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A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00105911
First received: March 17, 2005
Last updated: April 6, 2015
Last verified: February 2007
  Purpose
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 Intervention
Depressive Disorders
Anxiety Disorders
Pulmonary Disease, Chronic Obstructive
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Estimated Enrollment: 222
Study Start Date: July 2002
Study Completion Date: June 2005
Arms Assigned Interventions
Arm 1 Behavioral: Cognitive Behavioral Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Moderate depression or anxiety, COPD

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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 
Study First Received: March 17, 2005
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on December 09, 2016