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D003863: Depressi

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 (124)


Name (Synonyms) Correlation
drug4130 survey Wiki 0.21
drug4022 other Wiki 0.18
drug4066 quesionnair Wiki 0.13
Name (Synonyms) Correlation
drug613 CONVALESCENT PLASMA Wiki 0.13
drug4164 venipuncture in peripheral vein Wiki 0.13
drug484 Biological sampling Wiki 0.13
drug2596 Positive Minds Strong Bodies Enhanced Wiki 0.13
drug2324 Online Intervention Mental Health COVID-19 Wiki 0.13
drug3157 Social media & news consumption Wiki 0.13
drug4068 questionnair about Emerging Legal and Ehical Disputes Over Patient Confidentiality Wiki 0.13
drug4019 oral co-trimoxazole Wiki 0.13
drug4060 psychological assessment Wiki 0.13
drug4058 psycho-education video Wiki 0.13
drug3998 non applicable Wiki 0.13
drug555 Brief Skills for Safer Living Wiki 0.13
drug4017 online questionnaires Wiki 0.13
drug947 Cross-sectional observational study Wiki 0.13
drug801 Clevudine Wiki 0.13
drug4005 none, this study is observational Wiki 0.13
drug4077 realtime PCR Wiki 0.13
drug4132 surveys and questionnaires Wiki 0.13
drug3813 blood sample for seroepidemiological investigation Wiki 0.13
drug3853 covid-19 positive pregnant women Wiki 0.13
drug3069 Self-focused acts Wiki 0.13
drug4156 turkish physicians Wiki 0.13
drug3359 TMS Wiki 0.13
drug4138 telephone consult Wiki 0.13
drug4018 online survey Wiki 0.13
drug455 Behavioral: OCAT Wiki 0.13
drug2323 Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop Wiki 0.13
drug3601 Use of social media during COVID-19 Wiki 0.13
drug1417 Group CBT Wiki 0.13
drug3623 VRC-SRSDNA015-00-VP Wiki 0.13
drug4014 olfactory device Wiki 0.13
drug3062 Self Study Wiki 0.13
drug477 Biological Wiki 0.13
drug454 Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material Wiki 0.13
drug933 Covid ICU containment measures Wiki 0.13
drug2847 Reinforcement learning message delivery Wiki 0.13
drug3266 State-trait anxiety inventory scale Wiki 0.13
drug451 Beck Depression Inventory (BDI) Wiki 0.13
drug2064 Minimal Attention Control Intervention Wiki 0.13
drug4016 online mindfulness group Wiki 0.13
drug2679 Prospective study across two time-points examining the impact of viral mitigation protocols on mental health Wiki 0.13
drug4144 this study is non- interventional Wiki 0.13
drug316 Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery Wiki 0.13
drug1154 Edinburgh Postnatal Depression Scale (EDPS) Wiki 0.13
drug4032 photobiomodulation and photodynamic therapy Wiki 0.13
drug3066 Self-System Therapy Wiki 0.13
drug4108 sham TMS Wiki 0.13
drug3594 Urine Test Wiki 0.13
drug611 COMPASS Wiki 0.13
drug4106 serum inflammatory biomarkers Wiki 0.13
drug2766 RECHARGE Wiki 0.13
drug3867 e-Psychotherapy Wiki 0.13
drug3711 Web-based psychosocial peer-to-peer support Wiki 0.13
drug2595 Positive Emotion Skills Course Wiki 0.13
drug943 Crisis intervention therapy Wiki 0.13
drug3625 Vaccine Wiki 0.13
drug4079 recovered covid 19 patients plasma Wiki 0.13
drug3455 Therapist Guided E-Therapy Wiki 0.13
drug2057 Mindfulness exercises Wiki 0.13
drug3127 Simha Kriya Wiki 0.13
drug4143 theraputic heparin Wiki 0.13
drug4010 observation Wiki 0.13
drug3065 Self-Help Therapy Wiki 0.13
drug3743 Yoga Wiki 0.13
drug4098 samling of oropharynx and nasopharynx Wiki 0.13
drug453 Behavioral Activation in real-life Wiki 0.13
drug553 Brief Behavioral Activation with Mental Imagery Wiki 0.13
drug3587 Uniform random message delivery Wiki 0.13
drug4177 zinc gluconate and ascorbic acid Wiki 0.13
drug3588 Universal Screening Arm Wiki 0.13
drug3995 no intervention. observational cohort study Wiki 0.13
drug3148 Slef questionnaires fulfilment Wiki 0.13
drug2421 Pandemic control measures Wiki 0.13
drug1838 Limbix Spark Wiki 0.13
drug4057 prophylactic lactoferrin daily Wiki 0.13
drug43 38 questions questionnaire Wiki 0.13
drug4027 patients COVID 19 Wiki 0.13
drug4069 questionnaire Wiki 0.13
drug4168 vitamin d Wiki 0.13
drug1360 GAD-7 (General Anxiety Disorder) scale Wiki 0.13
drug394 BGB DXP593 Wiki 0.13
drug505 Blood Test Wiki 0.13
drug4127 stem cells Wiki 0.13
drug1136 EPDS (Edinburgh Postnatal Depression Scale) Wiki 0.13
drug3376 Taste test Wiki 0.13
drug4056 prophylactic heparin Wiki 0.13
drug949 Cross-sectional study investigating the association of NPIs with mental health Wiki 0.13
drug2842 Registery Data Collection Wiki 0.13
drug556 Brief cognitive behavioral therapy Wiki 0.13
drug2675 Prosocial acts Wiki 0.13
drug4087 rhDNase I Wiki 0.13
drug684 CRI management Wiki 0.13
drug456 Behavioral: OCAT-sham Wiki 0.13
drug2394 PHQ-9 (Patient Health Questionnaire) Depression Scale Wiki 0.13
drug1709 Intervention group CoronaCope Wiki 0.13
drug4048 pre-operative screening Wiki 0.13
drug2489 Physical Exam Wiki 0.13
drug2817 Reading a Book Wiki 0.13
drug552 Brief Behavioral Activation Treatment Wiki 0.13
drug4067 questionaire to husband and wife Wiki 0.13
drug3215 Standard charity resources Wiki 0.13
drug3665 Virtual Reality Behavioral Activation Wiki 0.13
drug2051 Mindfulness Wiki 0.09
drug1956 MagPro X100 Stimulator, B70 Fluid-Cooled Coil Wiki 0.09
drug2691 Psychoeducation Wiki 0.09
drug1192 Enhanced Usual Care Wiki 0.09
drug4102 serology Wiki 0.09
drug474 Bicalutamide 150 Mg Oral Tablet Wiki 0.09
drug498 Biospecimen Collection Wiki 0.07
drug4099 self-administered questionnaire Wiki 0.07
drug527 Blood sampling Wiki 0.07
drug4012 observational Wiki 0.07
drug3309 Survey Wiki 0.07
drug2334 Online survey Wiki 0.06
drug2742 Questionnaire Administration Wiki 0.05
drug2741 Questionnaire Wiki 0.05
drug518 Blood sample Wiki 0.04
drug829 Colchicine Wiki 0.04
drug2855 Remdesivir Wiki 0.03
drug3221 Standard of Care Wiki 0.02
drug2505 Placebo Wiki 0.02

