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

NCT04442204 | Unknown DMC

• 1 other identifier: REK125510-10
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire 9

  • 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.

  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.

• Generalized Anxiety Disorder 7

  • 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).

  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.

Interventions

Prospective study across two time-points examining the impact of viral mitigation protocols on mental health OTHER

Prospective study across two time-points examining the impact of viral mitigation protocols on mental health

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adults residing in Norway experiencing identical mitigation protocols, having equal opportunity of partaking in the survey.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oslo: lead
• Modum Bad: collaborator

Related Publications (3)

• Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.

  PMID: 31447721 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Omid Ebrahimi, Double PhD Candidate

  University of Oslo

  PRINCIPAL INVESTIGATOR

• Asle Hoffart, PhD

  Modum Bad

  PRINCIPAL INVESTIGATOR

• Sverre Urnes Johnson, PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omid V. Ebrahimi, Double PhD Candidate

CONTACT

+47-22845295; omideb@uio.no

Sverre Urnes Johnson, PhD

CONTACT

+47-22845295; s.u.johnson@psykologi.uio.no

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 22, 2020
• Study Start: June 22, 2020
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06