<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/NCT04442243</url>
  </required_header>
  <id_info>
    <org_study_id>REK125510 (4)</org_study_id>
    <nct_id>NCT04442243</nct_id>
  </id_info>
  <brief_title>PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up</brief_title>
  <official_title>PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up</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>
      The aim of this study is to investigate the levels of trauma and mental symptoms (i.e.,&#xD;
      depression and anxiety) among health workers and public service providers 3 months after (T2)&#xD;
      the strict social distancing government initiated non-pharmacological interventions (NPIs)&#xD;
      related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study&#xD;
      also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured&#xD;
      during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses/Research questions:&#xD;
&#xD;
      H1: There will be a significant decrease in PTSD-symptoms, anxiety and depression from T1 to&#xD;
      T2.&#xD;
&#xD;
      Exploratory: Examine the differences in levels of trauma, anxiety, depression and quality of&#xD;
      life among different health workers, public service providers, demographic subgroups, and&#xD;
      between those working directly vs indirectly with COVID-19 patients at T2. Examine the&#xD;
      differences in change of trauma, anxiety and depression among different health workers,&#xD;
      public service providers, demographic subgroups, and between those working directly vs&#xD;
      indirectly with COVID-19 patients.&#xD;
&#xD;
      H2: Higher level at T1 and less reduction from T1 to T2 in metacognition, strategies,&#xD;
      burnout, worry about job and economy, interpersonal problems at baseline will be associated&#xD;
      with less reduction in PTSD-symptom from T1 to T2, above and beyond direct vs. indirect&#xD;
      exposure to trauma, demographic variables (age and gender, living with a partner, living with&#xD;
      children).&#xD;
&#xD;
      This study is part of 'The Norwegian COVID-19, Mental Health and Adherence Project',&#xD;
      involving multiple studies.&#xD;
&#xD;
      Sample size The sample size at T1 was 1778 participants. The sample size at T2 is not yet&#xD;
      clarified, but we expect 50% drop out.&#xD;
&#xD;
      Sample size rationale The mentioned 'Norwegian COVID-19 and Mental Health and Adherence&#xD;
      Project' involves multiple studies, where some involve a Complex Systems (Network analysis&#xD;
      approach). These multivariate analyses require large samples and power analysis was conducted&#xD;
      accordingly. Following power analysis guidelines by Fried &amp; Cramer (2017), it is recommended&#xD;
      that the number of participants be at the very least three times larger than the number of&#xD;
      estimated parameters. However, more conservative recommendations by Roscoe (1975) for&#xD;
      multivariate research, recommends sample size that is ten times larger than the number of&#xD;
      estimated parameters.&#xD;
&#xD;
      Stopping rule:&#xD;
&#xD;
      The data collection will start at June 22th and continue until as many as possible of 1778&#xD;
      respondents at T1 have submitted the questionnaire. The data-collection at T2 will be stopped&#xD;
      after three weeks.&#xD;
&#xD;
      Indices:&#xD;
&#xD;
      Given Acceptable Cronbach's alpha (above 0.7) two items was combined to represent worry about&#xD;
      work and economy. On the CAS1 four items were combined into the subscale &quot;positive&#xD;
      metacognition&quot;, four items were combined into the subscale &quot;negative metacognition&quot;, and 8&#xD;
      items were combined into the subscale strategies (Nordahl &amp; Wells, 2019). Interpersonal&#xD;
      problems consisted of 17 items selected from the IIP-64. Burnout was measured with a single&#xD;
      item. Worry about job and economy were measured with two time-points.&#xD;
&#xD;
      Statistical models:&#xD;
&#xD;
      Descriptive statistics with frequency tables including N, mean and SDs or median and&#xD;
      interquartile range depending on the data will be presented. A cut-off of 31 on the PCL-5&#xD;
      will be used together with the DSM-5 diagnostic guidelines applied to the PCL-5 to categorize&#xD;
      participants as fulfilling the PTSD symptom criteria or not. Participants indicating scores&#xD;
      of 2 or above on at least one of five re-experiencing symptoms, one of two avoidance&#xD;
      symptoms, two of seven symptoms of negative alterations in cognition and mood and two of six&#xD;
      arousal symptoms were classified as fulfilling the PTSD symptom criteria. Subclinical PTSD&#xD;
      will be assessed by specifying how large part of the sample which fulfill parts of the&#xD;
      PTSD-criterias, more specifically have at least one symptom above threshold (2 or above) in&#xD;
      each symptom-group. The results will be benchmarked against national and international&#xD;
      studies.&#xD;
&#xD;
      For PHQ-9, scores above 10 are considered as cut-off indicating that the patient is within&#xD;
      the depressive area.&#xD;
&#xD;
      For GAD-7 a cut-off of 8 and above will be used.&#xD;
&#xD;
      Paired sample t-test or paired samples Wilcoxon Test will be used to compare the&#xD;
      PTSD-symptoms at T2, depending on the nature of the data.&#xD;
&#xD;
      A One-way ANOVA or Kruskal-Wallis test, depending on level of skewness, will be conducted to&#xD;
      exploratory investigate differences between the different types of health-workers (e.g.&#xD;
