A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD
|ClinicalTrials.gov Identifier: NCT00105911|
Recruitment Status : Completed
First Posted : March 18, 2005
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorders Anxiety Disorders Pulmonary Disease, Chronic Obstructive||Behavioral: Cognitive Behavioral Therapy||Not Applicable|
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 were to compare CBT for anxiety and depression with COPD education for COPD patients with moderate-to-severe anxiety and/or depressive symptoms.
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.
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|
|Official Title:||A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD|
|Study Start Date :||July 2002|
|Actual Study Completion Date :||June 2005|
Behavioral: Cognitive Behavioral Therapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105911
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mark E. Kunik, MD MPH||Michael E. DeBakey VA Medical Center, Houston, TX|