Correlated MeSH Terms (20)


Name (Synonyms) Correlation
D003866 Depressive Disorder NIH 0.51
D019052 Depression, Postpartum NIH 0.31
D003865 Depressive Disorder, Major NIH 0.17
Name (Synonyms) Correlation
D001008 Anxiety Disorders NIH 0.15
D001238 Asphyxia Neonatorum NIH 0.13
D000067292 Alcohol Drinking in College NIH 0.13
D013405 Suicide NIH 0.09
D059020 Suicidal Ideation NIH 0.09
D001714 Bipolar Disorder NIH 0.09
D000077062 Burnout, Psychological NIH 0.07
D007319 Sleep Initiation and Maintenance Disorders NIH 0.06
D020920 Dyssomnias NIH 0.06
D020447 Parasomnias NIH 0.05
D002055 Burnout, Professional NIH 0.05
D013315 Stress, Psychological NIH 0.05
D020521 Stroke NIH 0.03
D040921 Stress Disorders, Traumatic NIH 0.02
D013313 Stress Disorders, Post-Traumatic NIH 0.02
D016638 Critical Illness NIH 0.02
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0000716 Depressivity HPO 0.47
HP:0012768 Neonatal asphyxia HPO 0.13
HP:0100754 Mania HPO 0.09
Name (Synonyms) Correlation
HP:0100785 Insomnia HPO 0.06

Clinical Trials

Navigate: Correlations   HPO

There are 63 clinical trials


1 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:Depressi 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
2 Concurrent fMRI-guided rTMS and Cognitive Therapy for the Treatment of Major Depressive Episodes

Background: Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective. Objective: To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression. Eligibility: Adults ages 18-65 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks. Design: Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests. Phase 1 is 1-4 visits in 1 week. Participants will have: - Brain MRI. Participants will lie on a table in a scanner. - Questions about their medical history and psychology symptoms - Tests of mood and thinking - Tests of brain activity. Participants may do tasks during these tests: - A cone with magnetic detectors is put on the head. - A cap with electrodes is put on the scalp. - TMS. A brief electrical current passes through a wire coil on the scalp. - A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock. Phase 2 is about 6 to 7 weeks. - There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks. - Participants will receive rTMS and another therapy by computer. - For rTMS, repeated pulses will pass through the coil. - This is followed by up to 3 additional visits, when: - Participants will repeat Phase 1 tests - Participants will rate their depression symptoms. Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.

NCT03289923
Conditions
  1. Major Depressive Disorder
Interventions
  1. Other: sham TMS
  2. Device: TMS
  3. Behavioral: Self-System Therapy
  4. Behavioral: Mindfulness exercises
MeSH:Depressive Disorder Depression Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

Description: change in magnitude of BOLD signal with fMRI bold signal from DLPFC

Measure: Change in magnitude of Bold signal

Time: 6 weeks after initiating intervention

Secondary Outcomes

Description: Recordings of brain activity

Measure: Electrophysiological changes using MEG and EEG measures

Time: 6 weeks after initiating intervention

Description: Clinical symptom scales from which we derive scores

Measure: Clinical Rating Scales: BSL, C-SSRS, CTQ, HAM-A, NIH-BFI, PANAS, RBANS, RRS, SHAPS, and TLEQ

Time: Variable: some 6 weeks after initiating intervention; others weekly
3 Characterization and Treatment of Adolescent Depression

Background: Almost 20% of Americans have depression. It is a leading cause of disability because it is chronic and it starts early. The highest incidence is among adolescents and young adults. But researchers don t know much about why some people become depressed whilst others don t. One possibility is that the way people process rewarding stimuli could be related to their risk for depression. Objective: To characterize and treat depression in youth by focusing on reward processing. Eligibility: People ages 11 17 with major depressive disorder or subthreshold depression Healthy volunteers ages 11 17 Design: Participants will be screened with interviews and questionnaires. They will have memory, thinking, and concentration tests. They may have a urine pregnancy test or have photos or videos taken. At the initial visit, participants will: Perform tasks and be interviewed Have functional magnetic resonance imaging (MRI) scans. For this, participants will lie in a metal cylinder in a magnetic field. They will do study tasks while looking at a screen in the scanner. Look at pictures of stimuli that signal win (rewards) or loss and get money for making certain choices. Have brain and eye activity monitored Do tasks in a virtual reality environment Wear an activity monitor Choose to have blood taken for research studies Perform tasks while in magneto-encephalography a machine that uses sensitive magnetic sensors to measure the brain s electric activity Participants will get phone prompts at home to ask about their mood. Participants will have several follow-up visits the first year, then 1-2 each year until they are 25. They will repeat some tasks above. Some participants with depression can elect to receive outpatient treatment at NIH and can receive inpatient treatment at NIH, if they wish. None of the treatments are experimental, that is, all treatments are standard and have an evidence base. Patients will have more visits before and after they have treatment. They will do some of the tests above plus drug testing. Participants who are in treatment and their parents will talk with a Senior Attending physician, a nurse, social worker, or psychologist. Those in outpatient treatment will have practice work between visits. Those who are inpatients will have practice work during their inpatient treatment and adjustments to medication can be made.

