The Mental Health Status of the General Population During the COVID-19 Pandemic and Its Association With Adherence to Government-initiated Non-pharmacological Epidemiological Interventions (NPI's)

NCT04356365 | Completed DMC

• 1 other identifier: REK125510
• Study Type: observational
• Target: 10,084
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to investigate the levels of common psychopathology symptoms (i.e., depression and generalized anxiety) in a general 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 generalized anxiety and depressive symptoms, as well as predictors of adherence rates to government-initiated non-pharmacological epidemiological interventions (NPI's). 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.
• Provide a foundation for policymakers and health-care professionals to employ interventions that protect the general public against possibly increased psychological stressors, suffering and dysfunction during society's handling of the pandemic.
• Help policymakers better understand the associations of demographic variables and psychological symptoms with adherence, providing an initial understanding of adherence rates, which may be used to help society fight against the COVID-19-virus from an epidemiological perspective by promoting factors that increase adherence.

Conditions

Depression; Generalized Anxiety; Adherence to Non-pharmacological Epidemiological Interventions (NPIs)

Keywords

COVID-19; Social distancing, quarantine, isolation; Non-pharmacological interventions (NPIs); Depression; Generalized anxiety; Adherence to epidemiological interventions (NPIs)

Outcome Measures

Primary Outcomes (3)

• 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.

  All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (non-pharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

• 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. Higher scores indicate greater anxiety severity, and scores that are above the cut-off 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).

  All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (non-pharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

• Measures of adherence

  Measures of adherence to all eight non-pharmacological interventions (NPIs) employed against COVID-19 is measured, with each item being on a five-point Likert scale (0-4).

  All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (non-pharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway

Interventions

Cross-sectional study investigating the association of NPIs with mental health OTHER

Cross-sectional study investigating the association of NPIs with mental health

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Both Biological Sex and self-representation of gender are measured. All participants are welcome to partake in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adults residing in Norway, having equal opportunity of being contacted (see detailed description section) To hold the NPI variable constant, the stopping rule of data collection was at once if the NPIs were modified; new NPI were added; NPIs were removed; or novel information about modification of NPIs were given.

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 NPIs, and
• Who had provided 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

Study Sites (1)

University of Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

Depression; Generalized Anxiety Disorder; COVID-19

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Anxiety Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Omid V. E Ebrahimi, Double PhD Candidate

  University of Oslo

  PRINCIPAL INVESTIGATOR

• Asle Hoffart, PhD

  Professor at University of Oslo

  PRINCIPAL INVESTIGATOR

• Sverre Urnes Johnson, PhD

  Associate Professor at University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Research Fellow (PI)

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 22, 2020
• Study Start: March 31, 2020
• Primary Completion: April 7, 2020
• Study Completion: April 7, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

NO (1)