CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


HP:0000716: DepressivityHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (39)


Name (Synonyms) Correlation
drug1672 MagPro X100 Stimulator, B70 Fluid-Cooled Coil Wiki 0.32
drug1145 GAD-7 (General Anxiety Disorder) scale Wiki 0.22
drug269 Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery Wiki 0.22
drug41 38 questions questionnaire Wiki 0.22
drug1974 Online Intervention Mental Health COVID-19 Wiki 0.22
drug2109 Physical Exam Wiki 0.22
drug3020 Urine Test Wiki 0.22
drug3133 Written Information Wiki 0.22
drug553 COVID-19 antibodies testing Wiki 0.22
drug3040 VRC-SRSDNA015-00-VP Wiki 0.22
drug1099 Feeling Good Digital App Wiki 0.22
drug450 Blood samples (collection of 5 mL of blood in a dry tube) Wiki 0.22
drug684 Clinical interview Wiki 0.22
drug433 Blood collection Wiki 0.22
drug3014 Universal Screening Arm Wiki 0.22
drug2612 Serum tube collection Wiki 0.22
drug2735 Standardised questionnaires Wiki 0.22
drug471 Brief Behavioral Activation Treatment Wiki 0.22
drug2028 PHQ-9 (Patient Health Questionnaire) Depression Scale Wiki 0.22
drug3520 zinc Wiki 0.22
drug387 Behavioral Activation in real-life Wiki 0.22
drug1573 Lifestyle change promotion program Wiki 0.22
drug430 Blood Test Wiki 0.22
drug350 BLD-2660 Wiki 0.22
drug3041 Vaccine Wiki 0.22
drug2052 Pandemic control measures Wiki 0.22
drug3078 Virtual Reality Behavioral Activation Wiki 0.22
drug2258 Prospective study across two time-points examining the impact of viral mitigation protocols on mental health Wiki 0.22
drug2833 Taste test Wiki 0.22
drug1755 Mindfullness based cognitive program Wiki 0.22
drug1843 Nasopharyngeal swabs Wiki 0.22
drug958 EPDS (Edinburgh Postnatal Depression Scale) Wiki 0.22
drug453 Blood test Wiki 0.16
drug1983 Online survey Wiki 0.11
drug2551 Saliva collection Wiki 0.10
drug654 Chloroquine Wiki 0.08
drug443 Blood sample Wiki 0.07
drug2774 Survey Wiki 0.07
drug2311 Questionnaire Wiki 0.04

Correlated MeSH Terms (15)


Name (Synonyms) Correlation
D003866 Depressive Disorder NIH 1.00
D003863 Depression, NIH 0.50
D003865 Depressive Disorder, Major NIH 0.45
D019052 Depression, Postpartum NIH 0.25
D001238 Asphyxia Neonatorum NIH 0.22
D000067292 Alcohol Drinking in College NIH 0.22
D061218 Depressive Disorder, Treatment-Resistant NIH 0.22
D001008 Anxiety Disorders NIH 0.21
D001714 Bipolar Disorder NIH 0.16
D020920 Dyssomnias NIH 0.10
D020447 Parasomnias NIH 0.09
D013315 Stress, Psychological NIH 0.04
D040921 Stress Disorders, Traumatic NIH 0.04
D013313 Stress Disorders, Post-Traumatic NIH 0.04
D004194 Disease NIH 0.04

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0012768 Neonatal asphyxia HPO 0.22
HP:0100754 Mania HPO 0.16

There are 20 clinical trials

Clinical Trials


1 Characterization and Treatment of Adolescent Depression

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

NCT03388606 Depression
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

Description: changes in MFQ scores over time

Measure: Moody and Feelings Questionnaire

Time: Ongoing

2 Using a Diagnostic Taste Test as a Surrogate Biomarker to Predict Drug Effectiveness in Patients With Depression (MDD)

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

NCT03645447 Depression Diagnostic Test: Taste test
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

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

Measure: Change in taste threshold with antidepressant treatment

Time: 4-6 weeks (per patient)

