<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/NCT04444336</url>
  </required_header>
  <id_info>
    <org_study_id>REK125510-16</org_study_id>
    <nct_id>NCT04444336</nct_id>
  </id_info>
  <brief_title>Information Sources and Their Relationship to Depressive and Anxiety Symptoms During the COVID-19 Pandemic: A Network Study</brief_title>
  <official_title>Information Sources and Their Relationship to Depressive and Anxiety Symptoms During the COVID-19 Pandemic: A Network Study</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>
      This study aims to investigate the association between the use different information sources&#xD;
      to obtain information about the COVID-19 pandemic and symptoms of psychopathology (i.e.,&#xD;
      depression and anxiety).&#xD;
&#xD;
      Research Question:&#xD;
&#xD;
      How central are different sources of information used to obtain knowledge about the COVID-19&#xD;
      pandemic in network along with depressive and anxiety symptoms? Which sources of information&#xD;
      are most strongly connected to different symptoms of depression and anxiety? Staying away&#xD;
      from information will be measured in the present study. As avoidance is a type of safety&#xD;
      behavior in anxiety disorders, we are further eager to investigate the centrality of this&#xD;
      behavior in the network. Furthermore, multiple studies using latent-variable paradigms have&#xD;
      established a relationship between sum-scores of depression and social anxiety use in&#xD;
      general. We are further interested in examining this potential link more thoroughly and&#xD;
      detailed in the present network study. The findings of this study, although they will be&#xD;
      cross-sectional and require further examination in studies with temporal data structure, will&#xD;
      be an important and interesting starting point giving initial ideas about potential&#xD;
      mechanisms that may be involved in use of information sources in pandemics and mental health&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Question 1:&#xD;
&#xD;
      How central are different sources of information used to obtain knowledge about the COVID-19&#xD;
      pandemic in network along with depressive and anxiety symptoms? Which sources of information&#xD;
      are most strongly connected to different symptoms of depression and anxiety?&#xD;
&#xD;
      Staying away from information will be measured in the present study. As avoidance is a type&#xD;
      of safety behavior in anxiety disorders, the investigators are further eager to investigate&#xD;
      the centrality of this behavior in the network. Furthermore, multiple studies using&#xD;
      latent-variable paradigms have established a relationship between sum-scores of depression&#xD;
      and social anxiety use in general. The investigators are further interested in examining this&#xD;
      potential link more thoroughly and detailed in the present network study. The findings of&#xD;
      this study, although they will be cross-sectional and require further examination in studies&#xD;
      with temporal data structure, will be an important and interesting starting point giving&#xD;
      initial ideas about potential mechanisms that may be involved in use of information sources&#xD;
      in pandemics and mental health.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The estimated network will consist of 23 items (9: PHQ-9; 7: GAD-7; 7: information sources to&#xD;
      obtain information about COVID-19). The network will be estimated using the R package qgraph&#xD;
      (Epskamp et al., 2012). Network stability and accuracy tests will be conducted using R&#xD;
      package bootnet (Epskamp, et al., 2018). An undirected partial correlation network will be&#xD;
      estimated, resulting in associations between each pair of symptoms controlling for all other&#xD;
      associations among symptoms. Centrality indices will be reported. The appropriate correlation&#xD;
      method will be applied following an assessment of the data (e.g., with regards to possible&#xD;
      skewness).&#xD;
&#xD;
      The network will further be regularized using Graphical Least Absolute Shrinkage and&#xD;
      Selection Operator (GLASSO), with Extended Bayes Information Criterion (EBIC). The tuning&#xD;
      parameter will be set to 0.5, as is recommended practice. Centrality table and plots will be&#xD;
      depicted, and difference test of edges conducted.&#xD;
&#xD;
      Additionally, the investigators will investigate differences in network structure across&#xD;
      major demographic subgroups in the sample (e.g., gender). All analyses and questions&#xD;
      addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol&#xD;
      will be defined as exploratory.&#xD;
&#xD;
      The sources of information include: 1) National television and radio channels; 2) national&#xD;
      and regional, and local newspapers; 3) Use of social media for information; 4) use of blogs,&#xD;
      podcasts, forums or other Internet sources; 5) information obtained from peers (i.e., friends&#xD;
      and family); 6) Other sources of information; 7) actively staying away from information.&#xD;
&#xD;
      Inference criteria:&#xD;
&#xD;
      p &lt; 0.05 to determine significance.&#xD;
&#xD;
      Sample size and power calculation:&#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. The&#xD;
      network to be constructed for this study consists of 7 anxiety items (GAD-7), 9 depression&#xD;
      symptom items (PHQ-9), and the 7 pre-specified items above concerning medium of information&#xD;
      and extent of use. Consequently, the network consists of 23 items. 23x(23-1)/2 x 3 = at least&#xD;
      759 participants (according to guidelines by Fried &amp; Cramer, 2017). Thus, following these two&#xD;
      approaches respectively, between 759 to 2530 participants are required. Data will be&#xD;
      collected for three weeks, and participants are based on a representative sample of Norwegian&#xD;
      adults with equal opportunity to partake in the study following 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 any provided data is possible at any moment. The&#xD;
      investigators do not expect participants to withdraw their data and thus expect no missing&#xD;
      data. However, if participants do withdraw their data, the investigators will conduct&#xD;
      state-of-art missing data analysis 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The 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>Behavioral</intervention_type>
    <intervention_name>Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms</intervention_name>
    <description>Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms</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, reached through a random digital sample,&#xD;
        providing consent digitally.&#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>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </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>Asle Hoffart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Modum Bad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Omid V. Ebrahimi, Double PhD Candidate</last_name>
    <phone>+47-22845295</phone>
    <email>omideb@uio.no</email>
  </overall_contact>
  <reference>
    <citation>Fried EI, Cramer AOJ. Moving Forward: Challenges and Directions for Psychopathological Network Theory and Methodology. Perspect Psychol Sci. 2017 Nov;12(6):999-1020. doi: 10.1177/1745691617705892. Epub 2017 Sep 5.</citation>
    <PMID>28873325</PMID>
  </reference>
  <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>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 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>COVID-19</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/NCT04444336
org study id: REK125510-16
nct id: NCT04444336
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the association between the use different information sources
      to obtain information about the COVID-19 pandemic and symptoms of psychopathology (i.e.,
      depression and anxiety).

