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D001008: Anxiety Disorders

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 (95)


Name (Synonyms) Correlation
drug401 Baricitinib Wiki 0.39
drug473 Blood collection on admission and longitudinally Wiki 0.22
drug474 Blood collection on their first consultation and 10 to 14 days later Wiki 0.22
Name (Synonyms) Correlation
drug476 Blood draw Wiki 0.18
drug462 Biosensors Wiki 0.16
drug948 Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms Wiki 0.16
drug1988 Meditation app usage Wiki 0.16
drug457 Biological: mRNA-1273: 50 mcg Wiki 0.16
drug2685 Psychoeducational intervention Wiki 0.16
drug3823 e-Psychotherapy Wiki 0.16
drug391 BRII-198 Wiki 0.16
drug3808 covid-19 positive pregnant women Wiki 0.16
drug918 Coronavirus Anxiety Scale , COVID-19 Phobia Scale Wiki 0.16
drug1406 HADS Wiki 0.16
drug420 Berberine Wiki 0.16
drug450 Biological test Wiki 0.16
drug455 Biological: COVID-19 convalescent plasma Wiki 0.16
drug456 Biological: mRNA-1273: 100 mcg Wiki 0.16
drug2057 MinnRAP Peer Support Program Wiki 0.16
drug4100 survey work Wiki 0.16
drug787 Clinical interview Wiki 0.16
drug855 Confinement and Communication During the COVID-19 Pandemic Wiki 0.16
drug471 Blood collection Wiki 0.16
drug421 Bereavement Virtual Support Group Wiki 0.16
drug2836 Remote Problem Management Plus Wiki 0.16
drug946 Cross Sectional study using scientifically validated psychometric Scales Wiki 0.16
drug1214 Essential Oil Blend Wiki 0.16
drug472 Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection Wiki 0.16
drug3276 Survey administration Wiki 0.16
drug1241 Experiences in Close Relationship Scale questionnaire (ECR-S) Wiki 0.16
drug2404 Pandemic control measures Wiki 0.16
drug467 Blood D-dimer assay Wiki 0.16
drug3017 Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] Wiki 0.16
drug3478 Trauma-informed yoga video recording Wiki 0.16
drug2602 Post Traumatic Stress Disorder questionnaire (PTSD-8) Wiki 0.16
drug2084 Montmorrillonite Wiki 0.16
drug2005 Mental Health questionnaire Wiki 0.16
drug464 Biospecimen collection Wiki 0.16
drug263 Anxiety Reduction Training Wiki 0.16
drug438 Bioarginina® Wiki 0.16
drug3140 Solution-Focused Support Program Wiki 0.16
drug871 Control Blend Wiki 0.16
drug1378 Generalized Anxiety Disorder-7 (GAD 7) Wiki 0.16
drug405 Baricitinib or Anakinra Wiki 0.16
drug1775 Kundalini Yoga and Anxiety Reduction Training Wiki 0.16
drug416 Behaviour Change Technique Intervention to Improve Quality of Life Wiki 0.16
drug2675 Prospective study across two time-points examining the impact of viral mitigation protocols on mental health Wiki 0.16
drug430 Best available treatment Wiki 0.16
drug395 Background questionnaire Wiki 0.16
drug398 Bamlanivimab Wiki 0.16
drug441 Biological Wiki 0.16
drug802 Cognitive Behavioural Group Therapy for Perinatal Anxiety Wiki 0.16
drug1303 Feeling Good Digital App Wiki 0.16
drug451 Biological/Vaccine: Angiotensin peptide (1-7) derived plasma Wiki 0.16
drug3016 Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] Wiki 0.16
drug1987 Meditation and Anxiety Reduction Training Wiki 0.16
drug1265 Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki 0.16
drug1636 Impact of COVID-19 questionnaire Wiki 0.16
drug853 Computer task questionnaires Wiki 0.16
drug449 Biological sampling Wiki 0.16
drug1698 Intervention App Wiki 0.16
drug2420 Patient Health Questionnaire (PHQ-9) Wiki 0.16
drug444 Biological collection with nasopharyngeal samples, saliva, blood, stool and urine Wiki 0.16
drug418 Bemiparin sodium Wiki 0.16
drug1971 Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores Wiki 0.16
drug729 Cereset Research Wiki 0.16
drug461 Biosensor Wiki 0.16
drug3716 a survey Wiki 0.16
drug439 Biobehavioral Tele-rehabilitation Sessions Wiki 0.16
drug172 Aerobic Exercises Wiki 0.16
drug3622 Virtual-Care Cognitive Behavioural Therapy Wiki 0.16
drug475 Blood donation from convalescent donor Wiki 0.16
drug470 Blood and derivatives. Wiki 0.16
drug2315 Online Questionnaire Wiki 0.11
drug2514 Placebo Comparator Wiki 0.11
drug394 Bacille Calmette-Guérin (BCG) Wiki 0.11
drug417 Bemiparin Wiki 0.11
drug435 Bicalutamide 150 Mg Oral Tablet Wiki 0.11
drug2676 Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health Wiki 0.09
drug612 COVID-19 RT-PCR Wiki 0.09
drug2796 Ravulizumab Wiki 0.09
drug428 Best Supportive Care Wiki 0.08
drug463 Biospecimen Collection Wiki 0.08
drug2511 Placebo Administration Wiki 0.08
drug2317 Online Survey Wiki 0.07
drug2998 Saliva collection Wiki 0.06
drug2827 Remdesivir Wiki 0.05
drug1023 Dexamethasone Wiki 0.05
drug2732 Questionnaire Administration Wiki 0.05
drug3273 Survey Wiki 0.04
drug2490 Placebo Wiki 0.04
drug3199 Standard of care Wiki 0.03
drug884 Convalescent Plasma Wiki 0.03
drug3191 Standard of Care Wiki 0.02
drug1507 Hydroxychloroquine Wiki 0.02

Correlated MeSH Terms (23)


Name (Synonyms) Correlation
D003866 Depressive Disorder NIH 0.25
D003863 Depression, NIH 0.21
D019964 Mood Disorders NIH 0.16
Name (Synonyms) Correlation
D004194 Disease NIH 0.15
D040921 Stress Disorders, Traumatic NIH 0.12
D013313 Stress Disorders, Post-Traumatic NIH 0.12
D015775 Fractures, Stress NIH 0.11
D050497 Stillbirth NIH 0.11
D007752 Obstetric Labor, Premature NIH 0.11
D000068376 Compassion Fatigue NIH 0.11
D000067073 Psychological Trauma NIH 0.11
D009209 Myofascial Pain Syndromes NIH 0.09
D013315 Stress, Psychological NIH 0.08
D005356 Fibromyalgia NIH 0.08
D007319 Sleep Initiation and Maintenance Disorders NIH 0.08
D001523 Mental Disorders NIH 0.07
D019052 Depression, Postpartum NIH 0.06
D000066553 Problem Behavior NIH 0.05
D020521 Stroke NIH 0.04
D000077062 Burnout, Psychological NIH 0.04
D016638 Critical Illness NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0000716 Depressivity HPO 0.22
HP:0003826 Stillbirth HPO 0.11
HP:0000708 Behavioral abnormality HPO 0.05
Name (Synonyms) Correlation
HP:0001297 Stroke HPO 0.04

Clinical Trials

Navigate: Correlations   HPO

There are 41 clinical trials


1 Online-based Survey of the Anxiety Associated With the COVID-19 Pandemic in the General Population in Germany

The study aims to systematically examine various aspects of the anxiety associated with the COVID-19 pandemic in Germany. The data collection is carried out online with longitudinal repeated measurements.

NCT04331106
Conditions
  1. Anxiety Related to the COVID-19 Pandemic
Interventions
  1. Diagnostic Test: Online Questionnaire
MeSH:Anxiety Disorders

Primary Outcomes

Description: To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.

Measure: Characteristics of COVID-19-related anxiety

Time: 1 day

Description: Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.

Measure: COVID-19-related anxiety symptoms

Time: 1 day

Secondary Outcomes

Description: Self-efficacy and coping with the COVID-19 pandemic are measured with 13 self created items. Values ranging from 1 to 6; higher scores indicate a better outcome (except inverted items).

Measure: Self-efficacy and coping with COVID-19

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: Personal consequences of the COVID-19 pandemic in the last three weeks are collected with five self-created items.

Measure: Consequences of COVID-19 in the last three weeks.

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: General illness attitudes are measured with 3 subscales (Worry about illness; Thanatophobia; Bodily preoccupations) of the German version of the Illness Attitude Scales (IAS) by Hiller & Rief (2004). 9 Items; values ranging from 1 to 5, higher scores indicate a worse outcome.

Measure: General Illness Attitude

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: Frequency, effects and formats of consumed media related to COVID-19 are measured with 5 self created items.

Measure: Media reporting

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: To screen for general anxiety and depressive symptoms the German version of the Patient Health Questionnaire-4 (PHQ-4) by Löwe (2015) is used. 4 items; values ranging from 0 to 3, higher scores indicate a worse outcome.

Measure: Ultra-brief screening scale for anxiety and depression

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.

Measure: Change in characteristics of COVID-19-related anxiety

Time: Ebaseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months

Description: Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.