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

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

Time: 4-6 weeks (per patient)

Secondary Outcomes

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

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

Time: 4-6 weeks (per patient)

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

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

Time: 4-6 weeks (per patient)

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

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

Time: 4-6 weeks (per patient)

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

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

Time: 4-6 weeks (per patient)

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

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

Time: 12 months (duration of trial)

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

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

Time: 4-6 weeks (per patient)

3 Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

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

NCT03716869 Major Depressive Disorder Major Depressive Episode Other: Universal Screening Arm
MeSH:Depressive Disorder Depression Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

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

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

Time: up to 9 months

Secondary Outcomes

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

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

Time: up to 9 months

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

Measure: Suicidal Adolescent

Time: up to 9 months

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

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

Time: up to 9 months

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

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

Time: up to 9 months

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

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

Time: up to 9 months

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

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

Time: up to 9 months

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

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

Time: up to 9 months

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

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

Time: up to 9 months

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

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

Time: up to 9 months

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

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

Time: up to 9 months

Description: data aggregate by grade level only

Measure: Missed school days

Time: up to 9 months

Description: data aggregate by grade level only

Measure: Grade point average

Time: up to 9 months

Description: data aggregate by grade level only

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

Time: up to 9 months

Description: data aggregate by grade level only

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

Time: up to 9 months

Other Outcomes

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

Measure: Subgroup analyses based on school district demographic data

Time: up to 9 months

4 Scaling Up Maternal Mental Health Care by Increasing Access to Treatment (SUMMIT): A Study Protocol for Perinatal Depression and Anxiety

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

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

Primary Outcomes

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

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

Time: 3-months post-randomization

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

Measure: Treatment of perinatal depressive symptoms through telemedicine

Time: 3-months post-randomization

Secondary Outcomes

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

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

Time: 3-months post-randomization

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

Measure: Treatment of perinatal anxiety symptoms through telemedicine

Time: 3-months post-randomization

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

Measure: Child Mental Health Development

Time: 9 to 12 months post child birth

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

Measure: Response and Remission

Time: 3-months post-randomization

5 Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

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

NCT04268316 Major Depressive Disorder MDD Depres Depression Device: Virtual Reality Behavioral Activation Behavioral: Behavioral Activation in real-life
MeSH:Depression Depressive Disorder Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

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

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

Time: 4-weeks

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

Measure: Rates of dropout of VR-BA

Time: 4-weeks

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

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

Time: 4-weeks

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

Measure: Participant's use of the VR headset

Time: 4-weeks

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

Measure: Participant's acceptance of VR-BA treatment

Time: 4-weeks

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

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

Time: 4-weeks

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

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

Time: 4-weeks.

Secondary Outcomes

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

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

Time: 4-weeks

6 Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression

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

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

Primary Outcomes

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

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

Time: 4-6 weeks postpartum

Secondary Outcomes

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

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

Time: 4-6 weeks postpartum

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

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

Time: within the week after delivery

7 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 Parental Stress Depression 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

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 Anxiety Depression Pregnancy Related 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 A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic

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

NCT04384965 Major Depressive Disorder Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil
MeSH:Depressive Disorder Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

Description: Less than or equal to 10

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

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

Secondary Outcomes

Description: changes in scores

Measure: Change in HRSD-24

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

Description: 50% Reduction in score

Measure: Response on HRSD-24

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

Description: Less than or equal to 4

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

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

Description: 50% Reduction in score

Measure: Response on PHQ-9

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

Description: changes in scores

Measure: Change in PHQ-9

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

Description: Less than or equal to 4

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

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

Description: 50% Reduction in score

Measure: Response on GAD-7

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

Description: changes in scores

Measure: Change in GAD-7

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

Description: Less than or equal to 12

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

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

Description: 50% Reduction in Score

Measure: Response on BDI-II

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

Description: changes in scores

Measure: Change on BDI-II

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

Description: Score of 0

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

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

Description: changes in scores

Measure: Change on SSI

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

Description: changes in scores

Measure: Change in WHO Disability Assessment Schedule (WHODAS)

