<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/NCT04444713</url>
  </required_header>
  <id_info>
    <org_study_id>802810-2</org_study_id>
    <nct_id>NCT04444713</nct_id>
  </id_info>
  <brief_title>Do Network Centrality Predict Overall Depression Symptom Reduction With Lifting of Social Distancing Protocols?</brief_title>
  <official_title>Centrality in the Cross-sectional Network of Depressive Symptom and Metacognitive Variables During COVID-19: Do Central Variables Predict Overall Symptom Reduction From Periods of Strict to Lifted Social Distancing Protocols?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Modum Bad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Modum Bad</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 the study is to identify symptom-level intervention targets for depression related&#xD;
      to the COVID-19 outbreak. First, we will assess centrality indices of the network of&#xD;
      depression symptoms plus mechanism variables derived from the metacognitive model of&#xD;
      psychopathology measured at a period of strict social distancing protocols (T1). Then, we&#xD;
      will examine whether change in the most central symptom and metacognitive variables are more&#xD;
      related to overall symptom reduction from the period of strict (T1) to a period of lifted&#xD;
      social distancing protocols (T2) three months later. On the basis of the results,&#xD;
      interventions can be suggested that protect the general public against increased&#xD;
      psychological suffering and dysfunction during society's handling of pandemics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses (Hs) H1: In the cross-sectional depression-metacognitive network at T1, the&#xD;
      symptoms depressed mood, little interest/pleasure, and self-blame and the metacognitive&#xD;
      coping variables rumination/worry, threat monitoring, situational avoidance, thought&#xD;
      suppression, and uncontrollability of thoughts will be the most central variables.&#xD;
&#xD;
      H2: Reductions of the most central variables of the cross-sectional network from T1 to T2&#xD;
      will be more related to overall reduction of symptoms in the same time frame than reductions&#xD;
      of the less central variables.&#xD;
&#xD;
      Study design and participants The design is a longitudinal observational survey of the&#xD;
      general adult Norwegian population during the COVID-19 pandemic. Eligible participants are&#xD;
      all individuals of 18 years and above, who are living in Norway and thus experience identical&#xD;
      distancing protocols, and who provide informed consent to participate in the study. For this&#xD;
      study, only participants reaching the cut-off value (&gt;= 5; Kroenke et al, 2001) for&#xD;
      subclinical symptoms on the PHQ-9 at T1 will be included, amounting to 6 508 individuals. The&#xD;
      strict social distancing protocols were implemented in Norway at March 12. 2020 and the first&#xD;
      data collection in this period (T1) has already been done. It lasted seven days and was&#xD;
      between March 31st 2020 and April 7th 2020. Thus, the strict protocols had been held constant&#xD;
      during the two weeks prior to data collection, as well as during the data collection week.&#xD;
      Furthermore, no new information was given by the government during this period with regard to&#xD;
      changes of distancing protocols, keeping expectation effects constant. From June 15., the&#xD;
      majority of the distancing protocols will be lifted in Norway, and the T2 period is defined&#xD;
      from this date. Data are set to be collected from the sample providing data in the first&#xD;
      collection (N = 10 084), starting one week after the lifting of the protocols, that is, from&#xD;
      22th of June. The collection will last until enough data has been collected, but no longer&#xD;
      than three weeks.&#xD;
&#xD;
      Ethical approval of the study was granted by The Regional Committee for Medical and Health&#xD;
      Research Ethics and the Norwegian Centre for Research Data (reference numbers: 125510 and&#xD;
      802810, respectively, for the first data collection, and , respectively for the second data&#xD;
      collection), where the study protocol and analysis plan was approved prior to data&#xD;
      collection. The study is conducted in accordance with the guidelines of the Strengthening the&#xD;
      Reporting of Observational Studies in Epidemiology statement (STROBE; Von Elm et al., 2007).&#xD;
      The pre-registered protocol for a study of loneliness based on the first (T1) data collection&#xD;
      can be found at Clinicaltrials.gov (Identifier: NCT04365881). The study is part of The&#xD;
      Norwegian COVID-19, Mental Health and Adherence Project (Ebrahimi, Hoffart, &amp; Johnson, 2020).&#xD;
&#xD;
      Procedures The survey is disseminated online. At T1, it was disseminated in a systematic&#xD;
      manner to give the adult population an equal opportunity to participate in the study. The&#xD;
      dissemination procedure involved information about the survey through broadcasting on&#xD;
      national, regional, and local news channels and provision of the online survey to a random&#xD;
      selection of Norwegian adults on Facebook. The dissemination procedure is described in detail&#xD;
      elsewhere (Ebrahimi et al., 2020).&#xD;
&#xD;
      The stopping rule for the first data collection was designed to ensure that the SDPs were&#xD;
      held constant for two weeks prior to and the week during the data collection period, as well&#xD;
      as controlling for expectation effects by stopping data collection instantly once information&#xD;
      concerning forthcoming modification of the social distancing protocols were given. The second&#xD;
      data collection - approaching the 10 084 individuals of the first collection - will start one&#xD;
      week after the strict protocols are lifted (June 22.) and last three weeks.&#xD;
&#xD;
      Sample size and power The sample providing data at T1 comprised 10 084 participants,&#xD;
      ascertaining power for the questions asked. All these participants will be invited to partake&#xD;
      in the second data collection during the lifted prptocols period (T2) in accordance with the&#xD;
      study plan. The mentioned 'Norwegian COVID-19, Mental Health and Adherence Project' involves&#xD;
      multiple studies, where some involve a Complex Systems (Network analysis) approach. These&#xD;
      mutlivariate analyses require large samples and power analysis was conducted accordingly.&#xD;
      Following power analysis guidelines by Fried &amp; Cramer (2017), it is recommended that the&#xD;
      number of participants be at the very least three times larger than the number of estimated&#xD;
      parameters. However, more conservative recommendations by Roscoe (1975) for multivariate&#xD;
      research, recommends sample size that is ten times larger than the number of estimated&#xD;
      parameters. For our network of 9 PHQ-9 variables and 16 CAS-1 variables, the number of edges&#xD;
      in the network is 25*24/2 = 300. Thus, according to the conservative advice of Roscoe, the&#xD;