NCT03388606
Conditions
  1. Depression
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: changes in MFQ scores over time

Measure: Mood and Feelings Questionnaire

Time: Ongoing
4 Using a Diagnostic Taste Test as a Surrogate Biomarker to Predict Drug Effectiveness in Patients With Depression (MDD)

The study will be looking at whether a taste test device can be used as a diagnostic aid for depression. Taste tests will be carried out before and after first use of an antidepressant (prescribed by the patient's GP) and then again a month later a further taste test will be conducted. The results of these tests will be assessed to see if they correlate with the outcome of validated mood questionnaires carried out at the first and second visits.

NCT03645447
Conditions
  1. Depression
Interventions
  1. Diagnostic Test: Taste test
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: Change in taste threshold measures (sweet, salt, bitter, sour) between baseline and post-probe(s) at day 1 and 28 days after antidepressant treatment is initiated is assessed with the assistance of a taste test device.

Measure: Change in taste threshold with antidepressant treatment

Time: 4-6 weeks (per patient)

Description: Change in mood (assessed by score on the Beck Depression Inventory (BDI)) with antidepressant treatment is assessed. BDI scores may range from 0-63, where 0 demonstrates the lowest depression score and 63 the most severe depression.

Measure: Change in mood (assessed by score on the Beck Depression Inventory) with antidepressant treatment

Time: 4-6 weeks (per patient)

Secondary Outcomes

Description: Changes in scores on the Clinical Global Impression scale, as assessed by the participant's general medical practitioner is recorded. This scale ranges from 0-7, where 0 is the least severely ill and 7 the most severely ill.

Measure: Change in mood with antidepressant treatment, measured by the Clinical Global Impression Scale (CGI scale)

Time: 4-6 weeks (per patient)

Description: Change in mood with antidepressant treatment, measured by the Patient Health Questionnaire 9 (PHQ9). PHQ9 scores range from 0-27, where 0 is the score for the least depressed patients and 27 the most severely depressed patients.

Measure: Change in mood with antidepressant treatment, measured by the Patient Health Questionnaire 9 (PHQ9)

Time: 4-6 weeks (per patient)

Description: Change in mood with antidepressant treatment, measured by the Hospital Anxiety and Depression scale (HADS). HADS scores for depression range from 0-21, where 0-7 is normal, 8-10 borderline and 11+ indicates clinical depression

Measure: Change in mood with antidepressant treatment, measured by the Hospital Anxiety and Depression scale (HADS)

Time: 4-6 weeks (per patient)

Description: Change in mood with antidepressant treatment, measured by the Quick Inventory of Depressive symptomatology (QIDS). Scores for QIDS range from 0-27, where 0 indicates no symptoms of depression and 27 indicates the most severe depression.

Measure: Change in mood with antidepressant treatment, measured by the Quick Inventory of Depressive symptomatology (QIDS)

Time: 4-6 weeks (per patient)

Description: A computerised algorithm will be used to direct the taste test to assess taste sensitivity. The algorithm has been developed to direct the taste test, indicating which taste solutions should be presented to the participant in which order. Every solution presented is recorded, along with answers given. These will be examined after testing to validate the code's ability to follow the algorithm created and properly determine taste thresholds.

Measure: Validation of diagnostic algorithm, comparing the sequence of taste testing determined by software with the algorithm described in the software specification.

Time: 12 months (duration of trial)

Description: User views on ease of use of the device and testing process will be collected. Users will be asked to give ease of use a score from 1-5, where 1 is very easy and 5 is very difficult. Participants will also be asked whether they would use the taste test again.

Measure: User assessment of ease of use of the device and testing process.

Time: 4-6 weeks (per patient)
5 Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

The primary goal of the proposed study is to compare the effectiveness of universal school based screening for adolescent major depressive disorder to the current school process of targeted screening based on concerning behavior.

NCT03716869
Conditions
  1. Major Depressive Disorder
  2. Major Depressive Episode
Interventions
  1. Other: Universal Screening Arm
MeSH:Depressive Disorder Depression Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

Description: Universal 1) Adolescents with PHQ-9 score >10 (screen Sept-Mar of the school year) or who at any point in the year exhibit behavior concerning for MDD prompting a SAP triage request, 2) Adolescents identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one SAP recommendation. Prior Sept-Nov screening adjusted per school preference. Targeted 1) Adolescents with behavior concerning for MDD prompting a SAP triage request, 2) Adolescents identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one SAP recommendation Concern for MDD based on a primary or secondary potentially MDD related SAP "incoming referral reason" SAP triage is not diagnostic, so MDD identified based on recommendations for MDD related school or community services (e.g. mental health treatment services) HRSA funds mostly rural schools (anticipated N=3900; all rural but one school) and PCORI funds urban schools (anticipated N=13400

Measure: MDD composite: Adolescents MDD screen positive by PHQ-9 (universal arm) or with concern for MDD prompting Student Assistance Program (SAP) triage request, identified with MDD by SAP, and who engage with at least one SAP recommended service or treatment

Time: up to 9 months

Secondary Outcomes

Description: Universal screening arm: Adolescents who have a PHQ-9 score >10 (screening with the PHQ-9 is planned during the academic year, e.g. September to March) or who at any point in the school year exhibit behavior concerning for MDD which prompts self or collateral request for SAP triage. Targeted screening arm: Adolescents with behavior concerning for MDD which prompts self or collateral request for SAP triage at any point during the school year. Concern for MDD is based on a primary or secondary potentially MDD related SAP "incoming referral reason".

