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Anxiety and Depression in COPD; Prevalence, Detection and Prognosis

Sponsor
University Hospital, Akershus (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04427579
Collaborator
University of Oslo (Other), LHL Hospital Gardermoen (Other), Priory Hospital Altrincham (Other)
200
Enrollment
1
Location
89.6
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Anxiety and Depression in COPD; Prevalence, Detection and Prognosis
    Actual Study Start Date :
    Jun 15, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. COPD exacerbation rate [3 years]

      The number of moderate or severe exacerbations

    2. Mortality rate [3 years]

      The number of deaths

    Secondary Outcome Measures

    1. Assessment of Health-related Quality of Life With RAND-36 [3 years]

      The total score and subscale scores on RAND 36

    Other Outcome Measures

    1. The prevalence of anxiety disorder [1 year]

      Clinically diagnosed anxiety disorders

    2. The prevalence of depressive disorder [1 year]

      Clinically diagnosed depressive disorder

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participant in in-hospital pulmonary rehabilitation at LHL-hospital Gardermoen

    • Diagnosis of COPD

    Exclusion Criteria:
    • Acute exacerbated phase of COPD

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LHL-hospital Gardermoen Jessheim Norway

    Sponsors and Collaborators

    • University Hospital, Akershus
    • University of Oslo
    • LHL Hospital Gardermoen
    • Priory Hospital Altrincham

    Investigators

    • Principal Investigator: Gunnar Einvik, PhD, University Hospital, Akershus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gunnar Einvik, Post-doc candidate, MD, University Hospital, Akershus
    ClinicalTrials.gov Identifier:
    NCT04427579
    Other Study ID Numbers:
    • 2018/149
    First Posted:
    Jun 11, 2020
    Last Update Posted:
    Jun 11, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gunnar Einvik, Post-doc candidate, MD, University Hospital, Akershus
    Metacognitions
    Hospital Anxiety and Depression Scale
    Additional relevant MeSH terms:
    Disease
    Depression
    Depressive Disorder
    Anxiety Disorders

    Study Results

    No Results Posted as of Jun 11, 2020