      medical doctor and clinical psychologists) and public service providers (e.g., politicians,&#xD;
      social security), working directly vs indirectly. If there is significant differences between&#xD;
      the groups the investigators will either use a post hoc test, Tukey (HSD) or Dunn-Bonferroni,&#xD;
      depending on wether a parametric or non-parametric test has been used.&#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 majority of the data. Mixed models use maximum&#xD;
      likelihood estimation, which is the state of the art approach to handle missing data (Schafer&#xD;
      &amp; Graham, 2002). Especially if data are missing at random, which is likely in our survey,&#xD;
      mixed models give more unbiased results than the other analytic methods (O'Connel et al.,&#xD;
      2017).&#xD;
&#xD;
      In preliminary analyses, and for each of the dependent variables (PCL-5, GAD-7 and PHQ-9),&#xD;
      the combination of random effects and covariance structure of residuals that gives the best&#xD;
      fit 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 PCL-5, GAD-7 and PHQ-9 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 metacognition, strategies, burnout, worry about job and economy,&#xD;
      interpersonal problems will be added, together with the interactions of these constant&#xD;
      covariates with time. These interactions represent tests of H2 about the covariates&#xD;
      predicting change in PTSD-symptoms. Finally, the T2 levels of metacognition, strategies,&#xD;
      burnout, worry about job and economy, interpersonal problems as constant covariates will be&#xD;
      added, together with the interactions of these constant covariates with time. These&#xD;
      interactions represent tests of H2 about the change in the covariates from T1 to T2&#xD;
      predicting change in PTSD-symptoms from T1 to T2s.&#xD;
&#xD;
      Transformations Depending on degree of skewness compared to theoretical possibilities and&#xD;
      interpretations, variables will be assessed in their original and validated format as is&#xD;
      recommended practice, as long as this is possible. As this study examines psychopathology&#xD;
      levels amongst a general population (and not a clinical population), we do expect a skewed&#xD;
      data PTSD-symptoms on depressive and anxiety levels with most individuals reporting low&#xD;
      levels of PTSD -symptoms.&#xD;
&#xD;
      We will attempt to assess these variables in their original and validated format as is&#xD;
      recommended practice, as long as this is possible. However, if this is not possible to the&#xD;
      statistical assumptions behind the analyses, transformation may be needed to apply&#xD;
      interval-based methods. Alternatively a non-parametric test will be used.&#xD;
&#xD;
      Inference criteria&#xD;
&#xD;
      Given the large sample size in this study, we pre-define our significance level:&#xD;
&#xD;
      p &lt; 0.01 to determine significance&#xD;
&#xD;
      Data exclusion:&#xD;
&#xD;
      All health care or public service provides above 18 are included in this study. Vulnerable&#xD;
      health-care or public service providers - in this sample defined as doctors, nurses,&#xD;
      psychologists, and any other health-care workers, as well as politicians and social workers.&#xD;
      The participants reported if they worked directly or indirectly with COVID-19 patients.&#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>PTSD Checklist for DSM-5 (PCL-5)</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>PCL-5 is a 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot;The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire 9 (PHQ-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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder 7 (GAD-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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)</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>WEMWBS short version consist of 7 items</description>
  </secondary_outcome>
  <enrollment type="Anticipated">889</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Vulnerable health-care or public service providers was in this sample defined as doctors,&#xD;
        nurses, psychologists, and any other health-care workers, as well as politicians and social&#xD;
        workers. The participants reported if they worked directly or indirectly with COVID-19&#xD;
        patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health care or public service providers above 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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, 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>University of Oslo &amp; Modum Bad</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <phone>+47 41633313</phone>
    <email>sverreuj@psykologi.uio.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omid Ebrahimi</last_name>
    <email>omideb@uio.no</email>
  </overall_contact_backup>
  <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 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT04442243
org study id: REK125510 (4)
nct id: NCT04442243
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the levels of trauma and mental symptoms (i.e.,
      depression and anxiety) among health workers and public service providers 3 months after (T2)
      the strict social distancing government initiated non-pharmacological interventions (NPIs)
      related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study
      also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured
      during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.
Hypotheses/Research questions:

      H1: There will be a significant decrease in PTSD-symptoms, anxiety and depression from T1 to
      T2.

      Exploratory: Examine the differences in levels of trauma, anxiety, depression and quality of
      life among different health workers, public service providers, demographic subgroups, and
      between those working directly vs indirectly with COVID-19 patients at T2. Examine the
      differences in change of trauma, anxiety and depression among different health workers,
      public service providers, demographic subgroups, and between those working directly vs
      indirectly with COVID-19 patients.

      H2: Higher level at T1 and less reduction from T1 to T2 in metacognition, strategies,
      burnout, worry about job and economy, interpersonal problems at baseline will be associated
      with less reduction in PTSD-symptom from T1 to T2, above and beyond direct vs. indirect
      exposure to trauma, demographic variables (age and gender, living with a partner, living with
      children).

      This study is part of 'The Norwegian COVID-19, Mental Health and Adherence Project',
      involving multiple studies.

      Sample size The sample size at T1 was 1778 participants. The sample size at T2 is not yet
      clarified, but we expect 50% drop out.

      Sample size rationale The mentioned 'Norwegian COVID-19 and Mental Health and Adherence
      Project' involves multiple studies, where some involve a Complex Systems (Network analysis
      approach). These multivariate analyses require large samples and power analysis was conducted
      accordingly. Following power analysis guidelines by Fried & Cramer (2017), it is recommended
      that the number of participants be at the very least three times larger than the number of
      estimated parameters. However, more conservative recommendations by Roscoe (1975) for
      multivariate research, recommends sample size that is ten times larger than the number of
      estimated parameters.

      Stopping rule:

      The data collection will start at June 22th and continue until as many as possible of 1778
      respondents at T1 have submitted the questionnaire. The data-collection at T2 will be stopped
      after three weeks.

      Indices:

      Given Acceptable Cronbach's alpha (above 0.7) two items was combined to represent worry about
      work and economy. On the CAS1 four items were combined into the subscale "positive
      metacognition", four items were combined into the subscale "negative metacognition", and 8
      items were combined into the subscale strategies (Nordahl & Wells, 2019). Interpersonal
      problems consisted of 17 items selected from the IIP-64. Burnout was measured with a single
      item. Worry about job and economy were measured with two time-points.

      Statistical models:

      Descriptive statistics with frequency tables including N, mean and SDs or median and
      interquartile range depending on the data will be presented. A cut-off of 31 on the PCL-5
      will be used together with the DSM-5 diagnostic guidelines applied to the PCL-5 to categorize
      participants as fulfilling the PTSD symptom criteria or not. Participants indicating scores
      of 2 or above on at least one of five re-experiencing symptoms, one of two avoidance
      symptoms, two of seven symptoms of negative alterations in cognition and mood and two of six
      arousal symptoms were classified as fulfilling the PTSD symptom criteria. Subclinical PTSD
      will be assessed by specifying how large part of the sample which fulfill parts of the
      PTSD-criterias, more specifically have at least one symptom above threshold (2 or above) in
      each symptom-group. The results will be benchmarked against national and international
      studies.

      For PHQ-9, scores above 10 are considered as cut-off indicating that the patient is within
      the depressive area.

      For GAD-7 a cut-off of 8 and above will be used.

      Paired sample t-test or paired samples Wilcoxon Test will be used to compare the
      PTSD-symptoms at T2, depending on the nature of the data.

      A One-way ANOVA or Kruskal-Wallis test, depending on level of skewness, will be conducted to
      exploratory investigate differences between the different types of health-workers (e.g.
      medical doctor and clinical psychologists) and public service providers (e.g., politicians,
      social security), working directly vs indirectly. If there is significant differences between
      the groups the investigators will either use a post hoc test, Tukey (HSD) or Dunn-Bonferroni,
      depending on wether a parametric or non-parametric test has been used.

      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 majority of 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 (PCL-5, GAD-7 and PHQ-9),
      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 PCL-5, GAD-7 and PHQ-9 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 metacognition, strategies, burnout, worry about job and economy,
      interpersonal problems 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 PTSD-symptoms. Finally, the T2 levels of metacognition, strategies,
      burnout, worry about job and economy, interpersonal problems 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 PTSD-symptoms from T1 to T2s.

      Transformations Depending on degree of skewness compared to theoretical possibilities and
      interpretations, variables will be assessed in their original and validated format as is
      recommended practice, as long as this is possible. As this study examines psychopathology
      levels amongst a general population (and not a clinical population), we do expect a skewed
      data PTSD-symptoms on depressive and anxiety levels with most individuals reporting low
      levels of PTSD -symptoms.

      We will attempt to assess these variables in their original and validated format as is
      recommended practice, as long as this is possible. However, if this is not possible to the
      statistical assumptions behind the analyses, transformation may be needed to apply
      interval-based methods. Alternatively a non-parametric test will be used.

      Inference criteria

      Given the large sample size in this study, we pre-define our significance level:

      p < 0.01 to determine significance

      Data exclusion:

      All health care or public service provides above 18 are included in this study. Vulnerable
      health-care or public service providers - in this sample defined as doctors, nurses,
      psychologists, and any other health-care workers, as well as politicians and social workers.
      The participants reported if they worked directly or indirectly with COVID-19 patients.

      Exploratory:

      Questions addressed in the future paper which is not pre-specified will be defined as
      exploratory.
observational model: Other
time perspective: Prospective
measure: PTSD Checklist for DSM-5 (PCL-5)
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: PCL-5 is a 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.
measure: Patient Health Questionnaire 9 (PHQ-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.
measure: Generalized Anxiety Disorder 7 (GAD-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.
measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
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: WEMWBS short version consist of 7 items
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, Mr
role: Principal Investigator
affiliation: University of Oslo & Modum Bad
last name: Asle Hoffart, PhD
role: Principal Investigator
affiliation: University of Oslo & Modum Bad
last name: Sverre Urnes Johnson, PhD
phone: +47 41633313
email: sverreuj@psykologi.uio.no
last name: Omid Ebrahimi
email: omideb@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: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No