Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive; Major Depression
• Interventions: Behavioral: Enhanced Care; Behavioral: Treatment Adherence Intervention

• Registration Number: NCT00151372
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major depression, a condition that contributes to suffering but also to poor treatment adherence leading to increased disability and morbidity. This study investigates the effectiveness of a care management intervention aimed at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-07-07
• Status Verified: 2009-12
• Results First Submitted QC: 2009-12-07
• Last Update Submitted: 2009-12-07
• Results First Posted: 2010-01-11
• Last Update Posted: 2010-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• Chronic obstructive pulmonary disease by American Thoracic Society criteria
• Major depression by DSM-IV criteria
• 17-item Hamilton score >14
• English speaking

Exclusion Criteria

• Inability to give informed consent
• MiniMental score <24
• Aphasia
• Nursing home placement after discharge

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Care	Enhanced Care	In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
Treatment Adherence Intervention	Treatment Adherence Intervention	In the Treatment Adherence Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease treatment adherence and to help the participant overcome those obstacles.

Primary Outcome Measures

Name	Time	Method
Composite Antidepressant Score Scale (CAD)	28 Weeks	The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	28 Weeks	The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52.

Trial Locations

Locations (3)

Helen Hayes Hospital; 🇺🇸 West Haverstraw, New York, United States

Weill Medical College of Cornell University; 🇺🇸 White Plains, New York, United States

Burke Rehabilitation Hospital; 🇺🇸 White Plains, New York, United States