A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00105911
Collaborator
(none)
222
1
1
35
6.3

Study Details

Study Description

Brief Summary

The literature and our preliminary studies found that in COPD patients, psychosocial factors affect quality of life (QOL) and functioning more than would be expected given the severity of their disease. To improve QOL and functioning in the approximately 50% of COPD patients with significant anxiety and/or depressive symptoms, interventions are needed. Much research documents the utility of cognitive behavioral therapy (CBT) in treating depression and anxiety, showing it to have promise as a self-management intervention to improve QOL in COPD patients.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy
N/A

Detailed Description

Background:

The literature and our preliminary studies found that in COPD patients, psychosocial factors affect quality of life (QOL) and functioning more than would be expected given the severity of their disease. To improve QOL and functioning in the approximately 50% of COPD patients with significant anxiety and/or depressive symptoms, interventions are needed. Much research documents the utility of cognitive behavioral therapy (CBT) in treating depression and anxiety, showing it to have promise as a self-management intervention to improve QOL in COPD patients.

Objectives:

Objectives were to compare CBT for anxiety and depression with COPD education for COPD patients with moderate-to-severe anxiety and/or depressive symptoms.

Methods:

Veterans were recruited from VAMC clinics and through press releases. Two hundred and thirty-eight COPD patients with comorbid anxiety and/or depressive symptoms were randomized to either 8 weeks of CBT/usual care or 8 weeks of COPD Education/usual care. We hypothesized that COPD patients receiving CBT/usual care would improve more than COPD patients receiving COPD Education/usual care. Improvement was defined as increased disease-specific QOL, generic QOL, and 6-minute walk distance; and decreased depression, anxiety, and health service use. Outcomes were examined pre-, mid- and post-treatment and at 4, 8 and 12 months.

Status:

The study was scheduled to officially end December 31, 2005, but was granted a no-cost extension by HSR&D to complete data analyses and prepare final papers. The extension was granted through June 30, 2006. As of the date of this final report, the study is complete.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
222 participants
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD
Study Start Date :
Jul 1, 2002
Actual Study Completion Date :
Jun 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Behavioral: Cognitive Behavioral Therapy

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    Moderate depression or anxiety, COPD

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas United States 77030

    Sponsors and Collaborators

    • US Department of Veterans Affairs

    Investigators

    • Principal Investigator: Mark E. Kunik, MD MPH, Michael E. DeBakey VA Medical Center, Houston, TX

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    US Department of Veterans Affairs
    ClinicalTrials.gov Identifier:
    NCT00105911
    Other Study ID Numbers:
    • IIR 00-097
    First Posted:
    Mar 18, 2005
    Last Update Posted:
    Apr 7, 2015
    Last Verified:
    Feb 1, 2007
    Keywords provided by US Department of Veterans Affairs
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2015