<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/NCT04443361</url>
  </required_header>
  <id_info>
    <org_study_id>REK125510 (7)</org_study_id>
    <nct_id>NCT04443361</nct_id>
  </id_info>
  <brief_title>Insomnia After the COVID-19 Pandemic</brief_title>
  <official_title>Insomnia 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>
      The aim of this study is to investigate the levels of insomnia 3 months after (T2) the strict&#xD;
      physical distancing government initiated physical distancing protocols related to the&#xD;
      COVID-19 pandemic (T1). The study also aims to investigate how predictors measured after and&#xD;
      before the COVID-19 pandemic are associated with sleep problems at T2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis/Research Questions H1: What is the level of mental insomnia following three months&#xD;
      of strict mitigation strategies (i.e., physical distancing) in the general adult population&#xD;
      during the COVID-19 pandemic? The mean level of insomnia will be benchmarked against the mean&#xD;
      level of insomnia in similar pre-pandemic samples.&#xD;
&#xD;
      Exploratory: What is the level of insomnia in different demographic subgroups.&#xD;
&#xD;
      H2: The level of metacognition, strategies, worry about job and economy, health-anxiety and&#xD;
      physical activity at T2 will predict insomnia at T2, beyond and above, age, gender, and&#xD;
      education.&#xD;
&#xD;
      Exploratory: Does metacognition, strategies, worry about job and economy, health-anxiety and&#xD;
      physical activity at T1 predict Insomnia at T2, beyond and above psychiatric diagnosis, age,&#xD;
      gender, and education and predictors at T2?&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      A hierarchical regression analysis will be conducted using BIS as the dependent variable. In&#xD;
      the first step stable characteristics (control variables) will be included: age, gender and&#xD;
      education. In the second step metacognition, strategies, worry about job and economy,&#xD;
      health-anxiety and physical activity at T2 will be included. Part-correlation will be&#xD;
      reported for step 2, presenting the effect size of the predictors on insomnia. In the third&#xD;
      step, anxiety and depression at T2 will be included as control for the variables at the next&#xD;
      step. In the last step metacognition, strategies, worry about job and economy, health-anxiety&#xD;
      and physical activity, at T1 will be included.&#xD;
&#xD;
      Multicollinearity and other statistical assumptions will be checked. Multicollinearity will&#xD;
      be assessed with common guidelines (VIF &lt; 5 and Tolerance &gt; 0.2; Hocking, 2003; O'Brian,&#xD;
      2007). Descriptive statistics with frequency tables including N, means and SDs and other&#xD;
      standard descriptive statistics will be used to examine the level of insomnia. Subgroup&#xD;
      differences will be examined with chi-squared statistics or other statistic based on the&#xD;
      characteristics of the data (e.g. skewness).&#xD;
&#xD;
      All analysis and questions addressed in the forthcoming paper that are not pre-specificd in&#xD;
      this pre-registered protocol will be defined as exploratory.&#xD;
&#xD;
      Sensitivity analyses and random subsample replications of the main finding will be conducted&#xD;
      following selection of a random sample of participants that ensure a proportional ratio&#xD;
      between the collected sample and the adult population in Norway&#xD;
&#xD;
      Measures On the CAS1 four items were combined into the subscale &quot;positive metacognition&quot;,&#xD;
      four items were combined into the subscale &quot;negative metacognition&quot;, and 8 items were&#xD;
      combined into the subscale strategies (Nordahl &amp; Wells, 2019). Physical activity was measured&#xD;
      with a single item. Worry about job and economy consisted of two items. Health anxiety&#xD;
      consists of four items.&#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, alternatively the use&#xD;
      of non-parametric tests.&#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 present study is part of a larger project with the part aiming to investigate predictors&#xD;
      of sleep trough regression analysis, and the second part aiming to examine directional&#xD;
      relations among specific symptoms and their centrality through network analysis. Thus, the&#xD;
      power calculations are based on power required for network analysis.&#xD;
&#xD;
      Following power analysis guidelines by Fried &amp; Cramer (2017), it is recommended that the&#xD;
      number of participants are three times larger than the number of estimated parameters.&#xD;
      However, more conservative recommendations by Roscoe (1975) for multivariate research,&#xD;
      recommends sample size that is ten times larger than the number of estimated parameters.&#xD;
      Thus, following these two approaches respectively, between 1584 to 5280 participants are&#xD;
      required. Data will be collected for three weeks, and participants are based on a&#xD;
      representative and random sample of Norwegian adults, randomly selected and provided equal&#xD;
      opportunity to partake in the study, providing digital consent.&#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 had provided digital consent to partake in the study.&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
      • Children and adolescents (individuals below 18) Adults not residing in Norway during the&#xD;
      measurement period&#xD;
&#xD;
      Missing data:&#xD;
&#xD;
      The TSD system (Services for Sensitive Data), a platform used in Norway to store&#xD;
      person-sensitive data verifies participants officially through a kind of national ID number&#xD;
      to give them full right to withdraw their data at any time, following the European GDPR&#xD;
      (General Data Protection Regulation) laws. Accordingly, participants are allowed to withdraw&#xD;
      their own data at any time. The survey includes mandatory fields of response. Participation&#xD;
      is voluntarily, and withdrawal of provided data is possible at any moment. We do not expect&#xD;
      participants to withdraw their data and thus expect no missing data. However, if participants&#xD;
      do withdraw their data, we will conduct state-of-art missing data analyses and investigate&#xD;
      whether data is missing at random.&#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>Bergen insomnia scale (BIS)</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>Bergen Insomnia scale is developed as a short measure of insomnia consisting of six items measured on a 8-point Likert-scale (Pallesen et al., 2008)</description>
  </primary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Insomnia</condition>
  <condition>Metacognitive Beliefs</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Sleep</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The 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 had provided digital consent to partake in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Children and adolescents (individuals below 18) Adults not residing in Norway during the&#xD;
        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>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_official>
    <last_name>Sverre Urnes Johnson, 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>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 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</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/NCT04443361
org study id: REK125510 (7)
nct id: NCT04443361
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 insomnia 3 months after (T2) the strict
      physical distancing government initiated physical distancing protocols related to the
      COVID-19 pandemic (T1). The study also aims to investigate how predictors measured after and
      before the COVID-19 pandemic are associated with sleep problems at T2.
Hypothesis/Research Questions H1: What is the level of mental insomnia following three months
      of strict mitigation strategies (i.e., physical distancing) in the general adult population
      during the COVID-19 pandemic? The mean level of insomnia will be benchmarked against the mean
      level of insomnia in similar pre-pandemic samples.

