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The Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial

Writing Committee for the ENRICHD Investigators

JAMA. 2003;289:3106-3116.

Context  Depression and low perceived social support (LPSS) after myocardial infarction (MI) are associated with higher morbidity and mortality, but little is known about whether this excess risk can be reduced through treatment.

Objective  To determine whether mortality and recurrent infarction are reduced by treatment of depression and LPSS with cognitive behavior therapy (CBT), supplemented with a selective serotonin reuptake inhibitor (SSRI) antidepressant when indicated, in patients enrolled within 28 days after MI.

Design, Setting, and Patients  Randomized clinical trial conducted from October 1996 to April 2001 in 2481 MI patients (1084 women, 1397 men) enrolled from 8 clinical centers. Major or minor depression was diagnosed by modified Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria and severity by the 17-item Hamilton Rating Scale for Depression (HRSD); LPSS was determined by the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Instrument (ESSI). Random allocation was to usual medical care or CBT-based psychosocial intervention.

Intervention  Cognitive behavior therapy was initiated at a median of 17 days after the index MI for a median of 11 individual sessions throughout 6 months, plus group therapy when feasible, with SSRIs for patients scoring higher than 24 on the HRSD or having a less than 50% reduction in Beck Depression Inventory scores after 5 weeks.

Main Outcome Measures  Composite primary end point of death or recurrent MI; secondary outcomes included change in HRSD (for depression) or ESSI scores (for LPSS) at 6 months.

Results  Improvement in psychosocial outcomes at 6 months favored treatment: mean (SD) change in HRSD score, -10.1 (7.8) in the depression and psychosocial intervention group vs -8.4 (7.7) in the depression and usual care group (P<.001); mean (SD) change in ESSI score, 5.1 (5.9) in the LPSS and psychosocial intervention group vs 3.4 (6.0) in the LPSS and usual care group (P<.001). After an average follow-up of 29 months, there was no significant difference in event-free survival between usual care (75.9%) and psychosocial intervention (75.8%). There were also no differences in survival between the psychosocial intervention and usual care arms in any of the 3 psychosocial risk groups (depression, LPSS, and depression and LPSS patients).

Conclusions  The intervention did not increase event-free survival. The intervention improved depression and social isolation, although the relative improvement in the psychosocial intervention group compared with the usual care group was less than expected due to substantial improvement in usual care patients.

Authors/Writing Committee for the ENRICHD Investigators: Lisa F. Berkman, PhD (study chair and coprincipal investigator), Harvard University, Boston, Mass; James Blumenthal, PhD (principal investigator), Duke University, Durham, NC; Matthew Burg, PhD (principal investigator), Yale University, New Haven, Conn; Robert M. Carney, PhD (principal investigator), Washington University, St Louis, Mo; Diane Catellier, DrPH (principal investigator), University of North Carolina at Chapel Hill; Marie J. Cowan, PhD, RN, University of California, Los Angeles; Susan M. Czajkowski, PhD (project officer and writing committee chair), National Heart, Lung, and Blood Institute, Bethesda, Md; Robert DeBusk, MD (principal investigator), Stanford University, Palo Alto, Calif; James Hosking, PhD (principal investigator, 1995-2001), University of North Carolina at Chapel Hill; Allan Jaffe, MD (study cochair), Mayo Clinic, Rochester, Minn; Peter G. Kaufmann, PhD, National Heart, Lung, and Blood Institute, Bethesda, Md; Pamela Mitchell, PhD (principal investigator), University of Washington, Seattle; James Norman, PhD, National Heart, Lung, and Blood Institute, Bethesda, Md; Lynda H. Powell, PhD (principal investigator), Rush Presbyterian-St Luke's Medical Center, Chicago, Ill; James M. Raczynski, PhD (principal investigator), University of Alabama at Birmingham; Neil Schneiderman, PhD (principal investigator), University of Miami, Coral Gables, Fla. Dr Raczynski is now with the University of Arkansas for Medical Sciences, Little Rock.

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