Predictors and Mechanisms of Depression and Anxiety During the COVID-19 Pandemic
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|ClinicalTrials.gov Identifier: NCT04442204|
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 23, 2020
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
|Condition or disease||Intervention/treatment|
|Depression Anxiety||Other: Prospective study across two time-points examining the impact of viral mitigation protocols on mental health|
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|Official Title:||Predictors and Mechanisms of Depression and Anxiety During the COVID-19 Pandemic|
|Estimated Study Start Date :||June 22, 2020|
|Estimated Primary Completion Date :||July 13, 2020|
|Estimated Study Completion Date :||July 13, 2020|
- Other: Prospective study across two time-points examining the impact of viral mitigation protocols on mental health
Prospective study across two time-points examining the impact of viral mitigation protocols on mental health
- Patient Health Questionnaire 9 [ Time Frame: 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. ]• 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.
- Generalized Anxiety Disorder 7 [ Time Frame: 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. ]• 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442204
|Contact: Omid V. Ebrahimi, Double PhD Candidateemail@example.com|
|Contact: Sverre Urnes Johnson, PhDfirstname.lastname@example.org|
|Principal Investigator:||Omid Ebrahimi, Double PhD Candidate||University of Oslo|
|Principal Investigator:||Asle Hoffart, PhD||Modum Bad Psychiatric Hospital|
|Principal Investigator:||Sverre Urnes Johnson, PhD||University of Oslo|