Measure: Change in COVID-19-related anxiety symptoms

Time: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 12 months
2 Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers

Background: The COVID-19 outbreak has caused many changes to people s normal social patterns. The respiratory illness has been the major focus of public health efforts. But most experts also agree that government and public health mandates to slow the spread of the illness, such as social distancing, have a significant effect on people s mental health. Environmental stressors, such as constraints on activities, social contact, and access to resources, take a toll. Researchers want to learn how stressors related to COVID-19 affect mental health over time. Objective: To learn the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of people. Eligibility: English-speaking adults ages 18 and older Design: This study will be conducted online. Participants will give their first and last name and email address. They will indicate if they have ever been in an NIH research study. They will get a username and password. Every 2 weeks for up to 6 months, participants will complete online study surveys. They will get email reminders. Some surveys will be repeated. At the end of the study, they will complete a set of end-of-study surveys. The surveys will ask about the following: Age, sex, race, and other sociodemographic data Mental and medical illness history and treatment Family medical history Mobility, self-care, and life activities Behaviors related to alcohol and substance use disorder Mental illness symptoms Psychological distress Stressors caused by the COVID-19 pandemic. Participants will get links to mental health resources, such as hotlines. They will also get guidance on steps to take to seek care or support. Study website: nimhcovidstudy.ctss.nih.gov

NCT04339790
Conditions
  1. Healthy Volunteer
  2. Mood Disorder
  3. Anxiety Disorder
  4. Preexisting Medical Condition
MeSH:Disease Anxiety Disorders Mood Disorders

Primary Outcomes

Description: Thoughts and feelings about mental health impact of COVID-19

Measure: NIMH COVID Study survey - adult responses

Time: Biweekly online responses

Secondary Outcomes

Description: Ratings on measures of mental health symptoms and distress

Measure: DSM XC and KS survey

Time: Biweekly online self report
3 A Prospective Cohort Study Investigating Oncology-patient-reported Anxiety, Mood, and Quality of Life During the COVID-19 Pandemic (ONCOVID Trial)

ONCOVID is a prospective cohort study investigating oncology-patient-reported anxiety, mood, and quality of life during the COVID-19 pandemic. Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (COVID-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, and WHO Quality of Life-BREF). Data collection occurs at baseline and follow-up surveys are performed after 6, 12, and 24 weeks.

NCT04340219
Conditions
  1. Cancer
Interventions
  1. Other: Survey administration
MeSH:Anxiety Disorders

Primary Outcomes

Measure: Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29).

Time: Week 0

Measure: Depression at baseline measured by the 7-item depression subscale of the 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression); in terms of proportions (0-4 vs ≥ 5).

Time: Week 0

Measure: Anxiety at baseline measured by the 7-item anxiety subscale of the DASS-21 (DASS-21-Anxiety); in terms of proportions (0-3 vs ≥ 4).

Time: Week 0

Measure: Stress at baseline measured by the 7-item stress subscale of the DASS-21 (DASS-21-Stress); in terms of proportions (0-7 vs ≥ 8).

Time: Week 0

Secondary Outcomes

Measure: Distress measured at baseline by the CPDI; in terms of continuous values.

Time: Week 0

Measure: Depression at baseline measured by the DASS-21-Depression; in terms of continuous values.

Time: Week 0

Measure: Anxiety at baseline measured by the DASS-21-Anxiety; in terms of continuous values.

Time: Week 0

Measure: Stress at baseline measured by the DASS-21-Stress; in terms of continuous values.

Time: Week 0

Measure: Domain-specific quality of life at baseline measured by the 7-item physical health domain of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire (WHOQOL-BREF-Physical health); in terms of continuous values.

Time: Week 0

Measure: Domain-specific quality of life at baseline measured by the 6-item psychological health domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Psychological health); in terms of continuous values.

Time: Week 0

Measure: Domain-specific quality of life at baseline measured by the 3-item social relationships domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Social relationships); in terms of continuous values.

Time: Week 0

Measure: Domain-specific quality of life at baseline measured by the 8-item environment domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Environment); in terms of continuous values.

Time: Week 0

Measure: Overall perception of quality of life and overall perception of health at baseline measured by the two items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire-in terms of continuous values.

Time: Week 0

Measure: Change from baseline in distress measured by CDPI; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues values.

Time: 24 weeks

Measure: Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Physical health; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Psychological health; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Social relationship; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Environment; in terms of continuous values.

Time: 24 weeks

Measure: Change from baseline in overall perception of quality of life and overall perception of health measured by the 2 items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire; in terms of continuous values.

Time: 24 weeks

Measure: The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics

Time: Week 0-6-12-24
4 Impact of a Minimal Psychoeducational Intervention Versus Standard of Care on Anxiety Among Hospitalized COVID-19 Patients in Denmark: a Randomized Clinical Trial

Background: There is limited knowledge on the psychological implications of COVID-19 among hospitalized patients and their close relatives. Moreover, evidence-based psychological interventions targeting hospitalized COVID-19 patients and their relatives are currently lacking. Objective: To test a minimal psychoeducational intervention versus standard of care for reducing anxiety among hospitalized COVID-19 patients. Methods and analysis: The trial is a Randomized Controlled Trial (RCT) with a 1 month and 3 month follow-up. Hospitalized COVID-19 patients are consecutively included at admission and randomized 1:1 to either an intervention or control group. Patients randomized to the intervention group will receive a minimal psychoeducational intervention just prior to discharge from the hospital. The goal of the intervention is that patients will be prepared and learn to interpret and react to physical and psychological symptoms that are related to recovering from a COVID-19 infection. Data is collected using standardized and validated patient reported outcome measures (PROMs) to assess mental health outcomes. The primary outcome is patient reported anxiety as assess by the Hospital Anxiety and Depression Scale. Perspectives: This study will provide a comprehensive understanding of the psychological implications of the COVID-19 outbreak. If successful, the minimal intervention is easily implemented in daily clinical practice.

NCT04351789
Conditions
  1. COVID-19
  2. Mental Health
  3. Psychoeducation
  4. Anxiety
Interventions
  1. Other: Psychoeducational intervention
MeSH:Anxiety Disorders

Primary Outcomes

Description: Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

Measure: Anxiety 1 month

Time: 1 month post discharge

Secondary Outcomes

Description: Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

Measure: Anxiety 3 months

Time: 3 months post discharge

Description: Depression measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of depression.

Measure: Depression 3 months

Time: 3 months post discharge

Description: PTSD symptoms measured by the Harvard Trauma Questionnaire. Range in score: 16 - 64. Higher scores = more symptoms of PTSD

Measure: Post Traumatic Stress Disorder (PTSD) symptoms 3 months

Time: 3 months post discharge

Description: Anxiety measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of anxiety.

Measure: Anxiety 12 months

Time: 12 months post discharge

Description: PTSD symptoms measured by the Harvard Trauma Questionnaire. Range in score: 16 - 64. Higher scores = more symptoms of PTSD

Measure: Post Traumatic Stress Disorder (PTSD) symptoms 12 months

Time: 12 months post discharge

Description: Depression measured by the Hospital Anxiety and Depression Scale. Range in score: 0 - 28. Higher scores = more symptoms of depression.

Measure: Depression 12 months

Time: 12 months post discharge
5 Effectiveness of Using a Meditation App in Reducing Anxiety and Improving Well-being During the Covid-19 Pandemic

This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and future outlook during the Covid-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses.

NCT04369378
Conditions
  1. Anxiety
  2. Well-being
Interventions
  1. Behavioral: Meditation app usage
MeSH:Anxiety Disorders

Primary Outcomes

Description: Assessed by survey questions (in part adapted from GAD7)

Measure: Anxiety

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions (in part adapted from WHO-5)

Measure: Well-being

Time: Immediate post-intervention (compare with pre-intervention data)

Secondary Outcomes

Description: Assessed by survey questions

Measure: Future outlook & hopefulness

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions

Measure: Sleep habits

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions (frequency of consuming whole foods and prepared meals)

Measure: Nutrition habits

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions (anticipated and actual continued usage of app)

Measure: Meditation app continued usage

Time: Immediate post-intervention (compare with pre-intervention data)

Description: Assessed by survey questions (in part adapted from GAD7)

Measure: Anxiety

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions (in part adapted from WHO-5)

Measure: Well-being

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions

Measure: Future outlook & hopefulness

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions

Measure: Sleep habits

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions (frequency of consuming whole foods and prepared meals)

Measure: Nutrition habits

Time: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

Description: Assessed by survey questions (anticipated and actual continued usage of app)

Measure: Meditation app continued usage

Time: 2 months post-intervention (compare with immediate post-intervention data)
6 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
7 Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses

Background: Researchers think that people s mental health and behavior will be very affected by the steps taken to slow the spread of COVID-19, such as social distancing. Also, the threat of disease and death, to people and their loved ones, can cause much stress. Researchers want to learn more about these stressors and how they are affecting people. Objective: To study the relationship of affective, cognitive, and behavioral responses to stressors related to COVID-19 with neuroimaging and behavioral data collected before COVID-19. Eligibility: English-speaking adults age 18 and older Design: This online study will include both new participants and those who have taken part in past National Institute of Mental Health studies. All will complete the same surveys and tasks. Participants will give their name and email address. They will get a username and password. The file that links their username to their personal data will be kept secure. Participants will complete a set of surveys about the following: - Sociodemographic data, such age, race, and income - Education and work status - Mental and medical illness and treatment - Family medical history - Mood - COVID-19 experience - Anxiety - Substance and alcohol use - Attention control - Other mental health related topics. Participants will complete a finger-tapping task. For this, they will press a key a certain number of times in a limited period. They will get to practice the task. After the task, they will complete a survey about it. It will take about 1 hour to complete the surveys and the task. About 8 months later, participants will be contacted to repeat the surveys and task. Compensation is provided.