      Exploratory: What is the level of insomnia in different demographic subgroups.

      H2: The level of metacognition, strategies, worry about job and economy, health-anxiety and
      physical activity at T2 will predict insomnia at T2, beyond and above, age, gender, and
      education.

      Exploratory: Does metacognition, strategies, worry about job and economy, health-anxiety and
      physical activity at T1 predict Insomnia at T2, beyond and above psychiatric diagnosis, age,
      gender, and education and predictors at T2?

      Statistical analysis:

      A hierarchical regression analysis will be conducted using BIS as the dependent variable. In
      the first step stable characteristics (control variables) will be included: age, gender and
      education. In the second step metacognition, strategies, worry about job and economy,
      health-anxiety and physical activity at T2 will be included. Part-correlation will be
      reported for step 2, presenting the effect size of the predictors on insomnia. In the third
      step, anxiety and depression at T2 will be included as control for the variables at the next
      step. In the last step metacognition, strategies, worry about job and economy, health-anxiety
      and physical activity, at T1 will be included.

      Multicollinearity and other statistical assumptions will be checked. Multicollinearity will
      be assessed with common guidelines (VIF < 5 and Tolerance > 0.2; Hocking, 2003; O'Brian,
      2007). Descriptive statistics with frequency tables including N, means and SDs and other
      standard descriptive statistics will be used to examine the level of insomnia. Subgroup
      differences will be examined with chi-squared statistics or other statistic based on the
      characteristics of the data (e.g. skewness).

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

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

      Measures 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). Physical activity was measured
      with a single item. Worry about job and economy consisted of two items. Health anxiety
      consists of four items.

      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, alternatively the use
      of non-parametric tests.

      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 present study is part of a larger project with the part aiming to investigate predictors
      of sleep trough regression analysis, and the second part aiming to examine directional
      relations among specific symptoms and their centrality through network analysis. Thus, the
      power calculations are based on power required for network analysis.

      Following power analysis guidelines by Fried & Cramer (2017), it is recommended that the
      number of participants are 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.
      Thus, following these two approaches respectively, between 1584 to 5280 participants are
      required. Data will be collected for three weeks, and participants are based on a
      representative and random sample of Norwegian adults, randomly selected and provided equal
      opportunity to partake in the study, providing digital consent.

      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 had provided digital consent to partake in the study.

      Exclusion Criteria:

      • Children and adolescents (individuals below 18) Adults not residing in Norway during the
      measurement period

      Missing data:

      The TSD system (Services for Sensitive Data), a platform used in Norway to store
      person-sensitive data verifies participants officially through a kind of national ID number
      to give them full right to withdraw their data at any time, following the European GDPR
      (General Data Protection Regulation) laws. Accordingly, participants are allowed to withdraw
      their own data at any time. The survey includes mandatory fields of response. Participation
      is voluntarily, and withdrawal of provided data is possible at any moment. We do not expect
      participants to withdraw their data and thus expect no missing data. However, if participants
      do withdraw their data, we will conduct state-of-art missing data analyses and investigate
      whether data is missing at random.

      Exploratory:

      Questions addressed in the future paper which is not pre-specified will be defined as
      exploratory.
observational model: Other
time perspective: Prospective
measure: Bergen insomnia scale (BIS)
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: Bergen Insomnia scale is developed as a short measure of insomnia consisting of six items measured on a 8-point Likert-scale (Pallesen et al., 2008)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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
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: Sleep Initiation and Maintenance Disorders
sharing ipd: No