Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

NCT00151372 | Completed Results DMC

• 2 other identifiers: 0201005319R01HL071992-05
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 3

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Major Depression

Outcome Measures

Primary Outcomes (1)

• Composite Antidepressant Score Scale (CAD)

  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.

  28 Weeks

Secondary Outcomes (1)

• Hamilton Depression Rating Scale

  28 Weeks

Study Arms (2)

Treatment Adherence Intervention

EXPERIMENTAL

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.

Behavioral: Treatment Adherence Intervention

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

Interventions

Treatment Adherence Intervention BEHAVIORAL

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.

Treatment Adherence Intervention

Enhanced Care BEHAVIORAL

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.

Enhanced Care

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Helen Hayes Hospital

West Haverstraw, New York, 10993, United States

Location

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

Weill Medical College of Cornell University

White Plains, New York, 10605, United States

Location

Related Publications (1)

• Solomonov N, Kerchner D, Bein O, Lee CE, Diaz JL, Ciarleglio A, Kim S, Sirey JA, Gunning FM, Raue PJ, Banerjee S, Arean PA, Alexopoulos GS. Precision Assignment to Psychosocial Interventions for Late-Life Depression: An Automated Treatment Decision Rule. JAMA Psychiatry. 2025 Nov 1;82(11):1075-1084. doi: 10.1001/jamapsychiatry.2025.2518.

  PMID: 40960814 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: George S. Alexopoulos, M.D.
• Organization: Weill Cornell Medical College

gsalexop@med.cornell.edu

914-997-5767

Study Officials

• George S Alexopoulos, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: March 1, 2002
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 11, 2010
• Results First Posted: January 11, 2010

Record last verified: 2009-12

Locations

US (3)