptoms. The second primary out come measure is to calculate the change in the mean scores of GAD-7 from baseline to the end of the study between the intervention and the control.

Measure: Change in Anxiety symptoms measured by Generalized Anxiety Disorder-7

Time: 6-12 WEEKS

Secondary Outcomes

Description: Proportion of subjects with Significant Depression (Defined as PHQ-9 total score ≥ 10 ) in each arm

Measure: Proportion of subjects with Significant Depression

Time: 6-12 weeks

Description: Proportion of subjects with Significant Anxiety (Defined as GAD-7 total score ≥ 10 ) in each arm

Measure: Proportion of subjects with Significant Anxiety

Time: 6-12 weeks
16 ''(COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women"

In our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease regressed are planned. (Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms 17-29 points = moderate depressive symptoms 30-63 points = severe depressive symptoms

NCT04384887
Conditions
  1. COVID
  2. Anxiety
  3. Depression, Postpartum
Interventions
  1. Behavioral: covid-19 positive pregnant women
MeSH:Depression, Postpartum Depression Anxiety Disorders

Primary Outcomes

Description: Evaluation of depression and anxiety score changes of covid-19 positive pregnants Pregnant women are questioned how this period was affected, as the pandemic period loaded with extra stress and caused depression and anxiety.

Measure: Evaluation of depression and anxiety score changes of covid-19 positive pregnants

Time: 4 months
17 Impact of COVID-19 Pandemic on Depression and Quality of Life: Cross Sectional Study on Turkish Society and Suggestions on Potential Solution

It is aimed to investigate the depression and quality of life of Turkish society caused by Covid-19 pandemic and reveal the relationship between them

NCT04394078
Conditions
  1. Depression
  2. Quality of Life
  3. Covid 19
  4. Social Isolation
Interventions
  1. Other: Online survey
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: Participants are asked to give information about: age, gender, educational status, height, weight, occupation, working status, city inhabited, whether they live alone or with someone, whether they have a chronic disease, have a pet, do physical activity, eat healthy and sufficient, have qualified sleep, whether they are supported economically.

Measure: Sociodemographic information form

Time: two months after Covid 19 recognised as pandemic

Description: Zung depression scale, developed by Zung (Zung, 1965), is patient rating depression scale, was used to asses four domains related to depression; somatic, mood disorders, psychomotor and psychological disorders. Each question is rated on a 4-point Likert scale (0- never, 1- sometimes, 2- frequently, 3- always). Scale contains 10 straight 10 reverse questions. The total score is calculated from the raw score obtained (total score = (raw score / 80) * 100). Accordingly, scores less than 50 are normal or no psychopathology; between 50 and 59 points indicates mild level, between 60 and 69 points indicate moderate level and 70 and above points indicate severe level depression (Thurber et al., 2002). The validity reliability of the scale was studied on Turkish society (Gencdogan & Nihal, 2011)

Measure: Zung Depression Scale

Time: two months after Covid 19 recognised as pandemic

Description: World Health Organization Quality of Life Bref is the short version of the WHOQOL-100 to assess the health-related quality of life (Harper et al., 1998), which has efficient psychometric properties, valid and reliable for Turkish society (Eser et al., 1999). It is essential for epidemiological survey and international report has built for psychometric properties for 26 country where Turkey within (Skevington et al., 2004). It has 4 domains; physical health, psychology, social relations and environment. Each question is answered on a 5-point Likert scale. The raw score is converted into a percentage system. The quality of life is interpreted as good as it gets closer to 100% (Akvardar et al., 2006).

Measure: World Health Organization Quality of Life - Bref

Time: two months after Covid 19 recognised as pandemic
18 Effect of Brief Cognitive Behavioral Therapy Versus Crisis Intervention Therapy Through Telepsychiatry in Medical Staff During the COVID-19 Pandemic: A Multicentric Randomized Controlled Trial

The purpose of this randomized controlled trial is to determine the effect of two behavioral interventions: brief cognitive-behavioral therapy and crisis intervention therapy through telepsychiatry, over the level of perceived stress, anxiety, depression and post-traumatic stress symptoms during the COVID-19 pandemic in medical residents and medical staff at three hospitals in two cities of Honduras.

NCT04394455
Conditions
  1. Anxiety
  2. Depressive Symptoms
  3. Post Traumatic Stress Symptoms
  4. Perceived Stress
Interventions
  1. Behavioral: Brief cognitive behavioral therapy
  2. Behavioral: Crisis intervention therapy
MeSH:Depression

Primary Outcomes

Description: Patient Health Questionnaire 9 scale (PHQ-9), a 9 item scale with a score range from 0 to 27. A higher score means a worse outcome.

Measure: Rate reduction in Depressive symptoms

Time: 6 months after psychotherapeutic intervention has started

Description: General Anxiety Disorder 7 Scale (GAD-7), a 7 item scale with a score range from 0 to 21. A higher score means a worse outcome.

Measure: Rate reduction in Anxiety symptoms

Time: 6 months after psychotherapeutic intervention has started

Description: Post-traumatic Stress Scale for DSM-5 (PCL-5), a 20 item scale with a score range from 0 to 80. A higher score means a worse outcome.

Measure: Rate reduction in Post traumatic Stress symptoms

Time: 6 months after psychotherapeutic intervention has started

Description: Perceived stress scale (PSS), a 10 item scale with a score range from 0 to 40. A higher score means a worse outcome.

Measure: Rate reduction in Perceived stress level

Time: 6 months after psychotherapeutic intervention has started
19 Psychological Impact of Quarantine During the COVID-19 Outbreak and Worsening of Cardiovascular Risk in the French General Population: a Prospective Cohort Study

In response to the COVID-19 outbreak, the French government put in place home quarantine of the general population in order to limit the transmission of the virus. It is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. Our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk.

NCT04397835
Conditions
  1. COVID-19
  2. Anxiety
  3. Depression
  4. Stress
MeSH:Depression

Primary Outcomes

Description: The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of: - introduction or increase of antihypertensive, lipid-lowering or hypoglycaemic drug treatment on the prescription

Measure: worsening of cardiovascular risk (treatments)

Time: at 1, 6 and 12 month

Description: The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of increased smoking consumption

Measure: worsening of cardiovascular risk (smoking consumption)

Time: at 1, 6 and 12 month

Description: The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of alteration of the food balance

Measure: worsening of cardiovascular risk (food balance)

Time: at 1, 6 and 12 month

Description: The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of weight gain

Measure: worsening of cardiovascular risk (weight gain)

Time: at 1, 6 and 12 month

Description: The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of: - reduction in the level of physical activity

Measure: worsening of cardiovascular risk (physical activity)

Time: at 1, 6 and 12 month

Secondary Outcomes

Description: " Generalized Anxiety Disorder " (GAD-7) : Spitzer, R. L., Kroenke, K., Williams, J. B. W. et Löwe, B. (2006). A brief measure for assessing generalized anxiety disorder: The GAD-7. Archives of Internal Medicine, 166(10), 1092-1097.

Measure: psychological impact of the quarantine on anxiety

Time: at 1, 6 and 12 month

Description: "Patient Health Questionnaire " (PHQ-9) : Kroenke, K., Spitzer, R. L. et Williams, J. B. W. (2001). The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med, 16(9), 606-613.

Measure: psychological impact of the quarantine on health

Time: at 1, 6 and 12 month

Description: " Impact of Event Scale - Revised " (IES-R) : Weiss, D. S. et Marmar, C. R. (1996). The Impact of Event Scale-Revised. Dans J. P. Wilson et T. M. Keane (dir.). Assessing psychological trauma and PTSD. New York : Guildford Press. Brunet, A., St-Hilaire, A., Jehel, L. et King, S. (2003). Validation of a French Version of the Impact of Event Scale-Revised.

Measure: psychological impact of the quarantine on stress

Time: at 1, 6 and 12 month
20 Hearing and Supporting the Healthcare Workers: Mental Health Outcomes in Healthcare Workers During COVID-19

An online survey will be sent to healthcare workers (HCWs) in acute care hospitals to explore a variety of risk factors for negative psychological outcomes and levels of anxiety, depression and post-traumatic stress symptoms using validated scales. It is important to understand the sources of negative psychological impact on HCWs during this COVID-19 pandemic before hospitals and organizations can address and develop support programs to mitigate the stresses experienced by healthcare workers. Addressing and supporting the needs of our HCWs will be paramount in this COVID-19 pandemic and future outbreaks.

NCT04397848
Conditions
  1. Mental Health Wellness 1
  2. PTSD
  3. Anxiety
  4. Stress
  5. Depression
  6. COVID-19
  7. Healthcare Workers
MeSH:Depression

Primary Outcomes

Description: Scale to evaluate Post-traumatic Stress Disorder symptoms

Measure: Impact of Event Scale - Revised (IES-R)

Time: Two weeks

Description: Scale to evaluate anxiety symptoms

Measure: General Anxiety Disorder (GAD-7)

Time: Two weeks

Description: Scale to evaluate depressive symptoms

Measure: Patient Health Questionnaire (PHQ-9)

Time: Two weeks

Secondary Outcomes

Description: Qualitative data will be coded and analyzed to show emerging themes.

Measure: Qualitative Data

Time: Two weeks
21 Tools for Wellbeing COVID-19 National Study of Undergraduate Students

The study evaluates the effectiveness of yoga practices on reducing stress, negative emotion, anxiety, and depression and on increasing positive emotion, wellbeing and resilience. The study uses randomized wait-list control. All U.S. undergraduate students in 4-year universities and colleges age 18 or older are eligible to participate.

NCT04414371
Conditions
  1. Stress
  2. Anxiety
  3. Depression
  4. Resilience
  5. Wellbeing
  6. Mood
Interventions
  1. Other: Yoga
MeSH:Depression

Primary Outcomes

Description: 10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress

Measure: Stress

Time: Change from baseline stress at 1-Month

Description: 10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress

Measure: Stress

Time: Change from baseline stress at 2-Month

Description: 10-item Perceived Stress Scale (PSS), score 0-40, higher the score, higher stress

Measure: Stress

Time: Change from baseline stress in 3-Month

Description: 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

Measure: Wellbeing

Time: Change from baseline wellbeing in 2-week

Description: 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

Measure: Wellbeing

Time: Change from baseline wellbeing in 4-week

Description: 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

Measure: Wellbeing

Time: Change from baseline wellbeing in 6-week

Description: 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

Measure: Wellbeing

Time: Change from baseline wellbeing in 8-week

Description: 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

Measure: Wellbeing

Time: Change from baseline wellbeing in 10-week

Description: 14-item Warwick-Edinburgh Wellbeing Scale (WEMWBS), score14-70, higher score higher wellbeing

Measure: Wellbeing

Time: Change from baseline wellbeing in 12-week

Secondary Outcomes

Description: 2-item PHQ-4, score 2-8, higher score higher anxiety

Measure: Anxiety

Time: Change from baseline anxiety in 2-week

Description: 2-item PHQ-4, score 2-8, higher score higher anxiety

Measure: Anxiety

Time: Change from baseline anxiety in 4-week

Description: 2-item PHQ-4, score 2-8, higher score higher anxiety

Measure: Anxiety

Time: Change from baseline anxiety in 6-week

Description: 2-item PHQ-4, score 2-8, higher score higher anxiety

Measure: Anxiety

Time: Change from baseline anxiety in 8-week

Description: 2-item PHQ-4, score 2-8, higher score higher anxiety

Measure: Anxiety

Time: Change from baseline anxiety in 10-week

Description: 2-item PHQ-4, score 2-8, higher score higher anxiety

Measure: Anxiety

Time: Change from baseline anxiety in 12-week

Description: 2-item PHQ-4, score 2-8, higher score higher depression

Measure: Depression

Time: Change from baseline depression in 2-week

Description: 2-item PHQ-4, score 2-8, higher score higher depression

Measure: Depression

Time: Change from baseline depression in 4-week

Description: 2-item PHQ-4, score 2-8, higher score higher depression

Measure: Depression

Time: Change from baseline depression in 6-week

Description: 2-item PHQ-4, score 2-8, higher score higher depression

Measure: Depression

Time: Change from baseline depression in 8-week

Description: 2-item PHQ-4, score 2-8, higher score higher depression

Measure: Depression

Time: Change from baseline depression in 10-week

Description: 2-item PHQ-4, score 2-8, higher score higher depression

Measure: Depression

Time: Change from baseline depression in 12-week

Description: 6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience

Measure: Resilience

Time: Change from baseline resilience in 1-month

Description: 6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience

Measure: Resilience

Time: Change from baseline resilience in 2-month

Description: 6-item Brief Resilience Scale (BRS), score 6-30, higher score higher resilience

Measure: Resilience

Time: Change from baseline resilience in 3-month

Description: 10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect

Measure: Positive Affect

Time: Change from baseline positive affect in 2-week

Description: 10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect

Measure: Positive Affect

Time: Change from baseline positive affect in 4-week

Description: 10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect

Measure: Positive Affect

Time: Change from baseline positive affect in 6-week

Description: 10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect

Measure: Positive Affect

Time: Change from baseline positive affect in 8-week

Description: 10-item Positive Affect Scale, score - 10 to 50, higher score more positive affect

Measure: Positive Affect

Time: Change from baseline positive affect in 10-week

Description: 10-item Positive Affect Scale, score - 10 to 50, higher score higher positive affect

Measure: Positive Affect

Time: Change from baseline positive affect in 12-week

Description: 10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect

Measure: Negative Affect

Time: Change from baseline negative affect in 2-week

Description: 10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect

Measure: Negative Affect

Time: Change from baseline negative affect in 4-week

Description: 10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect

Measure: Negative Affect

Time: Change from baseline negative affect in 6-week

Description: 10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect

Measure: Negative Affect

Time: Change from baseline negative affect in 8-week

Description: 10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect

Measure: Negative Affect

Time: Change from baseline negative affect in 10-week

Description: 10-item Negative Affect Scale, score - 10 to 50, higher score higher negative affect

Measure: Negative Affect

Time: Change from baseline negative affect in 12-week
22 dePression, Anxiety, aNd acaDemic pErforMance In Covid-19: PANDEMIC Study.

This study aims to identify the preference of the class modalities (classroom or online) in undergraduate and graduate students. Additionally, to explore if the presence of any mental state alterations such as depression or anxiety due to the COVID-19 pandemic can alter their perception of academic performance.

NCT04420416
Conditions
  1. Depression, Anxiety
Interventions
  1. Other: Survey
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary Outcomes

Description: This scale will explore the effort and confidence of the participants. The minimum score for each facet is 10, and the maximum score is 70.

Measure: Academic Self-Concept Scale Score

Time: up to 3 months

Description: This inventory will be used to identify the presence and intensity of depressive disorders. The minimum score is 0, and the maximum score is 27.

Measure: PHQ-9 Score

Time: up to 3 months

Description: This questionnaire will be used to evaluate the presence and intensity of anxiety disorders. The minimum score is 0, and the maximum score is 21.

Measure: GAD-7 Score

Time: up to 3 months

Description: Students' preference of classroom or online classes.

Measure: Preference of teaching method

Time: up to 3 months

Description: Students' perception of changes in their academic performance: got better, worse, or stayed the same.

Measure: Self perceived academic performance

Time: up to 3 months

Description: Students' perception of changes in their grades: got better, worse, or stayed the same.

Measure: Academic grades changes

Time: up to 3 months
23 CoronaCope - Internet-based Cognitive Behavioural Therapy for Adults Suffering From Mental Health Problems Related to the Coronavirus Pandemic

The study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme a on adult mental health problems related to the current coronavirus pandemic. ICBT will be compared to a wait-list control group. Participants will be recruited in Sweden with a nationwide recruitment.

NCT04424212
Conditions
  1. Depression and Quality of Life Related to the Coronavirus Pandemic
Interventions
  1. Behavioral: Intervention group CoronaCope
MeSH:Coronaviru Coronavirus Infections Depression

Primary Outcomes

Description: Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item). Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 13-19, 20-28, and 29-63 points.

Measure: Becks Depression Inventory-II

Time: Change between baseline and end of treatment after seven weeks.

Description: Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.

Measure: Brunnsviken Brief Quality of Life Scale

Time: Change between baseline and end of treatment after seven weeks.

Secondary Outcomes

Description: Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.

Measure: Patient Health Questionnaire

Time: Change between baseline and end of treatment after seven weeks.

Description: The Alcohol Use Disorders Identification Test is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. 10 items and scores ranging from 0-40.

Measure: Alcohol Use Disorder Identification Test

Time: Change between baseline and end of treatment after seven weeks.

Description: Measure of insomnia severity and symptoms of disordered sleep. The total score can range between 0 (no sleep problems) to 28 (severe sleep problems and insomnia). Norm score ranges include low likelihood of sleep problems (0 to 7 points), some sleep problems (8 to 14 points), moderate sleep problems (15 to 21 points), severe sleep problems (22 to 28 points).

Measure: Insomnia Severity Index

Time: Change between baseline and end of treatment after seven weeks.

Description: Screening for health impact and exposure of the coronavirus pandemic.

Measure: The CoRonavIruS Health Impact Survey

Time: At baseline

Description: Assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The Impact of Event Scale-Revised yields a total score (ranging from 0 to 88).

Measure: Impact of Event Scale-Revised

Time: Change between baseline and end of treatment after seven weeks.

Description: It is a measure of the degree to which situations in one's life are appraised as stressful. It contains 10 items that are scored on a range between 0 (never) to 4 (very often).

Measure: Perceived Stress Scale

Time: Change between baseline and end of treatment after seven weeks.

Description: Same as during the treatment phase.

Measure: Becks Depression Inventory-II

Time: Change between posttreatment and 12-month follow-up.

Description: Same as during the treatment phase.

Measure: Brunnsviken Brief Quality of Life Scale

Time: Change between posttreatment and 12-month follow-up.
24 A Novel and Practical Accelerated Low-frequency Right-sided Stimulation Protocol as a Substitute for Patients With Bipolar Depression Needing Electroconvulsive Therapy During the COVID-19 Pandemic

The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.

NCT04427137
Conditions
  1. Bipolar Depression
Interventions
  1. Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil
MeSH:Depression Depressive Disorder Bipolar Disorder
HPO:Bipolar affective disorder Depressivity Mania

Primary Outcomes

Description: Less than or equal to 10 This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Secondary Outcomes

Description: changes in scores This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: 50% Reduction in score This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: changes in scores This scale is used to quantify the severity of symptoms of mania Scale range: 0-60 (total score) Lower scores indicate lower severity of manic symptoms (i.e., better outcome) Higher scores indicate higher severity of manic symptoms (i.e., worse outcome)

Measure: Change in Young Mania Rating Scale (YMRS)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: Less than or equal to 4 This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Remission on Patient Health Questionnaire (PHQ-9)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: 50% Reduction in score This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Response on Patient Health Questionnaire (PHQ-9)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: changes in scores This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Change in Patient Health Questionnaire (PHQ-9)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: Less than or equal to 4 This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)

Measure: Remission on General Anxiety Disorder 7 item (GAD-7)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: 50% Reduction in score This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)

Measure: Response on General Anxiety Disorder 7 item (GAD-7)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: changes in scores This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)

Measure: Change in General Anxiety Disorder 7 item (GAD-7)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: Less than or equal to 12 This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Remission on Beck Depression Inventory (BDI-II)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: 50% Reduction in Score This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Response on Beck Depression Inventory (BDI-II)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: changes in scores This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Change on Beck Depression Inventory (BDI-II)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: Score of 0 This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)

Measure: Remission on Beck Scale for Suicidal Ideation (SSI)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: changes in scores This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)

Measure: Change on Beck Scale for Suicidal Ideation (SSI)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: changes in scores

Measure: Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

Description: Includes number of treatment days needed and number going on to receive ECT

Measure: Proportion of Patients Maintaining Response During Relapse Prevention

Time: 24 weeks (Tapering and Relapse prevention phase)
25 Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients

To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period.

NCT04430049
Conditions
  1. Covid-19
  2. Family Members
  3. Critical Illness
Interventions
  1. Procedure: Covid ICU containment measures
MeSH:Critical Illness Depression

Primary Outcomes

Description: Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed 3 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms.

Measure: Anxiety

Time: at 3 months

Description: Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed 3 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms.

Measure: Depression

Time: at 3 months

Secondary Outcomes

Description: Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed 3 months after the ICU discharge of patient. IES-R ranges from 0 to 88; higher scores indicate worse symptoms

Measure: post-traumatic stress disorder

Time: at 3 months
26 Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia

The aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables

NCT04437342
Conditions
  1. Postpartum Depression
  2. Psychological Stress
  3. Maternal Distress
Interventions
  1. Other: PHQ-9 (Patient Health Questionnaire) Depression Scale
  2. Other: GAD-7 (General Anxiety Disorder) scale
  3. Other: 38 questions questionnaire
  4. Other: EPDS (Edinburgh Postnatal Depression Scale)
MeSH:Depression, Postpartum Depression Depressive Disorder Stress, Psychological
HPO:Depressivity

Primary Outcomes

Description: Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)

Measure: Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)

Time: 40 days postpartum

Secondary Outcomes

Description: Association between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)

Measure: Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)

Time: 10 minutes postpartum

Description: Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)

Measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain

Time: 2 minutes prior to discharge from the Postanaesthesia care unit

Description: Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)

Measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain

Time: 2 minutes after admission to the Postanaesthesia care unit
27 Predictors and Mechanisms of Depression and Anxiety During the COVID-19 Pandemic

Study description: The present study seeks to investigate the predictors and maintaining mechanisms of depression and anxiety symptoms during the COVID-19 pandemic, exactly 3 months following the strictest viral mitigation strategies initiated in Norway in response to the pandemic. This is the time period where the major pandemic protocols are lifted in Norway, following three months of strict pandemic mitigation protocols. The study further aims to identify subgroups with highest levels of depressive and anxiety symptoms during the measurement period, to identify vulnerable subgroups with maintained symptoms three months following the pandemic. Hypotheses and research questions: Research Question 1: What is the level of depressive and anxiety symptoms three months following the employment of the strict viral mitigation protocols (i.e., physical distancing protocols) in the general adult population? What are the proportion above the validated cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the strictest mitigation protocols to measurement the measurement period three months into pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will be a significant decrease in the proportion of the sample meeting validated cut-offs for depression and anxiety from T1 to T2. Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions, negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be related to less reduction in depression and anxiety, above and beyond age, gender, and education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived competence will be related to greater reduction in depression and anxiety, above and beyond, age, gender, and education. Exploratory: The investigators will further explore the proportion showing reliable change in depression and anxiety and investigate the differences in changes in depression and anxiety across different demographic subgroups in the sample

NCT04442204
Conditions
  1. Depression
  2. Anxiety
Interventions
  1. Other: Prospective study across two time-points examining the impact of viral mitigation protocols on mental health
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary Outcomes

Description: • The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9

Time: Data is set to be collected starting from 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.

Description: • The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: Data is set to be collected starting from 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.
28 Difficulties in Emotion-regulation and Interpersonal Problems, and Their Association With Anxiety and Depression During and After the COVID-19 Pandemic

Central indicators of psychological functioning such as difficulties in emotion regulation and habitual problems in one's relating to others are likely to have been substantially impacted by the COVID-19 amelioration measures of societal lock-down and physical (ne social) distancing. In turn, as these amelioration measures have been relaxed, that impact will presumably be reduced, gradually returning these factors to pre-crisis levels. Also, these factors are likely to predict mental health outcomes such as symptoms of depression and anxiety throughout the pandemic and beyond, so that levels of emotion regulation difficulties and interpersonal problems early on will predict later symptom status. Similarly reductions in such difficulties during the various phases of the outbreak will be associated with a concurrent reduction in psychological symptoms and reduced symptom levels at later stages.

NCT04442282
Conditions
  1. Anxiety
  2. Depression
  3. Interpersonal Problem
  4. Emotion Regulation
MeSH:Depression

Primary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9 (PHQ-9)

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019). The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: The Generalized Anxiety Disorder - 7

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Description: 6 items from DERS (Gratz & Roemer, 2004)

Measure: Difficulties in Emotion Regulation Scale

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Description: 17 Items from IIP-64 (Horowitz et al. 2000)

Measure: Interpersonal problems

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
29 Parental Stress After the Covid-19 Pandemic: Predictors and Outcome

The aim of this study is to investigate the levels of parental stress 3 months after (T2) the strict physical distancing government initiated physical distancing protocols related to the COVID-19 pandemic (T1). The study also aims to investigate how predictors measured during the COVID-19 pandemic are associated with parental stress 3 months after when the majority of the protocols are lifted.

NCT04442308
Conditions
  1. Parenting
  2. Anxiety
  3. Depression
  4. Anger
MeSH:Depression

Primary Outcomes

Description: The Danish Parental Stress Scale is developed as a short measure of parental stress consisting of nine items. Three items from this scale were chosen by a panel of clinical experts, with the aim of avoiding topological overlap: 1) I feel overwhelmed by the responsibility of being a parent, 2) The major source of stress in my life is my child(ren), and 3) It is difficult to balance different responsibilities because of my child(ren).

Measure: Parental stress

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
30 Status and Predictors of Mental Health Symptoms Among Migrants and Refugees During the COVID-19 Pandemic

Migrants and refugees are vulnerable subgroups in general with regards to symptoms of psychopathology. Furthermore, recent calls for paper urge investigation on current mental health status of migrants and refugees during the pandemic, as different barriers such as lack of emotional support from relatives, in addition to language barriers potentially impairing comprehension about the pandemic having the chance to increase symptoms of psychopathology such as anxiety and depression. This study seeks to investigate the levels of mental health symptoms (i.e., depression, general anxiety, and health anxiety) among immigrants and refugees in Norway during the COVID-19 pandemic. Demographic factors will be investigated to identify subgroups with increased risk of meeting clinically significant depression and anxiety symptoms, as established by validated cut-offs to be elaborated below. Furthermore, transdiagnostic predictors which may prove as useful intervention targets will be investigated.

NCT04443764
Conditions
  1. Migrants
  2. Anxiety
  3. Depression
MeSH:Depression

Primary Outcomes

Description: • The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area.

Measure: Patient Health Questionnaire 9

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

Measure: Generalized Anxiety Disorder 7

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Description: • Symptoms of health anxiety will be measured measured with two items from the validated Health Anxiety Inventory (HAI; Salkovskis et al., 2002), one item measuring specific fear of being infected by coronavirus, and an item measuring fear of dying by the coronavirus on a four-point Likert scale (0-3).

Measure: Health Anxiety Symptoms

Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire
31 Effect of COvid-19 on Mental Health in Syrian and Turkish Maintenance HemoDialysis Patients: COST-HD Study

SARS-COV infection first has begun at Wuhan, China, and then became a pandemic. The first COVID-19 case has been reported on March 11, 2020, in Turkey. People older than 65 years old have been locked down on March 21 and people younger than 20 years old locked down at April 03. A total lockdown has been done a few times lasting for 3 or 4 days, especially at weekends. Renal replacement modalities have been affected in different ways during the pandemic. Patients with kidney transplantation and patients performing home hemodialysis or peritoneal dialysis have been advised to perform self-isolation at homes. However, center hemodialysis patients continued to come dialysis centers obligatorily. Syrian civil war has been continuing since 2011, and Turkey has accepted millions of Syrian people in a position called temporary protection. There are many Syrian center hemodialysis patients both in Turkey and in our unit. The investigators do not know if pandemic affected Syrian patients different than Turkish ones. The aim of this study is to compare beck depression scores of Turkish and Syrian patients undergoing hemodialysis during the COVID-19 pandemic.

NCT04444557
Conditions
  1. Depression
  2. Hemodialysis
Interventions
  1. Other: Beck Depression Inventory (BDI)
MeSH:Depression

Primary Outcomes

Description: Total score of Beck Depression Inventory (Minimin score: 0, Maximum score: 63; higher scores mean worse outcome)

Measure: Score of Beck Depression Inventory

Time: through study completion, an average of 6 months
32 Centrality in the Cross-sectional Network of Depressive Symptom and Metacognitive Variables During COVID-19: Do Central Variables Predict Overall Symptom Reduction From Periods of Strict to Lifted Social Distancing Protocols?

The aim of the study is to identify symptom-level intervention targets for depression related to the COVID-19 outbreak. First, we will assess centrality indices of the network of depression symptoms plus mechanism variables derived from the metacognitive model of psychopathology measured at a period of strict social distancing protocols (T1). Then, we will examine whether change in the most central symptom and metacognitive variables are more related to overall symptom reduction from the period of strict (T1) to a period of lifted social distancing protocols (T2) three months later. On the basis of the results, interventions can be suggested that protect the general public against increased psychological suffering and dysfunction during society's handling of pandemics.

NCT04444713
Conditions
  1. Depressive Symptoms
  2. Metacognitive Variables
MeSH:Depression

Primary Outcomes

Description: The Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) consists of nine items covering the DSM-IV criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. The PHQ-9 has revealed good psychometric properties, as demonstrated by Kroenke, Spitzer, and Williams (2001).

Measure: Patient Health Questionnaire-9 (PHQ-9)

Time: From 22nd of June to 13th of July

Description: The Cognitive Attentional Syndrome-1 (CAS-1; Wells, 2009) measures maladaptive mental and behavioral coping with thoughts and feelings (8 items, 0-8 scales) and negative and positive metacognitions (8 items, 0-100 scales). The CAS-1 has proved to have satisfactory psychometric properties (Nordahl & Wells, 2019).

Measure: Cognitive-Attentional Syndrome-1 (CAS-1)

Time: From 22nd of June to 13th of July
33 Effectiveness of a Self-applied Positive Psychology Online Intervention Program "Mental Health COVID-19" in Mexican Population: A Randomized Controlled Trial.

This study evaluates the effectiveness of a Positive Psychology intervention, that is focused on increasing the positive emotions and strengths of human beings. It is compared to the effectiveness of an online treatment with the change of the same participants before and after receiving the treatment accompanied by a chat support service vs. the treatment solely. The changes are being assessed through worldwide validated measures such as psychometrics.

NCT04468893
Conditions
  1. Anxiety
  2. Depression
  3. Sleep Disturbance
Interventions
  1. Behavioral: Online Intervention Mental Health COVID-19
MeSH:Dyssomnias Parasomnias Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: The State/Trait Anxiety Inventory consists of two subscales of 20 items each that measure anxiety as a transient state of tension (Scale A-State), and as a characteristic of the personality relatively stable over time (Scale B -trait). The items are composed by an assertion to which the subject responds indicating their degree of identification. In the case of state anxiety, the scale goes from 1 (not at all), 2 (somewhat), 3 (moderately), 4 (very much), while in the trait anxiety it ranges from 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). In both, a percentage of the items evaluate well-being or absence of anxiety, while the rest of the items to the presence of anxiety. Scores range from 20 to 80, in each subscale, with higher scores correlating with greater anxiety. It is expected a statistically significant decrease (P < 0.05) in the anxiety symptoms.

Measure: Decrease in the score of Anxiety symptoms

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: The Beck Depression Inventory is a self-report that provides a measure of the presence and severity of depression. Contains 21 items indicative of symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, suicidal thoughts or desires, pessimism, etc. Each item is answered on a 4-point scale, from 0 to 3, where each number is identified differently for each item, in all of them 0 means absence and 3 full presence (e.g. sadness), except for items 16 (changes in the sleep pattern) and 18 (changes in appetite) that contain 7 categories. The minimum and maximum scores in the test are 0 and 63. Cut-off points ha that allow classifying those evaluated in one of the following four groups: 0-13, minimum depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. It is expected a statistically significant decrease (P < 0.05) in the depression symptoms.