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

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

Measure: Proportion of Patients Maintaining Response During Relapse Prevention

Time: 24 weeks (Tapering and Relapse prevention phase)

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

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

NCT04394078 Depression Quality of Life Covid 19 Social Isolation Other: Online survey
MeSH:Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

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

Measure: Sociodemographic information form

Time: two months after Covid 19 recognised as pandemic

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

Measure: Zung Depression Scale

Time: two months after Covid 19 recognised as pandemic

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

Measure: World Health Organization Quality of Life - Bref

Time: two months after Covid 19 recognised as pandemic

11 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 Depression, Anxiety 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

12 A Novel and Practical Accelerated Low-frequency Right-sided Stimulation Protocol as a Substitute for Patients With Bipolar Depression Needing Electroconvulsive Therapy During the COVID-19 Pandemic

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

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

Primary Outcomes

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

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

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

Secondary Outcomes

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

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

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

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

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

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

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

Measure: Change in Young Mania Rating Scale (YMRS)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Description: changes in scores

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

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

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

Measure: Proportion of Patients Maintaining Response During Relapse Prevention

Time: 24 weeks (Tapering and Relapse prevention phase)

13 Effectiveness of a Healthy Lifestyle Promotion Program as Adjunctive Teletherapy for Treatment-resistant Major Depression During Covid 19 Pandemic: A Randomized Clinical Trial Protocol

The main objective of the study will be to evaluate the effectiveness of an adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week Mindfulness-based cognitive therapy (MBCT) program 3) Treatment prescribed by their mental health team plus written lifestyle change suggestions plus 8-week lifestyle change promotion program. We will collect patient data using the questionnaires administered at baseline, immediately after the intervention, and at six and 12-month follow-up. The primary outcome will be depression severity and secondary outcomes will include health-related quality of life.

NCT04428099 Depressive Disorder, Treatment-Resistant Behavioral: Lifestyle change promotion program Behavioral: Mindfullness based cognitive program Behavioral: Written Information
MeSH:Depressive Disorder Depressive Disorder, Treatment-Resistant
HPO:Depressivity

Primary Outcomes

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

Measure: Depression severity

Time: 12 month

Secondary Outcomes

Description: Questionnaire (EQ-5D)

Measure: Health-related quality of life

Time: 12 month

14 Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia

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

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

Primary Outcomes

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

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

Time: 40 days postpartum

Secondary Outcomes

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

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

Time: 10 minutes postpartum

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

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

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

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

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

Time: 2 minutes after admission to the Postanaesthesia care unit

15 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 Depression Anxiety 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.

16 Prevalence of Mental Health Problems Among Undergraduate Students at the Universidad de Los Andes

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

NCT04447690 Student Mental Health Depression, Anxiety Depression Anxiety College Drinking Stress
MeSH:Depression Depressive Disorder Anxiety Disorders Alcohol Drinking in College
HPO:Depressivity

Primary Outcomes

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

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

Time: Up to 4 weeks

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

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

Time: Up to 4 weeks

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

Measure: CAGE

Time: Up to 4 weeks

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

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

Time: Up to 4 weeks

Secondary Outcomes

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

Measure: Sociodemographic characteristics

Time: Up to 4 weeks

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

Measure: General Health perception

Time: Up to 4 weeks

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

Measure: General Menta Health perception

Time: Up to 4 weeks

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

Measure: History of chronic diseases

Time: Up to 4 weeks

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

Measure: Physical activity

Time: Up to 4 weeks

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

Measure: Social activities

Time: Up to 4 weeks

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

Measure: Family functionality (APGAR)

Time: Up to 4 weeks

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

Measure: History of personal and family mental health problems

Time: Up to 4 weeks

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

Measure: Insomnia Severity Index (ISI)

