<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/NCT04442204</url>
  </required_header>
  <id_info>
    <org_study_id>REK125510-10</org_study_id>
    <nct_id>NCT04442204</nct_id>
  </id_info>
  <brief_title>Predictors and Mechanisms of Depression and Anxiety During the COVID-19 Pandemic</brief_title>
  <official_title>Predictors and Mechanisms of Depression and Anxiety 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>
      Study description:&#xD;
&#xD;
      The present study seeks to investigate the predictors and maintaining mechanisms of&#xD;
      depression and anxiety symptoms during the COVID-19 pandemic, exactly 3 months following the&#xD;
      strictest viral mitigation strategies initiated in Norway in response to the pandemic. This&#xD;
      is the time period where the major pandemic protocols are lifted in Norway, following three&#xD;
      months of strict pandemic mitigation protocols. The study further aims to identify subgroups&#xD;
      with highest levels of depressive and anxiety symptoms during the measurement period, to&#xD;
      identify vulnerable subgroups with maintained symptoms three months following the pandemic.&#xD;
&#xD;
      Hypotheses and research questions:&#xD;
&#xD;
      Research Question 1: What is the level of depressive and anxiety symptoms three months&#xD;
      following the employment of the strict viral mitigation protocols (i.e., physical distancing&#xD;
      protocols) in the general adult population? What are the proportion above the validated&#xD;
      cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant&#xD;
      decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the&#xD;
      strictest mitigation protocols to measurement the measurement period three months into&#xD;
      pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will&#xD;
      be a significant decrease in the proportion of the sample meeting validated cut-offs for&#xD;
      depression and anxiety from T1 to T2.&#xD;
&#xD;
      Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions,&#xD;
      negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be&#xD;
      related to less reduction in depression and anxiety, above and beyond age, gender, and&#xD;
      education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived&#xD;
      competence will be related to greater reduction in depression and anxiety, above and beyond,&#xD;
      age, gender, and education.&#xD;
&#xD;
      Exploratory: The investigators will further explore the proportion showing reliable change in&#xD;
      depression and anxiety and investigate the differences in changes in depression and anxiety&#xD;
      across different demographic subgroups in the sample&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses and research questions:&#xD;
&#xD;
      Research Question 1: What is the level of depressive and anxiety symptoms three months&#xD;
      following the employment of the strict viral mitigation protocols (i.e., physical distancing&#xD;
      protocols) in the general adult population? What are the proportion above the validated&#xD;
      cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant&#xD;
      decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the&#xD;
      strictest mitigation protocols to measurement the measurement period three months into&#xD;
      pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will&#xD;
      be a significant decrease in the proportion of the sample meeting validated cut-offs for&#xD;
      depression and anxiety from T1 to T2.&#xD;
&#xD;
      Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions,&#xD;
      negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be&#xD;
      related to less reduction in depression and anxiety, above and beyond age, gender, and&#xD;
      education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived&#xD;
      competence will be related to greater reduction in depression and anxiety, above and beyond,&#xD;
      age, gender, and education.&#xD;
&#xD;
      Explorative: The investigators will further explore the proportion showing reliable change in&#xD;
      depression and anxiety and investigate the differences in changes in depression and anxiety&#xD;
      across different demographic subgroups in the sample.&#xD;
&#xD;
      Statistical analyses:&#xD;
&#xD;
      Repeated surveys like the present one typically have missing data. Therefore, The&#xD;
      investigators 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, the state of the art approach in handling missing data (Schafer &amp; Graham, 2002).&#xD;
      Particularly, if data are missing at random, which is likely in our survey, mixed models&#xD;
      present more unbiased results than the other analytic methods (O'Connel et al., 2017).&#xD;
      Depression and anxiety will be used as dependent variables in two separate mixed models.&#xD;
&#xD;
      In preliminary analyses, and for each of the dependent variable (PHQ-9; GAD-7), 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).&#xD;
&#xD;
      First, H1 about decrease in GAD-7 and PHQ-9 will be investigated by using PHQ-9 (in one&#xD;
      analysis) and GAD-7 (in the other) as dependent variable in a model using time (T1 = 0; T2=&#xD;
      1) as a predictor. Second, demographic control variables will be added as predictors. Third,&#xD;
      the initial (T1) levels of negative metacognitions, positive metacognitions, unhelpful coping&#xD;
      strategies, physical activity, and perceived competence to deal with the crisis, will be&#xD;
      added as constant covariates, together with the interactions of these constant covariates&#xD;
      with time. These interactions represent tests of H2 about the covariates predicting change in&#xD;
      anxiety and depression, respectively. Finally, the present (T2) levels of negative&#xD;
      metacognitions, positive metacognitions, unhelpful coping strategies, physical activity, and&#xD;
      perceived competence to deal with the crisis will be added as constant covariates, together&#xD;
      with the interactions of these constant covariates with time. These interactions represent&#xD;
      tests of H2 about the change in the covariates from T1 to T2 predicting change in depression&#xD;
      and anxiety from T1 to T2, respectively.&#xD;
&#xD;
      Descriptive statistics with frequency tables including N, means and SDs and other standard&#xD;
      descriptive statistics will examine the research question concerning general levels of&#xD;
      depressive- and anxiety symptoms. Subgroup differences will be examined with chi-squared&#xD;
      statistics. To investigate the percentage of individuals with depressive and anxiety&#xD;
      symptoms, common cut-offs are used; including =&gt; 10 on PHQ-9 (Kroenke et al., 2001) and &gt;= 8&#xD;
      on GAD-7 (Johnson, Ulvenes, Øktedalen &amp; Hoffart, 2019).&#xD;
&#xD;
      All analyses and questions addressed in the forthcoming paper that are not pre-specified in&#xD;
      this pre-registered protocol will be defined as exploratory.&#xD;
&#xD;
      Sensitivity analyses and random subsample replications of the main findings will be conducted&#xD;
      following selection of a random sample of participants that ensure a proportionate ratio&#xD;
      between the collected sample and the adult population of Norway.&#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 (i.e., multiple regression). However, if this is not possible with&#xD;
      regards to the statistical assumptions behind the analyses, transformation (e.g., square root&#xD;
      or log-transformations) may be needed to apply interval-based methods. The investigators will&#xD;
      examine the degree of skewness and evaluate this against the assumptions and analyses before&#xD;
      choosing the appropriate analysis. The pre-registered and planned analyses include multiple&#xD;
      regression as long as assumptions are met. Alternatively a non-parametric test will be used.&#xD;
&#xD;
      Inference criteria Given the large sample size in this study, the investigators pre-define&#xD;
      their significance level: p &lt; 0.01 to determine significance.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      The sample size at T1 included a representative and random selection 10 084 adult&#xD;
      participants. For the present study at T2, all participants will be invited to participate in&#xD;
      accordance with the study plan. The data collection period will continue for up to three&#xD;
      weeks until as many of the participants at baseline have responded.&#xD;
&#xD;
      Eligibility criteria:&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
        -  Eligible participants are all 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 provide 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;
      Measures:&#xD;
&#xD;
      Outcome variables include the following validated measures: PHQ-9 and GAD-7. Predictor&#xD;
      variables include the following validated measures: positive metacognitions (measured with&#xD;
      CAS-1 subscale); negative metacognitions (measured with CAS-1 subscale); unhelpful coping&#xD;
      strategies (also called &quot;strategies&quot;; measured with CAS-1 subscale); physical activity&#xD;
      (measure of number of times participant has been physically active for at least 30 minutes in&#xD;
      an activity increasing pulse and leading to sweat for the past two weeks); perceived&#xD;
      competence to deal with the pandemic (measured with Basic Psychological Needs and Frustration&#xD;
      Scale, a single item adapted for the ability to deal pandemic consequences rather than&#xD;
      ability to deal with difficult situations in general).&#xD;
&#xD;
      Age, gender and education will be controlled for.&#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 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.</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 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.</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>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prospective study across two time-points examining the impact of viral mitigation protocols on mental health</intervention_name>
    <description>Prospective study across two time-points examining the impact of viral mitigation protocols on mental health</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adults residing in Norway experiencing identical mitigation protocols, having equal&#xD;
        opportunity of partaking in the survey.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible participants are all adults including those of 18 years and above,&#xD;
&#xD;
          -  Who are currently living in Norway and thus experiencing identical viral mitigation&#xD;
             protocols, and&#xD;
&#xD;
          -  Who provide 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;
      </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>Omid Ebrahimi, Double PhD Candidate</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asle Hoffart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Modum Bad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Omid V. Ebrahimi, Double PhD Candidate</last_name>
    <phone>+47-22845295</phone>
    <email>omideb@uio.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <phone>+47-22845295</phone>
    <email>s.u.johnson@psykologi.uio.no</email>
  </overall_contact_backup>
  <reference>
    <citation>Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.</citation>
    <PMID>31447721</PMID>
  </reference>
  <reference>
    <citation>Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.</citation>
    <PMID>11556941</PMID>
  </reference>
  <reference>
    <citation>Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.</citation>
    <PMID>16717171</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 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>Omid V. Ebrahimi</investigator_full_name>
    <investigator_title>Mr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT04442204
org study id: REK125510-10
nct id: NCT04442204
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study description:

      The present study seeks to investigate the predictors and maintaining mechanisms of
      depression and anxiety symptoms during the COVID-19 pandemic, exactly 3 months following the
      strictest viral mitigation strategies initiated in Norway in response to the pandemic. This
      is the time period where the major pandemic protocols are lifted in Norway, following three
      months of strict pandemic mitigation protocols. The study further aims to identify subgroups
      with highest levels of depressive and anxiety symptoms during the measurement period, to
      identify vulnerable subgroups with maintained symptoms three months following the pandemic.

      Hypotheses and research questions:

      Research Question 1: What is the level of depressive and anxiety symptoms three months
      following the employment of the strict viral mitigation protocols (i.e., physical distancing
      protocols) in the general adult population? What are the proportion above the validated
      cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant
      decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the
      strictest mitigation protocols to measurement the measurement period three months into
      pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will
      be a significant decrease in the proportion of the sample meeting validated cut-offs for
      depression and anxiety from T1 to T2.

      Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions,
      negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be
      related to less reduction in depression and anxiety, above and beyond age, gender, and
      education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived
      competence will be related to greater reduction in depression and anxiety, above and beyond,
      age, gender, and education.

      Exploratory: The investigators will further explore the proportion showing reliable change in
      depression and anxiety and investigate the differences in changes in depression and anxiety
      across different demographic subgroups in the sample
Hypotheses and research questions:

      Research Question 1: What is the level of depressive and anxiety symptoms three months
      following the employment of the strict viral mitigation protocols (i.e., physical distancing
      protocols) in the general adult population? What are the proportion above the validated
      cut-offs for depression and general anxiety? Hypothesis 1: There will be a significant
      decrease in the levels of depression and anxiety symptoms from the baseline (T1) with the
      strictest mitigation protocols to measurement the measurement period three months into
      pandemic (T2) where major pandemic mitigation protocols are lifted. Additionally, there will
      be a significant decrease in the proportion of the sample meeting validated cut-offs for
      depression and anxiety from T1 to T2.

      Hypothesis 2: Higher level at T1 and less reduction from T1 to T2 in positive metacognitions,
      negative metacognitions, and unhelpful coping strategies all measured with CAS-1, will be
      related to less reduction in depression and anxiety, above and beyond age, gender, and
      education. Higher level at T1 and increases from T1 to T2 in physical activity and perceived
      competence will be related to greater reduction in depression and anxiety, above and beyond,
      age, gender, and education.

      Explorative: The investigators will further explore the proportion showing reliable change in
      depression and anxiety and investigate the differences in changes in depression and anxiety
      across different demographic subgroups in the sample.

      Statistical analyses:

      Repeated surveys like the present one typically have missing data. Therefore, The
      investigators 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, the state of the art approach in handling missing data (Schafer & Graham, 2002).
      Particularly, if data are missing at random, which is likely in our survey, mixed models
      present more unbiased results than the other analytic methods (O'Connel et al., 2017).
      Depression and anxiety will be used as dependent variables in two separate mixed models.

      In preliminary analyses, and for each of the dependent variable (PHQ-9; GAD-7), 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).