Measure: Change in the symptoms of depression

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 represent mild, moderate, and severe anxiety symptom levels, respectively. It is expected a statistically significant decrease (P < 0.05) in the General Anxiety symptoms.

Measure: Change in the symptoms of General Anxiety Disorder

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: The Scale of Post-traumatic Stress Traits in the Mexican Youth Exposed to Social Violence It is a brief scale with 24 symptoms corresponding to the diagnosis of PTSD, to respond by self-report, and a scale was used discretely from 1 (strongly disagree) to 4 (strongly agree). The total score was obtained by arithmetic sum. The minimum possible is 24 and the maximum 96. It is expected a statistically significant decrease (P < 0.05) in the posttraumatic stress symptoms.

Measure: Change in the score of Posttraumatic stress symptoms

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: It is composed of seven items with options of 0 = nothing, 3 = a lot, and measures the fear in its emotional component, that is, the fear to adversities in the context and the feelings it disseminates, as well as others economic and social fears, in this case, adapted for the Sars-Cov2 pandemic. In previous studies, an acceptable internal consistency of .95 was reached. It consists of several items about the fear of being a SARS Cov2 victim in diverse contexts. In the present study, a Cronbach alpha coefficient of 0.96 was obtained. It is expected a statistically significant decrease (P < 0.05) in the widespread fear symptoms.

Measure: Changes in the Widespread fear Scale

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Description: This instrument assesses the quality patterns of sleep. It differentiates the "poor" and "good" sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is "5" that indicates a "poor" sleep quality. It is expected a statistically significant increase (P < 0.05) in the Sleep Quality Index.

Measure: Change in the score of The Pittsburgh Sleep Quality Index.

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]

Secondary Outcomes

Description: This scale aims to assess the frequency of attitudes, behaviors and plans to commit suicide. It is divided into 19 items with a response option of 0 to 2, giving a total of 0 to 38 where a score equal to or greater than 10 indicates an existing risk of suicide. This scale has been validated in the Mexican population (González-Macip & Díaz-Martínez, 2000).

Measure: Change on the Suicidal Thoughts Scale

Time: [Time Frame: 2 weeks to one month, depending on the development of the patient and the completion of the 15 modules.]
34 Stay Well at Home: A Text-messaging Study to Improve Mood and Help Cope With Social Distancing

The investigators have developed supportive text-messages in English and Spanish to help people cope with the stress and anxiety of COVID-19 social distancing. The purpose of this study is to examine if automated text-messages will improve depression and anxiety symptoms and enhance positive mood. Additionally, the investigators will compare the effectiveness of sending messages on a random schedule (using a micro-randomized trial design) or sent by a reinforcement learning policy on overall change in depression and anxiety symptoms and daily mood during the 8-week study.

NCT04473599
Conditions
  1. Depressive Symptoms
  2. Anxiety
  3. COVID-19
Interventions
  1. Behavioral: Uniform random message delivery
  2. Behavioral: Reinforcement learning message delivery
MeSH:Depression

Primary Outcomes

Description: Patient Health Questionnaire 9 item (PHQ-9). The PHQ-9 has scores from 0 to 27. Higher scores mean a worse outcome.

Measure: Depression scores

Time: Change from baseline to 8 week follow-up

Description: General Anxiety Disorder 7 item (GAD-7). The GAD-7 has scores from 0 to 21. Higher scores mean a worse outcome.

Measure: Anxiety scores

Time: Change from baseline to 8 week follow-up

Secondary Outcomes

Description: The self-reported mood rating 3 hours after receiving a message. The score is from 0-9. A higher mood rating indicates a better outcome.

Measure: Self reported mood ratings

Time: 8 weeks
35 Online Delivery of Psychotherapy, Tailored to Patients' Suffering From Mental Health Problems Due to COVID-19

The recent COVID-19 pandemic has affected many aspects of individuals social life and its negative consequences on Canadian public health go far beyond the direct overload of the hospital care system. Self-isolation and financial uncertainty can significantly deteriorate individuals' mental health, which is only going to aggravate with prolonged physical distancing strategies. Adding to this is the personal and public trauma of lost lives and soon there will be an unprecedented epidemic of mental health problems with crushing effects on the public health sector and economy. To meet this huge new demand for an already strained health system, there is a need for innovative new approaches that significantly expand the capacity of care delivery. While it may not be possible in the short term to increase the number of mental healthcare providers or the number of hours they work, improving their time spent efficiently might be the solution. Virtual care and online delivery of psychotherapy, shown to be clinically effective, efficient and cost-effective, might be the perfect solution to address the high demand faced now. The investigators aim to establish the first academic online psychotherapy clinic to manage mental health problems secondary to COVID-19. The goal is to evaluate the feasibility and efficacy of treating COVID-19 related mental health issues in this clinic, offering a 10-week, diagnosis-specific, online psychotherapy program. The investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based digital mental health platform, developed by the PI, Dr. Alavi. Potentially, this method of care delivery could increase care capacity by four-folds. The findings from this project have the potential to influence clinical practice and policy and increase accessibility to care during COVID-19 pandemic, without sacrificing the quality of care.

NCT04476667
Conditions
  1. Mental Health Issue
  2. Covid19
  3. Anxiety Disorders
  4. Depression
Interventions
  1. Behavioral: e-Psychotherapy
MeSH:Depression Anxiety Disorders

Primary Outcomes

Description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) - Scale: 0-3 (0 = never, 3 = frequently)

Measure: Change in Stress

Time: Baseline, week 6, week 12

Description: 14 Item Resilience Scale (RS-14) - Scale: 1-7 (1 = strongly disagree, 7 = strongly agree)

Measure: Change in Resilience

Time: Baseline, week 6, week 12

Description: The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Scale: 1-5 (1 = very poor, 5 = very good)

Measure: Change in Quality of Life Assessment

Time: Baseline, week 6, week 12

Description: Generalized Anxiety Disorder 7 (GAD-7) - Scale: 0-3 (0 = not at all, 3 = nearly every day)

Measure: Change in Symptom Severity - 1

Time: Baseline, week 6, week 12

Description: Montgomery-Asberg Depression Rating Scale (MADRS) - Scale: 0-6 (0 = not at all, 6 = frequent/very much)

Measure: Change in Symptom Severity - 2

Time: Baseline, week 6, week 12

Description: Patient Health Questionnaire 9 (PHQ-9) - Scale: 0-3 (0 = not at all, 3 = nearly every day)

Measure: Change in Symptom Severity - 3

Time: Baseline, week 6, week 12

Secondary Outcomes

Description: Healthcare providers who administered the e-psychotherapy for duration of project will be asked through focus groups questions surrounding the feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with respect to time commitment, feelings of 'connectedness' to participant, and any perceived benefits/drawbacks to e-psychotherapy.

Measure: Qualitative Information: Healthcare Providers

Time: Week 12

Description: In focus groups, participants will be asked questions regarding personal, social, and cultural factors (gender, sexuality, background, supportive resources, structural/social barriers, etc.) that could impact participant experience with e-psychotherapy. This will be extracted using an Interpretive Phenomenological Analysis (IPA) approach.

Measure: Qualitative Information: Personal, social, and cultural factors

Time: Week 12
36 Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic

Postpartum depression (PPD) represent around 15% of birth in developed countries. The context of the COVID-19 epidemy represents a possible source of additional emotional distress. The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.

NCT04487171
Conditions
  1. Postpartum Depression
  2. Covid19
  3. Prevalence
  4. Social Distance
Interventions
  1. Other: Questionnaire
MeSH:Depression, Postpartum Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: Variation of prevalence of clinically-significant post-partum depressive symptoms

Measure: Variation of prevalence of clinically-significant post-partum depressive symptoms

Time: up to 35 days after delivery
37 Mitigating Suicide Risk During the COVID-19 Pandemic Via Telehealth Using an Intensive Single Session of "Brief Skills for Safer Living"

Mental health concerns have been on the rise since the onset of the COVID-19 pandemic. The pandemic has worsened risk factors for suicide, including job loss, anxiety, depression, and loneliness. Timely and easy access to mental health services is a dire need, and this study will test the efficacy and feasibility of a brief clinical intervention, Brief Skills for Safer Living (Brief-SfSL), at reducing suicide risk. The goal of this study is to investigate whether Brief-SfSL, delivered online, is a suitable, acceptable and effective method for reducing suicide risk and providing timely mental health services. The results from this study will provide vital insight into effective interventions for suicide risk that are accessible and can be widely distributed.

NCT04495543
Conditions
  1. Suicidal Ideation
  2. Suicide
  3. Mental Health Issue
  4. Depression
Interventions
  1. Behavioral: Brief Skills for Safer Living
MeSH:Depression Suicide Suicidal Ideation

Primary Outcomes

Description: Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.

Measure: Change in suicidal ideation using Beck Scale for Suicide Ideation

Time: From baseline to 3 months; also administered at screening, 1 week and 1 month

Secondary Outcomes

Description: The QIDS-SR is a 16-item validated self-report depression scale. Total scores range from 0 (none) to 27 (very severe).

Measure: Change in depression symptoms using the Quick Inventory of Depressive Symptoms self-report scale (QIDS-SR)

Time: From baseline to 3 months; also administered at 1 week and 1 month

Description: The GAD-7 is a brief 7-item self-report scale measuring anxiety symptoms. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety.

Measure: Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)

Time: From baseline to 3 months; also administered at 1 week and 1 month

Description: The ACSS is a 20-item self-report instrument to assess the construct of acquired capability. Total scores range from 0 to 80, with higher scores reflecting greater acquired capability.

Measure: Change in Acquired Capability of Suicide Scale (ACSS)

Time: From baseline to 3 months; also administered at 1 week and 1 month

Description: The Interpersonal Needs Questionnaire is a 15-item self-report scale assessing connectedness to others and burdensomeness. Items are rated 1 to 7, with total scores ranging from 15 to 105. Higher scores reflect worse outcomes.

Measure: Change in Interpersonal Needs Questionnaire score

Time: From baseline to 3 months; also administered at 1 week and 1 month

Description: The DARS is a 26-item self-report scale measuring anhedonia across four domains. Items are scored on a 5-point Likert scale with lower total scores reflecting more severe anhedonia.

Measure: Change in Dimensional Anhedonia Rating Scale (DARS) score

Time: From baseline to 3 months; also administered at 1 week and 1 month

Description: The SDS is a brief 3-item self-report scale that probes work/school, social, and family/home functioning. Each item is scored from 0 to 10. Total scores range from 0 (unimpaired) to 30 (highly impaired).

Measure: Change in Sheehan Disability Scale (SDS) score

Time: From baseline to 3 months; also administered at 1 month

Description: Use of healthcare services will be assessed through four questions enquiring about the frequency and description of health care professional visits, use of mental health services, hospital admissions, and emergency room visits in the preceding specified time frame (1-3 months).

Measure: Change in Treatment Utilization

Time: From screening to 3 months; also administered at 1 month

Other Outcomes

Description: Feasibility and Acceptability survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the Brief-SfSL intervention.

Measure: Participant feedback on their experiences with specific aspects of the Brief-SfSL intervention

Time: 3 months
38 Mental Health Impact of the COVID-19 Pandemic Among Immigrants in Santiago, Chile (STRING-COVID)

Evidence suggests that social isolation affects mental health by increasing symptoms of anxiety and depression. One of the main components of the current COVID-19 pandemic is the social isolation imposed on the population. This study seeks to assess the impact of the physical and social living conditions of the pandemic in a cohort of urban immigrants in Chile (i.e. STRING) evaluated six months prior to the pandemic. Specific aims are to 1. Describe the variations in the levels of mental health of immigrants during and after the pandemic, 2. Calculate the effect of social isolation on the levels of mental health of the immigrant population, and 3. Identify risk / protective factors associated with increased mental health problems An online survey will be applied to the STRING cohort at two moments of the pandemic (i.e. during quarantines and after six months).

NCT04497636
Conditions
  1. Anxiety
  2. Depression
  3. Stress, Psychological
  4. Loneliness
  5. Social Isolation
MeSH:Depression Stress, Psychological

Primary Outcomes

Description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area. Specific cut-off for primary care samples in Chile have been found yielding a cut-off of 7 and above for high sensitivity and specificity (Saldivia, Aslan, Cova, Vicente, Inostroza & Rincón, 2019)

Measure: Depressive symptoms

Time: Month 1 (first follow-up) and month 6 (second follow-up)

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is used to measure symptoms of anxiety and worry. The questionnaire consists of seven items scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for primary care samples in Spain have been found yielding a cut-off of 10 and above for high sensitivity and specificity (García-Campayo et al, 2010).

Measure: Symptoms of anxiety

Time: Month 1 (first follow-up) and month 6 (second follow-up)

Description: The Impact of Events Scale (IES-R; Weiss & Marmar, 1997) is used to measure symptoms of post-traumatic stress disorder (PTSD). There scale consists of 22 questions which are scored on a five-point Likert scale (0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely). There are three subscales (i.e., avoidance, intrusion, hyperarousal) and the sum of the three subscales scores comprise the total score. A total score ≥33 indicates the likely presence of PTSD using criteria from the Diagnostic Symptom Manual (DSM-IV).

Measure: Symptoms of post-traumatic stress disorder

Time: Month 1 (first follow-up) and month 6 (second follow-up)

Description: Change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms, and World Health Organization (WHO)-5 well-being in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak.

Measure: Change in mental health symptoms, well-being from last 2 weeks before the pandemic to last 2 weeks during COVID-19 pandemic

Time: Change from last 2 weeks before pandemic to month 1 (first follow-up)

Secondary Outcomes

Description: Three-Item Revised UCLA Loneliness Scale

Measure: Loneliness

Time: Month 1 (first follow-up) and month 6 (second follow-up)

Description: Change in general physical health, self-rated, on a VAS scale from 0 to 100

Measure: Change in general physical health

Time: Change from last 2 weeks before pandemic to month 1 (first follow-up)

Description: Change in general mental, self-rated, on a VAS scale from 0 to 100

Measure: Change in general mental health

Time: Change from last 2 weeks before pandemic to month 1 (first follow-up)
39 A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls

The study is a randomized controlled trail with an observational arm and aims at collecting information on the prevalence of COVID 19 infection in seasoned yoga practitioners by comparing it with the prevalence of COVID-19 infection prevalence rates among age and gender matched control participants who do not practice yoga. The study hypothesizes that yoga practice promotes protection and enhances recovery from the COVID-19 infection. To prove the hypothesis, the study investigators are collecting and comparing responses from seasoned yoga practitioners to age and gender matched controls participants (who do not practice yoga routinely) regarding their recovery from the COVID 19 infection. Based on validated questionnaires on perceived stress, anxiety, depression, well-being, mindfulness, joy disposition, and resilience in participants over the study duration, the investigators also collect information on participant's mental and emotional predispositions.

NCT04498442
Conditions
  1. Covid19
  2. Stress
  3. Anxiety Depression
Interventions
  1. Behavioral: Simha Kriya
  2. Behavioral: Reading a Book
MeSH:Depression

Primary Outcomes

Description: The study aims to evaluate changes in perceived levels of stress in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Perceived Stress Scale. The scale measures the degree to which situations in participant's life are appraised as stressful. This is the primary outcome for our study. We assess for change in perceived stress levels by analyzing the PSS score for each participant and comparing it to pre & post intervention results.

Measure: Change in Perceived Stress Levels

Time: Baseline, 6 weeks and 12 weeks.

Secondary Outcomes

Description: The study aims to evaluate changes in resilience levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Brief Resilience Scale. The scale identifies the individual's ability to bounce back or recover from a stress. This is the key secondary outcome for our study. We assess for change in resilience levels by analyzing the 6-item BRS, which computes a score for each participant by dividing total score obtained/number of questions responded; (range 6-30) and comparing it to pre & post intervention results.