NCT04377100
Conditions
  1. Anxiety
  2. Healthy Volunteers
Interventions
  1. Behavioral: Computer task questionnaires
MeSH:Anxiety Disorders

Primary Outcomes

Description: To examine patterns of neural circuits connectivity as potential predictors of rating scores of affective, cognitive and behavioral (including task performance) responses to COVID-19 among healthy and clinically anxious participants who already participants in SNFA resting-state connectivity studies.

Measure: Patterns of neural connectivity as predictors

Time: Baseline and 14-20 months later
8 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
9 ''(COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women"

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

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

Primary Outcomes

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

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

Time: 4 months
10 Meditation and Yoga for Heightened Anxiety Related to COVID-19

This randomized clinical on-line study examines whether whether a daily practice of meditation or Kundalini Yoga with anxiety reduction training leads to a greater reduction in anxiety than anxiety reduction training alone.

NCT04386291
Conditions
  1. Generalized Anxiety
  2. Health Anxiety
Interventions
  1. Behavioral: Anxiety Reduction Training
  2. Behavioral: Kundalini Yoga and Anxiety Reduction Training
  3. Behavioral: Meditation and Anxiety Reduction Training
MeSH:Anxiety Disorders

Primary Outcomes

Description: Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse)

Measure: GAD-7

Time: Up to 32 weeks

Description: Health Anxiety 8-item scale (range 0-32, higher is worse)

Measure: Whiteley 8

Time: Up to 32 weeks

Secondary Outcomes

Description: Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse)

Measure: PHQ-8

Time: Up to 32 weeks

Description: Somatic Symptom Scale-8 an 8-item measure of symptom burden (range 0-32, higher is worse)

Measure: SS-8

Time: Up to 32 weeks

Description: An 8-item self-report measure of cognitive function (range 8-40, higher is worse)

Measure: Applied Cognition 1.0

Time: Up to 32 weeks

Description: A 4-item self-report assessment of sleep disturbance (range 4-20, higher is worse)

Measure: PROMIS-4 Sleep Disturbance

Time: Up to 32 weeks

Description: Emotional Regulation Questionnaire - a 10-item measure of emotional regulation; the reappraisal subscale has a range: of 6-42, higher score is considered positive; while the suppression subscale has a range of 4-28, higher score considered negative. ..

Measure: ERQ

Time: Up to 32 weeks

Description: A 10-item scale assessing the perception of events in one's life as stressful (0-40, higher represents higher perception of stress)

Measure: Perceived Stress Scale

Time: Up to 32 weeks

Description: A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance)

Measure: Brief Hypervigilance Scale

Time: Up to 32 weeks
11 A Double-blinded Randomized Controlled Trial to Examine the Effectiveness of a Mobile-based Intervention to Reduce Mental Health Problems in Healthcare Workers at the Frontline Against COVID-19 in Spain: the PsyCovidApp Trial

This study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress.

NCT04393818
Conditions
  1. Mental Health Disorder
  2. Depression
  3. Posttraumatic Stress Disorder
  4. Burnout
  5. Anxiety Disorders
Interventions
  1. Behavioral: Intervention App
MeSH:Disease Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders

Primary Outcomes

Description: Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)

Measure: Depression, anxiety and stress

Time: 2 weeks

Secondary Outcomes

Description: Davidson Trauma Scale (DTS). The DTS is a 17-item, Likert-scale, self-report instrument that assesses the 17 DSM-IV symptoms of PTSD. Both a frequency and a severity score can be determined. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). Higher scores are indicative a worse outcome.

Measure: Post-traumatic stress syndrome

Time: 2 weeks

Description: Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)

Measure: Insomnia

Time: 2 weeks

Description: General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)

Measure: Self Efficacy

Time: 2 weeks
12 The Professional Peer Resilience Initiative: Leveraging a Data-Driven Model to Maximize the Resilience of Healthcare Workers During the COVID-19 Pandemic

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.

NCT04396600
Conditions
  1. Stress
  2. Stress Disorder
  3. Stress, Psychological
  4. Trauma, Psychological
  5. Anxiety
  6. Anxiety State
  7. Post Traumatic Stress Disorder
  8. Secondary Traumatic Stress
  9. Professional Quality of Life
  10. Stress Related Disorder
  11. Stress Reaction
  12. Stress Risk
  13. Mental Resilience
  14. Emotional Resilience
Interventions
  1. Behavioral: MinnRAP Peer Support Program
MeSH:Disease Compassion Fatigue Fractures, Stress Anxiety Disorders Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Stress, Psychological Psychological Trauma

Primary Outcomes

Description: Professional Quality of Life Questionnaire (proQOL): min score of 10; max score of 50; higher scores mean worse outcome

Measure: Change in professional quality of life

Time: Before peer support program, through study completion (an average of 7 months)

Secondary Outcomes

Description: Stress Risk & Resilience Self-Index: min score 0; max score of 12; higher scores mean worse outcome

Measure: Change in mental health symptoms and resilience markers

Time: Before peer support program, through study completion (an average of 7 months)
13 Effect on the COVID-19 Pandemic-induced Reduction in Elective Surgery on Medical Events and Psychological Well-being of Patients Waiting for Cardiac Surgery

The effect and impact of postponing cardiac surgery / creating a waiting list as a result of COVID-19 on patients, both psychologically and symptomatically on three groups of patients: 1. The degree of anxiety and/or depression induced by their altered medical care trajectory. 2. The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit 3. The occurrence of reduced access to medical and psychological help

NCT04406181
Conditions
  1. Anxiety and Fear
  2. Anxiety Depression
  3. Anxiety Postoperative
  4. Psychological Stress
Interventions
  1. Behavioral: HADS
  2. Behavioral: a survey
MeSH:Anxiety Disorders Stress, Psychological

Primary Outcomes

Description: The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Measure: Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)

Time: 10 minutes

Description: The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.

Measure: Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit

Time: 10 minutes

Description: The occurrence of reduced access to medical and psychological help by means of an adjusted survey.

Measure: Reduced access to medical and psychological help

Time: 10 minutes
14 Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions

Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) have dramatically impacted the lives of children/adolescents (children) and families. The closure of schools, social and recreational activities, and modifications to work environments has led to significant changes in the way children and families are working, living and socializing. Although the impact on the mental health of children and families has not been well researched, it is anticipated that already stressed children and families with pre-COVID-19 mental health challenges are at significant risk for deterioration in their mental health. As such, the implementation, and evaluation (specifically: feasibility, acceptability and barriers) of virtual-care interventions to alleviate child and family anxiety and enhance family functioning are critical. Virtual-care also optimizes health equity initiatives in reducing social, economic and environmental barriers to services that can improve or maintain mental health (WHO, 2017; MOHLTC, 2018). The current study will evaluate an adapted virtual-care cognitive behavioural therapy (CBT) program for children with anxiety (VC-CBT). CBT has a strong evidence-base in treating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, and Chorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting the efficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr, and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate the feasibility, participation barriers related to social determinants of health (SDH) and acceptability of this virtual-care intervention in addressing mental health challenges associated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Early evaluation of this virtual-care intervention will enable future scale-up of this intervention during the post-pandemic recovery time-period and during subsequent COVID-19 waves, if necessary.

NCT04408027
Conditions
  1. Anxiety Disorder of Childhood or Adolescence
Interventions
  1. Behavioral: Virtual-Care Cognitive Behavioural Therapy
MeSH:Anxiety Disorders

Primary Outcomes

Description: Participation barriers related to Social Determinants of Health (SDH) will be captured to assess intervention feasibility. Participation barriers will be captured using the Social Determinants of Health Questionnaire (unpublished).

Measure: Participation Barriers

Time: The Social Determinants of Health Questionnaire will be administered at baseline only, for each participant (approximately one week prior to the first of twelve sessions in the intervention).

Description: Number of participants that were eligible for the study.

Measure: Number of Eligible Participants

Time: The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.

Description: Number of participants that were approached for the study.

Measure: Number of Participants Approached

Time: The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.

Description: Number of participants consented for the study.

Measure: Number of Participants Consented

Time: The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.

Description: Rates of refusal for participation in the study.

Measure: Rates of Refusal

Time: The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.

Description: Reasons for refusal for participation in the study.

Measure: Reasons for Refusal

Time: The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.

Description: The average number of sessions completed in total will be captured to evaluate intervention adherence.

Measure: Number of Sessions Completed in Total

Time: The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.

Description: The adherence index (calculated using the formula: sessions completed/total sessions scheduled [sum of sessions attended, rescheduled, no-showed and cancelled]) will be used to evaluate intervention adherence.

Measure: Adherence Index

Time: The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.

Description: The amount of time (in weeks) to complete the intervention will be captured to evaluate intervention implementation experience.

Measure: Amount of time (in weeks) to complete the intervention

Time: The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.

Description: The measure that will be used to assess the primary outcome of intervention acceptability is the Virtual Care Satisfaction Survey (Romanchych, unpublished).

Measure: Intervention Acceptability

Time: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).

Description: The measure that will be used to assess participant satisfaction is the Virtual Care Satisfaction Survey (Romanchych, unpublished).

Measure: Participant Satisfaction

Time: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).

Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after First Intervention Session

Time: The Working Alliance Inventory will be administered within approximately one week after completion of the first intervention session (estimated to occur approximately 1 to 2 weeks after initiation of the study).

Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after Sixth Intervention Session

Time: The Working Alliance Inventory will be administered within approximately one week after completion of the sixth intervention session (estimated to occur approximately 6 to 8 weeks after initiation of the study).

Description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).

Measure: Working Alliance Inventory after Final Intervention Session

Time: The Working Alliance Inventory will be administered within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).

Secondary Outcomes

Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Baseline Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.

Measure: Family Impact During a Pandemic at Baseline

Time: CRISIS (parent/caregiver and youth forms) will be completed virtually by children and parents at baseline (approximately one week prior to the first of twelve sessions in the intervention).

Description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Follow-Up Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.

Measure: Family Impact During a Pandemic after Final Intervention Session

Time: CRISIS forms will be completed virtually by children and parents, within approximately one week of completion of the twelfth (final) intervention session (approximately 12 to 16 weeks after initiation of the study).

Description: To evaluate the efficacy of the virtual-care CBT intervention, change in child anxiety will be measured using child and parent-report Screen for Child Anxiety Related Disorders (SCARED; Birmaher et al., 1997). The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school phobia. A total score of 25 of higher on the SCARED measure may indicate the presence of an anxiety disorder. Scores higher than 30 are more specific.

Measure: Efficacy of Virtual-Care CBT Intervention

Time: The SCARED questionnaire will be completed at both baseline and within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after study initiation).

Description: In order to evaluate the experience of clinicians (at The Hospital for Sick Children (SickKids) and the Centre for Community Mental Health (CCMH)) using virtual-care platforms during the work from home shift due to COVID-19 and to identify any challenges they may be facing, a Clinician Virtual Care Experience Survey (Romanchych, unpublished) will be administered.

Measure: Clinician Virtual Care Experience

Time: The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.
15 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
16 Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population

The aim of the study is to explore the psychological effects of the COVID-19 pandemic among Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items. With these results it will possible to identify coping strategies that can help Hungarian adults to deal with the difficulties arising from the pandemic.

NCT04426266
Conditions
  1. Questionnaire Designs
  2. COVID-19 Pandemic
  3. Psychological Stress
  4. Coping Skills
  5. Two-Item Generalised Anxiety Disorder
  6. Two-Item Generalised Anxiety Disorder Scale
  7. Patient Health Questionnaire Anxiety and Depression Scale
  8. Health Status Index
  9. Subjective Health Complaint
  10. Mood
MeSH:Anxiety Disorders Stress, Psychological

Primary Outcomes

Description: 6 items - age, sex, city of residence, marital status, level of education, employment status

Measure: sociodemopraphic factors

Time: 5 months

Description: Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress

Measure: perceived stress

Time: 5 months

Description: The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety

Measure: level of anxiety

Time: 5 months

Description: EQ5D-VAS, 1 item to examine health status

Measure: self-reported health state

Time: 5 months

Description: Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.

Measure: number of complaints

Time: 5 months

Description: Shortened (Hungarian) version of the Ways of Coping Questionnaire (WOC), 22 items to measure cognitive or behavioral strategies in coping with stressful situations

Measure: strategies in coping with stressful situations

Time: 5 months

Description: psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic, 2 open-ended questions (not obligatory to answer) in connection with psychological effects of the coronavirus pandemic (its effects on the participants' mood and ways of coping with difficulties arising from the pandemic).

Measure: psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic

Time: 5 months

Description: The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression

Measure: level of depression

Time: 5 months
17 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.
18 The Impact of Information Sources on Mental Health During the COVID-19 Pandemic

Study description: The present study seeks to investigate the impact of various sources of information on psychopathology, and specifically health anxiety, depression, and general anxiety, during the COVID-19 pandemic. The study will investigate the divergent impact of various information sources on these psychopathological symptoms during the pandemic. Hypotheses and research questions: Hypothesis 1: Media consumption across all information sources will significantly be associated with depression and anxiety symptoms, with increased media consumption in general associated with higher levels of health anxiety, depression, and general anxiety. Hypothesis 2: Using social media and online interactive platforms to obtain news about the pandemic in comparison to using traditional media (e.g., TV, radio, and newspapers) will be associated with higher levels of health anxiety, depression, and general anxiety. Actively staying away from information will further significantly be associated with higher levels of higher levels of health anxiety, depression, and general anxiety. Research Question 1: Is there a differential effect among different information sources on health anxiety, depression and general anxiety? To what extend and how are different information sources related to symptoms of health anxiety, depression, and general anxiety. Exploratory: Additionally, we will exploratory investigate to what extent the amount of use of different information sources impact health anxiety, depression, and general anxiety. We will also examine effect sizes with part correlations, to investigate information sources with the most and least detrimental impact on health anxiety, depression, and general anxiety. Furthermore, we will report which information platforms participants reported as most useful with regards to information concerning how to best deal with the pandemic.

NCT04442360
Conditions
  1. Depression
  2. Generalized Anxiety
  3. Health Anxiety
Interventions
  1. Behavioral: Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
MeSH:Anxiety Disorders

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.
19 Information Sources and Their Relationship to Depressive and Anxiety Symptoms During the COVID-19 Pandemic: A Network Study

This study aims to investigate the association between the use different information sources to obtain information about the COVID-19 pandemic and symptoms of psychopathology (i.e., depression and anxiety). Research Question: How central are different sources of information used to obtain knowledge about the COVID-19 pandemic in network along with depressive and anxiety symptoms? Which sources of information are most strongly connected to different symptoms of depression and anxiety? Staying away from information will be measured in the present study. As avoidance is a type of safety behavior in anxiety disorders, we are further eager to investigate the centrality of this behavior in the network. Furthermore, multiple studies using latent-variable paradigms have established a relationship between sum-scores of depression and social anxiety use in general. We are further interested in examining this potential link more thoroughly and detailed in the present network study. The findings of this study, although they will be cross-sectional and require further examination in studies with temporal data structure, will be an important and interesting starting point giving initial ideas about potential mechanisms that may be involved in use of information sources in pandemics and mental health

NCT04444336
Conditions
  1. Depression
  2. Anxiety
Interventions
  1. Behavioral: Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms
MeSH:Anxiety Disorders

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: The 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.
20 Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Naturalistic Cohort Study With a Digital Intervention

Studies have shown that admission to hospital during a coronavirus epidemic is associated with increased levels of anxiety, depression and panic disorder. During the SARS-CoV-2 pandemic in North London the Royal Free Hospital admitted over 500 patients with Covid-19. As part of the standard of care, these patients are screened at 8 weeks post discharge for signs of anxiety and depression. The Feeling Good app is a NHS approved digital application which utilises applied relaxation, mindfulness based cognitive therapy and positive visualisation through audio tracks for the treatment of anxiety and depression. This is a naturalistic cohort study aimed to track the post illness psychological symptoms of those who have been admitted with Covid-19 to the Royal Free hospital up to 5-7 months after discharge. The study population is those who are exhibiting anxiety or depressive symptoms as measure by the PHQ-2 or TSQ questionnaires. All those with symptoms will be offered free access to a NHS approved app for anxiety and depression, and followed up for 3 months after recruitment to track changes to their symptoms.

NCT04449627
Conditions
  1. Anxiety Disorders
  2. Post Traumatic Stress Disorder
  3. Depressive Disorder
  4. Covid19
Interventions
  1. Other: Feeling Good Digital App
MeSH:Disease Depressive Disorder Stress Disorders, Traumatic Anxiety Disorders Stress Disorders, Post-Traumatic
HPO:Depressivity

Primary Outcomes

Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Day 14

Secondary Outcomes

Description: The Patient Health Questionnaire (PHQ-9) is a screening tool for the identification of depressive disorders, which has been validated for use in primary care. Each of the nine items in the questionnaire is based on the DSM diagnostic criteria for clinical depression. The PHQ-9 is scored out of 27 according to severity, where score of 5-9 indicates mild depression, 10-14 moderate, 15-19 moderately severe, and 20 or above severe depression.

Measure: Depression as measured by the patient health questionnaire 9 (PHQ-9)

Time: 14 days and week 12

Description: The Trauma screening questionnaire (TSQ) is a 10 point scale used to identify symptoms of post traumatic stress disorder (PTSD), with a score between 0 and 10, with a score of 6 or higher scored as positive.

Measure: Trauma as measured by Trauma screening questionnaire (TSQ)

Time: 12 weeks

Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.

Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale

Time: Week 12

Other Outcomes

Description: Risk factors for psychological distress from admission with Covid-19 will be collected, these will include, age, gender, ethnicity, length of hospital stay, oxygen requirement, co-morbidites, years of education, smoking status, occupation.

Measure: Risk associated with distress

Time: Baseline analysis

Description: Framework analysis. Qualitative feedback of patient experience. Semi structured interviews of a subset of patients will be performed to gain further insight into the patient experience. These will be analysed using a framework thematic analysis, to identify themes which will then be used to code the text.

Measure: Qualitative analysis

Time: Baseline
21 Cultivating Calm During COVID-19: A Feasibility Study of Video-based Trauma-informed Yoga

This study will help the investigators understand whether it is feasible and acceptable for people to practice trauma-informed yoga using a pre-recorded video. This study will also explore the immediate effects of trauma-informed yoga on anxiety, mindfulness, and body awareness. The results of this study will inform future research on remote delivery of trauma-informed yoga for supporting psychological wellbeing.

