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A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

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ClinicalTrials.gov Identifier: NCT00105911
Recruitment Status : Completed
First Posted : March 18, 2005
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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
Depressive Disorders Anxiety Disorders Pulmonary Disease, Chronic Obstructive Behavioral: Cognitive Behavioral Therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : July 2002
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Arm 1 Behavioral: Cognitive Behavioral Therapy




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Moderate depression or anxiety, COPD

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105911


Locations
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Mark E. Kunik, MD MPH Michael E. DeBakey VA Medical Center, Houston, TX

Publications of Results:
Cully JA, Graham DP, Stanley MA, Kunik ME. Depressed and Anxious COPD Patients: Predictors of Psychotherapy Engagement from a Clinical Trial. Journal of Clinical Psychology in Medical Settings. 2007 Jan 1; 14:160-164.
Stanley MA, Veazey C, Hopko D, Diefenback G, Kunik ME. Anxiety and Depression in chronic obstructive pulmonary disease: a new intervention and case report. Cognitive and behavioral practice. 2005 Dec 1; 12(4):424-436.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00105911     History of Changes
Other Study ID Numbers: IIR 00-097
First Posted: March 18, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: February 2007

Keywords provided by VA Office of Research and Development:
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Disease
Depression
Anxiety Disorders
Lung Diseases
Depressive Disorder
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Respiratory Tract Diseases
Mood Disorders
Disease Attributes
Lung Diseases, Obstructive