MigrantsNCT04443764
Status and Predictors of Mental Health Symptoms Among Migrants and Refugees During the COVID-19 Pandemic
An observational study of Migrants and Anxiety, run by University of Oslo.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migrants, Anxiety, Depression
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2020to 13 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Refugees, first generation, and second generation migrants in Norway
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Migrants, Anxiety, Depression
- Keywords
- Metacognition, Refugees
- Medical subject headings
- Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start22 Jun 2020 (estimated)
- Primary completion13 Jul 2020 (estimated)
- Study completion13 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigrantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 287 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Sverre Urnes Johnson, University of Oslo
- Investigators
- Sverre Urnes Johnson, PhD, Principal investigator, University of Oslo & Modum BadKariAnne Vrabel, PhD, Principal investigator, Modum BadOmid Ebrahimi, Mr, Principal investigator, University of Oslo & Modum BadAsle Hoffart, PhD, Principal investigator, Modum Bad & University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443764
- Sponsor's protocol ID
- REK125510 (8)
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status and Predictors of Mental Health Symptoms Among Migrants and Refugees During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04443764
- Acronym / sponsor ID
- REK125510 (8)
- Conditions
- Migrants, Anxiety, Depression
- Keywords
- Metacognition, Refugees
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 287 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Modum Bad
- Study start
- 22 Jun 2020 (estimated)
- Primary completion
- 13 Jul 2020 (estimated)
- Study completion
- 13 Jul 2020 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Refugees, first generation, and second generation migrants in Norway
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sverre Urnes Johnson, PhD principal investigator
University of Oslo & Modum Bad
KariAnne Vrabel, PhD principal investigator
Modum Bad
Omid Ebrahimi, Mr principal investigator
University of Oslo & Modum Bad
Questions about this trial
What is this clinical trial studying?
An observational study of Migrants and Anxiety, run by University of Oslo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sverre Urnes Johnson, PhD (41633313, s.u.johnson@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.