<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/NCT04443699</url>
  </required_header>
  <id_info>
    <org_study_id>REK125510-12</org_study_id>
    <nct_id>NCT04443699</nct_id>
  </id_info>
  <brief_title>Predictors of Mental Well-being During the COVID-19 Pandemic</brief_title>
  <official_title>Predictors of Mental Well-being 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 factors associated with well-being in the general&#xD;
      population during the COVID-19 pandemic, three months following the introduction of the&#xD;
      strict social distancing interventions in Norway.&#xD;
&#xD;
      Hypotheses and research questions:&#xD;
&#xD;
      Research Question 1: What is the level of mental well-being following three months of strict&#xD;
      mitigation strategies (i.e., physical distancing) in the general adult population during the&#xD;
      COVID-19 pandemic? The mean level of mental well-being will be benchmarked against the mean&#xD;
      level of mental well-being in similar pre-pandemic samples.&#xD;
&#xD;
      Hypothesis 1: Physical activity, being employed, positive metacognitions, negative&#xD;
      metacognitions, and unhelpful coping strategies at T1 will significantly predict well-being&#xD;
      (T2). Being employed and increased reports of physical activity at T2 will predict higher&#xD;
      levels of mental well-being at the measurement period (T2) and serve as protective factors.&#xD;
      Increased positive metacognitions, negative metacognitions and unhelpful coping strategies&#xD;
      measured with CAS-1 at T2 will predict lower levels of well-being (T2). Additionally, we will&#xD;
      examine whether the obtained predictive relationships hold when depressive symptoms (PHQ-9)&#xD;
      and anxiety symptoms (GAD-7) at T2 will be controlled for.&#xD;
&#xD;
      Exploratory: Do the predictors physical activity, positive metacognitions, negative&#xD;
      metacognitions, unhelpful coping strategies, all at baseline (T1), predict mental well-being&#xD;
      at T2, beyond and above these same aforementioned predictors at T2 and age, gender, and&#xD;
      education?&#xD;
&#xD;
      In all predictive analyses, age, gender, and education will be controlled for.&#xD;
&#xD;
      Exploratory: We will exploratory investigate the differences in levels of mental well-being&#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 mental well-being following three months of strict&#xD;
      mitigation strategies (i.e., physical distancing) in the general adult population during the&#xD;
      COVID-19 pandemic? The mean level of mental well-being will be benchmarked against the mean&#xD;
      level of mental well-being in similar pre-pandemic samples.&#xD;
&#xD;
      Hypothesis 1: Physical activity, being employed, positive metacognitions, negative&#xD;
      metacognitions, and unhelpful coping strategies at T1 will significantly predict well-being&#xD;
      (T2). Being employed and increased reports of physical activity at T2 will predict higher&#xD;
      levels of mental well-being at the measurement period (T2) and serve as protective factors.&#xD;
      Increased positive metacognitions, negative metacognitions and unhelpful coping strategies&#xD;
      measured with CAS-1 at T2 will predict lower levels of well-being (T2). Additionally, we will&#xD;
      examine whether the obtained predictive relationships hold when depressive symptoms (PHQ-9)&#xD;
      and anxiety symptoms (GAD-7) at T2 will be controlled for.&#xD;
&#xD;
      Exploratory: Do the predictors physical activity, positive metacognitions, negative&#xD;
      metacognitions, unhelpful coping strategies, all at baseline (T1), predict mental well-being&#xD;
      at T2, beyond and above these same aforementioned predictors at T2 and age, gender, and&#xD;
      education?&#xD;
&#xD;
      In all predictive analyses, age, gender, and education will be controlled for.&#xD;
&#xD;
      Exploratory: The investigators will exploratory investigate the differences in levels of&#xD;
      mental well-being across different demographic subgroups in the sample.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      A hierarchical regression analysis will be conducted with SWEMWBS as the dependent variable.&#xD;
      In the first step stable characteristics (control variables) will be included: age, gender&#xD;
      and education. In the second step physical activity, being employed, positive metacognitions,&#xD;
      negative metacognitions, and unhelpful coping strategies at T2 will be included. Part&#xD;
      correlations will be examined for each step, presenting the effect size of the hypothesized&#xD;
      predictors on mental well-being. In the third step, anxiety and depression at T2 will be&#xD;
      included as control variables. In the final step, physical activity, being employed, positive&#xD;
      metacognitions, negative metacognitions, and unhelpful coping strategies at T1 will be&#xD;
      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).&#xD;
&#xD;
      Descriptive statistics with frequency tables including N, means, SDs and other standard&#xD;
      descriptive statistics will examine the research question concerning general levels of mental&#xD;
      well-being. Subgroup differences will be examined.&#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., hierarchical 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 analysis include&#xD;
      hierarchical regression as long as assumptions underlying this analysis is met.&#xD;
      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 and power calculation:&#xD;
&#xD;
      The present study is part of a larger project with the first part aiming to investigate&#xD;
      predictors of mental well-being through regression analyses, and the second part aiming to&#xD;
      examine directional relations amongst specific symptoms and their centrality through complex&#xD;
      systems approaches (i.e., network analysis). Consequently, power calculations are based on&#xD;
      power required for network analyses. Following power analysis guidelines by Fried &amp; Cramer&#xD;
      (2017), it is recommended that the number of participants are three times larger than the&#xD;
      number of estimated parameters. However, more conservative recommendations by Roscoe (1975)&#xD;
      for multivariate research, recommends sample size that is ten times larger than the number of&#xD;
      estimated parameters. Thus, following these two approaches respectively, between 1584 to 5280&#xD;
      participants are required. Data will be collected for three weeks, and participants are based&#xD;
      on a representative and random sample of Norwegian adults, randomly selected and provided&#xD;
      equal opportunity to partake in the study, providing digital consent.&#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. The investigators&#xD;
      do not expect participants to withdraw their data and thus expect no missing data. However,&#xD;
      if participants do withdraw their data, the investigators will conduct state-of-art missing&#xD;
      data analyses and investigate whether data is missing at random.&#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>The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)</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 Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) (Tennant et al., 2007) is a measure consisting of items related entirely to positive aspects of mental health and is covering subjective well-being and psychological functioning. The scale consists of 7 items scored on a five-point Likert scale ranging from 'none of the time' to 'all of the time'.</description>
  </primary_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Mental Well-being</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health</intervention_name>
    <description>Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adults above 18 years residing in Norway and thus experiencing identical mitigation&#xD;
        protocols are invited to participate the study, reaching randomly online with an equal&#xD;
        opportunity of participating.&#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>
    <gender_based>Yes</gender_based>
    <gender_description>Both Biological Sex and self-representation of gender are measured</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </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>Sverre Urnes Sverre Urnes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hoffart Hoffart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Modum Bad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sara Ebling, Cand.psychol. stud.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bergen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Omid Ebrahimi, Double PhD Candidate</last_name>
    <phone>+47-22845295</phone>
    <email>omideb@uio.no</email>
  </overall_contact>
  <reference>
    <citation>Ng Fat L, Scholes S, Boniface S, Mindell J, Stewart-Brown S. Evaluating and establishing national norms for mental wellbeing using the short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS): findings from the Health Survey for England. Qual Life Res. 2017 May;26(5):1129-1144. doi: 10.1007/s11136-016-1454-8. Epub 2016 Nov 16.</citation>
    <PMID>27853963</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 23, 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>
  </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/NCT04443699
org study id: REK125510-12
nct id: NCT04443699
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study description:

      The present study seeks to investigate factors associated with well-being in the general
      population during the COVID-19 pandemic, three months following the introduction of the
      strict social distancing interventions in Norway.

      Hypotheses and research questions:

      Research Question 1: What is the level of mental well-being 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 mental well-being will be benchmarked against the mean
      level of mental well-being in similar pre-pandemic samples.

      Hypothesis 1: Physical activity, being employed, positive metacognitions, negative
      metacognitions, and unhelpful coping strategies at T1 will significantly predict well-being
      (T2). Being employed and increased reports of physical activity at T2 will predict higher
      levels of mental well-being at the measurement period (T2) and serve as protective factors.
      Increased positive metacognitions, negative metacognitions and unhelpful coping strategies
      measured with CAS-1 at T2 will predict lower levels of well-being (T2). Additionally, we will
      examine whether the obtained predictive relationships hold when depressive symptoms (PHQ-9)
      and anxiety symptoms (GAD-7) at T2 will be controlled for.

      Exploratory: Do the predictors physical activity, positive metacognitions, negative
      metacognitions, unhelpful coping strategies, all at baseline (T1), predict mental well-being
      at T2, beyond and above these same aforementioned predictors at T2 and age, gender, and
      education?

      In all predictive analyses, age, gender, and education will be controlled for.

      Exploratory: We will exploratory investigate the differences in levels of mental well-being
      across different demographic subgroups in the sample.
Hypotheses and research questions:

      Research Question 1: What is the level of mental well-being 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 mental well-being will be benchmarked against the mean
      level of mental well-being in similar pre-pandemic samples.

      Hypothesis 1: Physical activity, being employed, positive metacognitions, negative
      metacognitions, and unhelpful coping strategies at T1 will significantly predict well-being
      (T2). Being employed and increased reports of physical activity at T2 will predict higher
      levels of mental well-being at the measurement period (T2) and serve as protective factors.
      Increased positive metacognitions, negative metacognitions and unhelpful coping strategies
      measured with CAS-1 at T2 will predict lower levels of well-being (T2). Additionally, we will
      examine whether the obtained predictive relationships hold when depressive symptoms (PHQ-9)
      and anxiety symptoms (GAD-7) at T2 will be controlled for.

      Exploratory: Do the predictors physical activity, positive metacognitions, negative
      metacognitions, unhelpful coping strategies, all at baseline (T1), predict mental well-being
      at T2, beyond and above these same aforementioned predictors at T2 and age, gender, and
      education?

      In all predictive analyses, age, gender, and education will be controlled for.

      Exploratory: The investigators will exploratory investigate the differences in levels of
      mental well-being across different demographic subgroups in the sample.

      Statistical analysis:

      A hierarchical regression analysis will be conducted with SWEMWBS as the dependent variable.
      In the first step stable characteristics (control variables) will be included: age, gender
      and education. In the second step physical activity, being employed, positive metacognitions,
      negative metacognitions, and unhelpful coping strategies at T2 will be included. Part
      correlations will be examined for each step, presenting the effect size of the hypothesized
      predictors on mental well-being. In the third step, anxiety and depression at T2 will be
      included as control variables. In the final step, physical activity, being employed, positive
      metacognitions, negative metacognitions, and unhelpful coping strategies 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, SDs and other standard
      descriptive statistics will examine the research question concerning general levels of mental
      well-being. Subgroup differences will be examined.

      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., hierarchical 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 analysis include
      hierarchical regression as long as assumptions underlying this analysis is 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 and power calculation:

      The present study is part of a larger project with the first part aiming to investigate
      predictors of mental well-being through regression analyses, and the second part aiming to
      examine directional relations amongst specific symptoms and their centrality through complex
      systems approaches (i.e., network analysis). Consequently, power calculations are based on
      power required for network analyses. 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.

      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. The investigators
      do not expect participants to withdraw their data and thus expect no missing data. However,
      if participants do withdraw their data, the investigators will conduct state-of-art missing
      data analyses and investigate whether data is missing at random.
observational model: Other
time perspective: Prospective
measure: The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
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 Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) (Tennant et al., 2007) is a measure consisting of items related entirely to positive aspects of mental health and is covering subjective well-being and psychological functioning. The scale consists of 7 items scored on a five-point Likert scale ranging from 'none of the time' to 'all of the time'.
intervention type: Behavioral
intervention name: Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
description: Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Both Biological Sex and self-representation of gender are measured
minimum age: 18 Years
maximum age: N/A
last name: Omid Ebrahimi, Double PhD Candidate
role: Principal Investigator
affiliation: University of Oslo
last name: Sverre Urnes Sverre Urnes, PhD
role: Principal Investigator
affiliation: University of Oslo
last name: Hoffart Hoffart, PhD
role: Principal Investigator
affiliation: Modum Bad
last name: Sara Ebling, Cand.psychol. stud.
role: Principal Investigator
affiliation: University of Bergen
last name: Omid Ebrahimi, Double PhD Candidate
phone: +47-22845295
email: omideb@uio.no
citation: Ng Fat L, Scholes S, Boniface S, Mindell J, Stewart-Brown S. Evaluating and establishing national norms for mental wellbeing using the short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS): findings from the Health Survey for England. Qual Life Res. 2017 May;26(5):1129-1144. doi: 10.1007/s11136-016-1454-8. Epub 2016 Nov 16.
PMID: 27853963
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Omid V. Ebrahimi
investigator title: Mr.
mesh term: COVID-19