<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/NCT04427579</url>
  </required_header>
  <id_info>
    <org_study_id>2018/149</org_study_id>
    <nct_id>NCT04427579</nct_id>
  </id_info>
  <brief_title>Anxiety and Depression in COPD; Prevalence, Detection and Prognosis</brief_title>
  <official_title>Anxiety and Depression in COPD; Prevalence, Detection and Prognosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LHL Hospital Gardermoen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Priory Hospital Altrincham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Akershus</source>
  <oversight_info>
    <has_dmc>No</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 current cohort study of 300 stable COPD patients aims to assess the following topics:&#xD;
&#xD;
        -  The prevalence of anxiety and depressive disorders in patients with COPD&#xD;
&#xD;
        -  The screening properties of Hospital Anxiety and Depression Scale in patients with COPD&#xD;
&#xD;
        -  The prognostic influence by anxiety or depressive symptoms and anxiety or depressive&#xD;
           disorder.&#xD;
&#xD;
        -  whether characterization of 1) affective aspects of dyspnea symptoms or 2) persistent&#xD;
           styles of thinking (worry or rumination) and metacognitions that drive these may improve&#xD;
           the current recommendation of screening for anxiety and depression in COPD in relation&#xD;
           to its clinical relevance on functional status and three year outcome&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 15, 2018</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>COPD exacerbation rate</measure>
    <time_frame>3 years</time_frame>
    <description>The number of moderate or severe exacerbations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>3 years</time_frame>
    <description>The number of deaths</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Health-related Quality of Life With RAND-36</measure>
    <time_frame>3 years</time_frame>
    <description>The total score and subscale scores on RAND 36</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The prevalence of anxiety disorder</measure>
    <time_frame>1 year</time_frame>
    <description>Clinically diagnosed anxiety disorders</description>
  </other_outcome>
  <other_outcome>
    <measure>The prevalence of depressive disorder</measure>
    <time_frame>1 year</time_frame>
    <description>Clinically diagnosed depressive disorder</description>
  </other_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>COPD</condition>
  <condition>Anxiety Disorders</condition>
  <condition>Depressive Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All adults referred to and initiating a 2-4 weeks in-hospital rehabilitation course.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant in in-hospital pulmonary rehabilitation at LHL-hospital Gardermoen&#xD;
&#xD;
          -  Diagnosis of COPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute exacerbated phase of COPD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gunnar Einvik, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Akershus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LHL-hospital Gardermoen</name>
      <address>
        <city>Jessheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Akershus</investigator_affiliation>
    <investigator_full_name>Gunnar Einvik</investigator_full_name>
    <investigator_title>Post-doc candidate, MD</investigator_title>
  </responsible_party>
  <keyword>Metacognitions</keyword>
  <keyword>Hospital Anxiety and Depression Scale</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04427579
org study id: 2018/149
nct id: NCT04427579
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current cohort study of 300 stable COPD patients aims to assess the following topics:

        -  The prevalence of anxiety and depressive disorders in patients with COPD

        -  The screening properties of Hospital Anxiety and Depression Scale in patients with COPD

        -  The prognostic influence by anxiety or depressive symptoms and anxiety or depressive
           disorder.

        -  whether characterization of 1) affective aspects of dyspnea symptoms or 2) persistent
           styles of thinking (worry or rumination) and metacognitions that drive these may improve
           the current recommendation of screening for anxiety and depression in COPD in relation
           to its clinical relevance on functional status and three year outcome
observational model: Cohort
time perspective: Prospective
measure: COPD exacerbation rate
time frame: 3 years
description: The number of moderate or severe exacerbations
measure: Mortality rate
time frame: 3 years
description: The number of deaths
measure: Assessment of Health-related Quality of Life With RAND-36
time frame: 3 years
description: The total score and subscale scores on RAND 36
measure: The prevalence of anxiety disorder
time frame: 1 year
description: Clinically diagnosed anxiety disorders
measure: The prevalence of depressive disorder
time frame: 1 year
description: Clinically diagnosed depressive disorder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gunnar Einvik, PhD
role: Principal Investigator
affiliation: University Hospital, Akershus
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Akershus
investigator full name: Gunnar Einvik
investigator title: Post-doc candidate, MD
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
sharing ipd: No