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Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091962
Recruitment Status : Completed
First Posted : September 23, 2004
Results First Posted : April 14, 2016
Last Update Posted : April 14, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bruce Rollman, University of Pittsburgh

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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Depression Behavioral: Psychoeducation; Treatment recommendations Drug: Pharmacotherapy Other: Usual Care Not Applicable

Detailed Description:


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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Depression Following Bypass Surgery
Study Start Date : August 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Depressed Intervention
Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist
Behavioral: Psychoeducation; Treatment recommendations
Counseling program

Drug: Pharmacotherapy
Recommendations to patients' PCP for medication to treat depression

Active Comparator: Depressed Usual Care
"Usual care" for depression; feedback of the depression finding by the study team
Other: Usual Care
Physicians' Usual care

No Intervention: Non-Depressed Control Group
Non-depressed control group

Primary Outcome Measures :
  1. Generic Mental Health-Related Quality of Life [ Time Frame: Measured 8 months post-CABG ]

    The 36-item Medical Outcomes Study Form (v.2) Mental Component Scale (SF-36 MCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.

    Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994.

Secondary Outcome Measures :
  1. Hamilton Rating Scale for Depression [ Time Frame: 8 months post CABG ]
    The 17-item Depression Interview and Structured Hamilton (DISH) version of the Hamilton Rating Scale for Depression Standard provides an accurate DSM-IV diagnosis of a cardiac patient's mood disorder and a reliable HRS-D score. Range 0-52. Higher scores are worse. Psychosom Med. 2002;64(6):897-905

  2. Generic Physical Health-Related Quality of Life [ Time Frame: 8 months post CABG ]

    The 36-item Medical Outcomes Study Form (v.2) Physical Component Scale (SF-36 PCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.

    Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994.

  3. Disease-Specific Health-Related Quality of Life [ Time Frame: 8 months post CABG ]
    The 12-item Duke Activity Status Index (DASI). Scores range from 0-58.2, and higher scores the better the functional capacity (Am J Cardiol. 1989;64(10):651-654).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00091962

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United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
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Study Chair: Bruce L. Rollman University of Pittsburgh
Additional Information:
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bruce Rollman, Professor of Medicine, University of Pittsburgh Identifier: NCT00091962    
Other Study ID Numbers: 164
R01HL070000 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2004    Key Record Dates
Results First Posted: April 14, 2016
Last Update Posted: April 14, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Coronary Disease
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Myocardial Ischemia
Vascular Diseases