Measure: Changes in Resilience Levels

Time: Baseline, 6 weeks and 12 weeks

Description: The study aims to evaluate changes in Covid-19 prevalence in survey participants and the effect yoga or reading a book has over them. Based on the reported number of cases in the participant cohort we compute Period Prevalence for 3 specified time points. We assess for change in reported prevalence and stratify the results to match with region-wise prevalence.

Measure: Changes in Covid-19 Prevalence

Time: Baseline, 6 weeks and 12 weeks

Description: The study aims to evaluate changes in self-reported duration of fever and respiratory symptoms in Covid-19 positive survey participants and the effect yoga or reading a book has over them. Based on the reported number of positive cases in the participant cohort we compare the frequency of duration between the two cohorts i.e. yoga practitioners and control; followed by a comparison between the two control groups viz: yoga group vs idle group.

Measure: Changes in self-reported duration of fever and respiratory symptoms in COVID-19 positive participants

Time: Baseline, 6 weeks and 12 weeks

Description: The study aims to evaluate changes in self-reported readiness to return to work in Covid-19 positive survey participants and the effect yoga or reading a book has over them. Based on the reported number of positive cases in the participant cohort we compare the frequency of readiness between the two cohorts i.e. yoga practitioners and control; followed by a comparison between the two control groups viz: yoga group vs idle group.

Measure: Changes in self-reported readiness to return to work in COVID-19 positive participants

Time: Baseline, 6 weeks and 12 weeks

Other Outcomes

Description: We assessed for change in Mindfulness levels in all participants by using a short form of the validated scale for this purpose namely, Mindfulness Attention Awareness Scale (MAAS). The scale measures the individuals' ability for receptive awareness and attention to present. We compute the MAAS scores for each participant which is a mean score for 5 item questionnaires and compare the pre & post intervention results to look for change.

Measure: Changes in Mindfulness

Time: Baseline, 6 weeks and 12 weeks

Description: We assess for change in the individuals' ability to feel joy and look for it in the mundane by using a validated scale for this purpose namely, Dispositional Positive Emotions Scale (DPES) particularly the Joy subscale. The Sub-scale measures the individuals' dispositional ability to feel joy in life. We compute the DPES-JOY subscale scores for each participant which is a mean score for 6 item questionnaires and compare the pre & post intervention results to look for change.

Measure: Changes in Dispositional Positive Emotions Scale (DPES- Joy subscale)

Time: Baseline, 6 weeks and 12 weeks

Description: The study aims to evaluate changes in anxiety and depression levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, 4 Item-Patient Health Questionnaire measuring Anxiety and Depression (PHQ-4) Scale. The 4 question scale screens for anxiety and depression in participants by computing sum for the responses (scores range: 0-12) and comparing it to pre & post intervention results.

Measure: Changes in 4 Item-Patient Health Questionnaire measuring Anxiety and Depression (PHQ-4) levels

Time: Baseline, 6 weeks and 12 weeks

Description: The study aims to evaluate changes in wellbeing levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Warwick- Edinburgh Wellbeing Scale (WEMWBS). The scale identifies the individual's aspects of mental health such as: positive affect, satisfying interpersonal relationship and positive functioning. We assess for change in 14 item well-being levels by analyzing the total WEMWBS score for each participant and comparing it to pre & post intervention results.

Measure: Changes in well being levels

Time: Baseline, 6 weeks and 12 weeks

Description: The purpose of the growth inventory is to capture the positive outcomes reported by a person who have experienced a traumatic event. This scale collects information from only those participants who identify as being hospitalized during the COVID-19 pandemic and look for their coping ability to the aftermath of the trauma. This 21 item scale is rated on a 6-point Likert response scale. Response from each of the 6 question is then summed to create a total PTGI score.

Measure: Changes in Post Traumatic Growth Inventory (PTGI) scores

Time: Baseline, 6 weeks and 12 weeks
40 Evaluation of Mental Health Status and Related Factors Among Physical Medicine & Rehabilitation Physicians During the Covid-19 Pandemic

In December 2019, a highly infectious disease caused by a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China. On March 11th 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Facing this critical situation, health care workers on the front line are at risk of developing psychological distress and other mental health symptoms. Physical medicine and rehabilitation (PM&R) physicians works both in specialty outpateint/inpatient clinic and pandemic outpatient/inpatient clinics during the outbreak. Accordingly, PM&R physicians are expected to be mentally affected by COVID-19 pandemic. In this study we aimed to evaluate mental health status of PM&R physicians and related factors during COVID-19 pandemic. This study is a cross-sectional survey which is conducted on an online platform. Demographic data, working conditions of PM&R physicians and factors that may be related to mental health status is questioned in the survey. The Depression, Anxiety and Stress Scale - 21 (DASS-21) is used to measure the emotional states of depression, anxiety and stress.The Insomnia Severity Index (ISI) is used to assess the severity of both nighttime and daytime components of insomnia.

NCT04500652
Conditions
  1. Anxiety
  2. Depression
  3. Insomnia
  4. Covid19
  5. Coronavirus
MeSH:Coronavirus Infections Sleep Initiation and Maintenance Disorders Depression
HPO:Insomnia

Primary Outcomes

Description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.

Measure: Depression, Anxiety and Stress Scales 21 Score

Time: 5 months

Description: The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.

Measure: Insomnia severity index score

Time: 5 months
41 Behavioral Activation and Mental Imagery Delivered Via Telephone for the Treatment of Depressive Symptoms in Older Individuals in Isolation During Covid-19: A Randomized Clinical Trial

This research study is designed to investigate the effects of a brief psychological intervention for improving depressed mood in older individuals (65 years and older) in isolation during the Coronavirus (COVID-19) pandemic. The treatment is delivered by telephone and consists of four weekly individual sessions. Two therapeutic methods are used in combination during this intervention: Behavioral activation (BA) and Mental Imagery (MI). BA involves identifying and scheduling enjoyable and meaningful activities to improve mood and reduce social isolation. To enhance BA efficacy and adherence, MI is paired with BA as MI is known to activate emotion and motivation. The MI intervention in this study involves having participants imagine, in vivid sensory detail, engaging in some of the activities that are scheduled during BA. Approximately 154 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving the intervention after 4 weeks. This procedure makes it possible to evaluate the effects of the treatment while not disadvantaging participants randomized to the control group. Participants will be asked to fill in questionnaires before, during (at the end of each intervention week), and after treatment (or waiting period for the control group). Questionnaires will also be sent 1-, 3- and 6 months after treatment to follow up on the results. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment.

NCT04508868
Conditions
  1. Depression
  2. Depressive Symptoms
Interventions
  1. Behavioral: Brief Behavioral Activation with Mental Imagery
  2. Behavioral: Minimal Attention Control Intervention
MeSH:Depression

Primary Outcomes

Description: MADRS-S is a nine-item questionnaire used to measure severity of depression. The score ranges from 0-54.

Measure: Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S

Time: Baseline; Intervention Week 1; Intervention Week 2; Intervention Week 3; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

Secondary Outcomes

Description: GDS-15 is a 15-item questionnaire used to identify depression in the elderly. The score ranges from 0-15.

Measure: Change from baseline in depressive symptoms using the Geriatric Depression Rating Scale 15, GDS-15

Time: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

Description: PHQ-9 is a nine-item questionnaire used to identify depression as well as measuring severity of depression. The score ranges from 0-27.

Measure: Change from baseline in depressive symptoms using the Patient Health Questionnaire 9, PHQ-9

Time: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

Description: MINI is a structured clinical interview used to assess the presence/absence of common psychiatric disorders.

Measure: Change in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI

Time: Baseline; Intervention Week 4.

Description: GAD-7 is a seven-item questionnaire used to identify generalized anxiety disorder as well as measuring severity of anxiety symptoms. The score ranges from 0-21.

Measure: Change from baseline in anxiety symptoms using the Generalized Anxiety Disorder 7-item, GAD-7

Time: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

Description: BADS-SF is a nine-item questionnaire used to measure changes in avoidance and activation. The score ranges from 0-54.

Measure: Change from baseline in behavioral activation using The Behavioral Activation for Depression Scale - Short Form, BADS-SF

Time: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

Description: WHODAS-12 is a 12-item questionnaire used to assess disability due to health conditions. The total score ranges from 0-48.

Measure: Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS

Time: Baseline; Intervention Week 4; 1 month post-intervention; 3 months post-intervention; 6 months post-intervention.

Description: NEQ is a 20-item questionnaire used to assess adverse and unwanted effects of psychological treatments.

Measure: Adverse and unwanted effects of the experimental intervention using the Negative Effects Questionnaire, NEQ

Time: Experimental Intervention Week 4.

Description: Psi-Q is a 35-item questionnaire assessing the vividness of mental imagery. In this study we plan to use the visual subscale with five items, with a total score ranging from 0-50.

Measure: Mental imagery is assessed at baseline using the Plymouth Sensory Imagery Questionnaire, Psi-Q

Time: Baseline; Intervention Week 4.
42 Survey About Anxious and Depressive Symptoms During COVID-19 in Women Who Have Medical History of Post-partum Depression: Interest of Tele-consultation

Women who were able to benefit from psychiatric follow-up during the quarantine by tele-consultation have a lower risk of anxious and depressive symptoms than those who did not receive follow-up.

NCT04516668
Conditions
  1. Post Partum Depression
MeSH:Depression, Postpartum Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: To compare depression and anxiety HAD score of women who have a medical history ofpost-partum depression according to a follow-up or not during the quarantine by tele-consultation Score less than or egal to 7 = no case Score between 8 and 10 = uncertain case Score higher than or equal to 11 = confirmed case

Measure: Evaluation of Hospital anxiety and depression scale (HAD)

Time: 15 minutes

Secondary Outcomes

Description: To compare the result of EPDS in women who have a child of less 2 years old according to a follow-up or not by tele-consultation during the quarantine

Measure: Evaluation of Edinburgh Postpartum Depression Scale (EPDS)

Time: 15 minutes

Description: Anxiety and depression of fathers will be assessed with HAD scale

Measure: Evaluation of HAD score in fathers

Time: 15 minutes

Description: EPDS will be assessed in fathers who have a child of less than 2 years old

Measure: Evaluation of EPDS in fathers

Time: 15 minutes

Description: The aim is to show that maternals anxious and depressive symptoms would be correlated to paternals positively symptoms

Measure: Study of the relationship between maternals and paternals symptoms

Time: 15 minutes

Description: Look for a correlation between the difficulties in child during the quarantine describe by parents and anxiety and depression symptoms in parents The difficulties in child will be illustrated with the rate of children with difficulties describe by the parents

Measure: Study of difficuties in child during the quarantine

Time: 15 minutes

Description: Description of risk factors and protection factors setting up by the family during this quarantine period

Measure: Risk and protection factors

Time: 15 minutes
43 Prosocial Behavior Can Safeguard Mental Health and Foster Emotional Well-being During the COVID-19 Pandemic: A Randomized Clinical Trial

The COVID-19 pandemic and the accompanying lockdown measures have made mental health a pressing public health concern. Acts that focus on benefiting others-known as prosocial behaviors-offer one promising intervention that is both flexible and low cost. However, neither the range of emotional states prosocial acts impact nor the size of those effects is currently clear, both of which directly influence its attractiveness as a treatment option. Using a large online sample from Canada and the United States, the investigators will examine the effect of a three-week prosocial intervention on two indicators of emotional well-being (happiness and the belief that one's life is valuable) and mental health (anxiety and depression). Respondents will be randomly assigned to perform prosocial, self-focused, or neutral behaviors each week. Two weeks after the intervention, a final survey will assess whether the intervention has a lasting effect on mental health and emotional well-being. The results will illuminate whether prosocial interventions are a viable approach to addressing mental health needs during the current COVID-19 pandemic, as well for those who face emotional challenges during normal times.

NCT04517006
Conditions
  1. Happiness
  2. Anxiety
  3. Depression
  4. Morality
Interventions
  1. Behavioral: Self-focused acts
  2. Behavioral: Prosocial acts
MeSH:Depression

Primary Outcomes

Description: The Subjective Happiness Scale consists of four items: (1) "In general, I consider myself _______." Responses options run from 1 = "not a very happy person" to 7= "a very happy person." (2) "Compared to most of my peers, I consider myself ________" with response options from 1 = "less happy" to 7 = "more happy." (3) "Some people are generally very happy. They enjoy life regardless of what is going on, getting the most out of everything. To what extent does this characterization describe you?" (1 = "not at all" to 7 = "a great deal"). (4) "Some people are generally not very happy. Although they are not depressed, they never seem as happy as they might be. To what extent does this characterization describe you?" (1= "not at all" to 7= "a great deal"; reverse coded) These four items will be averaged into a scale ranging from 1-7, where higher scores indicate greater subjective happiness.

Measure: Change in happiness from baseline using the subjective happiness scale

Time: baseline, end of weeks 1, 2, 3, and 5

Description: Respondents' individual perceptions of whether their life has value will be measured using the valued life subscale developed by Morgan and Farsides. This measure will consist of the average of the following four items: (1) "My life is worthwhile," (2) "My life is significant," (3) I really value my life," and (4) I hold my own life in high regard." In each instance, response options will run from -3 = "strongly disagree" to 3 = "strongly agree".

Measure: Change in valued life assessment from baseline using 4-item scale

Time: baseline, end of weeks 1, 2, 3, and 5

Description: Depression will be measured using the well-established 8-item short-form of the Centre for Epidemiological Studies-Depression Scale (CES-D). Respondents will report how often in the past week they (1) felt depressed, (2) felt that everything was an effort, (3) felt that sleep was restless, (4) felt happy (reverse coded), (5) enjoyed life (reverse coded), (6) felt lonely, (7) felt sad, and (8) could not get going. Responses will be scored where 0 = "rarely or none of the time," 1 = "some of the time," 2 = "a moderate amount of time," and 3 = "most or all of the time."

Measure: Change in depression from baseline using the CESD (8-item)

Time: baseline, end of weeks 1, 2, 3, and 5

Description: Anxiety will be measured with the Hospital Anxiety and Depression Scale-Anxiety (HADS-A), which is both commonly used and well-validated. This is a 7-item scales that asks respondents how often in the past week they: (1) felt tense or wound up, (2) got a frightened feeling as if something awful was about to happen, (3) had worrying thoughts go through their mind, (4) got a frightened feeling like butterflies in the stomach, (5) felt restless as if they had to be on the move, (6) had a sudden feeling of panic, and (7) could sit at ease and feel relaxed. To ensure consistency with our measure of depression, responses will be coded where 0 = "rarely or none of the time," 1 = "some of the time," 2 = "a moderate amount of time," and 3 = "most or all of the time."

Measure: Change in anxiety from baseline using the HADS-A

Time: baseline, end of weeks 1, 2, 3, and 5
44 Limbix Spark: A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19

Over 3 million teenagers in the USA have depression, and rates of depression and suicide are sharply increasing. Teenage depression has far-reaching consequences including impairments in academic and work performance and social and family relationships, substance abuse, and worsening of other health conditions, which can persist into adulthood. Access to mental health care for teenagers is limited due to a shortage of mental health providers and many teenagers and parents are reluctant to take antidepressants. COVID-19 and mandated physical and social distancing is expected to increase rates of teenage depression, and further limit access to traditional methods of care (e.g. psychotherapy). This highlights an urgent need to develop accessible, digital treatments for teenage depression to address the serious mental health impacts of the COVID-19 pandemic. This fully virtual study (https://www.limbix.com/spark) will compare the relative safety, effectiveness, and engagement of a mobile application based on cognitive behavioral therapy and behavioral activation (Limbix Spark), focusing on the idea that engaging in behaviors that are rewarding or provide a sense of mastery can be effective in reducing symptoms of depression. Limbix Spark will be compared to a mobile app containing educational material about depression (Psychoeducation).

NCT04524598
Conditions
  1. Depression
Interventions
  1. Device: Limbix Spark
  2. Other: Psychoeducation
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: Change in depressive symptoms measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression).