      First, H1 about decrease in GAD-7 and PHQ-9 will be investigated by using PHQ-9 (in one
      analysis) and GAD-7 (in the other) as dependent variable in a model using time (T1 = 0; T2=
      1) as a predictor. Second, demographic control variables will be added as predictors. Third,
      the initial (T1) levels of negative metacognitions, positive metacognitions, unhelpful coping
      strategies, physical activity, and perceived competence to deal with the crisis, will be
      added as constant covariates, together with the interactions of these constant covariates
      with time. These interactions represent tests of H2 about the covariates predicting change in
      anxiety and depression, respectively. Finally, the present (T2) levels of negative
      metacognitions, positive metacognitions, unhelpful coping strategies, physical activity, and
      perceived competence to deal with the crisis will be added as constant covariates, 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 depression
      and anxiety from T1 to T2, respectively.

      Descriptive statistics with frequency tables including N, means and SDs and other standard
      descriptive statistics will examine the research question concerning general levels of
      depressive- and anxiety symptoms. Subgroup differences will be examined with chi-squared
      statistics. To investigate the percentage of individuals with depressive and anxiety
      symptoms, common cut-offs are used; including => 10 on PHQ-9 (Kroenke et al., 2001) and >= 8
      on GAD-7 (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).

      All analyses and questions addressed in the forthcoming paper that are not pre-specified in
      this pre-registered protocol will be defined as exploratory.

      Sensitivity analyses and random subsample replications of the main findings will be conducted
      following selection of a random sample of participants that ensure a proportionate ratio
      between the collected sample and the adult population of Norway.

      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 (i.e., multiple regression). 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. The investigators will
      examine the degree of skewness and evaluate this against the assumptions and analyses before
      choosing the appropriate analysis. The pre-registered and planned analyses include multiple
      regression as long as assumptions are met. Alternatively a non-parametric test will be used.

      Inference criteria Given the large sample size in this study, the investigators pre-define
      their significance level: p < 0.01 to determine significance.

      Sample size:

      The sample size at T1 included a representative and random selection 10 084 adult
      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.

      Eligibility criteria:

      Inclusion Criteria:

        -  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 provide digital consent to partake in the study.

      Exclusion Criteria:

        -  Children and adolescents (individuals below 18)

        -  Adults not residing in Norway during the measurement period

      Measures:

      Outcome variables include the following validated measures: PHQ-9 and GAD-7. Predictor
      variables include the following validated measures: positive metacognitions (measured with
      CAS-1 subscale); negative metacognitions (measured with CAS-1 subscale); unhelpful coping
      strategies (also called "strategies"; measured with CAS-1 subscale); physical activity
      (measure of number of times participant has been physically active for at least 30 minutes in
      an activity increasing pulse and leading to sweat for the past two weeks); perceived
      competence to deal with the pandemic (measured with Basic Psychological Needs and Frustration
      Scale, a single item adapted for the ability to deal pandemic consequences rather than
      ability to deal with difficult situations in general).

      Age, gender and education will be controlled for.
observational model: Other
time perspective: Prospective
measure: Patient Health Questionnaire 9
time frame: Data is set to be collected starting from 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.
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 22nd of June until enough data has been collected.The data collection period will last no longer than three weeks.
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).
intervention type: Other
intervention name: Prospective study across two time-points examining the impact of viral mitigation protocols on mental health
description: Prospective study across two time-points examining the impact of viral mitigation protocols on mental health
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Omid Ebrahimi, Double PhD Candidate
role: Principal Investigator
affiliation: University of Oslo
last name: Asle Hoffart, PhD
role: Principal Investigator
affiliation: Modum Bad
last name: Sverre Urnes Johnson, PhD
role: Principal Investigator
affiliation: University of Oslo
last name: Omid V. Ebrahimi, Double PhD Candidate
phone: +47-22845295
email: omideb@uio.no
last name: Sverre Urnes Johnson, PhD
phone: +47-22845295
email: s.u.johnson@psykologi.uio.no
citation: Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.
PMID: 31447721
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PMID: 11556941
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PMID: 16717171
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Omid V. Ebrahimi
investigator title: Mr.
mesh term: COVID-19
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders