Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

Overview

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.

Full Title of Study: “Treatment Effectiveness in Depressed Patients With Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2008

Interventions

  • 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.
  • 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 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Composite Antidepressant Score Scale (CAD)
    • Time Frame: 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 Measures

  • Hamilton Depression Rating Scale
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Weill Medical College of Cornell University
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • George S. Alexopoulos, M.D., Weill Medical College of Cornell University
  • Overall Official(s)
    • George S Alexopoulos, MD, Principal Investigator, Weill Medical College of Cornell University

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