NCT04453514
Conditions
  1. Anxiety
Interventions
  1. Behavioral: Trauma-informed yoga video recording
MeSH:Anxiety Disorders

Primary Outcomes

Description: Total number of participants

Measure: Number of participants enrolled over 3 months

Time: 3 months

Description: Count of participants enrolled each week

Measure: Number of participants enrolled per week over 3 months

Time: 3 months

Description: Proportion of participants who enroll out of the total who access the consent form

Measure: Proportion of participants who enroll in the study over 3 months

Time: 3 months

Description: Proportion of participants that reach the final page of the study out of the total who provided informed consent

Measure: Proportion of participants who complete the study over 3 months

Time: 3 months

Description: Proportion of participants who filled out less than 70% of the items per questionnaire; mean proportion of items skipped per questionnaire

Measure: Proportion of missing data over 3 months

Time: 3 months

Description: Proportion of participants who self-report watching the video in its entirety and for whom time stamps show that the time elapsed on the page where the video is embedded is greater than or equal to 80% of the length of the video

Measure: Proportion of participants who complete the 45-minute video over 3 months

Time: 3 months

Secondary Outcomes

Description: The State Trait Anxiety Inventory (STAI) - Y6 is a 6-item, validated self-report questionnaire that assesses state anxiety when used with instructions that specify: "indicate how you feel right now, in this moment." Responses to each item are provided on a 4 point Likert Scale ('Not at all' to 'Very much'). The instrument is scored as the mean of 6 items, multiplied by 20 to use the interpretation guide for the full STAI scale.

Measure: Mean change in state anxiety from immediately before to immediately after yoga using the State Trait Anxiety Scale - 6 item short form

Time: immediately before/after

Description: The State Mindfulness Scale is a 21-item, validated self-report questionnaire that assesses state mindfulness. The State Mindfulness Scale is comprised of two subscales, State Mindfulness of Mind and State Mindfulness of Body. Responses to each item are provided on a 5 point Likert Scale ('Not at all' to 'Very much'). The instrument is scored as the sum of scores from each subscale. For this outcome, the State Mindfulness of Mind subscale will be used.

Measure: Mean change in state mindfulness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Mind subscale)

Time: immediately before/after

Description: The State Mindfulness Scale is a 21-item, validated self-report questionnaire that assesses state mindfulness. The State Mindfulness Scale is comprised of two subscales, State Mindfulness of Mind and State Mindfulness of Body. Responses to each item are provided on a 5 point Likert Scale ('Not at all' to 'Very much'). The instrument is scored as the sum of scores from each subscale. For this outcome, the State Mindfulness of Body subscale will be used.

Measure: Mean change in body awareness from immediately before to immediately after yoga using the State Mindfulness Scale (State Mindfulness of Body subscale)

Time: immediately before/after
22 Effect of COVID-19 Pandemic on Perceived Stress, Anxiety, Mood, and Training Quality in Elite Athletes.

In this study, the investigator aims to measure stress, anxiety, mood, life satisfaction measures among elite athletes during COVID-19 and measure the relationship between these measures and the changes in training characteristics in elite athletes during the COVID-19 pandemic.

NCT04453566
Conditions
  1. COVID-19
  2. Life Satisfaction
  3. Anxiety
  4. Mental Health Wellness 1
  5. Athlete
  6. Stress
Interventions
  1. Other: Online Survey
MeSH:Anxiety Disorders

Primary Outcomes

Description: Sociodemographic information and training characteristics Participants asked to provide sociodemographic information. Also, the difference in training frequency, duration, and quality after COVID-19 pandemic measured via 22 self-created questions.

Measure: Sociodemographic information and training characteristics

Time: at inclusion

Description: The Beck Anxiety Inventory (Beck et al., 1988) has been widely used to measure the severity of anxiety by self-report and showed to has internal consistency and high test-retest reliability. The Turkish version of the BAI proved to be a reliable and valid measure (Ulusoy et al., 1993). The participant rates how much each symptom has bothered the participant in the past week in the 21-item self-report questionnaire. The symptoms are rated on a four-point scale, ranging from ''not at all'' (0) to ''severely'' (4).

Measure: The Beck Anxiety Inventory (BAI)

Time: one week

Description: The Visual Analogue Scale (0 not stressed at all - 10 maximum amount of stress) used to measure self-reported stress and anxiety in elite athletes before and during the COVID-19 pandemic. The VAS showed to be an efficient tool for assessing self-reported stress and anxiety.

Measure: The Visual Analogue Scale (VAS)

Time: at inclusion

Description: The 14-item version of PSS scale asks patients how often they had experienced thoughts and feelings such as control irritations and stress during the previous one month, with responses ranging from 0 (never) to 4 (very often). The Turkish PSS proved to be a reliable and valid tool to measure perceived stress. The final score obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Higher scores indicating higher levels of perceived stress.

Measure: Perceived Stress Scale (PSS)

Time: one month

Description: The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985) is a 5-item measure designed to measure global cognitive judgments of one's life satisfaction. The answers ranging from 1 (strongly disagree) to 7 (strongly agree). Items are summed to create a total score with higher scores indicating a greater degree of satisfaction with life.

Measure: Satisfaction with Life Scale

Time: at inclusion

Description: The BRUMs scale is based on the Profile of Mood States. The Turkish version of the BRUMS scale studied on Turkish athletes, 24-item measures and six subscales in the original version decreased to 19 items and four subscales: anger, depression, vigor, fatigue. The results of the study proved to be valid and reliable (Cakiroglu et al., 2016). Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time. The results within the subscale are summed and a score range from 0 to 16.

Measure: Brunel mood scale (BRUMS)

Time: at inclusion
23 EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial

Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.

NCT04455360
Conditions
  1. Post Traumatic Stress Disorder
  2. Intensive Care Psychiatric Disorder
  3. Anxiety Disorders
  4. Depression
  5. Critical Care
  6. COVID
Interventions
  1. Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol
MeSH:Disease Critical Illness Stress Disorders, Traumatic Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders Problem Behavior
HPO:Behavioral abnormality

Primary Outcomes

Description: Feasibility will be determined by the following measures: Able to recruit >30% of eligible patients approached Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. Protocol adherence Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. Outcome measures completed in 75% or more of trial participants

Measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints

Time: 12 months

Secondary Outcomes

Description: The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms

Measure: Post-Traumatic stress disorder

Time: 6 months post-hospital discharge

Description: Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression

Measure: Anxiety and depression

Time: 6 months

Description: Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment

Measure: Cognitive function

Time: 6 months post-hospital discharge

Description: EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.

Measure: Health Related Quality of Life

Time: 6 months post-hospital discharge

Description: WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles

Measure: Health and disability

Time: 6 months post-hospital discharge

Description: Wrist worn physical activity monitoring

Measure: Physical activity

Time: 6 months post-hospital discharge

Description: Patient generated subjective global assessment

Measure: Nutritional status

Time: 6 months post-hospital discharge
24 Self-assessment of Anxiety Level and Oral Hygiene Practice in Dental Students of Cairo University During Covid-19 Pandemic

Covid-19, the infection caused by a novel corona virus detected in December 2019 in Wuhan (Hubei province), is now a pandemic announced by World Health Organization, raising concerns of widespread panic and increasing anxiety in individuals. This outbreak results in mass quarantine in Egypt since middle of March 2020. Brooks et al. (2019) reviewed and reported quarantine could bring "post traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma.". Many universities decided to suspend in-person classes and evacuate students in responding to the intensifying concerns surrounding Covid-19. This action can lead to negative psychological consequences among college students. Oral health related behavior and attitudes habits correlate with oral health status and can be considered to be its predictors . There is a claim of potential connection between high bacterial load in the mouth and complications associated with Covid-19 infection. Bacteria present in the meta genome of patients severely infected with Covid-19 included high reads for Prevotella, Staphylococcus, and Fusobacterium, all usually commensal organisms of the mouth. Over 80% of patients in ICU exhibited an exceptionally high bacterial load. Accordingly, the investigators assume that good oral hygiene better to be maintained during a Covid-19 outbreak in order to reduce the bacterial load in the mouth and the risk of a bacterial super infection in case of catching the infection . While there seems to be a common belief that psychosocial stress affects oral hygiene behavior, this assumption has rarely been proved9 Dental students, as the future providers of dental care, are ex¬pected to be role models for their patients regarding the oral hygiene practice and they supposed to be aware of the importance of preserving the oral health. Thus, we intended to select them as our population to study how the level of anxiety during pandemic could affect the practice of oral hygien

NCT04460469
Conditions
  1. Anxiety
  2. Covid19
  3. Oral Hygiene
MeSH:Anxiety Disorders

Primary Outcomes

Description: By questionnaire

Measure: correlate between the level of anxiety and the practice of oral hygiene during covid-19 pandemic in dental students of Cairo university

Time: 2 months
25 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
26 Turkish Validity And Reliability of the SARS-CoV-2 Anxiety Scale

The coronavirus outbreak has adversely affected individuals in the community, as in the rest of the world. However, in order to carry out this epidemic period in a healthy and conscious manner, determining the anxiety levels of individuals in the society and supporting them psychologically is of great importance. In order to achieve this, healthcare professionals working clinically or academically have important duties. This study was planned to test its validity and reliability in order to adapt the Coronavirus Anxiety Scale to Turkish.

NCT04490473
Conditions
  1. Anxiety
  2. SARS-CoV Infection
Interventions
  1. Other: survey work
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Anxiety Disorders

Primary Outcomes

Description: anxiety increase in SARS-CoV-2 in humans.

Measure: Anxiety in SARS-CoV-2

Time: 4 weeks

Description: The ratio of SARS-CoV-2 anxiety scale to beck anxiety scale is similar.

Measure: Ratio of SARS-CoV-2 anxiety scale to beck anxiety scale

Time: 4 weeks
27 Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).

