NCT04443764

Brief Summary

Migrants and refugees are vulnerable subgroups in general with regards to symptoms of psychopathology. Furthermore, recent calls for paper urge investigation on current mental health status of migrants and refugees during the pandemic, as different barriers such as lack of emotional support from relatives, in addition to language barriers potentially impairing comprehension about the pandemic having the chance to increase symptoms of psychopathology such as anxiety and depression. This study seeks to investigate the levels of mental health symptoms (i.e., depression, general anxiety, and health anxiety) among immigrants and refugees in Norway during the COVID-19 pandemic. Demographic factors will be investigated to identify subgroups with increased risk of meeting clinically significant depression and anxiety symptoms, as established by validated cut-offs to be elaborated below. Furthermore, transdiagnostic predictors which may prove as useful intervention targets will be investigated.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

21 days

First QC Date

June 19, 2020

Last Update Submit

June 22, 2020

Conditions

Keywords

MetacognitionRefugees

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.

    Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

  • 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 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

  • Health Anxiety Symptoms

    • Symptoms of health anxiety will be measured measured with two items from the validated Health Anxiety Inventory (HAI; Salkovskis et al., 2002), one item measuring specific fear of being infected by coronavirus, and an item measuring fear of dying by the coronavirus on a four-point Likert scale (0-3).

    Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Refugees, first generation, and second generation migrants in Norway

You may qualify if:

  • Eligible participants are all refugees, first generation, and second generation migrants.
  • 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
  • Those not defined as vulnerable health-care professionals or public servide providers (see definition above)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Sverre Urnes Johnson, PhD

    University of Oslo & Modum Bad

    PRINCIPAL INVESTIGATOR
  • KariAnne Vrabel, PhD

    Modum Bad

    PRINCIPAL INVESTIGATOR
  • Omid Ebrahimi, Mr

    University of Oslo & Modum Bad

    PRINCIPAL INVESTIGATOR
  • Asle Hoffart, PhD

    Modum Bad & University of Oslo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sverre Urnes Johnson, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professer Sverre Urnes Johnson

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 23, 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

Data Sharing

IPD Sharing
Will not share