Time: Up to 4 weeks

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

Measure: University violence and bullying

Time: Up to 4 weeks

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

Measure: Sexuality and sexual health

Time: Up to 4 weeks

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

Measure: Sense of Social and Academic Fit (SSAF)

Time: Up to 4 weeks

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

Measure: COVID-19 questions

Time: Up to 4 weeks

17 Psychological Impact of Admission With Covid-19 During the SARS-CoV-2 Pandemic: Clinical Trial of a Digital Intervention to Improve Wellbeing

This is a randomised control trial to look at the impact of a digital tool, which uses relaxation and mindfullness based cognitive therapy, for twelve days on those who have prolonged mental distress from being admitted with Covid-19 during the peak of the SARS-CoV-2 epidemic.

NCT04449627 Anxiety Disorders Post Traumatic Stress Disorder Depressive Disorder 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 12

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: 12 days and week 8

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: 8 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 8

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

18 Effectiveness of a Self-applied Positive Psychology Online Intervention Program "Mental Health COVID-19" in Mexican Population: A Randomized Controlled Trial.

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

NCT04468893 Anxiety Depression Sleep Disturbance Behavioral: Online Intervention Mental Health COVID-19
MeSH:Dyssomnias Parasomnias Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

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

Measure: Decrease in the score of Anxiety symptoms

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

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

Measure: Change in the symptoms of depression

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

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

Measure: Change in the symptoms of General Anxiety Disorder

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

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

Measure: Change in the score of Posttraumatic stress symptoms

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

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

Measure: Changes in the Widespread fear Scale

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

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

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

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

Secondary Outcomes

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

Measure: Change on the Suicidal Thoughts Scale

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

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

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

NCT04487171 Postpartum Depression Covid19 Prevalence Social Distance Other: Questionnaire
MeSH:Depression, Postpartum Depression Depressive Disorder
HPO:Depressivity

Primary Outcomes

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

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

Time: up to 35 days after delivery

20 Scaling Mental Healthcare in COVID-19 With Voice Biomarkers: An Observational Study

This study aims to advance research on group sessions for mental health. The first-of-its-kind study measuring various features in a group setting, combining rich metadata in creating state-of-the-art machine learning models, and developing workflows for mental health that are both scalable and personalized.

NCT04510519 Major Depressive Disorder Generalized Anxiety
MeSH:Depressive Disorder Depressive Disorder, Major
HPO:Depressivity

Primary Outcomes

Description: A repeated measures, within-subject design using exploratory techniques will identify the best group session features or combination of features that correlate with or predict change on the PHQ-9.

Measure: Patient Health Questionnaire (PHQ-9)

Time: March 30, 2021

Description: A repeated measures, within-subject design using exploratory techniques will identify the best group session features or combination of features that correlate with or predict change on the GAD-7.

Measure: Generalized Anxiety Disorder (GAD-7)

Time: June 20, 2021


HPO Nodes


HP:0000716: Depressivity
Genes 390
PDGFRB PFN1 DNAJC13 LIMK1 TRNS1 HTT LMAN2L CLN6 TSC2 FMR1 PSAP FGFR1 CPOX GBA GNAS DRD2 EPCAM NOTCH3 KISS1 ELN GABRG2 CLRN1 PON1 AARS2 PINK1 TBP ATRX RRM2B MAPT GPR35 UCHL1 PSEN1 SPRY4 PPARGC1A TACR3 FGF17 GNA11 C19ORF12 SNCA CP GLA HLA-DRB1 CHMP2B KCTD17 ND4 PDGFB MLH3 MSH2 NR4A2 USH2A ATP1A3 GIGYF2 PRNP TCF4 USH1C TRNQ DNMT1 RUNX1 HLA-DQB1 NEK1 ZC3H14 CLIP1 CACNA1G PDGFRB COQ2 TOR1A POLG GNAS OPTN MECP2 MAN2B1 GABRG2 C9ORF72 UNC13A GNRHR COX3 WDR11 GRN KCNT1 FMR1 ARVCF FBXO31 VPS13C MED25 SQSTM1 SLC6A4 MST1 MAPK1 MAPT MBOAT7 TRAPPC9 GBA ARSA ERBB4 UBQLN2 WFS1 MED23 SLC18A2 SQSTM1 PRNP ARMC5 TBP OCRL ATXN8OS TRNS1 USH1G ADGRV1 HS6ST1 GNAS GTF2IRD1 UFD1 TWNK TRNH C9ORF72 CCNF SGCE MAPT TARDBP RFC2 PLA2G6 TTC19 POLG XPR1 SNCAIP LRRK2 PRKCG DCTN1 PDGFRB PROKR2 TREM2 CLIP2 COMT GABRA1 XK TBC1D7 DNMT1 PRKACA JMJD1C NEFH SOD1 FRRS1L TRNL2 PRSS12 KDM5B DMPK CEP78 HIRA PPOX BCR VCP TARDBP EPM2A DNAJC5 COX1 PGAP1 MSH6 PMS1 MAN1B1 ND5 PRKAR1A RSRC1 DUSP6 HBB ST3GAL3 IQSEC1 CISD2 GSN ND6 EHMT1 TOR1A POLG ALMS1 LMNB1 CHD7 STX16 PRNP CHMP2B CFAP410 BCS1L PER3 TK2 TBX1 TUSC3 FA2H RPS20 AIMP1 FGF14 COX2 TREM2 DNA2 CLCN4 CPOX EDC3 CRBN GDAP2 SEC24C PAH FLT4 EPHA4 TMEM106B FGF8 EIF4G1 NSMF SLC2A1 AMACR SLC25A4 TRNL1 KISS1R FGF14 PAH RRM2B CBL ATP13A2 CHCHD10 DAO ATXN10 ADH1C CRADD PDGFB PMS2 TRNF PON2 LINS1 SYNJ1 ATXN8OS FUS PLA2G6 AP2S1 HNRNPA1 MSTO1 SNCA CACNA1H ND1 RREB1 PROK2 MYO7A SLC45A1 FUS JPH3 PODXL GLE1 SGCE GPR101 SPAST MATR3 MAN2B1 PON3 WHRN PRNP COASY PDCD1 LRRK2 GBA DCPS PDZD7 GNAS PPT1 COQ2 AIP GLT8D1 TGFBR2 MYO7A SMPD1 WFS1 PIGC KCNJ2 TWNK ANOS1 HTR2A POLG ATXN8 ABCA7 SARS1 AFG3L2 ANXA11 POLG PTPN22 RPS6KA3 SEMA4A TWNK PARK7 CC2D1A POLG2 GCH1 DGUOK HTRA2 BAZ1B TRNS2 TAF15 VPS35 ASXL1 ATXN2 HTT C12ORF4 CDH23 PCDH15 GP1BB PANK2 CACNA1G EZR HARS1 PIK3CA FAN1 FMO3 ATP1A3 MSTO1 NSUN2 PANK2 ARSG TNIK PINK1 PER2 TET3 TWNK SNCA CSF1R CLCN4 VCP GRIK2 GTF2I BMPR1A ATXN2 TET2 TBK1 TAC3 TRNN TBK1 FMN2 ATP7B SRPX2 THOC2 CRKL GRIN2A PTS VCP FIG4 NHLRC1 ARMC5 PRPH CDH23 TRNL1 CTSF ATXN10 TRNW JRK C9ORF72 CHCHD10 TBX1 GABRB3 CASR MLH1 PRKN SRSF2 CYP27A1 KRAS DCTN1 B3GALNT2 NDST1 PRNP HNMT HLA-DQB1 ANG TSC1 VAPB SLC20A2 METTL23 WASHC4 TBL2 CIB2 HMBS HMBS C9ORF72 DCTN1 PPP2R2B KCTD17 ESPN VCP POLG C9ORF72 PDE11A CBS GNRH1 PRNP TECR IDUA GNAS TRNS2 USP8 GLUD2 DNAJC6
Protein Mutations 4
A1298C C677T V158M V66M