Measure: Change in depressive symptoms

Time: Change from Baseline to Post treatment (5 weeks)

Secondary Outcomes

Description: Change in anxiety symptoms measured by the Generalized Anxiety Disorder (GAD-7) scale (min: 0; max: 21, with higher score indicating more severe anxiety).

Measure: Change in anxiety symptoms

Time: Change from Baseline to Post treatment (5 weeks)

Description: Change in parent report of child depressive symptoms measured by the Mood and Feelings Questionnaire (MFQ) (min: 0; max: 26, with higher score indicating more severe depression)

Measure: Change in parent report of child depressive symptoms

Time: Change from Baseline to Post treatment (5 weeks)
45 RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19

The healthcare industry is inherently demanding, stressful, and, at times, emotionally draining. On a typical day, many workers must make rapid and critical decisions, manage numerous demands, team conflicts, and challenging situations with patients and their families. For some health care workers (HCW), the current pandemic - COVID-19 - has also exacerbated these challenges. Providing psychological support is key in alleviating stress among HCWs, yet the situation does not require therapy because HCWs do not principally suffer from a mental disorder. RECHARGE was specifically developed for HCWs and is an abbreviated online version of Problem Management Plus, an evidence-based intervention that helps to cope with stress in times of crisis. As a brief psychological intervention for adults affected by adversity emerging from stress exposure, RECHARGE teaches people three well-documented strategies to manage acute stress (a: managing stress, b: managing worry, c: meaningful activity). It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioral activation, and enhancement of meaningful activities, which are all based on the principles of cognitive-behavioral therapy. The aim of this study is to evaluate the efficacy of RECHARGE to reduce stress in HCWs and enhance their work performance. Participants in this randomized controlled trial (RCT) study are randomly assigned to either RECHARGE or the active control group. To this end, stress including symptoms of burnout, worries, anxiety, depression, PTSD, and work performance will be measured at baseline, post-intervention, and at a 2 and 6 month follow up.

NCT04531774
Conditions
  1. Stress
  2. Burnout
  3. Anxiety
  4. Depression
  5. Covid19
Interventions
  1. Behavioral: RECHARGE
  2. Behavioral: Self Study
MeSH:Depression Burnout, Psychological

Primary Outcomes

Description: HCWs in the intervention condition (RECHARGE) demonstrate a lower level of distress after the intervention and at 2-month follow-up than HCWs in the active control condition.

Measure: Change from Baseline in psychological distress Kessler Psychological Distress Scale (K10) at Week 5 and Week 13

Time: Baseline (Week 1), post-intervention (Week 5) and 2 month follow-up (Week 13)

Secondary Outcomes

Description: HCWs in the intervention condition demonstrate fewer worries after the intervention and at 2-month follow-up than HCWs in the active control condition. Worries are measured using the Generalized Anxiety Disorder Assessment (GAD-7)

Measure: Fewer worries in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate less anxiety after the intervention and at 2-month follow-up than HCWs in the active control condition. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS).

Measure: Less anxiety symptoms in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate fewer symptoms of depression after the intervention and at 2-month follow-up than HCWs in the active control condition. Depression is measured using the Hospital Anxiety and Depression Scale (HADS).

Measure: Fewer depression symptoms in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate a lower level of burnout after the intervention and at 2-month follow-up than HCWs in the active control condition. Burnout is measured using the Maslach Burnout Inventory (MBI).

Measure: Lower level of burnout in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate less traumatic stress after the intervention and at 2-month follow-up than HCWs in the active control condition. Traumatic stress is measured using the PTSD Checklist (PCL-5).

Measure: Less traumatic stress in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate a lower level of distress due to perceived moral injury after the intervention and at 2-month follow-up than HCWs in the active control condition. Distress due to perceived moral injury is measured using Moral Injury Appraisals (MI).

Measure: Lower level of distress due to perceived moral injury in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate a higher work performance after the intervention and at 2-month follow-up than HCWs in the active control condition. Work performance is measured using the Work Ability Index (WAI).

Measure: Higher work performance in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)
46 Pilot RCT for COMPASS: an Online CBT Program Treating Anxiety and Low Mood in Long-term Conditions During the COVID-19 Pandemic.

This study is a single-centre, interventional randomised controlled trial. Participants will be individually randomised to receive either COMPASS online CBT + "usual care" (standard LTC charity support), or usual care only. Randomisation will be stratified by recruiting charity site to ensure a balance of participants with different LTCs across the intervention and control arm. Randomisation will occur using a 1:1 allocation ratio managed by RECAP software. Participants randomised to COMPASS will receive access to the online program. It consists of 11 online modules which target challenges associated with living with LTC(s) and includes, amongst other things, psycho-education, patient examples, interactive tasks and goal setting. Participants are linked to a therapist; 'guide', who will provide 6 x 30 minute support sessions delivered fortnightly in the format preferred by the client (phone and/or in-site message). Participants allocated to the usual care control arm will receive the usual care that is available to them via their charity. All charities include a helpline which can be accessed via telephone or email. The helplines at all charities offer one-off emotional and/or informational support provided by people trained in active listening and/or counselling skills. Additional support avenues that can be accessed may include online support groups, local community support groups and informational resources.

NCT04535778
Conditions
  1. Treatment of Illness-related Distress in Physical LTCs
Interventions
  1. Behavioral: COMPASS
  2. Behavioral: Standard charity resources
MeSH:Depression

Primary Outcomes

Description: A composite measure of Generalised Anxiety Disorder questionnaire (GAD-7) and Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.

Measure: Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Time: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)

Secondary Outcomes

Description: Social functioning. Min score = 0, Max score = 40 , with higher scores indicating greater functional impairment.

Measure: Change in Work and social adjustment scale (WSAS)

Time: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)

Description: Quality of life. Min score = 5, Max score = 15 , with higher scores more problems in the scale dimensions.

Measure: Change in EQ-5D-3L

Time: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)

Description: IPQ-R tailored to COVID-19 to establish emotional responses regarding the COVID-19 pandemic. Min score = 0, Max score = 24 , with higher scores indicating higher emotional responses.

Measure: Change in Illness perception questionnaire - revised (IPQ-R), emotional subscale

Time: At baseline, 6 weeks (mid-therapy) and 12 weeks (end of therapy)
47 Study on Incidence of Elective Surgery Postponed During COVID-19 Pandemic in Geriatric Population

The COVID-19 pandemic has disrupted routine hospital services globally. The hospital services include surgeries for benign diseases, cancer surgery and obstetric surgery. A study conducted by CovidSurg Collaborative estimated that 28,404,603 operations would be cancelled or postponed during the peak 12 weeks of disruption due to COVID-19. Globally, 81.7% of benign surgery, 37.7% of cancer surgery and 25.4% of elective Caesarean sections would be cancelled or postponed. If countries increase their normal surgical volume by 20% post-pandemic, it would take a median 45 weeks to clear the backlog of operations resulting from COVID-19 disruption. This study aims to estimate total number of elective operations postponed during COVID-19 in geriatric population.

NCT04547218
Conditions
  1. Age Problem
  2. Surgery
  3. Depression, Anxiety
MeSH:Depression

Primary Outcomes

Description: The frequencies of diagnosed surgical indication before pandemic but surgeries deferred until re-opening of full elective lists will be documented.

Measure: Incidence of elective surgeries has postponed during COVID-19 pandemic in geriatric population

Time: June 2020 - October 2020

Secondary Outcomes

Description: The frequencies of diagnosed malignant cases with surgical indication before pandemic but surgeries deferred until re-opening of full elective lists will be documented.

Measure: Incidence of cancer surgeries postponed during COVID-19 pandemic in geriatric population

Time: June 2020 - December 2020

Description: Assessment using specific scores for depression and frailty prior to surgery

Measure: Physical and psychological impact of postponed elective surgery in geriatric population during COVID-19 pandemic

Time: June 2020 - December 2020
48 Assessment of Anxiety and Depression Among Pregnant Women During COVID-19 Pandemic

Pregnancy and early parenthood are life changing periods characterized by intense emotions and a high vulnerability to emotional problems. Overall 10 - 20 % of pregnant women and women in early postpartum period suffer from mental health problems. In the first months of 2020 , pregnant and breastfeeding women have also needed to face the COVID19 pandemic including the exceptional quarantine measures that have disturbed private and professional life . In addition to the fear of infection , these measures might have negatively impacted the emotional wellbeing of women . As depressive symptoms and anxiety in the pre and peripartum period have been associated with adverse maternal , neonatal and infant outcomes , the psychological impact of COVID19 , and its associated quarantine measures , on pregnant women and new mothers is cause for concern

NCT04558749
Conditions
  1. Covid19
Interventions
  1. Other: State-trait anxiety inventory scale
  2. Other: Edinburgh Postnatal Depression Scale (EDPS)
MeSH:Depression

Primary Outcomes

Description: This scale is composed of two parts, part one measures anxiety traits and part two measures anxiety state. Each part comprises 20 statements. This scale is a (4) point scale, with a score ranging a minimum of 20 grades to a maximum of 80 grades.

Measure: The mean scores anxiety and depression among pregnant women during COVID-19 pandemic

Time: one hour
49 Depression, Anxiety and SARS-CoV-2 Phobia in Post-stroke Patients During SARS-CoV-2 Pandemic

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has begun, first in Wuhan, China, and then became a pandemic. The first SARS-CoV-2 case in Turkey was reported on March 11, 2020. People older than 65 years old became subject to lock down measures beginning on March 21, while people younger than 20 years old became subject to lock down measures beginning on April 03. A total lock down has been implemented a few times lasting between 3 to 4 days, especially at weekends. Several studies show that mental health problems could occur in public during the SARS-CoV-2 pandemic. Depression and anxiety are a commonly known mental health issue in post-stroke patients. This patient population, who usually have to spend most of their time at home, remained completely at home and socially isolated due to the precautions required by the pandemic. Based on the above research evidence; depression, anxiety and phobia of SARS-CoV-2 may increase in the post stroke patients due to being in risk group and effects of measures taken against SARS-CoV-2 pandemic. Therefore, we aimed to assess the depression, anxiety and SARS-CoV-2 phobia in post stroke patients during SARS-CoV-2 outbreak, and to explore the potential influence factors.

NCT04560413
Conditions
  1. SARS-CoV-2
  2. Post-stroke Depression
  3. Anxiety and Fear
MeSH:Stroke Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity Stroke

Primary Outcomes

Description: The Hospital Anxiety and Depression Scale evaluation includes a total of 14 questions (score range 0-3), which are scored to separately estimate anxiety and depressive status (7 questions each). The individual score for the anxiety and depression subscales may vary from 0 to 21. The aim of this scoring system is not to make an objective diagnosis, but to determine the current presence and tendency to anxiety or depression at the time of diagnosis. A HADS score of 8 to 10 is broadly accepted as indicating mild symptoms, a score between 11-16 suggests moderate anxiety or depression, and a score of 16 or more indicates severe anxiety or depressive symptoms

Measure: Hospital Anxiety and Depression Scale

Time: 3 months

Description: The Covid 19 Phobia Scale is a self-report instrument with a five-point Likert-type scale to assess the levels of SARS-CoV-2 phobia. All items are rated on a 5-point scale from "strongly disagree (1)" to "strongly agree (5)." The scores on the scale can range between 20 and 100 and a higher score indicates a greater phobia in the respected subscales and total scale. In the present study total scale scores ranged from 20 to 100. The scale examines four main factors: psychological, psycho-somatic, economic and social

Measure: Covid 19 Phobia Scale

Time: 3 months
50 Symptoms of Depression, Stress and Burnout, and Long-term Psychological Impact in Health Care Professionals Exposed to the Novel Coronavirus Disease 2019 Outbreak (HARD-COVID-19 - Health cAre woRkers exposeD to covID-19)

Hospital health workers involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion , unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making. Preliminary data suggests that frontline and lay professionals suffer from different types of psychological distress. These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as Eye Movement Desensitization and Reprocessing (EMDR, desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19. This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).

NCT04570202
Conditions
  1. Depression
  2. Burnout, Professional
  3. Post Traumatic Stress Disorder
Interventions
  1. Behavioral: EMDR
MeSH:Burnout, Professional Depression Depressive Disorder Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Burnout, Psychological
HPO:Depressivity

Primary Outcomes

Description: This study is investigating three different conditions (PTSD, Depression and Burnout) each assessed with its own primary endpoint. Thus, the trial will have three primary endpoints. Change over a 6 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.

Measure: Efficacy on symptoms of Post-Traumatic Stress Disorder

Time: From inclusion to 6 months after inclusion

Description: Change over a 6 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.

Measure: Efficacy on symptoms of Burnout

Time: From inclusion to 6 months after inclusion

Description: Change over a 6 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.

Measure: Efficacy on symptoms of Depression

Time: From inclusion to 6 months after inclusion

Secondary Outcomes

Description: Change over a 3 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.

Measure: Short-term efficacy on symptoms of PTSD

Time: From inclusion to 3 months after inclusion

Description: Change over a 3 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.

Measure: Short-term efficacy on symptoms of Burnout

Time: From inclusion to 3 months after inclusion

Description: Change over a 3 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.

Measure: Short-term efficacy on symptoms of Depression

Time: From inclusion to 3 months after inclusion

Description: Change over a 12 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5) for the participants who will be enrolled in the trial at M0 of the cohort. The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.

Measure: Long-term efficacy on symptoms of PTSD

Time: From inclusion to 12 months after inclusion

Description: Change over a 12 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL) for the participants who will be enrolled in the trial at M0 of the cohort. The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.

Measure: Long-term efficacy on symptoms of Burnout

Time: From inclusion to 12 months after inclusion

Description: Change over a 12 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9) for the participants who will be enrolled in the trial at M0 of the cohort. The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.

Measure: Long-term efficacy on symptoms of Depression

Time: From inclusion to 12 months after inclusion

Description: Change over a 6 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7). The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are.

Measure: Efficacy on symptoms of Anxiety

Time: From inclusion to 6 months after inclusion

Description: Change over a 12 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7) for the participants who will be enrolled in the trial at M0 of the cohort. The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are.

Measure: Long-term efficacy on symptoms of Anxiety

Time: From inclusion to 12 months after inclusion

Description: Number of suicide attempts over a 6-month period from baseline

Measure: Efficacy on suicide attempts

Time: From inclusion to 6 months after inclusion

Other Outcomes

Description: Changes in the level of suicidal ideation over a 6 months period from baseline measured by Visual Analog Scale (VAS). The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is.

Measure: Efficacy on suicidal ideation

Time: From inclusion to 6 months after inclusion

Description: Changes in the level of suicidal ideation over a 12 months period from baseline measured by Visual Analog Scale (VAS) for the participants who are enrolled in the trial at M0 of the cohort. The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is.

Measure: Long-term efficacy on suicidal ideation

Time: From inclusion to 12 months after inclusion

Description: Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is.

Measure: Efficacy on the impact of health on functioning: Role Emotional

Time: From inclusion to 6 months after inclusion

Description: Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is.

Measure: Long-term efficacy on the impact of health on functioning: Role Emotional

Time: From inclusion to 12 months after inclusion

Description: Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is.

Measure: Efficacy on the impact of health on functioning: Role Physical

Time: From inclusion to 6 months after inclusion

Description: Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is.

Measure: Long-term efficacy on the impact of health on functioning: Role Physical

Time: From inclusion to 12 months after inclusion

Description: Evolution of substance use over 6 months

Measure: Substance use

Time: From inclusion to 6 months after inclusion

Description: Evolution of substance use over 12 months for the participants who are enrolled in the trial at M0 of the cohort

Measure: Long-term substance use

Time: From inclusion to 12 months after inclusion

Description: Evolution of medication use over 6 months

Measure: Medication use

Time: From inclusion to 6 months after inclusion

Description: Evolution of medication use over 12 months for the participants who are enrolled in the trial at M0 of the cohort

Measure: Long-term medication use

Time: From inclusion to 12 months after inclusion

Description: Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient.