Measure: MDD screen positive/concern: Adolescents who screen positive for MDD either by PHQ-9 (universal screening arm only) or by concern for MDD prompting a request for SAP triage

Time: up to 9 months

Description: Universal screening arm: Patient health questionnaire positive response to question #9 re: suicidal thoughts, which requires management by the state-mandated school crisis plan or student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district). Targeted screening arm: Student self or collateral report of suicidal thoughts, which requires management by the state-mandated school crisis plan (source school district). Any student suicide attempts or completed suicides shared with the school district will also be included.

Measure: Suicidal Adolescent

Time: up to 9 months

Description: Universal and targeted screening arms: Adolescents who are identified as having MDD based on triage by the school SAP team. As SAP triage is not diagnostic, MDD identified will be based on SAP recommendations for school or community services which are MDD related (e.g. mental health treatment services).

Measure: MDD identification: Adolescents who are identified as having MDD based on triage by the school SAP team

Time: up to 9 months

Description: Universal and targeted screening arms: Adolescents who successfully engage with at least one SAP recommendation. This may be fulfilled by parental report that an appointment was successfully scheduled.

Measure: MDD treatment engagement: Successful engagement with at least one SAP recommendation

Time: up to 9 months

Description: This performance measure represents the percentage of all students scoring Proficient or Advanced on the Mathematics Algebra I Keystone Exam. Algebra I Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.

Measure: Standardized test scores: Keystone exams mathematics (school district). This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing.

Time: up to 9 months

Description: This performance measure represents the percentage of all students scoring Proficient or Advanced on the ELA/Literature Keystone Exam. Literature Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.

Measure: Standardized test scores: Keystone exams English language arts (ELA; school district) This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing.

Time: up to 9 months

Description: This performance measure represents the percentage of all students scoring Proficient or Advanced on the Science/Biology Keystone Exam. Biology Keystone scores reflect students' best score to date for all 11th grade students enrolled in the school for the full academic year.

Measure: Standardized test scores: Keystone exams science (school district) This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing.

Time: up to 9 months

Description: This performance measure represents the percent of 12th grade students who have taken the PSAT or Plan at any time over the course of their educational experience.

Measure: Preliminary Scholastic Aptitude Test (PSAT)/Plan (school district) This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing.

Time: up to 9 months

Description: This performance measure represents the percent of 12th grade students meeting both SAT College and Career Readiness benchmarks and/or scoring 22 or higher on the ACT taken at any time over the course of their educational experience.

Measure: Scholastic Aptitude Test (SAT)/ American College Testing (ACT) performance (school district) This information may no longer be available due to COVID-19 school closures and cancellation of state standardized testing.

Time: up to 9 months

Description: data aggregate by grade level only schools currently track the number of student policy violations (e.g. for drug and alcohol, violence) and student suspensions

Measure: Student school policy violations and suspensions based on school district data

Time: up to 9 months

Description: data aggregate by grade level only

Measure: Missed school days

Time: up to 9 months

Description: data aggregate by grade level only

Measure: Grade point average

Time: up to 9 months

Description: data aggregate by grade level only

Measure: Grade advancement: This measure represents the percent of students promoted in each grade for the school (grades 9-11, school district data)

Time: up to 9 months

Description: data aggregate by grade level only

Measure: Graduation: This measure represents the percent of students who graduate 12th grade with a high school diploma (school district data)

Time: up to 9 months

Other Outcomes

Description: Sex (Male, Female), Ethnicity, Race, Rural/Urban

Measure: Subgroup analyses based on school district demographic data

Time: up to 9 months
6 Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents

Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.

NCT03831360
Conditions
  1. Depression
Interventions
  1. Behavioral: Yoga
  2. Behavioral: Group CBT
MeSH:Depression

Primary Outcomes

Description: Acceptability assessed with Qualitative interview

Measure: Qualitative interview

Time: post intervention (month 3)

Description: Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are measured on a 1-9 scale (not at all - very), Higher scores indicate greater credibility.

Measure: Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale

Time: Week 1

Description: Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. One of the 3 items are measured on a 1-9 scale (not at all - very), 2 are on a 0-10 scale (0-100%). Higher scores indicate greater expectations.

Measure: Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale

Time: Week 1

Description: Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale. Higher scores indicate greater client satisfaction.

Measure: The Client Satisfaction Questionnaire (CSQ-8)

Time: Post intervention (month 3)

Description: Yoga home practice assessed with a Home practice questionnaire. Duration, frequency, and type of formal and informal home yoga practice between class sessions.

Measure: Home practice questionnaire

Time: Post intervention (month 3)

Description: Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.

Measure: Systematic assessment of treatment-emergent events-general inquiry (SAFTEE)

Time: Post intervention (month 3)

Secondary Outcomes

Description: Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.

Measure: Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)

Time: Baseline to post intervention (month 3); Baseline to 6 months; Baseline to 9 months
7 Scaling Up Maternal Mental Health Care by Increasing Access to Treatment (SUMMIT): A Study Protocol for Perinatal Depression and Anxiety

SUMMIT (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1368). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether one brief, behavioral activation (BA) delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health nurses, with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, Chicago and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.

