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A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD
This study has been completed.
First Received: March 17, 2005   Last Updated: January 30, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105911
  Purpose

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

MedlinePlus related topics: Anxiety COPD (Chronic Obstructive Pulmonary Disease) Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Single Blind, Parallel Assignment
Official Title: A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 222
Study Start Date: July 2002
Study Completion Date: June 2005
Arms Assigned Interventions
1 Behavioral: Cognitive Behavioral Therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105911

Locations
United States, Alabama
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States, 35404
United States, Texas
Houston VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Mark E. Kunik, MD MPH Department of Veterans Affairs
  More Information

Publications:
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.
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.
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.
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):213-218.
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.
Kraus CA, Kunik ME, Stanley MA. Use of cognitive behavioral therapy in late-life psychiatric disorders. Geriatrics. 2007 Jun;62(6):21-6. Review.
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. 2007 Oct 9;:1-12 [Epub ahead of print]
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.
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; 14: 160-164.

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

Keywords provided by Department of Veterans Affairs:
Cognitive Behavioral Therapy

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009