Measure: Health care utilization

Time: From inclusion to 6 months after inclusion

Description: Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient. For the participants who are enrolled in the trial at M0 of the cohort

Measure: Long-term health care utilization

Time: From inclusion to 12 months after inclusion

Description: Proportion of those who will be offered EMDR and will actually receive EMDR

Measure: Acceptability of EMDR in the EMDR group

Time: From inclusion to 12 months after inclusion

Description: Number of sessions attended over the total planned number

Measure: Compliance in the EMDR group

Time: From inclusion to 12 months after inclusion
51 Low-intensity Psychosocial Interventions in Pregnant Women in Response to COVID-19: Maternal Mental Health Matters An Interventional Study

The purpose of this study is to assess the effectiveness of a telemental health intervention on the mental health of pregnant women during the COVID-19 crisis in Qatar.

NCT04594525
Conditions
  1. Perinatal Depression
  2. Specific Phobia
  3. Perinatal Anxiety
Interventions
  1. Other: Low-Intensity Psychosocial Interventions through Telemental health
MeSH:Depression

Primary Outcomes

Description: The EPDS-10 is a validated (English and Arabic versions) instrument that assesses perinatal depression. It consists of ten questions. The total score will range from zero (no depression) to 30 (severe depression).

Measure: Baseline (T0) perinatal depression through the 10-points Edinburgh Postnatal Depression (Scale (EPDS-10)

Time: Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation)

Description: The EPDS-10 is a validated (English and Arabic versions) instrument that assesses perinatal depression. It consists of ten questions. The total score will range from zero (no depression) to 30 (severe depression).

Measure: Change (T1-T0) from baseline perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at third trimester (T1)

Time: During the third trimester (Beginning of the 28th week till end of 42nd week of gestation)

Description: The EPDS-10 is a validated (English and Arabic versions) instrument that assesses perinatal depression. It consists of ten questions. The total score will range from zero (no depression) to 30 (severe depression).

Measure: Change (T2-T1) from third trimester perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 3-5 weeks postnatal (T2)

Time: During the postnatal phase (3-5 weeks after birth)

Description: The EPDS-10 is a validated (English and Arabic versions) instrument that assesses perinatal depression. It consists of ten questions. The total score will range from zero (no depression) to 30 (severe depression).

Measure: Change (T3-T2) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 2-4 months postnatal (T3)

Time: During the postnatal phase (2-4 months after birth)

Description: The EPDS-10 is a validated (English and Arabic versions) instrument that assesses perinatal depression. It consists of ten questions. The total score will range from zero (no depression) to 30 (severe depression).

Measure: Change (T4-T3) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 5-7 months postnatal (T4)

Time: During the postnatal phase (5-7 months after birth)

Description: The EPDS-10 is a validated (English and Arabic versions) instrument that assesses perinatal depression. It consists of ten questions. The total score will range from zero (no depression) to 30 (severe depression).

Measure: Change (T5-T4) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 8-10 months postnatal (T5)

Time: During the postnatal phase (8-10 months after birth)

Description: The Covid-9 Specific phobia questionnaire consists of seven items (five-item Likert-type scale). The answers include "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree". A total score is calculated ranging from 7 to 35. The higher the score, the greater the fear of cororonavirus-19.

Measure: Baseline (T0) Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire

Time: Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation)

Description: The Covid-9 Specific phobia questionnaire consists of seven items (five-item Likert-type scale). The answers include "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree". A total score is calculated ranging from 7 to 35. The higher the score, the greater the fear of cororonavirus-19.

Measure: Change (T1-T0) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at third trimester (T1)

Time: During the third trimester (Beginning of the 28th week till end of 42nd week of gestation)

Description: The Covid-9 Specific phobia questionnaire consists of seven items (five-item Likert-type scale). The answers include "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree". A total score is calculated ranging from 7 to 35. The higher the score, the greater the fear of cororonavirus-19.

Measure: Change (T2-T1) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 3-5 weeks after birth (T2)

Time: During the postnatal phase (3-5 weeks after birth)

Description: The Covid-9 Specific phobia questionnaire consists of seven items (five-item Likert-type scale). The answers include "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree". A total score is calculated ranging from 7 to 35. The higher the score, the greater the fear of cororonavirus-19.

Measure: Change (T3-T2) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 2-4 months after birth (T3)

Time: During the postnatal phase (2-4 months after birth)

Description: The Covid-9 Specific phobia questionnaire consists of seven items (five-item Likert-type scale). The answers include "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree". A total score is calculated ranging from 7 to 35. The higher the score, the greater the fear of cororonavirus-19.

Measure: Change (T4-T3) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 5-7 months after birth (T4)

Time: During the postnatal phase (5-7 months after birth)

Description: The Covid-9 Specific phobia questionnaire consists of seven items (five-item Likert-type scale). The answers include "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree". A total score is calculated ranging from 7 to 35. The higher the score, the greater the fear of cororonavirus-19.

Measure: Change (T5-T4) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 8-10 months after birth (T5)

Time: During the postnatal phase (8-10 months after birth)

Description: A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety).

Measure: Baseline (T0) perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3)

Time: Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation)

Description: A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety).

Measure: Change (T1-T0) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at third trimester (T1)

Time: During the third trimester (Beginning of the 28th week till end of 42nd week of gestation)

Description: A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety).

Measure: Change (T2-T1) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 3-5 weeks after birth (T2)

Time: During the postnatal phase (3-5 weeks after birth)

Description: A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety).

Measure: Change (T3-T2) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 2-4 months after birth (T3)

Time: During the postnatal phase (2-4 months after birth)

Description: A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety).

Measure: Change (T4-T3) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 5-7 months after birth (T4)

Time: During the postnatal phase (5-7 months after birth)

Description: A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety).

Measure: Change (T5-T4) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 8-10 months after birth (T5)

Time: During the postnatal phase (8-10 months after birth)
52 Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use

This 3-arm study compares the effectiveness of an (1) 8-week mindfulness-based intervention, MBCT-R (Mindfulness-Based Cognitive Therapy for Resilience During COVID-19)+CHA MindWell vs. (2) iCBT (internet based Cognitive Behavioral Therapy)+ CHA MindWell vs. (3) CHA MindWell remote monitoring and telephone coaching alone on depressive symptoms as measured over the course of 24-weeks by the computerized adaptive mental health (CAT-MH) interview for depression (CAT-DI). Secondary outcomes include rates and levels of alcohol and drug use, as well as the number of required mental health clinician visits (televisits and in-person visits). Exploratory outcomes include stress-related affect reactivity and salivary inflammatory markers (e.g., interleukin-6).

NCT04595084
Conditions
  1. Depression
  2. Anxiety
  3. Substance Use
  4. Stress, Psychological
  5. Stress, Emotional
  6. Alcohol Use, Unspecified
  7. Drug Use
  8. Covid19
Interventions
  1. Behavioral: Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell
  2. Behavioral: Internet Cognitive Behavioral Therapy plus CHAMindWell
  3. Behavioral: CHAMindWell
MeSH:Depression Depressive Disorder Stress, Psychological
HPO:Depressivity

Primary Outcomes

Description: Change in depression symptom severity as measured by CAT-MH Depression Inventory (DI) scores completed at baseline and every 4 weeks during the 24 weeks after randomization. Difference between MBCT-R arm and CHA-MW monitoring alone arm is primary outcome. Difference between iCBT arm and CHA-MW monitoring alone arm is secondary outcome. Difference between iCBT arm and MBCT-R is an exploratory outcome.

Measure: Depression Severity (CAT-DI)

Time: Baseline, Weeks 4, 8, 12, 16, 20, 24

Secondary Outcomes

Description: Rates of positive toxicology screens for illicit drugs or unprescribed controlled substances at 24 weeks. Rates of positive toxicology for illicit drug use or controlled substances (non prescribed) at week 24 is the secondary outcome.

Measure: Drug Use Rates

Time: Week 24

Description: We will conduct an Alcohol Use History at Week 24. We will conduct 30-day alcohol and substance use history using the TimeLine Follow Back (TLFB) Method at Week 24 visit by telephone or video conference. Heavy Drinking Days in past 30 days is the secondary outcome.

Measure: Heavy Drinking Days

Time: Week 24

Description: Number of mental health clinician televisits during 24 weeks

Measure: Televisits

Time: Randomization through Week 24

Other Outcomes

Description: Participants report the frequency of emotions using a 5-point scale: 0 = none of the time, 1 = a little of the time, 2 = some of the time, 3 = most of the time, 4 = all of the time. The NA scale consists of 14 items: restless or fidgety, nervous, worthless, so sad nothing could cheer you up, everything is an effort, hopeless, lonely, afraid, jittery, irritable, ashamed, upset, angry, and frustrated. The PA scale consists of 13 items: in good spirits, cheerful, extremely happy, calm and peaceful, satisfied, full of life, close to others, like you belong, enthusiastic, attentive, proud, active, and confident. Daily NA and PA are calculated by averaging the items within each subscale, and then aggregating scores across interview days.

Measure: Positive and Negative Affect Reactivity Scales

Time: Weeks -4, -3, -2, -1, 0, 9, 10, 11

Description: The Daily Inventory of Stressful Events is used to assess whether each of 7 types of stressors occurred in the past 24 hours: argument, avoided an argument, stressor at work or school, stressor at home, discrimination, network stressor (i.e., stressful event that happened to a close friend or family member), and any other stressor. A day is categorized as a "stressor day" if the participant endorsed at least one stressor, or a "nonstressor day" if the participant indicated that no stressors occurred. Stressor frequency is defined as the percentage of interview days during which at least one stressor occurred. Salivary Cytokine Panels will be collected on two of these stressor and non stressor days respectively.

Measure: Daily Inventory of Stressful Events

Time: Weeks -4, -3, -2, -1, 9, 10, 11, 12

Description: Difference between mean level of salivary Interleukin-6 during 2 low stressor and 2 high stressor days is exploratory outcome. Evening salivary passive drool samples (which assess TNF-a, IL-1b and IL-8 in addition to IL-6) will be collected 4 times during weeks -4-0 and 4 times during weeks 9-12 during diary collection. They will be primed with REDCAP branching logic activated by 2 multi-stressor (high) stressor days and 2 no stressor days. REDCAP will specifically tell them to select a color/letter coded sampling contained and they will collect that sample that evening. They will place samples immediately in the freezer.

Measure: Inflammatory Cytokines (IL-6, IL-1b, IL-8, TNF-a)

Time: Weeks -4, -3, -2, -1, 9, 10, 11, 12

Description: A 15-item scale with content from six dimensions of experiential avoidance.

Measure: Brief Experiential Avoidance Questionnaire (BEAQ)

Time: Baseline, Weeks 4, 8, 12

Description: The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation using a 5 point Likert scale. The scale assesses 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Subscales are summed and a lower total score represents a better outcome. Individual subscales will also be assessed.

Measure: Difficulties in Emotion Regulation Scale (DERS)

Time: Baseline, Weeks 4, 8, 12

Description: The Perceived Stress Scale (PSS-14) (14 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often).

Measure: Perceived Stress Scale (PSS-14)

Time: Baseline, Weeks 4, 8, 12, 24

Description: The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored.

Measure: Self-Compassion Scale Short Form (SCS-SF)

Time: Baseline, Weeks 4, 8, 12

Description: The Multidimensional Assessment of Interoceptive Awareness (MAIA-2) is a 37 item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness. The scale assesses 8 aspects of interoceptive awareness: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Subscales are summed and a higher total score represents a better outcome. Individual subscales will also be assessed, especially Body Listen, Body Trust, and Self-Regulation.

Measure: Multidimensional Assessment of Interoceptive Awareness (MAIA-2)

Time: Baseline, Weeks 4, 8, 12

Description: The adult self-report COVID-19 Responses to Stress Questionnaire is a 72-item survey. Responses are recorded on a 4-point Likert scale (1 = Not at All, 4 = Very/A lot). Items in the RSQ cover 5 factors of coping and stress responses: primary control engagement coping (i.e., problem solving, emotional expression, emotional modulation), secondary control engagement coping (i.e., positive thinking, cognitive restructuring, acceptance, distraction), disengagement coping (i.e., avoidance, denial, wishful thinking); involuntary engagement (e.g., physiological arousal, rumination), and involuntary disengagement (e.g., emotional numbing).

Measure: Responses to Stress Questionnaire - COVID -19 (RSQ-COVID-19) Stress coping style (disengagement, involuntary engagement)

Time: Baseline, Weeks 12, 24

Description: This is a 20-item self-report measure of decentering and is conceptualized as a protective factor and capable of measuring resilience to depressive relapse. The EQ uses a 5-point Likert scale with responses from "never" to "all the time". A sample item from the decentering subscale is "I can observe unpleasant feelings without being drawn into them."

Measure: Experiences Questionnaire (EQ) (Rumination and Decentering)

Time: Baseline, Weeks 4, 8, 12

Description: Computer Adaptive Testing for Mental Health (CAT-MH) interviews are diagnostic interviews designed to be completed online using a computer, tablet or phone. Items from each of the modules for depression (CAT-DI), anxiety (ANX-CAT), mania and hypomania (M/HM-CAT), PTSD (PTSD-CAT), psychosis (PSY-S-CAT), suicidality (SS-CAT), and substance abuse (SUD-CAT) are chosen from large item banks based on multidimensional item response theory, adapting each item presented to the individual's severity so that different individuals are tested with different items depending on their severity level.

Measure: Computerized Adaptive Testing for Mental Health (CAT-MH) Interviews

Time: Screening, Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24

Description: The Beck Depression Inventory (BDI-II) is a 21-item self-report scale designed to assess depression severity over the past 2 weeks with well-established internal consistency, reliability and validity.

Measure: Beck Depression Inventory (BDI-II)

Time: Baseline

Description: Rank Desire for each intervention option will be assessed at baseline.

Measure: Rank Desire

Time: Baseline

Description: Credibility/Expectancy for the assigned option will be assessed at Week 2. Treatment expectancy and credibility for each arm will be assessed with the 4-item Credibility/ Expectancy Questionnaire (CEQ)

Measure: Credibility and Expectancy

Time: Week 2

Description: The COVID-19 Fear scale is a 7-item questionnaire recorded on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Responses to scale items were found to positively correlate with perceived vulnerability, hospital anxiety, and depression. Sample questions include "I am most afraid of coronavirus-19," and "It makes me uncomfortable to think about coronavirus-19."

Measure: COVID-19 Fear

Time: Baseline, Week 12

Description: Participants will be asked to self-report on REDCap.

Measure: COVID-19 status (self-report)

Time: Week 0, 4, 8, 12, 16, 20, 24

Description: Participants will be asked to complete a salivary sample to assess COVID-19 status. COVID-19 IgG samples: Antibodies for COVID-19 will be sampled at week 12 among all participants to establish whether they were exposed to COVID-19 during the study. They will place samples immediately in the freezer.

Measure: COVID-19 status (salivary IgG)

Time: Week 12

Description: The UCI Oral Health Questionnaire is an 12-item survey that asks sociodemographic questions, questions about oral and physical health, as well as additional oral health questions drawn from the WHO Oral Health Survey. The questionnaire includes basic questions about dental health characteristics of participants to be used as an exclusion criteria for the salivary collection portion of the study and to track changes in oral health that might impact salivary data collection.

Measure: UCI Oral Health Questionnaire

Time: Screening and at Week 12

Description: The Home Skills Use Diary will be completed for the 8 weeks during the intervention period and will come in two types (1: weekly mindfulness practice and resource use diary for the MBCT-R group and 2: General CBT coping skills use diary card for both the iCBT and CHA MindWell arms).

Measure: Home Skills Use Diary

Time: Weeks 1, 2, 3, 4, 5, 6, 7, 8

Description: The Adverse Event Patient Participant Self-Report Form will be systematically assessed at assessment timepoints (baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks and 24-weeks). In addition, group leaders and research coordinators will be trained to identify and report any adverse events that occur or are reported during weekly group visits.

Measure: Adverse Event Patient Participant Self-Report Form

Time: Baseline, Weeks 4, 8, 12, 16, 20, 24
53 Impact of COVID-19 Pandemic in Perinatal Mental Health

Introduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: The study and handling of the data will follow all national required data protection standards. Each researcher (or team of researchers) involved will submit the project to their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.

NCT04595123
Conditions
  1. Post Traumatic Stress Disorder
  2. Depression
  3. Anxiety
  4. Psychological Distress
MeSH:Depression Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Number of depressive symptoms evaluated by Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30. Higher scores mean worse outcome

Measure: Depressive symptoms

Time: June 2020- June 2021

Description: Number of Post-Traumatic Stress Disorders (PTSD) symptoms evaluated by check list of DSM-5. HIgher number of symptoms mean worse outcomes

Measure: Posttraumatic Stress Disorder

Time: June 2020- June 2021

Description: Number of anxiety symptoms evaluated by General Anxiety Disorder questionnaire (GAD 7). Scores range from 0 to 21. Higher scores mean worse outcomes.

Measure: Anxiety symptoms

Time: June 2020- June 2021
54 Post-COVID-19 Epidemic Depression Assessment in Adults in South Punjab Pakistan

To assess the depression in adults especially in post COVID-19 duration in the rural and urban settings.

NCT04604080
Conditions
  1. Depression, Anxiety
Interventions
  1. Other: service of questionnaire
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: % prevalence of depression in adult population of south punjab will be assessed

Measure: Prevalence estimation of depression in adults

Time: study will be completed in 15 days maximum
55 Assisting Family Physicians With Gaps in Mental Health Care Generated by the COVID-19 Pandemic: A Randomized Controlled Trial

During pandemics older adults with chronic physical conditions are a particularly vulnerable population for unmet mental health needs. This is a consequence of a number of factors which include decreased access to their doctors because of restrictions in visits in order to decrease risk of disease transmission and because doctors are seconded to provide medical services in areas of high priority. Since Public Health authorities worry that pandemics may be a reality of the future, this study is being operationalized during the present COVID-19 pandemic in order to see what can be learned about different ways to provide mental health care under such constraints. The study offers evidence-based approaches to managing feelings of anxiety or depression that may have existed prior to the onset of a pandemic, or that have arisen during a pandemic. It uses principles of cognitive behavioural therapy in which participants are offered self-care tools to help them develop strategies for dealing with their various symptoms. These tools have already been shown by the team to be effective in other contexts in studies DIRECT-sc (Effectiveness of a supported self-care intervention for depression compared to an unsupported intervention in older adults with chronic physical illnesses) and CanDIRECT (Effectiveness of a telephone-supported depression self-care intervention for cancer survivors). The present study, PanDIRECT (Assisting Family Physicians with Gaps in Mental Health Care Generated by the COVID-19 Pandemic), aims to answer the following questions: 1. Can these tools be used in the community care of mental health problems during pandemics? 2. Are they acceptable to patients? 3. Using a randomized control trial, does lay-coaching of use of these tools improve their use and patient outcomes? 4. Do family practitioners value patient information sent to them at the end of the trial

NCT04609371
Conditions
  1. Mental Health Wellness 1
  2. Coaching
  3. Pandemic
  4. Depression, Anxiety
  5. Self-care Tools
Interventions
  1. Behavioral: self-care tools
  2. Behavioral: lay telephone coaching
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: Number of consenting participants out of total number contacted over the recruitment period

Measure: Consent rate

Time: At recruitment

Description: Investigators will report on rates of missing data from baseline and follow-up questionnaires

Measure: Data completion rate

Time: From recruitment launch to completion of follow-up (4 months)

Description: Logs and checklists will be used to evaluate completion of intervention, as per protocol

Measure: Fidelity of intervention completion

Time: A 8 week follow-up

Description: Using the validated 9 item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 - higher score indicates more severe depression

Measure: Severity of depression symptoms

Time: At baseline

Description: Using the validated 9 item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 - higher score indicates more severe depression

Measure: Severity of depression symptoms

Time: At 8 week follow-up

Description: Using the validated 7 item General Anxiety Disorder (GAD-7) instrument. Scores range from 0 to 21 - higher score indicates more severe anxiety

Measure: Severity of anxiety symptoms

Time: At baseline

Description: Using the validated 7 item General Anxiety Disorder (GAD-7) instrument. Scores range from 0 to 21 - higher score indicates more severe anxiety

Measure: Severity of anxiety symptoms

Time: At 8 week follow-up

Description: Using questions developed by the team and administrative databases to assess use of hospital and mental health care services

Measure: Use of health care services

Time: At baseline

Description: Using questions developed by the team and administrative databases to assess use of hospital and mental health care services

Measure: Use of health care services

Time: At 8 week follow-up

Description: Using adherence questions developed by the team, not scored

Measure: Use of the self-care materials

Time: At 8 week follow-up
56 Open Trial of Emotion Regulation Training Via Telehealth for Distressed Adults During the COVID-19 Pandemic

This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.

NCT04615416
Conditions
  1. Distress, Emotional
  2. Emotional Dysfunction
  3. Anxiety
  4. Depression
Interventions
  1. Behavioral: Emotion Regulation Training via Telehealth
MeSH:Depression

Primary Outcomes

Description: Mood and Anxiety Symptoms Questionnaire (MASQ)

Measure: Changes in Anxiety, Depression, and Distress

Time: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Description: Depression Anxiety Stress Scale (DASS)

Measure: Changes in Anxiety, Depression, and Distress

Time: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Description: Penn State Worry Questionnaire (PSWQ)

Measure: Changes in Worry

Time: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Description: Rumination-Reflection Questionnaire (RRQ)

Measure: Changes in Rumination

Time: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Description: Sheehan Disability Scale (SDS)

Measure: Changes in Functional Impairment

Time: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Description: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)

Measure: Changes in Life Satisfaction

Time: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Description: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose

Measure: Changes in Life Satisfaction

Time: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

Secondary Outcomes

Description: Patient-Reported Outcomes Measurement Information System (PROMIS): Anxiety

Measure: Semi-Weekly Measures of Treatment Changes in Anxiety

Time: Semi-weekly over the course of four weeks

Description: Patient-Reported Outcomes Measurement Information System (PROMIS): Depression

Measure: Semi-Weekly Measures of Treatment Changes in Depression

Time: Semi-weekly over the course of four weeks

Description: Quick Inventory of Depressive Symptoms(QUIDS)

Measure: Semi-Weekly Measures of Treatment Changes in Depression Symptoms

Time: Semi-weekly over the course of four weeks

Description: Distress Thermometer (DT)

Measure: Semi-Weekly Measures of Treatment Changes in Distress

Time: Semi-weekly over the course of four weeks

Description: Brief Penn State Worry Questionnaire (PSWQ)

Measure: Semi-Weekly Measures of Treatment Changes in Worry

Time: Semi-weekly over the course of four weeks

Description: Brief Rumination-Reflection Questionnaire (RRQ)

Measure: Semi-Weekly Measures of Treatment Changes in Rumination

Time: Semi-weekly over the course of four weeks

Description: Emotion Regulation Questionnaire (ERQ)

Measure: Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation

Time: Semi-weekly over the course of four weeks

Description: Experiences Questionnaire (EQ)

Measure: Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation

Time: Semi-weekly over the course of four weeks

Description: The Attentional Control Scale (ACS)

Measure: Semi-Weekly Measures of Treatment Changes in Attentional Regulation

Time: Semi-weekly over the course of four weeks

Description: Client Satisfaction Questionnaire (CSQ)

Measure: Satisfaction and Usability of Treatment

Time: Post-Treatment (4-5 weeks after starting treatment)
57 A Clinical Study of Online Active Play Program With Adolescents During COVID-19 Lockdown

To assess the efficacy of an online, active play program (Revival Active Program) in reducing the symptoms of anxiety and depression in community-based adolescents,, a retrospective community based participatory research was conducted with 32 adolescents aged between 11-17 years old. Program was conducted during Covid-19 lockdown from March 2020 to June 2020 to support children and families in isolation.

NCT04618341
Conditions
  1. Anxiety
  2. Depression
MeSH:Depression

Primary Outcomes

Description: Screen for Child Anxiety Related Disorders (SCARED) child version was used to assess anxiety levels.

Measure: Anxiety

Time: Change from baseline anxiety at 6 weeks

Description: Severity Measure for Depression child version was used to measure depression levels

Measure: Depression

Time: Change from baseline depression at 6 weeks
58 Maternal Attachment and Depression Anxiety Score Evaluation in COVID-19 Positive Pregnant Women

Maternal attachment, Edinburgh depression scoring, and postpartum anxiety scale are evaluated in patients with covid-positive pregnancies in the 3rd month after birth.

NCT04629638
Conditions
  1. Covid19
  2. Depression, Anxiety
  3. Pregnancy Related
Interventions
  1. Other: Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary Outcomes

Description: Maternal attachment scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. High scores from the scale indicate high maternal attachment.

Measure: Maternal attachment in SARS- cov2 positive and negative pregnant women

Time: 3 months

Description: Edinburgh depression scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. All questions are scored between 0 and 3 and the highest possible score on the scale is 30. and shows advanced depression.

Measure: Edinburgh depression scores in in SARS- cov2 positive and negative pregnant women

Time: 3 months

Description: Postpartum anxiety scale scores evaluated in 250 covid-positive pregnant women in the 3rd month after birth. The results will be compared with the results of covid-negative pregnant women who gave birth in the same period. It can be said that the postpartum anxiety levels of those who score 73 and below on the scale are low, those who score between 74 and 100 are medium, and those who score 101 and above are high.

Measure: Postpartum anxiety scale scores in in SARS- cov2 positive and negative pregnant women

Time: 3 months
59 A Smartphone Intervention for Relational and Mental Well Being

The primary aim of this study is to provide and evaluate a phone-based intervention to improve relational and mental well-being during the COVID-19 crisis. This information also will help us understand how individuals are responding to COVID-19 and have the potential to inform psychological and policy level interventions.

NCT04629755
Conditions
  1. Depression
  2. Loneliness
  3. Relation, Interpersonal
  4. Covid19
Interventions
  1. Behavioral: Intervention
MeSH:Depression

Primary Outcomes

Description: Depressed mood was measured using the first two symptom items of the Patient Health Questionnaire-2, "I felt down, depressed, or hopeless today" and "I had little interest or pleasure in doing things today"; both were rated with a slider from 0 (None of the time) to 10 (All of the time) with anchors "Some of the time" and "Most of the time" spaced evenly between.

Measure: Change in depressed mood

Time: Measured every evening for 28 days; the first 6 days constituted baseline measurement; change was assessed over Days 7 - 28 with baseline as a covariate

Description: Loneliness was measured using two items adapted from the UCLA Loneliness Scale, "I felt lonely today" and "I felt left out today" using a slider from 0 (Not at all) to 10 (Extremely).

Measure: Change in loneliness

Time: Measured every evening for 28 days; the first 6 days constituted baseline measurement; change was assessed over Days 7 - 28 with baseline as a covariate

Description: Relationship quality was measured using two items, "I felt closer and more connected to important people in my life today" with a slider including 0 (Not at all), 5 (A moderate amount) and 10 (Very much so) and "I felt satisfied with my relationships today" with a slider from 0 (Not at all) to 10 (Extremely).

Measure: Change in relationship quality

Time: Measured every evening for 28 days; the first 6 days constituted baseline measurement; change was assessed over Days 7 - 28 with baseline as a covariate
60 Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19

Medical personnel working in the Intensive Care Unit will be examined by means of tests. Their aim is to check how work-related stress in a potentially lethal threat affects the occurrence of depression, stress, anxiety and sleep disorders. We also want to check whether people working in such extremely difficult conditions show no greater interest in death.

NCT04631497
Conditions
  1. Depression
Interventions
  1. Diagnostic Test: test
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: Beck's test the BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression

Measure: Depression

Time: 1 month

Description: Perceived Stress Scale (PSS) The PSS predicts both objective biological markers of stress and increased risk for disease among persons with higher perceived stress levels. For example, those with higher scores (suggestive of chronic stress) on the PSS fend worse on biological markers of aging, cortisol levels, immune markers, depression, infectious disease,wound healing, and prostate-specific antigen levels in men. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positivelystated items (items 4, 5, 7, & 8) and then summing across all scale items. A short 4 item scale can be made fromquestions 2, 4, 5 and 10 of the PSS 10 item scale.

Measure: Stress

Time: 1 month

Description: COPE test It is a self-written tool consisting of 60 statements, to which the respondent responds on a 4-point scale. It allows the assessment of 15 strategies for responding to stressful situations.

Measure: Deal with Stress

Time: 1 month

Secondary Outcomes

Description: the scale of the fascination with death The Death Obsession Scale (DOS) was made by Abdel-Khalek. It was intended to be a main component in the death distress const.ruct: death anxiety, death depression, and death obsession. The DOS assesses a multidimensional trait. It is responded to on a five-point Likert-type rating scale as follows: No (1), A little (2), A fair amount (3), Much (4) and Very much (5). The total score can range from 15 to 75.

Measure: Stress 2

Time: 1 month
61 A Pragmatic Superiority Randomized Controlled Trial Comparing Telepsychoeducation Plus Personalized Videos vs. Telepsychoeducation Without Personalized Videos for the Prevention of Future Emotional Distress in Professionals From Essential Services With Low to Moderate Levels of Emotional Distress in Brazil in the Context of COVID-19

A pragmatic superiority randomized controlled trial comparing Telepsychoeducation plus personalized videos vs. Telepsychoeducation without personalized videos for the prevention of future emotional distress in professionals and students from essential services with low to moderate levels of emotional distress in Brazil. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.

NCT04632082
Conditions
  1. Mental Health Wellness 1
  2. COVID
  3. Emotional Distress
  4. Depressive Symptoms
  5. Anxiety Symptoms
  6. Irritability
  7. Telepsychotherapy
Interventions
  1. Behavioral: Telepsychoeducation with personalized videos
  2. Behavioral: Telepsychoeducation without personalized videos
MeSH:Depression

Primary Outcomes

Description: Proportion of participants with a T score equal or above 70 in any of three emotional distress subscales (Patient-Reported Outcomes Measurement Information System - or PROMIS - of Depression, Anxiety and Anger)

Measure: Incident Cases in 6 months

Time: 6-months

Secondary Outcomes

Description: Proportion of participants with a T score equal or above 60 in any of the emotional distress scales (PROMIS - of Depression, Anxiety and Anger)

Measure: Incident cases

Time: 1, 3 an 6-months

Description: Service satisfaction measured by the net-promoter score at the end of the treatment (proportion of promoters - scores of 9 or 10)

Measure: Service Satisfaction

Time: 2-weeks

Description: Mean score change in quality of life scale (PROMIS General Life Satisfaction Scale or GLSS)

Measure: Improvement in Quality of Life

Time: 1, 3 and 6-months
62 Comparing Two Online Single-Session Interventions for Adolescent Depression: Outcomes of a Randomized Trial

Most mental health problems emerge by age 14, often leading to chronic impairments and adverse impacts for individuals, families, and societies. Any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. In a fully-online trial, youths ages 13-16 will be randomized to 1 of 3 self-administered single-session interventions (SSIs): a behavioral activation SSI, targeting behavioral MD symptoms; an SSI teaching growth mindset, targeting cognitive MD symptoms; or a control SSI. The investigators will test each SSI's relative benefits, versus the control, on depressive symptoms and proximal outcomes such as hopelessness. Results will reveal whether SSIs that were designed to address behavioral versus cognitive symptoms differentially benefit adolescents with elevated depressive symptoms.

NCT04634903
Conditions
  1. Depression
Interventions
  1. Behavioral: Supportive Therapy SSI
  2. Behavioral: Behavioral Activation SSI
  3. Behavioral: Growth Mindset SSI
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: The Children's Depression Inventory (CDI) 2 - short form (CDI-SF) is a reliable, valid measure of youth depression severity, normed for youth age and sex and yielding raw and T scores.

