<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/NCT04442282</url>
  </required_header>
  <id_info>
    <org_study_id>REK125510 (5)</org_study_id>
    <nct_id>NCT04442282</nct_id>
  </id_info>
  <brief_title>Difficulties in Emotion-regulation and Interpersonal Problems During and After the COVID-19 Pandemic</brief_title>
  <official_title>Difficulties in Emotion-regulation and Interpersonal Problems, and Their Association With Anxiety and Depression During and After 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>
      Central indicators of psychological functioning such as difficulties in emotion regulation&#xD;
      and habitual problems in one's relating to others are likely to have been substantially&#xD;
      impacted by the COVID-19 amelioration measures of societal lock-down and physical (ne social)&#xD;
      distancing. In turn, as these amelioration measures have been relaxed, that impact will&#xD;
      presumably be reduced, gradually returning these factors to pre-crisis levels. Also, these&#xD;
      factors are likely to predict mental health outcomes such as symptoms of depression and&#xD;
      anxiety throughout the pandemic and beyond, so that levels of emotion regulation difficulties&#xD;
      and interpersonal problems early on will predict later symptom status. Similarly reductions&#xD;
      in such difficulties during the various phases of the outbreak will be associated with a&#xD;
      concurrent reduction in psychological symptoms and reduced symptom levels at later stages.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses/Research questions:&#xD;
&#xD;
      H1: There will be a significant decrease in emotion-regulation difficulties (DERS) and&#xD;
      interpersonal problems from T1 to T2.&#xD;
&#xD;
      Exploratory: Examine the difference in interpersonal problems and DERS among different&#xD;
      sub-groups before and after the COVID-19 pandemic&#xD;
&#xD;
      H2: Higher level at T1 and less reduction from T1 to T2 in emotion-regulation difficulties&#xD;
      and interpersonal problems will be associated with less reduction in anxiety and depression&#xD;
      from T1 to T2, above and beyond, demographic variables (age, gender, education).&#xD;
&#xD;
      Exploratory: Explore the different octants of IIP as predictors of changes for anxiety and&#xD;
      depression.&#xD;
&#xD;
      This study is part of 'The Norwegian COVID-19, Mental Health and Adherence Project',&#xD;
      involving multiple studies.&#xD;
&#xD;
      Statistical models:&#xD;
&#xD;
      Repeated surveys like the present one typically have high drop-out and substantial missing&#xD;
      data. Therefore, we will use mixed models instead of paired t-tests, repeated measures&#xD;
      ANOVAs, and ordinary linear regression to analyze 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 (GAD-7 and PHQ-9, DERS ,&#xD;
      IIP), the combination of random effects and covariance structure of residuals that gives the&#xD;
      best fit for the &quot;empty&quot; model (the model without fixed predictors except the intercept) will&#xD;
      be 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 DERS and IIP, GAD-7 and PHQ 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 DERS and IIP as constant covariates will be added, together with the&#xD;
      interactions of these constant covariates with time. These interactions represent tests of H2&#xD;
      about the covariates predicting change in anxiety and depression. Finally, the T2 levels of&#xD;
      DERS and IIP as constant covariates will be added, together with the interactions of these&#xD;
      constant covariates with time. These interactions represent tests of H2 about the change in&#xD;
      the covariates from T1 to T2 predicting change in anxiety and depression 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. 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;
      Missing data Maximum likelihood&#xD;
&#xD;
      Sensitivity analyses Sensitivity analyses will be conducted after selecting a random sample&#xD;
      of participants to reflect the proportion of subgroups in the Norwegian adult population.&#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 (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. 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>The 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).&#xD;
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>Difficulties in Emotion Regulation Scale</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>6 items from DERS (Gratz &amp; Roemer, 2004)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interpersonal problems</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>17 Items from IIP-64 (Horowitz et al. 2000)</description>
  </primary_outcome>
  <enrollment type="Anticipated">5041</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Interpersonal Problem</condition>
  <condition>Emotion Regulation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        General population in Norway.&#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 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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ole Andrè Solbakken, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jon Monsen, PhD</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>University of Oslo &amp; 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_contact>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <phone>41633313</phone>
    <email>s.u.johnson@psykologi.uio.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omid Ebrahimi, Mr</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 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 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>COVID-19</mesh_term>
    <mesh_term>Depression</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/NCT04442282
org study id: REK125510 (5)
nct id: NCT04442282
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Central indicators of psychological functioning such as difficulties in emotion regulation
      and habitual problems in one's relating to others are likely to have been substantially
      impacted by the COVID-19 amelioration measures of societal lock-down and physical (ne social)
      distancing. In turn, as these amelioration measures have been relaxed, that impact will
      presumably be reduced, gradually returning these factors to pre-crisis levels. Also, these
      factors are likely to predict mental health outcomes such as symptoms of depression and
      anxiety throughout the pandemic and beyond, so that levels of emotion regulation difficulties
      and interpersonal problems early on will predict later symptom status. Similarly reductions
      in such difficulties during the various phases of the outbreak will be associated with a
      concurrent reduction in psychological symptoms and reduced symptom levels at later stages.
Hypotheses/Research questions:

      H1: There will be a significant decrease in emotion-regulation difficulties (DERS) and
      interpersonal problems from T1 to T2.

      Exploratory: Examine the difference in interpersonal problems and DERS among different
      sub-groups before and after the COVID-19 pandemic

      H2: Higher level at T1 and less reduction from T1 to T2 in emotion-regulation difficulties
      and interpersonal problems will be associated with less reduction in anxiety and depression
      from T1 to T2, above and beyond, demographic variables (age, gender, education).

      Exploratory: Explore the different octants of IIP as predictors of changes for anxiety and
      depression.

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

      Statistical models:

      Repeated surveys like the present one typically have high drop-out and substantial 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 and PHQ-9, DERS ,
      IIP), 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 DERS and IIP, GAD-7 and PHQ 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 DERS and IIP as constant covariates 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 and depression. Finally, the T2 levels of
      DERS and IIP 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 and depression 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. 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

      Missing data Maximum likelihood

      Sensitivity analyses Sensitivity analyses will be conducted after selecting a random sample
      of participants to reflect the proportion of subgroups in the Norwegian adult population.

      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 (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. 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: The 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).
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: Difficulties in Emotion Regulation Scale
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: 6 items from DERS (Gratz & Roemer, 2004)
measure: Interpersonal problems
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: 17 Items from IIP-64 (Horowitz et al. 2000)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Ole Andrè Solbakken, PhD
role: Principal Investigator
affiliation: University of Oslo
last name: Jon Monsen, PhD
role: Principal Investigator
affiliation: University of Oslo
last name: Asle Hoffart, PhD
role: Principal Investigator
affiliation: University of Oslo & Modum Bad
last name: Omid Ebrahimi, Mr
role: Principal Investigator
affiliation: University of Oslo & Modum Bad
last name: Sverre Urnes Johnson, PhD
phone: 41633313
email: s.u.johnson@psykologi.uio.no
last name: Omid Ebrahimi, Mr
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: COVID-19
mesh term: Depression
sharing ipd: No