      Research Question:

      How central are different sources of information used to obtain knowledge about the COVID-19
      pandemic in network along with depressive and anxiety symptoms? Which sources of information
      are most strongly connected to different symptoms of depression and anxiety? Staying away
      from information will be measured in the present study. As avoidance is a type of safety
      behavior in anxiety disorders, we are further eager to investigate the centrality of this
      behavior in the network. Furthermore, multiple studies using latent-variable paradigms have
      established a relationship between sum-scores of depression and social anxiety use in
      general. We are further interested in examining this potential link more thoroughly and
      detailed in the present network study. The findings of this study, although they will be
      cross-sectional and require further examination in studies with temporal data structure, will
      be an important and interesting starting point giving initial ideas about potential
      mechanisms that may be involved in use of information sources in pandemics and mental health
Research Question 1:

      How central are different sources of information used to obtain knowledge about the COVID-19
      pandemic in network along with depressive and anxiety symptoms? Which sources of information
      are most strongly connected to different symptoms of depression and anxiety?

      Staying away from information will be measured in the present study. As avoidance is a type
      of safety behavior in anxiety disorders, the investigators are further eager to investigate
      the centrality of this behavior in the network. Furthermore, multiple studies using
      latent-variable paradigms have established a relationship between sum-scores of depression
      and social anxiety use in general. The investigators are further interested in examining this
      potential link more thoroughly and detailed in the present network study. The findings of
      this study, although they will be cross-sectional and require further examination in studies
      with temporal data structure, will be an important and interesting starting point giving
      initial ideas about potential mechanisms that may be involved in use of information sources
      in pandemics and mental health.

      Statistical analysis:

      The estimated network will consist of 23 items (9: PHQ-9; 7: GAD-7; 7: information sources to
      obtain information about COVID-19). The network will be estimated using the R package qgraph
      (Epskamp et al., 2012). Network stability and accuracy tests will be conducted using R
      package bootnet (Epskamp, et al., 2018). An undirected partial correlation network will be
      estimated, resulting in associations between each pair of symptoms controlling for all other
      associations among symptoms. Centrality indices will be reported. The appropriate correlation
      method will be applied following an assessment of the data (e.g., with regards to possible
      skewness).

      The network will further be regularized using Graphical Least Absolute Shrinkage and
      Selection Operator (GLASSO), with Extended Bayes Information Criterion (EBIC). The tuning
      parameter will be set to 0.5, as is recommended practice. Centrality table and plots will be
      depicted, and difference test of edges conducted.

      Additionally, the investigators will investigate differences in network structure across
      major demographic subgroups in the sample (e.g., gender). All analyses and questions
      addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol
      will be defined as exploratory.

      The sources of information include: 1) National television and radio channels; 2) national
      and regional, and local newspapers; 3) Use of social media for information; 4) use of blogs,
      podcasts, forums or other Internet sources; 5) information obtained from peers (i.e., friends
      and family); 6) Other sources of information; 7) actively staying away from information.

      Inference criteria:

      p < 0.05 to determine significance.

      Sample size and power calculation:

      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. The
      network to be constructed for this study consists of 7 anxiety items (GAD-7), 9 depression
      symptom items (PHQ-9), and the 7 pre-specified items above concerning medium of information
      and extent of use. Consequently, the network consists of 23 items. 23x(23-1)/2 x 3 = at least
      759 participants (according to guidelines by Fried & Cramer, 2017). Thus, following these two
      approaches respectively, between 759 to 2530 participants are required. Data will be
      collected for three weeks, and participants are based on a representative sample of Norwegian
      adults with equal opportunity to partake in the study following 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 any 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 analysis and investigate whether data is missing at random.
observational model: Other
time perspective: Cross-Sectional
measure: The 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: Behavioral
intervention name: Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms
description: Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms
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
healthy volunteers: Accepts Healthy Volunteers
last name: Omid Ebrahimi, Double PhD Candidate
role: Principal Investigator
affiliation: University of Oslo
last name: Asle Hoffart, PhD
role: Principal Investigator
affiliation: Modum Bad
last name: Sverre Urnes Johnson, PhD
role: Principal Investigator
affiliation: University of Oslo
last name: Omid V. Ebrahimi, Double PhD Candidate
phone: +47-22845295
email: omideb@uio.no
citation: Fried EI, Cramer AOJ. Moving Forward: Challenges and Directions for Psychopathological Network Theory and Methodology. Perspect Psychol Sci. 2017 Nov;12(6):999-1020. doi: 10.1177/1745691617705892. Epub 2017 Sep 5.
PMID: 28873325
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
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Omid V. Ebrahimi
investigator title: Principal investigator
mesh term: COVID-19
mesh term: Anxiety Disorders