Measure: Change in adolescent depressive symptom severity

Time: Pre-SSI to 3-month follow-up

Secondary Outcomes

Description: Four items from a self-report version of the SITBI-SF were used to assess lifetime history of suicide ideation, suicide attempts, and deliberate self-harm. The SITBI-SF is a widely used measure of the continuum of suicidality and self-harm and has demonstrated high test-retest reliability, high internal consistency, and moderate-to-high concurrent validity. Score range for this measure can range widely (per wide variation in instances of self-harming behaviors across one's lifetime); thus, we anticipate a minimum score of 0 and are unable to predict the top (maximum) score.

Measure: Change in Self-Injurious Thoughts and Behaviors Interview-Short Form (SITBI-SF)

Time: Pre-SSI to 3-month follow-up

Description: Youths' approach versus disengagement from rewarding activities will be assessed via the BADS-SF, a 9-item self-report questionnaire with strong reliability, predictive validity, and sensitivity to change following BA for adolescent depression symptoms. The BADS-SF has two subscales, both of relevance to this study: Activation (goal-directed engagement in rewarding activities) and Avoidance (engagement in rumination and avoidance rather than active coping).

Measure: Change in Behavioral Activation for Depression Scale - Short Form

Time: Pre-SSI to 3-month follow-up

Description: The State Hope Scale asks participants to rate 6 statements based on how they think about themselves right now. Participants rate the 6 statements on an 8 point scale ranging from 0 (Definitely False) to 8 (Definitely True). Total score ranges from 6 to 48 (3 to 24 for each of two subscales). There are two subscales for pathway thinking and agency thinking, respectively with higher scores representing higher total hope, pathway thinking, and agency thinking, respectively.

Measure: Change in State Hope Scale

Time: Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up

Description: 4 item version (BHS-4; referenced as 'How I Think Scale' in appended materials): This scale asks participants to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Total score ranges from 0 to 12, with a higher score indicating greater levels of hopelessness.

Measure: Change in Beck Hopelessness Scale - 4 Item Version

Time: Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up

Description: The IPTQ asks youth to rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-7 Likert scale (e.g. "Your personality is something about you that you can't change very much.") Higher mean scores (range: 1-7) on these three items indicate a stronger fixed personality mindset, lower scores, a stronger growth personality mindset.

Measure: Change in Implicit Personality Theory Questionnaire

Time: Pre-SSI, Immediately Post-SSI

Description: The PFS asks youth to rate agreement with 7 statements indicating perceived acceptability of an SSI (e.g. "I enjoyed the program") on a 5-point Likert scale (1="really disagree"; 5="totally agree"). The PFS also assesses youths' open-response feedback on each SSI. A score of 3.5/5 or above on any given PFS item is interpreted as an "acceptable" rating on that item.

Measure: Program Feedback Scale

Time: Immediately Post-SSI only

Other Outcomes

Description: Participants will be asked to report demographic information including age, sex assigned at birth, gender identity, primary language, school grade, race/ethnicity, sexual/romantic attraction, experiences, and orientation, and zip code. This measure will also assess mental health treatment history and pubertal status.

Measure: Demographic Questions

Time: Pre-SSI only

Description: Immediately pre-intervention, participants will be asked to rate their perceived socioeconomic and social status using the two items from the MacArthur Scale of Subjective Social Status-Youth Version. Respondents indicate where they see themselves on a ladder with 10 rungs (range: 1 to 10 for both items, where 1 = families with most money/education/jobs and youth with highest respect/grades/social standing; 10 = families with least money/education/jobs and youth with lowest respect/grades/social standing).

Measure: Perceived Socioeconomic and Social Status

Time: Pre-SSI only

Description: The MVPS is a self-report scale assessing adolescents' experiences of peer victimization. This study will include the social manipulation, verbal victimization, and physical victimization scales, totaling 12 items (4 items per subscale). Higher scores on any given subscale indicate more frequent victimization of specific type. Adolescents rate how often peers have victimized them in various ways in the past year (e.g. "called me names"; "tried to turn my friends against me").

Measure: Multidimensional Peer Victimization Scale

Time: Pre-SSI only

Description: The ULS is a widely used self-report scale of loneliness in adolescents. The brief 8-item version will be used here. Adolescents rate agreement with 8 items reflecting loneliness (e.g. "I feel left out"; "I feel isolated from others"). Higher summed-scores across all 8 items reflect higher levels of loneliness. The ULS has shown adequate reliability and validity in adolescent samples.

Measure: UCLA Loneliness Scale

Time: Pre-SSI only

Description: The SRET is a web-based behavioral measure of self-referent information processing biases that assesses judgements of self-descriptiveness, response latencies and free recall of emotionally valanced stimuli. Participants make decisions about whether positive and negative adjectives are self-descriptive. Participants view various adjectives (26 positive adjectives, 26 negative adjectives) one at a time and make rapid judgments about whether or not each word presented described themselves following word offset. Participants will be told to use the Q or P keys on their keyboard to answer whether the word described them or not. Each trial will be followed by a 1,500 ms intertrial interval.

Measure: Self-Referential Encoding Task (SRET)

Time: Pre-SSI

Description: The Expanded Everyday Discrimination Scale will be measured pre-intervention to gauge the levels of relatively minor, every-day, chronic discrimination experienced by participants. The original scale (Williams et al., 1997) asks participants, "In your day-to-day life, how often do any of the following things happen to you?" for 9 items (e.g. "you are treated with less courtesy than other people are") on a 5-point Likert scale (1= "never"; 6 = "almost every day"). These items assess the participant's observations about how others treat and act around them on a daily basis. The expanded version of this scale includes a 10th item, "You are followed around in stores." Scores on the Expanded Everyday Discrimination Scale range from 10-60, with higher scores indicating higher levels of chronic discrimination experienced by participants. Respondents are also asked to identify what they believe to be the main reason(s) for these experiences (e.g. gender, race, age, etc.).

Measure: Discrimination

Time: Pre-SSI

Description: The GAD-7 measures the severity of clinical anxiety symptoms, based on diagnostic criteria for generalized anxiety disorder. The GAD-7 includes 7 items asking respondents how often, during the last 2 weeks, they were bothered by each of 7 anxiety symptoms. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively; thus total sum-scores may range from 0-21 and average scores from 0 to 3.

Measure: Generalized Anxiety Disorder 7 (GAD-7)

Time: Pre-SSI

Description: Youths will self-report perceived family social status related to the COVID-19 pandemic began (ie current perceived family social status), along with which among several COVID-19-related challenges they have faced (e.g., parent has lost job; school has closed; less contact with friends; know someone who was sick with COVID-19; more conflict at home; feel bored/restless; other [free response]). Item choices will be adapted from those included in the CDC's publicly-available item bank for research on COVID-19.

Measure: COVID-19-related stressors

Time: Pre-SSI only

Description: The Child Trauma Screen-Reaction Scale (CTS-RS) is a reliable, valid self-report measure of youth traumatic stress symptom severity, including event-related somatic symptoms, intrusive memories, avoidance, sleep problems, and mood and behavioral changes. For this study, instructions will read: "For many kids and teens, the COVID-19 (or 'coronavirus') pandemic has been scary or very upsetting. Sometimes, events that are scary or upsetting can affect how people think, feel, and act. The next questions ask how you have been feeling and thinking recently." Youth will rate 6 statements describing traumatic stress symptoms (e.g., 'strong feelings in your body when you think about COVID-19 (sweating, heart beats fast, feel sick)') according to their frequency over the past 30 days (Never/Rarely; 1-2 times in the past month; 1-2 times in the past week; 3+ times per week).

Measure: Change in COVID-19-related Trauma Symptoms

Time: Pre-SSI to 3-month follow-up

Description: Disordered eating behaviors will be measured at pre-intervention and 3-month follow-up using The Dietary Restriction Screener. The DRS-2 is a 9-item measure evaluating restrictive eating, bingeing, and purging behaviors in participants. 6 items ask participants whether or not they have engaged in restrictive eating, bingeing, or purging behaviors in the past year or in the past 3 months (0 = no; 1 = yes). The other 3 items assess the frequency of these behaviors over the past 28 days.

Measure: Disordered Eating

Time: Pre-SSI to 3-month follow-up

Description: The ACEs questionnaire asks about exposure to violence, childhood emotional, physical, or sexual abuse, and household dysfunction during childhood. ACEs have shown robust associations with a range of adverse health and behavioral outcomes across the lifespan [yes/no]. Questions asked in this measure include: At any point since you were born… Did you often or very often feel that… No one in your family loved you or thought you were important or special? or Your family didn't look out for each other, feel close to each other, or support each other? Were your parents ever separated or divorced? Did you live with anyone who was a problem drinker or alcoholic, or who used street drugs? Was a household member depressed or mentally ill, or did a household member attempt suicide? Did a household member go to prison?

Measure: Adverse Childhood Experiences (ACEs) scale

Time: Pre-SSI only

Description: The BSTAD questionnaire asks respondents to report retrospectively on their personal and friends' tobacco and drug use over the past year the past year (yes/no), including questions about how frequently (in days) the respondent recalls using alcohol, tobacco, and other drugs.

Measure: Brief Screener for Tobacco, Alcohol, and Other Drugs (BSTAD)

Time: Pre-SSI only

Description: Participants rate their perceived changes in levels of pre- to post-SSI hopelessness and ability to solve problems. The questions are: Compared to before doing this activity, to what extent are you feeling hopeless right now? (Response options: much more hopeless = -2; a little more hopeless = -1; the same amount of hopeless = 0; a little less hopeless = 1; a lot less hopeless = 2). Compared to before doing this activity, to what extent are you able to solve the problems facing you right now? (Response options: Much less able to solve problems = -2; a little less able to solve problems = -1; the same amount able to solve problems = 0; a little more able to solve problems = 1; a lot more able to solve problems = 2)

Measure: Perceived pre-to-post SSI change items

Time: Immediately Post-SSI only
63 Building Mental Health Resilience in the COVID-19 Pandemic.

In this study, we test brief video interventions for those with elevated depressive symptoms. We randomize participants to one of three conditions. (1) An entrée condition involving in-depth coverage a set of cognitive behavioral therapy (CBT) skills. (2) A sampler condition which introduces three sets of CBT skills. (3) A control condition involving no skills. Among those in the entrée condition, participants are further randomized to one of three CBT skills. We plan on two sets of primary comparisons. First, we will compare the effects of each form of video intervention (i.e., entrée and sampler) to the control condition. Second, we will compare the entrée and sampler conditions. We will recruit participants from Amazon's Mechanical Turk program (MTurk). In the intervention conditions, participants will be asked to watch several videos and practice skills using worksheets. They will also be asked to practice skills introduced in the videos in the week following the intervention. In the control condition, participants will not watch videos. One week after the intervention, all participants will respond to a follow-up assessment.

NCT04643964
Conditions
  1. Depressive Symptoms
Interventions
  1. Behavioral: Entrée: Cognitive skills
  2. Behavioral: Entrée: Behavioral skills
  3. Behavioral: Entrée: Interpersonal skills
  4. Behavioral: Sampler skills
MeSH:Depression

Primary Outcomes

Description: The Quick Inventory of Depressive Symptoms-Self Report is a 16-item self-report scale that measures depressive symptom severity. Scores range from 0 to 27, with higher scores indicating greater depressive symptoms.

Measure: Change in the Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR)

Time: Baseline, 1-2 weeks after baseline

Secondary Outcomes

Description: The Ways of Responding Questionnaire is a measure of compensatory skills taught in CBT for depression. Participants respond to 6 hypothetical stressful situations in which their initial thoughts regarding the event are given. Quality scores range from 0 to 6, with higher scores indicating greater CBT skills.

Measure: Change in the Ways of Responding Questionnaire (WOR)

Time: Baseline, 1-2 weeks after baseline

Description: The Styles of Emotion Response Questionnaire is a 36-item self-report scale that measures the extent to which respondents endorse four different domains of coping skills: cognitive, behavioral, interpersonal, and mindfulness. For each item, participants are asked how often they use the strategy and how much feeling upset negatively impacts the use of this strategy. Scores from the first three skills are secondary outcomes. Scores range from 18-90 in each domain, with higher scores indicating greater coping skill use.

Measure: Change in the Styles of Emotion Response Questionnaire (SERQ)

Time: Baseline, 1-2 weeks after baseline

Description: The University of California, Los Angeles (UCLA) Loneliness Scale, Version 3 is a 20-item self-report scale that measures subjective feelings of loneliness and isolation. Scores range from 20-80, with higher scores indicating greater subjective experience of loneliness.

Measure: Change in the University of California, Los Angeles (UCLA) Loneliness Scale, Version 3

Time: Baseline, 1-2 weeks after baseline
64 The Effect of Aerobic Training Versus Cognitive Behavioral Therapy in Management of Anxiety, Depression and Stress-related to Covid 19 Pandemics Among University Students: a Comparative Study

Anxiety and depression disorders (ADD) have the highest overall prevalence rate among psychiatric disorders in young females. Its manifestations are disabling, distressing a substantial negative impact on the quality of life. The purpose of this study was to compare the effect of cognitive-behavioral therapy and physical therapy on female students with mild to moderate anxiety and depression.

NCT04662021
Conditions
  1. Anxiety Depression Disorder
Interventions
  1. Other: Aerobic Exercises
MeSH:Depression Anxiety Disorders

Primary Outcomes

Description: The DASS 21 is a 21 item self-report questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety

Measure: DASS 21

Time: 8 weeks
65 An Online Cultural Experience to Support Mental Health in People Aged 16-24 During COVID-19: the O-ACEPOP (Online Active Community Engagement Proof of Principle) Study

O-ACE POP is a randomised controlled trial of an online cultural experience named Ways of Being, compared to a typical museum website (the Ashmolean Museum). The primary aim is to compare these two interventions by efficacy on mood, distress (depression and anxiety), flourishing and investigate potential mechanisms of action, as well as the feasibility of a larger scale RCT.

NCT04663594
Conditions
  1. Depression
  2. Anxiety
Interventions
  1. Other: WofB
  2. Other: Ashmolean Website
MeSH:Depression

Primary Outcomes

Description: Is a widely used scale of emotion and comprises 20 items, 10 measuring positive affect (excited, inspired etc) and 10 measuring negative affect (upset, afraid etc), on a Likert Scale of 1 (very slightly) to 5 (extremely). We will be measuring change between baseline and time-points (in Timeframe)

Measure: PANAS

Time: Baseline, Days 2-4 (morning and evening), Day 5, six weeks

Description: The K10 is a well validated self-report measure of distress (depression and anxiety). We will be measuring change between baseline and time-points (in Timeframe)

Measure: K10

Time: Baseline, Day 5, six weeks

Secondary Outcomes

Description: The facial expression recognition task provides an objective measure of emotional bias which is associated with vulnerability to depression. We will be measuring change between baseline and time-points (in Timeframe)

Measure: Facial expression recognition task

Time: Baseline, Day 5, six weeks

Description: This is an instrumental learning task in which the participant gains or loses points by choosing between two paired images. The participant is told that some images are more likely (but not always) to be associated with gains and some with losses. The explicit aim is to maximize points. We will be measuring change between baseline and time-points (in Timeframe)

Measure: Decision Making Task

Time: Baseline, Day 5, six weeks

Description: The Flourishing Scale is an 8-item measure of self-perceived success in domains such as self-esteem, relationships, optimism and purpose. We will be measuring change between baseline and time-points (in Timeframe)

Measure: Flourishing

Time: Baseline, Day 5, six weeks

Description: The UCLA Loneliness Scale is a self-report inventory that uses a Likert-type scale to assess subjective feelings of loneliness. In addition we will add an item directly asking about loneliness. We will be measuring change between baseline and time-points (in Timeframe).

Measure: Loneliness

Time: Baseline, Day 5, six weeks

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on December 13, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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