      required sample size is 3 000.&#xD;
&#xD;
      Blinding No blinding is involved in this study.&#xD;
&#xD;
      Is there any additional blinding in this study? Not applicable&#xD;
&#xD;
      Randomization No randomization.&#xD;
&#xD;
      Sampling Plan&#xD;
&#xD;
      Existing Data Registration prior to the analysis of the T1 data and prior to the collection&#xD;
      of the T2 data.&#xD;
&#xD;
      Explanation of existing data The pandemics (and the consequent social distancing protocols)&#xD;
      occurred, by its very nature, unexpectedly and the project could not be planned in advance.&#xD;
      Thus, the first data collection started immediately and before pre-registration. It started&#xD;
      during the time-period with the strictest protocols in Norway, and the first data collection&#xD;
      was stopped before these protocols were modified or new information about them were added. We&#xD;
      have avoided any network analysis of the data.&#xD;
&#xD;
      Manipulated variables Not applicable/NA&#xD;
&#xD;
      Statistical analysis To test H1, the network of the 9 PHQ items and the 16 CAS-1 items will&#xD;
      be estimated using the R package qgraph (Epskamp et al., 2012) in a random half of the&#xD;
      sample. Network stability tests will be conducted using R package bootnet (Epskamp, et al.,&#xD;
      2018). An undirected partial correlation network will be estimated, resulting in associations&#xD;
      between each pair of symptoms controlling for all other associations among symptoms.&#xD;
      Centrality indices - strength and betweenness - will be computed according to the method of&#xD;
      Robinaugh et al. (2016). Strength refers to how strongly a node relates to other nodes.&#xD;
      Betweenness refers to how important a node is in paths between other nodes. Hypothesis 2 will&#xD;
      be tested in the other random half of the sample. The outcomes of interest will be the degree&#xD;
      to which change in a variable from T1 to T2 correlates with the change in the PHQ-9 total&#xD;
      score (minus the variable examined if it is a symptom).&#xD;
&#xD;
      Missing data There are no missing data in the first data collection because the survey&#xD;
      includes only mandatory responses. Dropout from the second data collection is to be expected,&#xD;
      but the amount of missing data is uncertain. The multiple imputation procedure in SPSS will&#xD;
      be used to impute missing data.&#xD;
&#xD;
      Exploratory analysis We may do other exploratory analysis that we have not yet thought of at&#xD;
      the time of preregistration. If we do such exploratory analyses, we will explicitly state&#xD;
      them as exploratory in the published manuscript following common publishing guidelines.&#xD;
&#xD;
      Other The data include one directly identifiable variable (contact information) for&#xD;
      participants in accordance to the General Data Protection Regulation (GDPR) law in EU, which&#xD;
      is to give the participants the opportunity to have their data deleted upon request. Data are&#xD;
      thus kept on a safe server belonging to the University of Oslo and will be accessed first&#xD;
      following de-identification.&#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>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>From 22nd of June to 13th of July</time_frame>
    <description>The Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, &amp; Williams, 2001) consists of nine items covering the DSM-IV criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. The PHQ-9 has revealed good psychometric properties, as demonstrated by Kroenke, Spitzer, and Williams (2001).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive-Attentional Syndrome-1 (CAS-1)</measure>
    <time_frame>From 22nd of June to 13th of July</time_frame>
    <description>The Cognitive Attentional Syndrome-1 (CAS-1; Wells, 2009) measures maladaptive mental and behavioral coping with thoughts and feelings (8 items, 0-8 scales) and negative and positive metacognitions (8 items, 0-100 scales). The CAS-1 has proved to have satisfactory psychometric properties (Nordahl &amp; Wells, 2019).</description>
  </primary_outcome>
  <enrollment type="Anticipated">10084</enrollment>
  <condition>Depressive Symptoms</condition>
  <condition>Metacognitive Variables</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible participants are all individuals of 18 years and above, who are living in Norway&#xD;
        and thus experience identical distancing protocols, and who provide informed consent to&#xD;
        participate in the study. For this study, only participants reaching the cut-off value (&gt;=&#xD;
        5; Kroenke et al, 2001) for subclinical symptoms on the PHQ-9 at T1 will be approached for&#xD;
        a second measurement (T2), amounting to 6 508 individuals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all adults residing in Norway during the government-initiated interventions for the&#xD;
             COVID-19 pandemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asle Hoffart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo and Modum Bad</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Omid Ebrahimi, CandPsychol</last_name>
    <role>Principal Investigator</role>
    <affiliation>Modum Bad and University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo and Modum Bad</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asle Hoffart, PhD</last_name>
    <phone>+4790594733</phone>
    <email>asle.hoffart@modum-bad.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sverre Urnes Johnson, PhD</last_name>
    <phone>+4741633313</phone>
    <email>Sverre.Johnson@modum-bad.no</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 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>Modum Bad</investigator_affiliation>
    <investigator_full_name>Asle Hoffart</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT04444713
org study id: 802810-2
nct id: NCT04444713
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to identify symptom-level intervention targets for depression related
      to the COVID-19 outbreak. First, we will assess centrality indices of the network of
      depression symptoms plus mechanism variables derived from the metacognitive model of
      psychopathology measured at a period of strict social distancing protocols (T1). Then, we
      will examine whether change in the most central symptom and metacognitive variables are more
      related to overall symptom reduction from the period of strict (T1) to a period of lifted
      social distancing protocols (T2) three months later. On the basis of the results,
      interventions can be suggested that protect the general public against increased
      psychological suffering and dysfunction during society's handling of pandemics.
Hypotheses (Hs) H1: In the cross-sectional depression-metacognitive network at T1, the
      symptoms depressed mood, little interest/pleasure, and self-blame and the metacognitive
      coping variables rumination/worry, threat monitoring, situational avoidance, thought
      suppression, and uncontrollability of thoughts will be the most central variables.

      H2: Reductions of the most central variables of the cross-sectional network from T1 to T2
      will be more related to overall reduction of symptoms in the same time frame than reductions
      of the less central variables.

      Study design and participants The design is a longitudinal observational survey of the
      general adult Norwegian population during the COVID-19 pandemic. Eligible participants are
      all individuals of 18 years and above, who are living in Norway and thus experience identical
      distancing protocols, and who provide informed consent to participate in the study. For this
      study, only participants reaching the cut-off value (>= 5; Kroenke et al, 2001) for
      subclinical symptoms on the PHQ-9 at T1 will be included, amounting to 6 508 individuals. The
      strict social distancing protocols were implemented in Norway at March 12. 2020 and the first
      data collection in this period (T1) has already been done. It lasted seven days and was
      between March 31st 2020 and April 7th 2020. Thus, the strict protocols had been held constant
      during the two weeks prior to data collection, as well as during the data collection week.
      Furthermore, no new information was given by the government during this period with regard to
      changes of distancing protocols, keeping expectation effects constant. From June 15., the
      majority of the distancing protocols will be lifted in Norway, and the T2 period is defined
      from this date. Data are set to be collected from the sample providing data in the first
      collection (N = 10 084), starting one week after the lifting of the protocols, that is, from
      22th of June. The collection will last until enough data has been collected, but no longer
      than three weeks.

      Ethical approval of the study was granted by The Regional Committee for Medical and Health
      Research Ethics and the Norwegian Centre for Research Data (reference numbers: 125510 and
      802810, respectively, for the first data collection, and , respectively for the second data
      collection), where the study protocol and analysis plan was approved prior to data
      collection. The study is conducted in accordance with the guidelines of the Strengthening the
      Reporting of Observational Studies in Epidemiology statement (STROBE; Von Elm et al., 2007).
      The pre-registered protocol for a study of loneliness based on the first (T1) data collection
      can be found at Clinicaltrials.gov (Identifier: NCT04365881). The study is part of The
      Norwegian COVID-19, Mental Health and Adherence Project (Ebrahimi, Hoffart, & Johnson, 2020).

      Procedures The survey is disseminated online. At T1, it was disseminated in a systematic
      manner to give the adult population an equal opportunity to participate in the study. The
      dissemination procedure involved information about the survey through broadcasting on
      national, regional, and local news channels and provision of the online survey to a random
      selection of Norwegian adults on Facebook. The dissemination procedure is described in detail
      elsewhere (Ebrahimi et al., 2020).

      The stopping rule for the first data collection was designed to ensure that the SDPs were
      held constant for two weeks prior to and the week during the data collection period, as well
      as controlling for expectation effects by stopping data collection instantly once information
      concerning forthcoming modification of the social distancing protocols were given. The second
      data collection - approaching the 10 084 individuals of the first collection - will start one
      week after the strict protocols are lifted (June 22.) and last three weeks.

      Sample size and power The sample providing data at T1 comprised 10 084 participants,
      ascertaining power for the questions asked. All these participants will be invited to partake
      in the second data collection during the lifted prptocols period (T2) in accordance with the
      study plan. The mentioned 'Norwegian COVID-19, Mental Health and Adherence Project' involves
      multiple studies, where some involve a Complex Systems (Network analysis) approach. These
      mutlivariate analyses require large samples and power analysis was conducted accordingly.
      Following power analysis guidelines by Fried & Cramer (2017), it is recommended that the
      number of participants be at the very least 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. For our network of 9 PHQ-9 variables and 16 CAS-1 variables, the number of edges
      in the network is 25*24/2 = 300. Thus, according to the conservative advice of Roscoe, the
      required sample size is 3 000.

      Blinding No blinding is involved in this study.

      Is there any additional blinding in this study? Not applicable

      Randomization No randomization.

      Sampling Plan

      Existing Data Registration prior to the analysis of the T1 data and prior to the collection
      of the T2 data.

      Explanation of existing data The pandemics (and the consequent social distancing protocols)
      occurred, by its very nature, unexpectedly and the project could not be planned in advance.
      Thus, the first data collection started immediately and before pre-registration. It started
      during the time-period with the strictest protocols in Norway, and the first data collection
      was stopped before these protocols were modified or new information about them were added. We
      have avoided any network analysis of the data.

      Manipulated variables Not applicable/NA

      Statistical analysis To test H1, the network of the 9 PHQ items and the 16 CAS-1 items will
      be estimated using the R package qgraph (Epskamp et al., 2012) in a random half of the
      sample. Network stability 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 - strength and betweenness - will be computed according to the method of
      Robinaugh et al. (2016). Strength refers to how strongly a node relates to other nodes.
      Betweenness refers to how important a node is in paths between other nodes. Hypothesis 2 will
      be tested in the other random half of the sample. The outcomes of interest will be the degree
      to which change in a variable from T1 to T2 correlates with the change in the PHQ-9 total
      score (minus the variable examined if it is a symptom).

      Missing data There are no missing data in the first data collection because the survey
      includes only mandatory responses. Dropout from the second data collection is to be expected,
      but the amount of missing data is uncertain. The multiple imputation procedure in SPSS will
      be used to impute missing data.

      Exploratory analysis We may do other exploratory analysis that we have not yet thought of at
      the time of preregistration. If we do such exploratory analyses, we will explicitly state
      them as exploratory in the published manuscript following common publishing guidelines.

      Other The data include one directly identifiable variable (contact information) for
      participants in accordance to the General Data Protection Regulation (GDPR) law in EU, which
      is to give the participants the opportunity to have their data deleted upon request. Data are
      thus kept on a safe server belonging to the University of Oslo and will be accessed first
      following de-identification.
observational model: Ecologic or Community
time perspective: Prospective
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: From 22nd of June to 13th of July
description: The Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) consists of nine items covering the DSM-IV criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. The PHQ-9 has revealed good psychometric properties, as demonstrated by Kroenke, Spitzer, and Williams (2001).
measure: Cognitive-Attentional Syndrome-1 (CAS-1)
time frame: From 22nd of June to 13th of July
description: The Cognitive Attentional Syndrome-1 (CAS-1; Wells, 2009) measures maladaptive mental and behavioral coping with thoughts and feelings (8 items, 0-8 scales) and negative and positive metacognitions (8 items, 0-100 scales). The CAS-1 has proved to have satisfactory psychometric properties (Nordahl & Wells, 2019).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Asle Hoffart, PhD
role: Principal Investigator
affiliation: University of Oslo and Modum Bad
last name: Omid Ebrahimi, CandPsychol
role: Principal Investigator
affiliation: Modum Bad and University of Oslo
last name: Sverre Urnes Johnson, PhD
role: Principal Investigator
affiliation: University of Oslo and Modum Bad
last name: Asle Hoffart, PhD
phone: +4790594733
email: asle.hoffart@modum-bad.no
last name: Sverre Urnes Johnson, PhD
phone: +4741633313
email: Sverre.Johnson@modum-bad.no
responsible party type: Principal Investigator
investigator affiliation: Modum Bad
investigator full name: Asle Hoffart
investigator title: Prof
mesh term: Depression