Treatment of Depressed COPD Patients - Full Text View

Sponsors and Collaborators:	Weill Medical College of Cornell University National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00151372

Purpose

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 AHCPR guidelines. We 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 over a 52-week post discharge follow-up period.

Condition	Intervention
Pulmonary Disease, Chronic Obstructive Major Depression	Behavioral: Treatment Adherence Behavioral: Enhanced Care

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Treatment Effectiveness in Depressed Patients With COPD

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

treatment adherence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

depressive symptomatology [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	September 2002
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention: Experimental In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and COPD treatment adherence and to help the participant overcome those obstacles.	Behavioral: Treatment Adherence The care management intervention aims at facilitating adherence to a treatment algorithm based on AHCPR guidelines. We 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.
Enhanced Care: Active Comparator 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.	Behavioral: Enhanced Care For subjects in the Enhanced Care group, physicians providing aftercare will receive no clinical instructions by the research team, but will be informed in writing of the patients' diagnosis and will be provided with a copy of the AHCPR guidelines for the treatment of depression in primary care with an addendum updating the tables describing SSRI side effect and dosage profiles. We expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in COPD patients.

Arms

Assigned Interventions

Intervention: Experimental

In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and COPD treatment adherence and to help the participant overcome those obstacles.

Behavioral: Treatment Adherence

The care management intervention aims at facilitating adherence to a treatment algorithm based on AHCPR guidelines. We 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.

Enhanced Care: Active Comparator

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.

Behavioral: Enhanced Care

For subjects in the Enhanced Care group, physicians providing aftercare will receive no clinical instructions by the research team, but will be informed in writing of the patients' diagnosis and will be provided with a copy of the AHCPR guidelines for the treatment of depression in primary care with an addendum updating the tables describing SSRI side effect and dosage profiles. We expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in COPD patients.

Eligibility

Ages Eligible for Study:	50 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

COPD 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151372

Locations

United States, New York
Weill Medical College of Cornell University
White Plains, New York, United States, 10605
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
Helen Hayes Hospital
West Haverstraw, New York, United States, 10993

Sponsors and Collaborators

Weill Medical College of Cornell University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

George S Alexopoulos, MD

Weill Medical College of Cornell University

More Information

Responsible Party:	Weill Medical College of Cornell University ( George S. Alexopoulos, M.D. )
Study ID Numbers:	R01MH64085-04
Study First Received:	September 6, 2005
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00151372
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Lung Diseases, Obstructive
Depression
Respiratory Tract Diseases
Mental Disorders
Lung Diseases
Mood Disorders

Chronic Disease
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009