Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Treatment Effectiveness in Depressed Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151372
• Other study ID #: 0201005319
• Secondary ID: R01HL071992-05
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: December 7, 2009
• Start date: March 2002
• Est. completion date: July 2008

Study information

• Verified date: December 2009
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Depressive Disorder, Major
• Lung Diseases
• Lung Diseases, Obstructive
• Major Depression
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Treatment Adherence Intervention
The care management intervention aims 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.
• 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 Agency for Health Care Policy and Research (AHCPR) guidelines for the treatment of depression in primary care with an addendum updating the tables describing Selective Serotonin Reuptake Inhibitors (SSRI) side effect and dosage profiles. The investigators expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in chronic obstructive pulmonary disease patients.

Locations

Country	Name	City	State
United States	Helen Hayes Hospital	West Haverstraw	New York
United States	Burke Rehabilitation Hospital	White Plains	New York
United States	Weill Medical College of Cornell University	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Antidepressant Score Scale (CAD)		28 Weeks	No
Secondary	Hamilton Depression Rating Scale		28 Weeks	No