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Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00105911 |
The literature and our preliminary studies find that in COPD patients anxiety and depression affect quality of life and functioning over and above what would be expected given disease severity. Thus, in order to improve quality of life and functioning in the 20% of COPD patients with significant anxiety and/or depression symptoms, interventions are needed to help manage psychological symptoms. Considering the wealth of research that has documented the utility of cognitive behavioral therapy (CBT) in treating anxiety and depression, CBT shows promise as a self-management intervention to improve quality of life in this population.
Condition | Intervention |
---|---|
Depressive Disorders Anxiety Disorders Pulmonary Disease, Chronic Obstructive |
Behavioral: Cognitive Behavioral Therapy |
Study Type: | Interventional |
Study Design: | Treatment, Single Blind, Parallel Assignment |
Official Title: | A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD |
Estimated Enrollment: | 222 |
Study Start Date: | July 2002 |
Study Completion Date: | June 2005 |
Arms | Assigned Interventions |
---|---|
1 | Behavioral: Cognitive Behavioral Therapy |
Background:
The literature and our preliminary studies find that in COPD patients anxiety and depression affect quality of life and functioning over and above what would be expected given disease severity. Thus, in order to improve quality of life and functioning in the 20% of COPD patients with significant anxiety and/or depression symptoms, interventions are needed to help manage psychological symptoms. Considering the wealth of research that has documented the utility of cognitive behavioral therapy (CBT) in treating anxiety and depression, CBT shows promise as a self-management intervention to improve quality of life in this population.
Objectives:
This proposal is a randomized control trial designed to examine the efficacy of manual based CBT.
Methods:
Subjects were recruited from the MEDVAMC through direct recruitment and use of administrative databases. Two hundred and forty-three COPD patients with comorbid anxiety and/or depression symptoms were randomized to either eight weeks of CBT/usual care or eight weeks of COPD Education/usual care. We hypothesized that COPD patients receiving CBT/usual care will show greater improvement when compared to COPD patients receiving COPD Education/usual care. Improvement is defined as increased disease specific quality of life (QOL), generic QOL, and six-minute walk distance; and decreased depression, anxiety, and health service use. Outcomes will be examined pre-treatment, mid-treatment, post-treatment and at 4, 8 and 12 months.
Status:
Follow-up assessments ended June 2005. Data cleaning is complete and preliminary statistical analyses are being conducted. Two papers have been published and five papers are accepted or in press. One paper has been submitted for publication (under review) with an additional five papers in varying stages of planning and preparation. The study was scheduled to officially end December 31, 2005. However, the study 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Moderate depression or anxiety, COPD Exclusion Criteria:
United States, Alabama | |
VA Medical Center, Tuscaloosa | |
Tuscaloosa, Alabama, United States, 35404 | |
United States, Texas | |
Houston VA Medical Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Mark E. Kunik, MD MPH | Department of Veterans Affairs |
Responsible Party: | Department of Veterans Affairs ( Kunik, Mark - Principal Investigator ) |
Study ID Numbers: | IIR 00-097 |
Study First Received: | March 17, 2005 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00105911 History of Changes |
Health Authority: | United States: Federal Government |
Cognitive Behavioral Therapy |
Lung Diseases, Obstructive Depression Respiratory Tract Diseases Anxiety Disorders Mental Disorders Lung Diseases |
Mood Disorders Chronic Disease Depressive Disorder Behavioral Symptoms Pulmonary Disease, Chronic Obstructive |
Disease Attributes Depression Disease Depressive Disorder Behavioral Symptoms Lung Diseases, Obstructive Pathologic Processes |
Anxiety Disorders Respiratory Tract Diseases Mental Disorders Lung Diseases Mood Disorders Chronic Disease Pulmonary Disease, Chronic Obstructive |