NCT04153864
Conditions
  1. Perinatal Depression
Interventions
  1. Behavioral: Brief Behavioral Activation Treatment
MeSH:Asphyxia Neonatorum Depression Depressive Disorder
HPO:Depressivity Neonatal asphyxia

Primary Outcomes

Description: Brief BA psychological treatment is delivered by non-specialist providers. The perinatal depressive symptoms are measured by the Edinburgh Postnatal Depression Scale. The minimum and maximum values for the Edinburgh Postnatal Depression Scale are 0 and 30 respectively. Higher scale scores are associated with higher perinatal depressive symptoms. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Treatment of perinatal depressive symptoms by non-specialist providers

Time: 3-months post-randomization

Description: Brief BA psychological treatment is delivered through telemedicine. The perinatal depressive symptoms are measured by the Edinburgh Postnatal Depression Scale. The minimum and maximum values for the Edinburgh Postnatal Depression Scale are 0 and 30 respectively. Higher scale scores are associated with higher perinatal depressive symptoms. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Treatment of perinatal depressive symptoms through telemedicine

Time: 3-months post-randomization

Secondary Outcomes

Description: Brief BA psychological treatment is delivered by non-specialist providers. The anxiety symptoms are measured by the Generalized Anxiety 7 Item Questionnaire. The minimum and maximum values for the Generalized Anxiety 7 Item Questionnaire are 0 and 21 respectively. Higher scale scores are associated with higher perinatal anxiety symptoms. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Treatment of perinatal anxiety symptoms by non-specialist providers

Time: 3-months post-randomization

Description: Brief BA psychological treatment is delivered through telemedicine. The anxiety symptoms are measured by the Generalized Anxiety 7 Item Questionnaire. The minimum and maximum values for the Generalized Anxiety 7 Item Questionnaire are 0 and 21 respectively. Higher scale scores are associated with higher perinatal anxiety symptoms. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Treatment of perinatal anxiety symptoms through telemedicine

Time: 3-months post-randomization

Description: Child mental development is measured by Bayley Mental Developmental Scale III and the provision of psychosocial stimulation by the mother measured by Home Observation Measurement Evaluation. Cognitive development, expressive and receptive language, and fine and gross motor development composite scores are measured by Bayley Mental Developmental Scale III. The composite scores are scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Higher scaled scores are associated with higher mental health development in child. The minimum and maximum values for the Home Observation Measurement Evaluation scale scores are 0 and 45 respectively. Higher scores are associated with more enriched environment.

Measure: Child Mental Health Development

Time: 9 to 12 months post child birth

Description: Response and Remission is measured by Patient Health Questionnaire 9. The minimum and maximum values for Patient Health Questionnaire 9 are 0 and 27 respectively. Response and Remission is defined as PHQ-9 of less than 10 and 5 respectively. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Response and Remission

Time: 3-months post-randomization
8 Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

The primary purpose of this study is to test the safety and feasibility of virtual reality (VR) technology in the use of behavioral activation (BA) as a treatment for major depressive disorder (MDD). The secondary purpose of this study is to examine whether any evidence of clinical efficacy exists for VR delivered BA.

NCT04268316
Conditions
  1. Major Depressive Disorder
  2. MDD
  3. Depres
  4. Depression
Interventions
  1. Device: Virtual Reality Behavioral Activation
  2. Behavioral: Behavioral Activation in real-life
MeSH:Depression Depressive Disorder Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

Description: This outcome will be measured using the "Intention to use Technology " questions of the Technology Acceptance Model questionnaire. These are questions 11, 12, and 13 and allow participants the option of circling Strongly Disagree, Disagree, Neutral, Agree, or Strongly Agree.

Measure: Participant's desire to continue using VR after the study ends

Time: 4-weeks

Description: Participant treatment dropout will be compared across each study arm.

Measure: Rates of dropout of VR-BA

Time: 4-weeks

Description: This outcome will be measured using the "Attitudes Toward Use " questions of the Technology Acceptance Model questionnaire. These are questions 7, 8, 9, and 10 and allow participants the option of circling Strongly Disagree, Disagree, Neutral, Agree, or Strongly Agree.

Measure: Participant's satisfaction with the VR-BA treatment

Time: 4-weeks

Description: This will be measured by noting the amount of times the VR headset is used.

Measure: Participant's use of the VR headset

Time: 4-weeks

Description: This will be measured using the overall Technology Acceptance Model questionnaire, which encompasses 13 questions and allows participants the option of circling Strongly Disagree, Disagree, Neutral, Agree, or Strongly Agree.

Measure: Participant's acceptance of VR-BA treatment

Time: 4-weeks

Description: This will be determined by the Simulator Sickness Questionnaire, which names 16 adverse symptoms and asks participants to circle as compared to baseline: No more than usual, Slightly more than usual, Moderately more than usual, or Severely more than usual.

Measure: How well can participants tolerate the VR-BA treatment?

Time: 4-weeks

Description: This will be measured using the Presence Questionnaire, which asks three questions and asks the participants to circle either Not at all, Slightly, Moderately, Strongly, or Very Strongly.

Measure: How present did individuals in the VR-BA treatment feel?

Time: 4-weeks.

Secondary Outcomes

Description: How participants' depression scores PHQ-9 change over time using VR-BA compared to BA in real life and a waitlist control. The PHQ-9 is a 9-question screener with a score range of 0-29, with 29 indicating the most severe depression and 0 indicating a lack of depression symptoms.

Measure: Clinical efficacy of using VR as a tool to deliver BA

Time: 4-weeks
9 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)
10 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
11 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, they 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 they 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 internet 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 EPDS in urban women living in Hong Kong and Shanghainese women. Scores of EPDS range from min = 0 to max=30. The higher the more depressed a woman is.

Measure: Edinburgh Postnatal Depression Scale (EPDS)

Time: 4-6 weeks postpartum

Secondary Outcomes

Description: Association 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

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
12 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
13 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
14 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 9 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
15 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)
16 A Positive Affect Regulation sKills Intervention to Decrease Stress During a Pandemic: A Single Arm, Non-Randomized Trial of a Public Platform

The Positive Affect Regulation sKills (PARK) Course is an online program containing a series of positive emotion skills for individuals experiencing stress and distress as a result of the COVID-19 outbreak, recommended/mandatory social distancing, and other related stressors (e.g., loss of income, shortages of daily essentials, etc.). The study specifically targets positive emotion, and offers an array of skills in a self-guided online delivery platform, making the program accessible and convenient in times when social distancing and self-quarantine are paramount to quell the spread of COVID-19. Our main aims are: Aim 1: To explore the effects of PARK on anxiety, depression, feelings of social isolation, positive affect, and a sense of meaning and purpose. Aim 2: To test whether age or gender moderate the effects of the program.

NCT04367922
Conditions
  1. Anxiety
  2. Depression
  3. Social Isolation
Interventions
  1. Behavioral: Positive Emotion Skills Course
MeSH:Depression

Primary Outcomes

Description: Assessed using PROMIS Anxiety (CAT)

Measure: Change in anxiety

Time: Baseline, 6 weeks, 6 months

Description: Assessed using PROMIS Depression (CAT)

Measure: Change in depression

Time: Baseline, 6 weeks, 6 months

Description: Assessed using PROMIS Social Isolation (CAT)

Measure: Change in feelings of social isolation

Time: Baseline, 6 weeks, 6 months

Description: Assessed using PROMIS Positive Affect (CAT)

Measure: Change in positive affect

Time: Baseline, 6 weeks, 6 months

Description: Assessed using PROMIS Meaning and Purpose (CAT)

Measure: Change in sense of meaning and purpose

Time: Baseline, 6 weeks, 6 months
17 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
18 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
19 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
20 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
21 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)
22 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
23 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
24 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
25 ''(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 levelsWÄ°TH 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
26 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
27 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
28 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
29 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
30 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
31 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
32 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: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.
33 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)
34 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
35 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:Depressi 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
36 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.
37 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 Pro
  4. Interpersonal Problem
  5. 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
38 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
39 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
40 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
41 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
42 Prevalence of Mental Health Problems Among Undergraduate Students at the Universidad de Los Andes

This project seeks to know the prevalence of mental health problems among undergraduate students, through internationally and nationally validated screening instruments. The project also aims to understand better the associated factors contributing to the mental health problems of this population. Through the critical analysis of the results, our proposal aims to establish the prevalence of anxiety, depression, suicidality and substance use, and the association with socioeconomic features, academic stress, sense of belonging to the university, interpersonal relationships, and sleep habits among other factors. Once finalized the study, the results obtained will be disseminated to the university community and published in peer-reviewed journals. The results will help the university authorities to design and implement measures to prevent mental health problems in this community.

NCT04447690
Conditions
  1. Student
  2. Mental Health
  3. Depression, Anxiety
  4. Depression
  5. Anxiety
  6. College Drinking
  7. Stress
MeSH:Depression Depressive Disorder Anxiety Disorders Alcohol Drinking in College
HPO:Depressivity

Primary Outcomes

Description: Self-reported symptoms with the Depression, Anxiety and Stress Scale (DASS-21), which have 21 items, each scoring between 0 and 3, the minimum score is 0 and the maximum score of 63. The cut-off score for the depression subscale is 6, Anxiety is 5, Stress is 6.

Measure: Depression, Anxiety and Stress Scale (DASS-21)

Time: Up to 4 weeks

Description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment. This scale has 6 items and each item has to be answered Yes or No. The total score is 6. A score of 0 is no ideation is present.

Measure: Columbia-Suicide Severity Rating Scale (C-SSRS)

Time: Up to 4 weeks

Description: Self-report of harmful alcohol drinking. 4 items. CAGE stands for: C: Have you felt the need to Cut down drinking? A: Have you ever felt Annoyed by criticism of drinking? G: Have you had Guilty feelings about drinking? E: Do you ever take a morning Eye opener (a drink first thing in the morning to steady your nerves or get rid of a hangover)? The range score goes from 0 to 4. The point cut off is >= 2.

Measure: CAGE

Time: Up to 4 weeks

Description: Adaptation of The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) interview model, including prescription and nonprescription drugs and vaping. It has 8 items exploring the frequency of substance use in the last 3 months (daily, weekly, yearly) and the problems associated with the use. It explores the use of 10 kinds of drugs.

Measure: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

Time: Up to 4 weeks

Secondary Outcomes

Description: Ad hoc self-report survey: Current age University enrollment year Current years of study Sex Gender Civil status Parenting and number of child(s) Nationality Etnicity Ocupational situation: only study, part-time worker, fulltime worker and study Carrer Maximum parents studies degree: analphabet, school, undergraduate, postgraduate; complete or incomplete studies. Payment of studies: credit, schollarship, self-pay Travel time from home to campus: minutes, hours.

Measure: Sociodemographic characteristics

Time: Up to 4 weeks

Description: Self-perception on a subjective analogous scale of physical health

Measure: General Health perception

Time: Up to 4 weeks

Description: Self-perception on a subjective analogous scale of mental health

Measure: General Menta Health perception

Time: Up to 4 weeks

Description: Ad hoc self-report survey of any previous chronic physical disease

Measure: History of chronic diseases

Time: Up to 4 weeks

Description: Ad hoc self-report survey of minutes of physical activity during the past week

Measure: Physical activity

Time: Up to 4 weeks

Description: Ad hoc self-report survey of time spent with friends or social gatherings

Measure: Social activities

Time: Up to 4 weeks

Description: Family functionality APGAR score: a 5-item measure of perceived family support in the domains of adaptation, partnership, growth, affection, and resolve. E.g. "I find that my family accepts my wishes to take on new activities or make changes in my lifestyle". Scores range from 0 to 10, being 10 a total satisfaction with family functionality.

Measure: Family functionality (APGAR)

Time: Up to 4 weeks

Description: Ad hoc self-report questionnaire of personal and family mental health history: Previous diagnosis of depression, bipolar disorder, panic attacks, anxiety disorders, eating disorders, ADHD. Current psychotherapy of psychiatric medication Family history of psychiatric disorders

Measure: History of personal and family mental health problems

Time: Up to 4 weeks

Description: Self-report of insomnia perception. it has 7 items, and responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Scores ranges from 0 to 28. A clinical Insomnia threshold score of 15.

Measure: Insomnia Severity Index (ISI)

Time: Up to 4 weeks

Description: Ad hoc self-report survey of violence suffered from teachers, administrative, auxiliaries, and other students; discrimination and bullying.

Measure: University violence and bullying

Time: Up to 4 weeks

Description: Ad hoc self-report survey of sexual health, including sexual orientation, the current status of an emotional relationship, number of sex partners in the last year, history of Sexually Transmitted Disease (STD).

Measure: Sexuality and sexual health

Time: Up to 4 weeks

Description: Sense of Social and Academic Fit (SSAF) is a self-report questionnaire of 17 items, with responses on a Likert format from 1-7. It measures academic and social sense of belonging. The score is produced as the average of the scores reported in each item. The minimum score is 1 and the maximum score is 17. A higher score means higher sense of belonging.

Measure: Sense of Social and Academic Fit (SSAF)

Time: Up to 4 weeks

Description: Ad-hoc self-report survey of current perception and possible diagnosis of COVID-19: Fear or preoccupation about getting COVID-19 Sense of severity if diagnosed with COVID-19 Fear or preoccupation about a family member or friend to get COVID-19 Current diagnosis of COVID-19 A family member diagnosed with COVID19 Sense of compliance with social isolation and quarantine Persons living with (family, friends, alone) Frequency of: going out of home, gather with others, virtual socialization, keeping a routine, exercise realized, recreative activities, meditation or prayer, seek information about the situation of COVID19 Frequency of the following symptoms: nervousness, hopelessness, depression, amount of effort required to realize activities, self-value, anhedonia.

Measure: COVID-19 questions

Time: Up to 4 weeks
43 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.]
44 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
45 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
46 Online 1-Day CBT-Based Workshops for Postpartum Depression

Postpartum depression (PPD) already affects up to 1 in 5 women and left untreated costs $150,000 per case over the lifespan. Under normal conditions, just 10% of women with PPD get evidence-based treatment, a situation that has worsened substantially during COVID-19. The purpose of this study is to a assess if self-referred, online adaptation of a 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop for PPD delivered up to 30 women at a time can lead to reductions in PPD, if the workshops are cost-effective, and to assess workshop impact on common complications of PPD (anxiety, partner relationship discord, problems with mother-infant attachment). 334 women will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control). Study measures will be collected at baseline (immediately before treatment workshop) and 12 weeks later (immediately before wait list control workshop).

NCT04485000
Conditions
  1. Postpartum Depression
Interventions
  1. Behavioral: Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop
MeSH:Depression, Postpartum Depression

Primary Outcomes

Description: The gold standard measure of PPD in clinical practice/research. A change of 4 points is recognized as a clinically meaningful/significant improvement.

Measure: Edinburgh Postnatal Depression Scale (EPDS)

Time: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.

Secondary Outcomes

Description: Healthcare resource utilization data will be collected using a questionnaire based on the Canadian Community Health Survey and the Service Use and Resources Form adapted for the postpartum period and used in previous PPD research. Costs will be calculated using provincial or other standard billing rates.

Measure: Cost-effectiveness: Costs of service

Time: Resources consumed over the 12-week trial period from the perspective of public healthcare payer will be measured.

Description: The EQ-5D-5L, a utility-based health-related quality of life instrument will be used. Its validity in measuring the impact of depression is established. Its Canadian scoring algorithm will be used. For each participant, a QALY will be calculated by multiplying the health utility for the matching time period (i.e., the area under the curve approach).

Measure: Cost-effectiveness: Quality-Adjusted Life Year (QALY)

Time: QALYs will be measured over the 12-week trial period.

Other Outcomes

Description: A 7-item self-report scale of symptoms of generalized anxiety disorder, the most common PPD comorbidity.

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

Time: 12 weeks

Description: 25-item maternal-report scale of mother-infant attachment.

Measure: Postpartum Bonding Questionnaire

Time: 12 weeks

Description: The SPS is a 24-item self-report measures of the degree to which an individual's social relationships provide support.

Measure: Social Provisions Scale

Time: 12 weeks

Description: A 37-item meausure of infant behavior and temperament.

Measure: Infant Behavior Questionnaire - Revised (Very Short Form)

Time: 12 weeks

Description: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.

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

Time: 12 weeks
47 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
48 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
49 The Impact of Mindfulness on Prenatal Depression, Anxiety and Stress in Mothers at Risk of Preterm Delivery

Anxiety, depression and stress are common during pregnancy. These have been found to negatively impact mother and child outcomes. When anxiety, depression, and stress are present in pregnant women, it is therefore important to manage them to improve the outcome of the mother and her child. Although pregnancy itself has been shown to increase anxiety, depression and stress, these issues are further elevated in high-risk pregnancy groups. Mothers at risk of preterm delivery (less than 37 weeks gestational age), have been found to have higher rates of depression, anxiety and stress compared to uncomplicated term pregnancies. In addition, anxiety, depression and stress symptoms themselves increase the risk for preterm delivery, creating a vicious cycle for this high-risk group. Mindfulness is a tool that has been during pregnancy to reduce depression, anxiety, and stress. Many studies have found mindfulness to be an appropriate management option in normal term pregnancies. To date, there have been no studies that have looked at Mindfulness as a tool for mothers admitted due to risk of preterm delivery. This study will explore the impact of teaching mindfulness skills to inpatient mothers at risk of preterm delivery and studying its effects on maternal depression, anxiety, and stress. This study involves providing Mindfulness strategies during the mother's inpatient admission for the risk of preterm delivery for four consecutive weeks. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of mindfulness on anxiety, depression and stress. The participants will also be encouraged to maintain a weekly mindfulness log. The results of this research may lead to future studies looking at the impact of mindfulness practice for high-risk pregnancies. This will also help open up the possibility of offering such courses for inpatient and outpatient high-risk pregnancies in the future.

