NCT00105911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 17, 2005

Last Update Submit

April 6, 2015

Conditions

Keywords

Cognitive Behavioral Therapy

Study Arms (1)

Arm 1

OTHER
Behavioral: Cognitive Behavioral Therapy

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate depression or anxiety, COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (11)

  • 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.

  • 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.

  • 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.

  • 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.

    RESULT
  • Kraus CA, Kunik ME, Stanley MA. Use of cognitive behavioral therapy in late-life psychiatric disorders. Geriatrics. 2007 Jun;62(6):21-6.

  • 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.

  • 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.

  • 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.

  • 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.

    RESULT
  • 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.

  • 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.

MeSH Terms

Conditions

Depressive DisorderAnxiety DisordersPulmonary Disease, Chronic Obstructive

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mark E. Kunik, MD MPH

    Michael E. DeBakey VA Medical Center, Houston, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2005

First Posted

March 18, 2005

Study Start

July 1, 2002

Study Completion

June 1, 2005

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations