<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04443764</url>
  </required_header>
  <id_info>
    <org_study_id>REK125510 (8)</org_study_id>
    <nct_id>NCT04443764</nct_id>
  </id_info>
  <brief_title>Status and Predictors of Mental Health Symptoms Among Migrants and Refugees During the COVID-19 Pandemic</brief_title>
  <official_title>Status and Predictors of Mental Health Symptoms Among Migrants and Refugees During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Modum Bad</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Migrants and refugees are vulnerable subgroups in general with regards to symptoms of&#xD;
      psychopathology. Furthermore, recent calls for paper urge investigation on current mental&#xD;
      health status of migrants and refugees during the pandemic, as different barriers such as&#xD;
      lack of emotional support from relatives, in addition to language barriers potentially&#xD;
      impairing comprehension about the pandemic having the chance to increase symptoms of&#xD;
      psychopathology such as anxiety and depression. This study seeks to investigate the levels of&#xD;
      mental health symptoms (i.e., depression, general anxiety, and health anxiety) among&#xD;
      immigrants and refugees in Norway during the COVID-19 pandemic. Demographic factors will be&#xD;
      investigated to identify subgroups with increased risk of meeting clinically significant&#xD;
      depression and anxiety symptoms, as established by validated cut-offs to be elaborated below.&#xD;
      Furthermore, transdiagnostic predictors which may prove as useful intervention targets will&#xD;
      be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research question What is the levels of mental health symptoms (i.e., depression, general&#xD;
      anxiety, and health anxiety) among immigrants and refugees in Norway during the COVID-19&#xD;
      pandemic? The results will be benchmarked against the levels of mental symptoms in national&#xD;
      and international surveys.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      H1: There will be a significant decrease in the levels of health anxiety, depression, and&#xD;
      general anxiety symptoms at the measurement period three months into the pandemic (T2) as&#xD;
      compared to the baseline period (T1) with the strictest mitigation protocols in place during&#xD;
      the first weeks of the pandemic.&#xD;
&#xD;
      H2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions, negative&#xD;
      metacognitions, unhelpful coping strategies, loneliness will be associated with less&#xD;
      reduction in anxiety, depression and health anxiety from T1 to T2 above, and beyond age,&#xD;
      gender, and education. Higher level at T1 and less reduction from T1 to T2 in emotional&#xD;
      support will be associated with more reduction in anxiety, depression and health anxiety from&#xD;
      T1 to T2.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Repeated surveys like the present one typically have a lot of drop out and missing data.&#xD;
      Therefore, we will use mixed models instead of paired t-tests, repeated measures ANOVAs, and&#xD;
      ordinary linear regression to analyze the data. Mixed models use maximum likelihood&#xD;
      estimation, which is the state of the art approach to handle missing data (Schafer &amp; Graham,&#xD;
      2002). Especially if data are missing at random, which is likely in our survey, mixed models&#xD;
      give more unbiased results than the other analytic methods (O'Connel et al., 2017).&#xD;
&#xD;
      In preliminary analyses, and for each of the dependent variables (GAD-7, PHQ-9) HAI, the&#xD;
      combination of random effects and covariance structure of residuals that gives the best fit&#xD;
      for the &quot;empty&quot; model (the model without fixed predictors except the intercept) will be&#xD;
      chosen. Akaike's Information Criterion (AIC) will used to compare the fit of different&#xD;
      models. Models that give a reduction in AIC greater than 2 will be considered better (Burnham&#xD;
      &amp; Anderson, 2004). The program SPSS 25.0 will be used (IBM Corp, 2018).&#xD;
&#xD;
      First, H1 about decrease in GAD-7, PHQ-9 and HAI will be tested by using anxiety or&#xD;
      depression as dependent variable in a model using time (T1 period = 0, T2 period = 1) as a&#xD;
      predictor. Second, demographic group variables will be added as predictors. Third, the&#xD;
      initial (T1) levels of positive metacognitions, negative metacognitions and unhelpful coping&#xD;
      strategies as measured with CAS-1, loneliness, and emotional support measured will be added,&#xD;
      together with the interactions of these constant covariates with time. These interactions&#xD;
      represent tests of H2 about the covariates predicting change in anxiety, depression and&#xD;
      health anxiety. Finally, the T2 levels of positive metacognitions, negative metacognitions&#xD;
      and unhelpful coping strategies as measured with CAS-1, loneliness, and emotional support as&#xD;
      constant covariates will be added, together with the interactions of these constant&#xD;
      covariates with time. These interactions represent tests of H2 about the change in the&#xD;
      covariates from T1 to T2 predicting change in anxiety, depression and health anxiety from T1&#xD;
      to T2s.&#xD;
&#xD;
      Inference criteria We pre-define the significance level: p &lt; 0.05 to determine significance.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      The sample size at T1 included 574 participants. For the present study at T2, all&#xD;
      participants will be invited to participate in accordance with the study plan. The data&#xD;
      collection period will continue for up to three weeks until as many of the participants at&#xD;
      baseline have responded.&#xD;
&#xD;
      Measures:&#xD;
&#xD;
      Positive metacognitions, negative metacognitions and unhelpful coping strategies will be&#xD;
      measured with the CAS 1 (Wells, 2009): Emotional support will be measured with two items and&#xD;
      loneliness is measured with the The UCLA Loneliness Scale-8 (ULS-8; Hays &amp; DiMatteo,&#xD;
      1987)which measures the frequency and intensity of aspects of the lonely experience.&#xD;
&#xD;
      Possible transformations:&#xD;
&#xD;
      All variables will be assessed in their original and validated format as is recommended&#xD;
      practice, as long as this is possible with regards to statistical assumptions underlying the&#xD;
      pre-defined analyses. However, if this is not possible with regards to the statistical&#xD;
      assumptions behind the analyses, transformation (e.g., square root or log-transformations)&#xD;
      may be needed to apply interval-based methods, alternatively the use of non-parametric tests.&#xD;
&#xD;
      Missing data:&#xD;
&#xD;
      Maximum likelihood&#xD;
&#xD;
      Exploratory:&#xD;
&#xD;
      Questions addressed in the future paper which is not pre-specified will be defined as&#xD;
      exploratory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 22, 2020</start_date>
  <completion_date type="Anticipated">July 13, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 13, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire 9</measure>
    <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</time_frame>
    <description>• The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder 7</measure>
    <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</time_frame>
    <description>The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams &amp; 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 &amp; Hoffart, 2019).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Anxiety Symptoms</measure>
    <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</time_frame>
    <description>• 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).</description>
  </primary_outcome>
  <enrollment type="Anticipated">287</enrollment>
  <condition>Migrants</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Refugees, first generation, and second generation migrants in Norway&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible participants are all refugees, first generation, and second generation&#xD;
             migrants.&#xD;
&#xD;
          -  Adults including those of 18 years and above&#xD;
&#xD;
          -  Who are currently living in Norway and thus experiencing identical NPIs, and&#xD;
&#xD;
          -  Who had provided digital consent to partake in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents (individuals below 18)&#xD;
&#xD;
          -  Adults not residing in Norway during the measurement period&#xD;
&#xD;
          -  Those not defined as vulnerable health-care professionals or public servide providers&#xD;
             (see definition above)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo &amp; Modum Bad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>KariAnne Vrabel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Modum Bad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Omid Ebrahimi, Mr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo &amp; Modum Bad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asle Hoffart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Modum Bad &amp; University of Oslo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <phone>41633313</phone>
    <email>s.u.johnson@psykologi.uio.no</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Sverre Urnes Johnson</investigator_full_name>
    <investigator_title>Associate Professer Sverre Urnes Johnson</investigator_title>
  </responsible_party>
  <keyword>Metacognition</keyword>
  <keyword>Refugees</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04443764
org study id: REK125510 (8)
nct id: NCT04443764
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
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
description: • 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.
measure: 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
description: 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).
measure: 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
description: • 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).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sverre Urnes Johnson, PhD
role: Principal Investigator
affiliation: University of Oslo & Modum Bad
last name: KariAnne Vrabel, PhD
role: Principal Investigator
affiliation: Modum Bad
last name: Omid Ebrahimi, Mr
role: Principal Investigator
affiliation: University of Oslo & Modum Bad
last name: Asle Hoffart, PhD
role: Principal Investigator
affiliation: Modum Bad & University of Oslo
last name: Sverre Urnes Johnson, PhD
phone: 41633313
email: s.u.johnson@psykologi.uio.no
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Sverre Urnes Johnson
investigator title: Associate Professer Sverre Urnes Johnson
mesh term: COVID-19
sharing ipd: No