Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105911
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-17
Brief Title:
A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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 andor depressive symptoms
Methods
Veterans were recruited from VAMC clinics and through press releases Two hundred and thirty-eight COPD patients with comorbid anxiety andor depressive symptoms were randomized to either 8 weeks of CBTusual care or 8 weeks of COPD Educationusual care We hypothesized that COPD patients receiving CBTusual care would improve more than COPD patients receiving COPD Educationusual 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 HSRD 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
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 andor 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 andor depressive symptoms
Methods
Veterans were recruited from VAMC clinics and through press releases Two hundred and thirty-eight COPD patients with comorbid anxiety andor depressive symptoms were randomized to either 8 weeks of CBTusual care or 8 weeks of COPD Educationusual care We hypothesized that COPD patients receiving CBTusual care would improve more than COPD patients receiving COPD Educationusual 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 HSRD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None