NCT04496115
Conditions
  1. Stress
  2. Anxiety
  3. Depression
  4. Mindfulness
Interventions
  1. Behavioral: Mindfulness
MeSH:Depression

Primary Outcomes

Description: using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.

Measure: Change in stress symptoms

Time: Change from recruitment to 4 weeks after

Description: using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Minimum score is 0. Maximum score is 21. And using the Pregnancy Related Anxiety Scale. Scores for individual question range from 1 (Not at all) to 5 (Very much). Minimum score is 10. Maximum score is 50. A high score in both scales means a high level of anxiety symptoms.

Measure: Change in anxiety symptoms

Time: Change from recruitment to 4 weeks after

Description: using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.

Measure: Change in depression symptoms

Time: Change from recruitment to 4 weeks after

Description: using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90. And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale. A high score in both scales (and subscales)means a high mindful awareness level.

Measure: Change in mindful awareness

Time: Change from recruitment to 4 weeks after

Secondary Outcomes

Description: Duration of mindfulness practice

Measure: Mindfulness practice

Time: 4 weeks

Description: Gestational age of the newborn (in weeks and days) at the time of delivery

Measure: Gestational age

Time: variable (less than 20 weeks from recruitment)
50 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)
51 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
52 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
53 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.
54 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
55 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
56 Single-Arm Feasibility Study of a Transdiagnostic Course for Common Mental Health Problems in Primary Care

This study investigates the feasibility of a transdiagnostic course that is intended to work for a large variety of patient groups with clinically significant depression or anxiety in primary care. This is a prospective single-group study where 68 adults with clinically significant symptoms of depression or general anxiety, and up to 25 adults with subclinical symptoms, attend up to 6 weekly structured large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. If necessary, due to the covid-19 pandemic, the course will be held online.

NCT04522713
Conditions
  1. Depression
  2. Anxiety
Interventions
  1. Behavioral: Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material
MeSH:Depression

Primary Outcomes

Description: Theoretical range: 7-28, higher score indicates higher satisfaction

Measure: Satisfaction with treatment as indicated by a mean Client Satisfaction Questionnaire (CSQ-8) score of at least 22

Time: Post-treatment assessment (immediately after treatment, completed within 45 days)

Secondary Outcomes

Description: Session attendance registered once each week by a clinician during the treatment period

Measure: Adherence operationalized as the average number of completed sessions

Time: From week 1 to week 6

Description: Dichotomous outcome (Jacobson & Truax, 1991) based on the Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression)

Measure: At least 1/3 patients reporting a clinically significant improvement in symptoms of depression

Time: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)

Description: Dichotomous outcome (Jacobson & Truax, 1991) based on the GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety)

Measure: At least 1/3 patients reporting a clinically significant improvement in symptoms of general anxiety

Time: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)

Measure: Change in lifestyle behaviors

Time: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)

Description: Weekly question: "Since the last assessment, have you experienced any adverse event, side effect, or unwanted effect of your participation in this study?"

Measure: Number of adverse events

Time: From week 1 to week 6

Description: Clinical interview

Measure: Proportion of patients in need of additional treatment

Time: Post-treatment assessment (within 45 days after treatment)

Description: Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression)

Measure: Average change in symptoms of depression

Time: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)

Description: GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety)

Measure: Average change in general anxiety

Time: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)

Description: Perceived Stress Scale, 10-item version (PSS-10, theoretical range: 0-40, higher score indicates more perceived stress)

Measure: Average change in perceived stress

Time: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)

Description: World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2, theoretical range: 0-100, higher score indicates more disability)

Measure: Average change in disability

Time: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
57 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)
58 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)
59 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)
60 Building Community Capacity for Disability Prevention for Minority Elders - Renewal

This study aims to address treatment and service disparities and prevent disability among racial/ethnic and linguistic minority elders. It tests the effectiveness and implementation readiness of the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), a combined mental and physical health intervention designed to be implemented in low-resource community settings. This renewal grant project includes a streamlined intervention with new components designed to improve and maintain participant outcomes.

NCT04545593
Conditions
  1. Depression
  2. Anxiety
  3. Physical Disability
Interventions
  1. Behavioral: Positive Minds Strong Bodies Enhanced
  2. Behavioral: Enhanced Usual Care
MeSH:Depression

Primary Outcomes

Description: >/= 70% of participants attending >/= 50% of their intervention sessions, reporting satisfaction with treatment.

Measure: Acceptability

Time: 6 months at end of treatment

Description: Widely used measure of depression and anxiety in clinical monitoring and outcome assessment.

Measure: Hopkins Symptom Checklist-25 (change)

Time: Baseline and 3, 6, and 12 months after baseline

Description: Assessment of standing balance, timed 4-m walk, and timed test of five chair-rise repetitions, to assess functional limitations. A virtual option will be used while in person assessment is not possible due to COVID-19.

Measure: Short Physical Performance Battery (change)

Time: Baseline and 3, 6, and 12 months after baseline

Description: Self-report instrument designed to measure both functional capacity and components of disability.

Measure: Late-Life Function and Disability Instrument (LLFDI) - functional component (change)

Time: Baseline and 3, 6, and 12 months after baseline
61 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
62 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
63 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

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Data processed on September 26, 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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