Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery

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

Detailed Description
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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.

Official Title
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Treatment of Depression Following Bypass Surgery

Conditions
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Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression

Intervention / Treatment
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* Behavioral: Psychoeducation; Treatment recommendations
* Drug: Pharmacotherapy
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depressed Intervention<br>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<br>* Counseling program<br>Drug: Pharmacotherapy<br>* Recommendations to patients' PCP for medication to treat depression<br>|
| Active Comparator: Depressed Usual Care<br>Usual care for depression; feedback of the depression finding by the study team | Other: Usual Care<br>* Physicians' Usual care<br>|
| No Intervention: Non-Depressed Control Group<br>Non-depressed control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generic Mental Health-Related Quality of Life | 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. | Measured 8 months post-CABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression | 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 | 8 months post CABG | 
| Generic Physical Health-Related Quality of Life | 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. | 8 months post CABG | 
| Disease-Specific Health-Related Quality of Life | 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). | 8 months post CABG |