A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105911
First received: March 17, 2005
Last updated: February 6, 2014
Last verified: February 2007

March 17, 2005
February 6, 2014
July 2002
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Complete list of historical versions of study NCT00105911 on ClinicalTrials.gov Archive Site
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A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD
A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

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.

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.

Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Depressive Disorders
  • Anxiety Disorders
  • Pulmonary Disease, Chronic Obstructive
Behavioral: Cognitive Behavioral Therapy
Arm 1
Intervention: Behavioral: Cognitive Behavioral Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
June 2005
Not Provided

Inclusion Criteria:

Moderate depression or anxiety, COPD

Exclusion Criteria:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105911
IIR 00-097
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Mark E. Kunik, MD MPH Michael E DeBakey VA Medical Center
Department of Veterans Affairs
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP