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A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

Primary Purpose

Depressive Disorders, Anxiety Disorders, Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorders focused on measuring Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Moderate depression or anxiety, COPD Exclusion Criteria:

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 17, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00105911
Brief Title
A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD
Official Title
A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorders, Anxiety Disorders, Pulmonary Disease, Chronic Obstructive
Keywords
Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Enrollment
222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate depression or anxiety, COPD Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark E. Kunik, MD MPH
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18842932
Citation
Maurer J, Rebbapragada V, Borson S, Goldstein R, Kunik ME, Yohannes AM, Hanania NA; ACCP Workshop Panel on Anxiety and Depression in COPD. Anxiety and depression in COPD: current understanding, unanswered questions, and research needs. Chest. 2008 Oct;134(4 Suppl):43S-56S. doi: 10.1378/chest.08-0342.
Results Reference
result
PubMed Identifier
17922939
Citation
Kunik ME, Veazey C, Cully JA, Souchek J, Graham DP, Hopko D, Carter R, Sharafkhaneh A, Goepfert EJ, Wray N, Stanley MA. COPD education and cognitive behavioral therapy group treatment for clinically significant symptoms of depression and anxiety in COPD patients: a randomized controlled trial. Psychol Med. 2008 Mar;38(3):385-96. doi: 10.1017/S0033291707001687. Epub 2007 Oct 9.
Results Reference
result
PubMed Identifier
17209145
Citation
Kunik ME, Azzam PN, Souchek J, Cully JA, Wray NP, Krishnan LL, Nelson HA, Stanley MA. A practical screening tool for anxiety and depression in patients with chronic breathing disorders. Psychosomatics. 2007 Jan-Feb;48(1):16-21. doi: 10.1176/appi.psy.48.1.16.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
17547480
Citation
Kraus CA, Kunik ME, Stanley MA. Use of cognitive behavioral therapy in late-life psychiatric disorders. Geriatrics. 2007 Jun;62(6):21-6.
Results Reference
result
PubMed Identifier
16343032
Citation
Burgess A, Kunik ME, Stanley MA. Chronic obstructive pulmonary disease: assessing and treating psychological issues in patients with COPD. Geriatrics. 2005 Dec;60(12):18-21. No abstract available.
Results Reference
result
PubMed Identifier
16308576
Citation
Roundy K, Cully JA, Stanley MA, Veazey C, Souchek J, Wray NP, Kunik ME. Are anxiety and depression addressed in primary care patients with chronic obstructive pulmonary disease? A chart review. Prim Care Companion J Clin Psychiatry. 2005;7(5):213-8. doi: 10.4088/pcc.v07n0501.
Results Reference
result
PubMed Identifier
15821196
Citation
Kunik ME, Roundy K, Veazey C, Souchek J, Richardson P, Wray NP, Stanley MA. Surprisingly high prevalence of anxiety and depression in chronic breathing disorders. Chest. 2005 Apr;127(4):1205-11. doi: 10.1378/chest.127.4.1205.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
16844889
Citation
Cully JA, Graham DP, Stanley MA, Ferguson CJ, Sharafkhaneh A, Souchek J, Kunik ME. Quality of life in patients with chronic obstructive pulmonary disease and comorbid anxiety or depression. Psychosomatics. 2006 Jul-Aug;47(4):312-9. doi: 10.1176/appi.psy.47.4.312.
Results Reference
result
PubMed Identifier
16315269
Citation
Ferguson CJ, Stanley M, Souchek J, Kunik ME. The utility of somatic symptoms as indicators of depression and anxiety in military veterans with chronic obstructive pulmonary disease. Depress Anxiety. 2006;23(1):42-9. doi: 10.1002/da.20136.
Results Reference
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A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

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