<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/NCT04421612</url>
  </required_header>
  <id_info>
    <org_study_id>126376</org_study_id>
    <nct_id>NCT04421612</nct_id>
  </id_info>
  <brief_title>COVID-19 - No Health Without Mental Health</brief_title>
  <acronym>Co-COVID-19</acronym>
  <official_title>COVID-19 - No Health Without Mental Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Corona pandemic is affecting the whole world and since March 12.th 2020 there has been&#xD;
      strict qurantene and social isolation interventions in Norway. The aim of this intervention&#xD;
      is to reduce the negative and fatal effects of the pandemic. The pandemic and the&#xD;
      restrictions that follows it is assumed to affect the mental health of the general&#xD;
      population. In this research project we want to examine the use and the effects of a digital&#xD;
      self-guided psychological intervention with the aim to increase coping and to reduce&#xD;
      psychological problems during and after the pandemic. The participants will be randomized to&#xD;
      either an intensive group (new module every 3rd day) or to an ordinary group (new module&#xD;
      every 5th day).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention was developed in a crossdiciplinary and cross-sectorial team within the&#xD;
      framework of the research project INTROMAT, an ICT Lighthouse research project funded by the&#xD;
      Norwegian Research Council. The content of the digital covid-19 intervention was based on&#xD;
      four previously developed digital interventions, all based on systematic user-involvement and&#xD;
      user-testing, from our group. The person-based approach inspired the development of the&#xD;
      intervention. Based on the research literature and experience from our existing digital&#xD;
      interventions we started the development with establishing guiding principles. The&#xD;
      intervention consists of 8 modules.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2020</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Group one recieve a new module every three days. Group two recive a new module every 5 days.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Patient Health Questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>measures depression severity with nine items scored 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;), corresponding to the criteria for major depression in the DSM-5. The sum of the scores for the nine items ranges from 0 to 27</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Generalized Anxiety Disorder Scale</measure>
    <time_frame>6 months</time_frame>
    <description>measures anxiety severity with seven items scored 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;). The total score ranges from 0 to 21</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and negative affect</measure>
    <time_frame>6 months</time_frame>
    <description>In the instructions to the PANAS scales in the current study, participants were asked, ''To what extent do you generally feel this way, that is, how do you feel on average?'' Each PANAS scale comprises 10 specific mood-related adjectives, rated on a 5-point scale from not at all to very much</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>6 months</time_frame>
    <description>Widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Scale</measure>
    <time_frame>6 months</time_frame>
    <description>structured survey used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Covid19</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Intensive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group recieve access to a new module every 3rd day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ordinary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group recieve access to a new module every 5th day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Co-mestring (co-coping)</intervention_name>
    <description>8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences</description>
    <arm_group_label>Intensive</arm_group_label>
    <arm_group_label>Ordinary</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  read and write norwegian&#xD;
&#xD;
          -  above 18 years&#xD;
&#xD;
          -  Mild and moderate stress&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current treatment for mental health disorders&#xD;
&#xD;
          -  history or present severe mental health disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5020</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 5, 2021</last_update_submitted>
  <last_update_submitted_qc>May 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>There is a plan to share anonymous interaction-data. Health data are undecided</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421612
org study id: 126376
nct id: NCT04421612
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The Corona pandemic is affecting the whole world and since March 12.th 2020 there has been
      strict qurantene and social isolation interventions in Norway. The aim of this intervention
      is to reduce the negative and fatal effects of the pandemic. The pandemic and the
      restrictions that follows it is assumed to affect the mental health of the general
      population. In this research project we want to examine the use and the effects of a digital
      self-guided psychological intervention with the aim to increase coping and to reduce
      psychological problems during and after the pandemic. The participants will be randomized to
      either an intensive group (new module every 3rd day) or to an ordinary group (new module
      every 5th day).
The intervention was developed in a crossdiciplinary and cross-sectorial team within the
      framework of the research project INTROMAT, an ICT Lighthouse research project funded by the
      Norwegian Research Council. The content of the digital covid-19 intervention was based on
      four previously developed digital interventions, all based on systematic user-involvement and
      user-testing, from our group. The person-based approach inspired the development of the
      intervention. Based on the research literature and experience from our existing digital
      interventions we started the development with establishing guiding principles. The
      intervention consists of 8 modules.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group one recieve a new module every three days. Group two recive a new module every 5 days.
primary purpose: Supportive Care
masking: None (Open Label)
measure: The Patient Health Questionnaire
time frame: 6 months
description: measures depression severity with nine items scored 0 ("not at all") to 3 ("nearly every day"), corresponding to the criteria for major depression in the DSM-5. The sum of the scores for the nine items ranges from 0 to 27
measure: The Generalized Anxiety Disorder Scale
time frame: 6 months
description: measures anxiety severity with seven items scored 0 ("not at all") to 3 ("nearly every day"). The total score ranges from 0 to 21
measure: Positive and negative affect
time frame: 6 months
description: In the instructions to the PANAS scales in the current study, participants were asked, ''To what extent do you generally feel this way, that is, how do you feel on average?'' Each PANAS scale comprises 10 specific mood-related adjectives, rated on a 5-point scale from not at all to very much
measure: Perceived Stress Scale
time frame: 6 months
description: Widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.
measure: Client Satisfaction Scale
time frame: 6 months
description: structured survey used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction
arm group label: Intensive
arm group type: Experimental
description: This group recieve access to a new module every 3rd day.
arm group label: Ordinary
arm group type: Experimental
description: This group recieve access to a new module every 5th day.
intervention type: Behavioral
intervention name: Co-mestring (co-coping)
description: 8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences
arm group label: Intensive
arm group label: Ordinary
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Norway
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided
ipd description: There is a plan to share anonymous interaction-data. Health data are undecided