NCT04491071
Conditions
  1. Stress Disorder
Interventions
  1. Diagnostic Test: Generalized Anxiety Disorder-7 (GAD 7)
  2. Diagnostic Test: Background questionnaire
  3. Diagnostic Test: Impact of COVID-19 questionnaire
  4. Diagnostic Test: Confinement and Communication During the COVID-19 Pandemic
  5. Diagnostic Test: Mental Health questionnaire
  6. Diagnostic Test: Patient Health Questionnaire (PHQ-9)
  7. Diagnostic Test: Post Traumatic Stress Disorder questionnaire (PTSD-8)
  8. Diagnostic Test: Experiences in Close Relationship Scale questionnaire (ECR-S)
MeSH:Anxiety Disorders Stress Disorders, Traumatic

Primary Outcomes

Description: test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry. Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety

Measure: Results of the Generalized Anxiety Disorder (GAD-7)

Time: 5 Minutes

Secondary Outcomes

Description: Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.

Measure: Results of the Mental Health questionnaire

Time: 5 minutes

Description: assess depression during the pandemic Scored between 0-27: Cut offs: 0-4 = None 5-9 = Mild depression 10-14 = Moderate depression 15-19 = Moderately severe depression 20-27 = Severe depression

Measure: Results of the Patient Health Questionnaire (PHQ-9)

Time: 5 minutes

Description: Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.

Measure: Results of the Post Traumatic Stress Disorder (PTSD-8)

Time: 5 minutes

Description: Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.

Measure: Results of the Experiences in Close Relationship Scale questionnaire (ECR-S)

Time: 5 minutes
28 Augmented Cognitive Behavioural Group Therapy for Perinatal Anxiety During a Global Pandemic (COVID-19)

This study will evaluate the effectiveness of an augmented version of our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol with cognitive and behavioural strategies composed of critical COVID-related anxiety, worry, and impact content.

NCT04495803
Conditions
  1. Perinatal Anxiety
  2. Covid19
Interventions
  1. Other: Cognitive Behavioural Group Therapy for Perinatal Anxiety
MeSH:Anxiety Disorders

Primary Outcomes

Description: Changes in anxiety symptoms will be assessed through the STICSA to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing anxiety symptoms. Items on the STICSA are rated on a 4-point likert scale ranging from 1 (not at all) to 4 (very much so), with higher scores indicating worse anxiety symptoms. The STICSA has two subscales (i.e., cognitive subscale and somatic subscale) and a total score that will be used in analysis. Ten items comprise the cognitive subscale, meaning scores can range from 10-40. Eleven items comprise the somatic subscale, meaning scores can range from 11 -44. The total score is a sum of both subscales with possible total scores in the range of 21-84.

Measure: State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)

Time: 8 weeks

Secondary Outcomes

Description: Due to the level of ongoing uncertainty that exists surrounding COVID-19, changes in intolerance of uncertainty will be assessed by the 27-item IUS to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing intolerance of uncertainty. The IUS can be scored across two-factors, in addition to a total score. Factor 1 includes items assessing uncertainty as having negative behavioural and self-referent implications (e.g., uncertainty keeps me from living a full life) and Factor 2 assesses uncertainty as being unfair and spoiling things in life (e.g., I can't stand being taken by surprise). Items are rated on a 5-point Likert type scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).

Measure: Intolerance of Uncertainty Scale (IUS)

Time: 8 weeks

Description: Changes in worry symptoms will be assessed by the PSWQ. The PSWQ is a 16-item self-administered tool designed to assess worry symptoms. Items are assessed on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me), with higher scores indicating increased worry.

Measure: Penn State Worry Questionnaire (PSWQ)

Time: 8 weeks

Description: Changes in mood symptoms will be assessed through the EPDS. Items on the EPDS are rated from 0-3, with higher total scores indicating more depressive symptoms. Possible scores on the EPDS range from 0-30. A clinical cut-off of 13 is used to indicate probable depression.

Measure: Edinburgh Postnatal Depression Scale (EPDS)

Time: 8 weeks

Description: Changes in worry and anxiety associated with COVID-19 will be examined using the CSS. The CSS is a 36-item self-report scale designed to measure worry and anxiety associated with the novel COVID-19 pandemic. Each item is rated on a 5-point Likert scale ranging from 0 to 4. The CSS has 5 subscales: danger and contamination fears, fears about economic consequences, xenophobia, compulsive checking and traumatic stress symptoms.

Measure: COVID-19 Stress Scales (CSS)

Time: 8 weeks

Description: Changes in pregnancy-specific anxiety will be assessed with the PRAQ-R2. Items are scored on 5-point Likert scale. Respondents are asked to circle the answer that applies most accurately to their situation and higher scores are reflective of greater pregnancy-specific anxiety. The PRAQ-R2 contains three subscales: fear of giving birth, worries about bearing a handicapped child, and concern about own appearance.

Measure: Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2)

Time: 8 weeks

Description: Changes in postpartum-specific anxiety will be assessed with the PSAS. Items are scored on a 4-point Likert scale (0-3), with higher scores indicating greater anxiety symptoms. The PSAS has 4 subscales: maternal competence and attachment, infant safety and welfare, practical infant care, and psychosocial adjustment to motherhood.

Measure: Postpartum Specific Anxiety Scale (PSAS)

Time: 8 weeks

Description: Changes in severity and impairment associated with anxiety will be assessed with the OASIS. Respondents are asked to circle that answer that best describes their experience over the past week and items are scored on a 5-point Likert scale.

Measure: Overall Anxiety Severity and Impairment Scale (OASIS)

Time: 8 weeks

Description: Changes in parenting self-efficacy will be assessed with the PSOC. The PSOC is a 17-item self-report scale, in which items are scored on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree), with higher scores reflecting greater parenting sense of competency.

Measure: Parenting Sense of Competence Scale (PSOC)

Time: 8 weeks

Description: Changes in relationship satisfaction and adjustment will be assessed with the ADAS. The ADAS is a 7-item self-report scale, in which six of the items are scored on a 6-point Likert Scale, with higher scores reflecting greater relationship satisfaction. Item seven provides a global 'overall happiness' rating and is scored on 7-point Likert Scale ranging from 0 (extremely unhappy) to 6 (perfect).

Measure: Abbreviated Dyadic Adjustment Scale (ADAS)

Time: 8 weeks

Description: Changes in perceived social support will be assessed with the SPS. Items are scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating higher levels of perceived social support. The SPS has 6 subscales assessing dimensions of attachment, social integration, reassurance of worth, guidance, nurturance and reliance.

Measure: Social Provisions Scale (SPS)

Time: 8 weeks

Description: Changed in maternal attachment and bonding to the fetus will be assessed with the MAAS. For each item, respondents are asked to indicate the frequency in which each experience has occurred within the previous two weeks. The MAAS has two subscales that assess dimensions of quality of attachment and intensity of preoccupation. Items are scored on a 5-point Likert scale and scores range from 19 to 95 with higher scores indicating a higher level of attachment to the fetus.

Measure: Maternal Antenatal Attachment Scale (MAAS)

Time: 8 weeks

Description: Changes in maternal bonding with the infant will be assessed with the PBQ. Items are scored on a 6-point Likert scale ranging from 0 (always) to 5 (never), with higher scores indicating lower levels of bonding with the infant. The PBQ has four subscales: general bonding, rejection and pathological anger, anxiety about the infant, and incipient abuse.

Measure: Postpartum Bonding Questionnaire (PBQ)

Time: 8 weeks

Description: Client satisfaction of the augmented CBT for perinatal anxiety during a global pandemic will be assessed with the CSQ. Items are scored on a 4-point Likert scale from 1 to 4, with higher scores indicating higher levels of satisfaction with services.

Measure: Client Satisfaction Questionnaire (CSQ)

Time: 8 weeks

Description: Changes in participants perceived level of stress will be assessed with the PSS. The PSS is a 14-item self-report scale, with items scored on a 5-point Likert scale from 0 to 4, with higher total scores indicating higher perceived stress.

Measure: Perceived Stress Scale (PSS)

Time: 8 weeks
29 The Effect of Aromatherapy on COVID-19-induced Anxiety

The purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with COVID-19 testing.

NCT04495842
Conditions
  1. Stress
  2. Covid19
  3. Anxiety
Interventions
  1. Other: Essential Oil Blend
  2. Other: Control Blend
MeSH:Anxiety Disorders

Primary Outcomes

Description: The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.

Measure: Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes

Time: Baseline and at 15 minutes
30 Correlation of Fear of COVID-19 Infection and Dental Treatment Anxiety Among Netizens: A Cross-sectional Study.

Purpose: COVID-19 Pandemic has created fears, anxiety and worries among general population. COVID-19 airborne transmission is possible under circumstances in which procedures generate aerosols. Various dental treatment procedures can generate aerosols. This Cross Sectional Observational study was conducted with the following objectives: 1. Assessment of Fear of COVID-19 among netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. 2. Assessment of Dental Anxiety among netizens in Al Qassim provincen using (MDA) Modified Dental Anxiety 5 item Likert Scale. Methods: Sample size was (n=385) estimated based on the population size in Al Qassim province (Confidence Interval 95%, Design effect 1 & hypothesized % frequency of outcome factor of 50%). Assessment of Fear of COVID-19 was estimated using FEAR OF COVID-19, a 5 item Likert Scale. Assessment of Dental Anxiety was estimated using Modified Dental Anxiety 5 item Likert Scale. An online Survey form (Arabic & English) was developed using Google form application. The Google form link was shared to the netizens of Al Qassim province, across Social media platforms. Statistical analysis is done using SPSS 22.00 software program.

NCT04497818
Conditions
  1. Covid19
  2. Fear
  3. Dental Anxiety
Interventions
  1. Other: Cross Sectional study using scientifically validated psychometric Scales
MeSH:Anxiety Disorders

Primary Outcomes

Description: Assessed Fear of COVID-19 among netizens in Al Qassim province using FEAR OF COVID-19, a 5 item Likert Scale. Descriptive statistics is used to present the data.

Measure: Fear of COVID-19 infection

Time: 5th August 2020

Description: Assessed Dental Anxiety among netizens in Al Qassim province using (MDA) Modified Dental Anxiety 5 item Likert Scale. Descriptive statistics is used to present the data.

Measure: Dental Anxiety

Time: 5th August 2020

Description: The survey data is statistically analyzed to check for the correlation of the Fear of COVID-19 with Dental Anxiety among Netizens in Qassim region. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of Fear of COVID-19 infection & Dental Anxiety

Time: 5th August 2020

Secondary Outcomes

Description: The survey data is statistically analyzed to check for the correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of the nearest Dental treatment seeking time and Fear of COVID-19 infection.

Time: 5th August 2020

Description: The survey data is statistically analyzed to check for the correlation of the nearest Dental treatment seeking time and Dental Anxiety. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of the nearest Dental treatment seeking time and Dental Anxiety

Time: 5th August 2020

Description: The survey data is statistically analyzed to check for the correlation of Age and Fear of COVID-19 infection The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 will be considered statistically significant correlation of the variables analysed.

Measure: Correlation of the Age and Fear of COVID-19 infection

Time: 5th August 2020

Description: The survey data is statistically analyzed to check for the correlation of the Age and Dental Anxiety. The data obtained from the survey is subjected to appropriate analytical statistical tests to understand the correlation. A p-value of <0.05 is considered statistically significant correlation of the variables analysed.

Measure: Correlation of the Age and Dental Anxiety.

Time: 5th August 2020
31 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
32 COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor - CAASPtrial

Capture of anxiety for anomalies, stillbirth and preterm Labor of pregnant women during COVID-19 pandemia

NCT04568551
Conditions
  1. Anxiety State
MeSH:Obstetric Labor, Premature Stillbirth Anxiety Disorders
HPO:Stillbirth

Primary Outcomes

Description: Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison with different empiric studies of anxiety for anomalies in pandemics

Measure: anxiety for anomalies during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)

Time: 6 months

Description: Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison with different empiric studies of anxiety for stillbirths in pandemics

Measure: anxiety for stillbirths during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)

Time: 6 months

Description: Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison with different empiric studies of anxiety for preterm labour in pandemics

Measure: anxiety for preterm labour during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)

Time: 6 months
33 Anxiety and Burnout in Anesthetists and Intensive Care Unit Nurses During Covid-19 Pandemic

The aim is to measure anxiety level and burnout frequency of healthcare workers including attending physicians, residents and nurses working at intensive care unit during COVID-19 pandemic. The study protocol had consisted of three parts. The first part was related to demographic details including age, sex, marital status, working position, past medical history. The second part of the survey was validated Turkish form of Beck anxiety inventory (BAI) It has 21 questions. Every question is a somatic symptom of anxiety. Participants scored them regarding how this symptom bothered them past week. Items have four possible answers: not at all (0 point), mildly (1 point), moderate (2 point), severe (3 point). Total anxiety score can be between 0 and 63. Participants were categorized as no or mild anxiety if the total beck anxiety score was between 0-16, and moderate to severe anxiety if it was more than 16 The last part of the survey was validated Turkish form of Maslach Burnout Inventory (MBI) to evaluate components of BOS

NCT04604119
Conditions
  1. Sars-CoV2
  2. Anxiety
  3. Burnout
MeSH:Anxiety Disorders Burnout, Psychological

Primary Outcomes

Description: Measured by Beck anxiety inventory. Total anxiety score can be between 0 and 63. Participants were categorized as no or mild anxiety if the total beck anxiety score was between 0-16, and moderate to severe anxiety if it was more than 16

Measure: Anxiety

Time: 10-25 may

Secondary Outcomes

Description: Measured by Maslach Burnout Inventory. MBI has 7-point 22 Likerd type questions and subdivided into three parts to measure emotional exhaustion (EE) (9 items), depersonalization (DP) (5 items), personal accomplishment (PA) (8 items). High scores on EE and DP subscales and low score on PA subscale imply higher level of burnout

Measure: Burnout

Time: 10-25 may
34 Effect of Solution-Focused Support Program on Anxiety Levels of Parents With Children Aged 3-6 Years During the COVID-19 Pandemic

In this research, it was aimed to determine the anxiety levels of parents in the Covid-19 pandemic and to examine the effects of the Solution-Focused Support Program, which is planned to be given to parents with high anxiety levels.

NCT04609722
Conditions
  1. Anxiety
  2. Parents
  3. Covid19
Interventions
  1. Other: Solution-Focused Support Program
MeSH:Anxiety Disorders

Primary Outcomes

Description: STAI was developed by Spielberg et al. In 1970 to measure the trait and state anxiety levels of individuals and was adapted to Turkish by Öner and Le Compte (1983) (Gilik and Avşaroğlu 2017). There are a total of 40 questions in the State-Trait Anxiety Scale. The State Anxiety Sub-Scale (STAI-S) evaluates how an individual feels at a particular time and under certain conditions. The Trait Anxiety Subscale (STAI-T) generally assesses how an individual feels. The scores obtained from both scales vary between 20 and 80. High score indicates high anxiety level, low score indicates low anxiety level.

Measure: State-Trait Anxiety Inventory (STAI)

Time: 5 minutes
35 Pilot Feasibility Study of Remote Problem Management Plus to Improve Well-being and Functioning of Adults Affected by COVID-

This is a pilot feasibility study of remotely delivered Problem Management Plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by crisis. The current study will evaluate the feasibility and acceptability of the intervention when delivered remotely via Zoom to community members in New York City impacted by the COVID-19 pandemic. The investigator's goal is to use qualitative and quantitative approaches to inform procedures for a subsequent cluster randomized control trial of Problem Management Plus versus enhanced usual care. A mixed-methods design will be used to evaluate the feasibility, acceptability, perceived utility, and impact of the remotely delivered PM+ intervention, to determine recruitment and retention rates, to assess ethics and safety of trial procedures. Additionally, the study will evaluate the acceptability, feasibility and fidelity of the remote training and supervision of helpers trained to deliver the intervention.

NCT04617262
Conditions
  1. Depression
  2. Anxiety Disorders
  3. Psychological Distress
Interventions
  1. Behavioral: Remote Problem Management Plus
MeSH:Anxiety Disorders

Primary Outcomes

Description: 4-item measure of personalized distress and client-generated problems, function and wellbeing; minimum value = 0, maximum value = 20; higher scores mean greater distress

Measure: Psychological Outcomes Profile; Unabbreviated scale title "Psychological Outcomes Profile"

Time: 1 week post-intervention

Description: 9-item measure of depression symptoms; minimum value = 0, maximum value = 27; higher scores mean more severe depression symptoms

Measure: Patient Health Questionnaire; Unabbreviated scale title "Patient Health Questionnaire"

Time: 1 week post-intervention

Description: 7-item measure of anxiety symptoms; minimum value = 0 and maximum value = 21; higher scores mean more severe anxiety symptoms

Measure: Generalized Anxiety Disorder Scale; Unabbreviated scale title "Generalized Anxiety Disorder 7-item Scale"

Time: 1 week post-intervention

Secondary Outcomes

Description: 12-item measure of ability to engage in daily activities and functioning; minimum value = 0, maximum value = 48; higher scores mean worse disability outcomes

Measure: World Health Organization Disability Assessment Scale 2.0; Unabbreviated scale title "World Health Organization Disability Assessment Scale 2.0"

Time: 1 week post-intervention

Description: 26-item quality of life assessment of physical health, psychological health, social, relationships and environment; minimum value = 26 and maximum value = 130; higher scores mean better quality of life

Measure: World Health Organization Quality of Life Questionnaire-BREF; Unabbreviated scale title "World Health Organization Quality of Life Questionnaire-BREF"

Time: 1 week post-intervention

Description: 5-item assessment of dimensions of health status: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; minimum= 5, maximum = 25; higher score mean worse health outcomes

Measure: EuroQoL 5-dimension 5-level; Unabbreviated scale title "EuroQoL 5-dimension 5-level"

Time: 1 week post-intervention

Description: 19-item measure of sleep quality and disturbance; 19 items combined to form 7 "component" scores, each of which has a range of 0-3 points, 7 component scores are added to yield one global global score; minimum value = 0 and maximum value = 21; higher score means greater difficulty sleeping

Measure: Pittsburgh Sleep Quality Index; Unabbreviated scale title "Pittsburgh Sleep Quality Index"

Time: 1 week post-intervention

Description: 8-item assessment of the presence and severity of common somatic symptoms; minimum value = 0, maximum value = 32; higher score means more severe somatic symptoms

Measure: Somatic Symptom Scale-8; Unabbreviated scale title "Somatic Symptom Scale-8"

Time: 1 week post-intervention
36 Maternal Attachment and Depression Anxiety Score Evaluation in COVID-19 Positive Pregnant Women

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

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

Primary Outcomes

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

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

Time: 3 months

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

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

Time: 3 months

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

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

Time: 3 months
37 Evaluation of Covid-19 Anxiety and Phobia Levels of the Parents of Pediatric Patients

A pandemic that originated in the Wuhan region of China in December 2019 was detected as a new type of coronavirus disease called coronavirus 2019 (COVID-19). In the first phase of the outbreak, specialists explained ways to maintain physical health . However, pediatric surgical procedures and anesthesia applications continued during this period. Surgery in pediatric patients is an unpleasant and potentially 'threatening' experience, often followed by preoperative anxiety due to the child's illness, hospitalization, fear of anesthesia - especially the time of anesthesia induction - and the surgery itself . Anesthesia is a stressful procedure for the child and the entire family. Both the COVID-19 pandemic and the surgical procedure are reflected in the symptoms of anxiety, fear or acute stress disorder for children and their families. As the disease spread, investigators started to emphasize the importance of protecting mental health. Identifying factors that contribute to significant preoperative anxiety levels in pediatric patients and their parents can help healthcare professionals choose the most appropriate from a variety of alternative strategies for anxiety control. This study was planned to evaluate the COVID-19 anxiety and phobia levels of the parents of pediatric patients are scheduled to undergo surgery under general anesthesia in Turkey.

NCT04631172
Conditions
  1. SARS-CoV-2
  2. Anxiety and Fear
  3. Parents
Interventions
  1. Other: Coronavirus Anxiety Scale , COVID-19 Phobia Scale
MeSH:Anxiety Disorders

Primary Outcomes

Description: The Coronavirus Anxiety Scale (CAS), which was developed by Lee and validated in Turkish by Evren et al., was used to evaluate the COVID-19 anxiety level. In the validation study, the Cronbach's alpha of the Turkish version of CAS was 0.87. This results of the study showed that the CAS was highly reliable. CAS is a 5-point Likert-type scale. The scale consists of five questions and one dimension. Scoring of the scale is evaluated as 0 = never, 1 = rare, less than a day or two, 2 = a few days, 3 = more than a week, and 4 = almost every day in the last two weeks. The total score ranges from 0 to 20. Lee determined the CAS cut-off score of 9 to distinguish those with dysfunctional anxiety from those without anxiety.

Measure: Coronavirus Anxiety Scale (CAS)

Time: 5 months

Description: COVID 19 phobia scale (C19P-S) is a 20-item, 4-subdimension (psychological, somatic, social and economic) scale in which items are answered in a 5-point response format developed by Arpacı et al. 7 to measure the phobia that may develop against COVID-19. In the validation study, the Cronbach's alpha of the Turkish version of C19P-S was 0.92. In the present study, Cronbach's alpha was 0.94. The results of the study demonstrated that the C19P-S was exceptionally reliable. The scale items are rated between 1 "strongly disagree" and 5, "strongly agree. Sub-dimension scores are obtained by the sum of the points of the answers given to the items belonging to that sub-dimension, while the total C19P-S score is obtained by the total of the subdimension scores, ranging between 20 and 100 points.

Measure: COVID 19 phobia scale (C19P-S)

Time: 5 months
38 The Effect of Aerobic Training Versus Cognitive Behavioral Therapy in Management of Anxiety, Depression and Stress-related to Covid 19 Pandemics Among University Students: a Comparative Study

Anxiety and depression disorders (ADD) have the highest overall prevalence rate among psychiatric disorders in young females. Its manifestations are disabling, distressing a substantial negative impact on the quality of life. The purpose of this study was to compare the effect of cognitive-behavioral therapy and physical therapy on female students with mild to moderate anxiety and depression.

NCT04662021
Conditions
  1. Anxiety Depression Disorder
Interventions
  1. Other: Aerobic Exercises
MeSH:Depression Anxiety Disorders

Primary Outcomes

Description: The DASS 21 is a 21 item self-report questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety

Measure: DASS 21

Time: 8 weeks
39 Cereset Research To Reduce Stress And Anxiety In Healthcare Workers In The Time Of COVID-19

The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress and anxiety in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.

NCT04682197
Conditions
  1. Health Personnel
  2. Stress
  3. Anxiety
  4. Insomnia
  5. Hyperarousal
  6. Corona Virus Infection
  7. Covid19
Interventions
  1. Device: Cereset Research
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Sleep Initiation and Maintenance Disorders Anxiety Disorders
HPO:Insomnia

Primary Outcomes

Description: The Impact of Event Scale- Revised Scale assess intrusion, avoidance, and hyperarousal. The scale includes five new questions in addition to the original Impact of Event Scale created by Mardi Horowitz. Scores range from 0 to 88. Total scores ranging between 24-43 suggest that PTSD is a clinical concern; scores between 33-38 suggest best cutoff for probably PTSD; and scores of 39 and above suggest suppressed immune system functioning. The higher the score, the larger the impact of recent stress. There are three subscales evaluating intrusion avoidance, and hyperarousal.

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

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Secondary Outcomes

Description: The severity of insomnia symptoms is measured using two self-report symptom inventories with each data collection visit. This includes the Insomnia Severity Index (ISI). The ISI is a 7-question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. The higher the score, the more suggestive of insomnia.

Measure: Change in Insomnia Severity Index (ISI)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest increased depression.

Measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.

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

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience either in civilian life, or related to military service, respectively. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.

Measure: Change in PTSD Checklist for Civilians (PCL-C)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.

Measure: Change in Perceived Stress Scale (PSS)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Quality of Life Scale (QOLS) is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).

Measure: Change in Quality of Life Scale (QOLS)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Interpersonal Support Evaluation List - Shortened Version (ISEL-12) is a 12-item scale that was modified from a 40-item scale used to assess perceptions of social support. Three dimensions are evaluated: appraisal support, belonging support, and tangible support. Each item is scaled from 1 to 4 for "Definitely True" to "Definitely False." Scores are summed and higher scores correlate with more perceived social support.

Measure: Change in Interpersonal Support Evaluation List (ISEL-12)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Description: The Multiple Ability Self-Report Questionnaire (MASQ) is a self-report questionnaire commonly used to assess perceived cognitive dysfunction. The MASQ has 38 items and assesses five cognitive domains, including language, visual/perceptual ability, verbal memory, visual memory, and attention.

Measure: Change in Multiple Ability Self-Report Questionnaire (MASQ)

Time: Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
40 Investigation the Effect of Covid-19 Fear, Anxiety on Daily Life, Sleep Quality, and Anxiety-depression of the Patients With Fibromyalgia

The investigators planned to analyze the effect of Covid-19 fear and anxiety on the daily life, sleep quality and depression-anxiety levels of fibromyalgia patients.

NCT04686578
Conditions
  1. Fibromyalgia
  2. Covid-19 Fear
  3. Covid-19 Anxiety
  4. Daily Life
  5. Sleep Quality
  6. Anxiety Depression
MeSH:Fibromyalgia Myofascial Pain Syndromes Depression Anxiety Disorders

Primary Outcomes

Description: It is evaluated by the Coronavirus anxiety scale (CAS). It was developed by Lee et al. and Evren et al. were made validity and reliability of this scale in Turkish. It is 5-items scale, and each item scores between 0-4. The total score (ranging from 0 to 20) is calculated by adding up each item score. The higher the score, the greater the anxiety associated with coronavirus-19. Level of Covid-19 anxiety will be compared between fibromyalgia and control groups.

Measure: Level of Covid-19 anxiety

Time: 15 seconds

Description: It is evaluated with The Fear Covid-19 Scale which was developed by Ahorsu et al., and it was adapted into Turkish. It is 7-item scale, each item scores with 5-pont Likert scale. Total score is 35, and the higher score describe higher fear level. Level of Covid-19 fear will be compared between fibromyalgia and control groups.

Measure: Level of Covid-19 fear

Time: 15 seconds

Secondary Outcomes

Description: The daily life of fibromyalgia patients will be analyzed with Fibromyalgia Impact questionnaire (FIQ). It has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10. It is divided three domains: function, over impact, symptoms. The summed score for function (range 0 to 90) is divided by 3, the summed score or overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total score is the sum of the three modified domain scores, and total score ranges from 0 to 100. Higher scores indicate worse daily life. Investigators will be analyzed the relationship between CAS, the fear Covid-19 Scale, and the FIQ.

Measure: The Covid-19 anxiety and fear levels on daily life the patients with fibromyalgia

Time: 15 seconds

Description: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The sum of scores for these seven components yields one global score.The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality" Investigators will be analyzed the relationship between CAS, the fear Covid-19 Scale, and the PSQI.

Measure: The Covid-19 anxiety and fear levels on sleep quality the patients with fibromyalgia

Time: 15 seconds

Description: The anxiety and depression level will be evaluated with Hospital anxiety-and depression scale (HADS).The purpose of the scale is not to make a diagnosis. The scale is a self-report scale and consists of 14 questions, 7 of which investigate depression, and 7 of which investigate anxiety of patients.

Measure: The Covid-19 anxiety and fear levels on anxiety-depression the patients with fibromyalgia

Time: 15 seconds
41 COVID19 and Psychological Health: a Cross Sectional Evaluation of the Risks of Anxiety and Depression Among Patients Diagnosed With Covid 19

The covid-19 pandemic started to spread worldwide since December 2019. It promoted to an exaggerated psychological stress and anxiety in humans due to the intolerable symptoms higher than usual death of many infected patients. This study examines the corona related anxiety and if there is need for drug intervention to treat this anxiety. To answer these questions, a survey made to the hospitalized patients including sex, age, educational level, Marital state, and a standardized questionnaires (GAD-7 and PHQ-9) which has been validated and shown to possess good psychometric qualities in studies of participants from multiple populations.

NCT04689464
Conditions
  1. Covid19
  2. Anxiety
  3. Depression
MeSH:Depression Depressive Disorder Anxiety Disorders
HPO:Depressivity

Primary Outcomes

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: at the time of acute infection, average of 1 month

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: at the time of acute infection, average of 1 month

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on January 01, 2021.

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.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook