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Treatment of Depression Following Bypass Surgery - Article


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Counseling And Guidance




Clinical Trial: Treatment of Depression Following Bypass Surgery

This study is currently recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

To treat depression in patients who have undergone coronary artery bypass graft (CABG).

Condition Treatment or Intervention
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Depression
 Behavior: counseling,
 Drug: pharmacotherapy

MedlinePlus related topics:  Coronary Disease;   Depression;   Heart Diseases;   Heart Diseases--Prevention;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment, Randomized

Further Study Details: 

Study start: August 2003;  Expected completion: June 2008

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 not to demonstrate sufficient improvement in quality of life, with a resulting significantly higher level of healthcare costs.

DESIGN NARRATIVE: In this randomized trial, 300 patients will be recruited who show elevated levels of depressive symptoms at both 3-5 days following coronary artery bypass surgery (CABG) and when reassessed 2-weeks after hospital discharge. They will be randomized to receive either: (1) their physicians' "usual care" for depression; or (2) a stepped collaborative care program involving a telephone based nurse care manager who will contact patients at regular intervals to assess treatment preferences for depression (counseling, self-management workbook, pharmacotherapy, or specialty referral); promote adherence with care; and monitor the therapeutic response in concert with patients' primary care physicians and under the supervision of a study clinician. Also, 150 non-depressed 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 six months until the last study 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 physicians' "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 non-depressed 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 on 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

Criteria

No eligibility criteria

Location and Contact Information


Pennsylvania
      University of Pittsburgh School of Medicine, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Dr. Bruce Rollman  412-692-4850    ROLLMANBL@MSX.UPMC.EDU 
Bruce L. Rollman,  Study Chair

Study chairs or principal investigators

Bruce Rollman,  University of Pittsburgh   

More Information

Study ID Numbers:  164
Record last reviewed:  December 2004
Last Updated:  January 10, 2005
Record first received:  September 20, 2004
ClinicalTrials.gov Identifier:  NCT00091962
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 4, 2008



Page Updated: November 5, 2004
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