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Predictors and Mechanisms of Depression and Anxiety During the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04442204
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
Modum Bad
Information provided by (Responsible Party):
Omid V. Ebrahimi, University of Oslo

Brief Summary:

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


Condition or disease Intervention/treatment
Depression Anxiety Other: Prospective study across two time-points examining the impact of viral mitigation protocols on mental health

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All adults residing in Norway experiencing identical mitigation protocols, having equal opportunity of partaking in the survey.
Criteria

Inclusion Criteria:

  • Eligible participants are all adults including those of 18 years and above,
  • Who are currently living in Norway and thus experiencing identical viral mitigation protocols, and
  • Who provide digital consent to partake in the study.

Exclusion Criteria:

  • Children and adolescents (individuals below 18)
  • Adults not residing in Norway during the measurement period

Information from the National Library of Medicine

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


Contacts
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Contact: Omid V. Ebrahimi, Double PhD Candidate +47-22845295 omideb@uio.no
Contact: Sverre Urnes Johnson, PhD +47-22845295 s.u.johnson@psykologi.uio.no

Sponsors and Collaborators
University of Oslo
Modum Bad
Investigators
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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
Publications:
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Responsible Party: Omid V. Ebrahimi, Mr., University of Oslo
ClinicalTrials.gov Identifier: NCT04442204    
Other Study ID Numbers: REK125510-10
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders