<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/NCT04444505</url>
  </required_header>
  <id_info>
    <org_study_id>REK125510-14</org_study_id>
    <nct_id>NCT04444505</nct_id>
  </id_info>
  <brief_title>Trait Versus State: The Differential Impact of Personality Traits, Coping Behaviors and Cognitions on Depression and Anxiety</brief_title>
  <official_title>Trait Versus State: The Differential Impact of Personality Traits, Coping Behaviors and Cognitions on Depression and Anxiety</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 present study aims to investigate the differential impact of different types of variables&#xD;
      on depression and anxiety. In particular, the impact of trait-variables (i.e., personality&#xD;
      measured with the brief Big Five Inventory (BFI-10)) are contrasted against state-variables,&#xD;
      including unhelpful coping behavior (measured with CAS-1) and cognitions including positive&#xD;
      metacognitions and negative metacognitions (both measured with CAS-1).&#xD;
&#xD;
      Personality is defined as a set of traits that is relatively consistent over time and&#xD;
      situation, and is subsequently less susceptible as a target mechanisms for therapy. Still,&#xD;
      researchers have devoted great efforts toward describing personality traits as related to&#xD;
      different psychopathological disorders. Consequently, the present study aims to investigate&#xD;
      the differential associations of traits (i.e., personality) versus state variables&#xD;
      (metacognitions and coping behaviors) on depression and anxiety.&#xD;
&#xD;
      The findings of the present study will provide important insights in finding important&#xD;
      associations between trait and state variables in relation to psychopathology, providing an&#xD;
      important foundation for further directional investigations with temporal data&#xD;
&#xD;
      Hypothesis 1: Neuroticism measured with (BFI-10), positive metacognitions, negative&#xD;
      metacognitions, and unhelpful coping strategies (the latter three measured with CAS-1), will&#xD;
      predict higher levels of depression and anxiety.&#xD;
&#xD;
      Research Question 1: How and to what extent are different traits related measured with BFI-10&#xD;
      related to depression and anxiety in the present pandemic sample?&#xD;
&#xD;
      Research Question 2: Are the trait or state variables most strongly associated with&#xD;
      depressive and anxiety symptoms? This question will be investigated using part correlations&#xD;
      in the multiple regression analyses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis 1: Neuroticism measured with (BFI-10), positive metacognitions, negative&#xD;
      metacognitions, and unhelpful coping strategies (the latter three measured with CAS-1), will&#xD;
      predict higher levels of depression and anxiety.&#xD;
&#xD;
      Research Question 1: How and to what extent are different traits related measured with BFI-10&#xD;
      related to depression and anxiety in the present pandemic sample?&#xD;
&#xD;
      Research Question 2: Are the trait or state variables most strongly associated with&#xD;
      depressive and anxiety symptoms? This question will be investigated using part correlations&#xD;
      in the multiple regression analyses.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Two hierarchical regression analyses will be conducted. 1) with PHQ-9 as the dependent&#xD;
      variable; and 2) the second with GAD-7 at as the dependent variable. Both analyses will&#xD;
      include the following variables and the following steps: In step 1, the demographic variables&#xD;
      age, gender, and education will be included in the model. In step 2 two, the trait-variables&#xD;
      (i.e., all five personality traits measured with BFI-10) will be included. In the final step,&#xD;
      the three state-variables positive metacognitions, negative metacognitions (CAS-1), and&#xD;
      unhelpful coping strategies (CAS-1) will be included.&#xD;
&#xD;
      Part correlations will be reported for each regression analysis, presenting the effect size&#xD;
      of the hypothesized predictors on depression and anxiety. A part (semi-partial) correlation&#xD;
      gives the least biased and easiest interpretable estimate of the strength of a predictive&#xD;
      relationship (Dudgeon, 2016). It is the correlation between the outcome and the aspects of&#xD;
      the predictor unique from all the other predictors. As a type of correlation, its size can be&#xD;
      evaluated according to Cohen's (1988) criteria: small &gt;=0.10, medium &gt;=0.30, large &gt;=0.50.&#xD;
&#xD;
      Both analysis include the following 5 trait-predictor variables: Neuroticism (BFI-10),&#xD;
      Openness (BFI-10), Conscientiousness (BFI-10), Extroversion-Introversion (BFI-10), and&#xD;
      Agreeableness (BFI-10).&#xD;
&#xD;
      The state-predictor variables are as mentioned: positive metacognitions (CAS-1 subscale);&#xD;
      negative metacognitions (CAS-1 subscale); unhelpful coping behaviors (CAS-1 subscale).&#xD;
&#xD;
      Multicollinearity and other statistical assumptions will be checked using examined.&#xD;
      Multicollinearity will be assessed with common guidelines (VIF &lt; 5 and Tolerance &gt; 0.2;&#xD;
      Hocking, 2003; O'Brian, 2007).&#xD;
&#xD;
      If any further analyses or questions are addressed in the forthcoming paper that are not&#xD;
      pre-specified in this pre-registered protocol, they will be explicitly defined as&#xD;
      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;
      Sample size and power calculation:&#xD;
&#xD;
      The present study is part of a larger project with the first part aiming to investigate&#xD;
      information source predictors of mental health through regression analyses, and the second&#xD;
      part aiming to examine directional relations amongst specific sources of information and&#xD;
      their centrality through complex systems approaches (i.e., network analysis). Consequently,&#xD;
      power calculations are based on power required for network analyses. Following power analysis&#xD;
      guidelines by Fried &amp; Cramer (2017), it is recommended that the number of participants are&#xD;
      three times larger than the number of estimated parameters. However, more conservative&#xD;
      recommendations by Roscoe (1975) for multivariate research, recommends sample size that is&#xD;
      ten times larger than the number of estimated parameters. Thus, following these two&#xD;
      approaches respectively, between 1305 to 4350 participants are required. Data will be&#xD;
      collected for three weeks, and participants are based on a representative and random sample&#xD;
      of Norwegian adults, randomly selected and provided equal opportunity to partake in the&#xD;
      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>Patient Health Questionnaire 9</measure>
    <time_frame>Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks</time_frame>
    <description>The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer &amp; Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder 7</measure>
    <time_frame>Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks</time_frame>
    <description>The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams &amp; Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen &amp; Hoffart, 2019).</description>
  </primary_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prospective study 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 will 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>
  <reference>
    <citation>Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.</citation>
    <PMID>11556941</PMID>
  </reference>
  <reference>
    <citation>Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.</citation>
    <PMID>16717171</PMID>
  </reference>
  <reference>
    <citation>Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.</citation>
    <PMID>31447721</PMID>
  </reference>
  <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 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>Omid V. Ebrahimi</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04444505
org study id: REK125510-14
nct id: NCT04444505
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study aims to investigate the differential impact of different types of variables
      on depression and anxiety. In particular, the impact of trait-variables (i.e., personality
      measured with the brief Big Five Inventory (BFI-10)) are contrasted against state-variables,
      including unhelpful coping behavior (measured with CAS-1) and cognitions including positive
      metacognitions and negative metacognitions (both measured with CAS-1).

