Status and Predictors of Mental Health Symptoms Among Migrants and Refugees During the COVID-19 Pandemic

June 22, 2020 updated by: Sverre Urnes Johnson, University of Oslo
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.

Study Overview

Status

Unknown

Detailed Description

Research question What is 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? The results will be benchmarked against the levels of mental symptoms in national and international surveys.

Hypothesis:

H1: There will be a significant decrease in the levels of health anxiety, depression, and general anxiety symptoms at the measurement period three months into the pandemic (T2) as compared to the baseline period (T1) with the strictest mitigation protocols in place during the first weeks of the pandemic.

H2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions, negative metacognitions, unhelpful coping strategies, loneliness will be associated with less reduction in anxiety, depression and health anxiety from T1 to T2 above, and beyond age, gender, and education. Higher level at T1 and less reduction from T1 to T2 in emotional support will be associated with more reduction in anxiety, depression and health anxiety from T1 to T2.

Statistical analysis:

Repeated surveys like the present one typically have a lot of drop out and missing data. Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and ordinary linear regression to analyze the data. Mixed models use maximum likelihood estimation, which is the state of the art approach to handle missing data (Schafer & Graham, 2002). Especially if data are missing at random, which is likely in our survey, mixed models give more unbiased results than the other analytic methods (O'Connel et al., 2017).

In preliminary analyses, and for each of the dependent variables (GAD-7, PHQ-9) HAI, the combination of random effects and covariance structure of residuals that gives the best fit for the "empty" model (the model without fixed predictors except the intercept) will be chosen. Akaike's Information Criterion (AIC) will used to compare the fit of different models. Models that give a reduction in AIC greater than 2 will be considered better (Burnham & Anderson, 2004). The program SPSS 25.0 will be used (IBM Corp, 2018).

First, H1 about decrease in GAD-7, PHQ-9 and HAI will be tested by using anxiety or depression as dependent variable in a model using time (T1 period = 0, T2 period = 1) as a predictor. Second, demographic group variables will be added as predictors. Third, the initial (T1) levels of positive metacognitions, negative metacognitions and unhelpful coping strategies as measured with CAS-1, loneliness, and emotional support measured will be added, together with the interactions of these constant covariates with time. These interactions represent tests of H2 about the covariates predicting change in anxiety, depression and health anxiety. Finally, the T2 levels of positive metacognitions, negative metacognitions and unhelpful coping strategies as measured with CAS-1, loneliness, and emotional support as constant covariates will be added, together with the interactions of these constant covariates with time. These interactions represent tests of H2 about the change in the covariates from T1 to T2 predicting change in anxiety, depression and health anxiety from T1 to T2s.

Inference criteria We pre-define the significance level: p < 0.05 to determine significance.

Sample size:

The sample size at T1 included 574 participants. For the present study at T2, all participants will be invited to participate in accordance with the study plan. The data collection period will continue for up to three weeks until as many of the participants at baseline have responded.

Measures:

Positive metacognitions, negative metacognitions and unhelpful coping strategies will be measured with the CAS 1 (Wells, 2009): Emotional support will be measured with two items and loneliness is measured with the The UCLA Loneliness Scale-8 (ULS-8; Hays & DiMatteo, 1987)which measures the frequency and intensity of aspects of the lonely experience.

Possible transformations:

All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses. However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods, alternatively the use of non-parametric tests.

Missing data:

Maximum likelihood

Exploratory:

Questions addressed in the future paper which is not pre-specified will be defined as exploratory.

Study Type

Observational

Enrollment (Anticipated)

287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Refugees, first generation, and second generation migrants in Norway

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 9
Time Frame: 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
• 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
Time Frame: 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
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
Time Frame: 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
• 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Asle Hoffart, PhD, Modum Bad & University of Oslo
  • Principal Investigator: KariAnne Vrabel, PhD, Modum Bad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 22, 2020

Primary Completion (Anticipated)

July 13, 2020

Study Completion (Anticipated)

July 13, 2020

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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