Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bruce Rollman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00091962
First received: September 20, 2004
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).


Condition Intervention
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Depression
Behavioral: Counseling
Drug: Pharmacotherapy
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Depression Following Bypass Surgery

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Improvement in health related quality of life [ Time Frame: Measured 8 months post-CABG ] [ Designated as safety issue: No ]

Enrollment: 455
Study Start Date: August 2003
Study Completion Date: December 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Collaborative care program for depression involving a telephone-based nurse care manager
Behavioral: Counseling
Counseling program
Drug: Pharmacotherapy
Medication to treat depression
Placebo Comparator: 2
Control group will receive usual care for depression
Behavioral: Usual Care
Usual care for depression

Detailed Description:

BACKGROUND:

Cardiovascular disease morbidity and mortality is an important health issue. Depression has emerged as a risk factor for increased morbidity and mortality in patients with coronary heart disease. CABG is a surgical procedure that is specifically directed to improvement in quality of life for patients with severe coronary artery disease, though its impact on mortality is questionable. Patients with depression after CABG are found to not demonstrate sufficient improvement in quality of life, resulting in a significantly higher level of healthcare costs.

DESIGN NARRATIVE:

In this randomized study, 300 patients who show elevated levels of depressive symptoms at 3 to 5 days following CABG and at 2 weeks after hospital discharge will be recruited. They will be randomized to receive either 1) their physician's "usual care" for depression, or 2) a stepped collaborative care program involving a telephone-based nurse care manager. The nurse care manager will contact patients at regular intervals to assess treatment preferences for depression (e.g., counseling, self-management workbook, pharmacotherapy, or specialty referral), promote adherence with care, and monitor the therapeutic response in concert with patient's primary care physicians and under the supervision of a study clinician. One hundred and fifty nondepressed post-CABG patients will be randomly selected to serve as a control cohort to facilitate comparisons with the depressed patients on various baseline and follow-up measures, and to better understand the benefits derived from depression treatment (total N=450). Blinded telephone assessments will be conducted at 2, 4, 8, and 12 months post CABG and then every 6 months until the last patient completes his/her 8-month assessment (range: 8-44 months follow-up). Intent-to-treat analyses will be used to test the primary hypothesis that the intervention will produce at least a clinically meaningful 0.5 effect size improvement in health related quality of life (HRQoL) at 8 months post CABG, as measured by the SF-36 Mental Component Summary score, compared to patients who receive their primary care physician's "usual care" for depression. The secondary hypotheses are that compared to "usual care" patients, intervention patients will 1) experience higher levels of functional status, and lower levels of depressive symptoms, risk for future cardiovascular events, and health services costs, and 2) report similar levels of HRQoL as nondepressed post-CABG patients. Providing evidence-based, stepped, collaborative care treatment for post-CABG depression may be an ideal method for organized health care delivery systems to improve outcomes. The focus on HRQoL and health services costs will facilitate comparisons of the benefits derived from the intervention to that of other established treatments of cardiovascular risk factors and care for other chronic conditions.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recently underwent CABG (combined or redo procedure) at one of 8 Pittsburgh area study hospitals
  • A PHQ score greater than 10 OR if nondepressed control, a PHQ score less than 5 at both 2 days post CABG to the date of discharge following CABG and when reassessed 2 weeks after hospital discharge
  • Folstein Mini-Mental State Examination (MMSE) score greater than or equal to 24
  • Able to be evaluated and treated for depression as an outpatient post CABG
  • Has a household telephone

Exclusion Criteria:

  • Presently in treatment with a mental health specialist
  • Actively suicidal
  • History of psychotic illness
  • History of bipolar illness according to subject self-report and past medical history
  • Current alcohol dependence or other substance abuse as evidenced by chart review and the CAGE questionnaire
  • Organic mood syndromes, including those secondary to medical illness or drugs
  • Presence of non-cardiovascular conditions that are likely to be fatal within 1 year
  • Unstable medical condition as indicated by history, physical, and/or laboratory findings
  • Previous enrollment in the study cohort
  • Non-English speaking, illiterate, or possessing any other communication barrier
  • If nondepressed control, current or previous diagnosis or treatment of depression
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091962

Locations
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Study Chair: Bruce L. Rollman University of Pittsburgh
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruce Rollman, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00091962     History of Changes
Other Study ID Numbers: 164, R01HL070000, R01 HL70000
Study First Received: September 20, 2004
Last Updated: December 7, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Depression
Depressive Disorder
Heart Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Behavioral Symptoms
Mental Disorders
Mood Disorders
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014