      Personality is defined as a set of traits that is relatively consistent over time and
      situation, and is subsequently less susceptible as a target mechanisms for therapy. Still,
      researchers have devoted great efforts toward describing personality traits as related to
      different psychopathological disorders. Consequently, the present study aims to investigate
      the differential associations of traits (i.e., personality) versus state variables
      (metacognitions and coping behaviors) on depression and anxiety.

      The findings of the present study will provide important insights in finding important
      associations between trait and state variables in relation to psychopathology, providing an
      important foundation for further directional investigations with temporal data

      Hypothesis 1: Neuroticism measured with (BFI-10), positive metacognitions, negative
      metacognitions, and unhelpful coping strategies (the latter three measured with CAS-1), will
      predict higher levels of depression and anxiety.

      Research Question 1: How and to what extent are different traits related measured with BFI-10
      related to depression and anxiety in the present pandemic sample?

      Research Question 2: Are the trait or state variables most strongly associated with
      depressive and anxiety symptoms? This question will be investigated using part correlations
      in the multiple regression analyses.
Hypothesis 1: Neuroticism measured with (BFI-10), positive metacognitions, negative
      metacognitions, and unhelpful coping strategies (the latter three measured with CAS-1), will
      predict higher levels of depression and anxiety.

      Research Question 1: How and to what extent are different traits related measured with BFI-10
      related to depression and anxiety in the present pandemic sample?

      Research Question 2: Are the trait or state variables most strongly associated with
      depressive and anxiety symptoms? This question will be investigated using part correlations
      in the multiple regression analyses.

      Statistical analysis:

      Two hierarchical regression analyses will be conducted. 1) with PHQ-9 as the dependent
      variable; and 2) the second with GAD-7 at as the dependent variable. Both analyses will
      include the following variables and the following steps: In step 1, the demographic variables
      age, gender, and education will be included in the model. In step 2 two, the trait-variables
      (i.e., all five personality traits measured with BFI-10) will be included. In the final step,
      the three state-variables positive metacognitions, negative metacognitions (CAS-1), and
      unhelpful coping strategies (CAS-1) will be included.

      Part correlations will be reported for each regression analysis, presenting the effect size
      of the hypothesized predictors on depression and anxiety. A part (semi-partial) correlation
      gives the least biased and easiest interpretable estimate of the strength of a predictive
      relationship (Dudgeon, 2016). It is the correlation between the outcome and the aspects of
      the predictor unique from all the other predictors. As a type of correlation, its size can be
      evaluated according to Cohen's (1988) criteria: small >=0.10, medium >=0.30, large >=0.50.

      Both analysis include the following 5 trait-predictor variables: Neuroticism (BFI-10),
      Openness (BFI-10), Conscientiousness (BFI-10), Extroversion-Introversion (BFI-10), and
      Agreeableness (BFI-10).

      The state-predictor variables are as mentioned: positive metacognitions (CAS-1 subscale);
      negative metacognitions (CAS-1 subscale); unhelpful coping behaviors (CAS-1 subscale).

      Multicollinearity and other statistical assumptions will be checked using examined.
      Multicollinearity will be assessed with common guidelines (VIF < 5 and Tolerance > 0.2;
      Hocking, 2003; O'Brian, 2007).

      If any further analyses or questions are addressed in the forthcoming paper that are not
      pre-specified in this pre-registered protocol, they will be explicitly 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.

      Sample size and power calculation:

      The present study is part of a larger project with the first part aiming to investigate
      information source predictors of mental health through regression analyses, and the second
      part aiming to examine directional relations amongst specific sources of information 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 1305 to 4350 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: Patient Health Questionnaire 9
time frame: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks
description: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area
measure: Generalized Anxiety Disorder 7
time frame: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks
description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for Norwegian samples have been found yielding a cut-off of 8 and above for high sensitivity and specificity (Johnson, Ulvenes, Øktedalen & Hoffart, 2019).
intervention type: Other
intervention name: Prospective study 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
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PMID: 11556941
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PMID: 16717171
citation: Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.
PMID: 31447721
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Omid V. Ebrahimi
investigator title: Principal investigator
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders