Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD)
Clinical Trials URL:
Study Type: Clinical Trial
Prepared on March 15, 2011
Study Dates: September 1995 - September 2005
Consent: Unrestricted Consent
Commercial Use Restrictions: No
NHLBI Division: DCVS
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information
The objective of this study was 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.
Previous studies have proven that depression and low perceived social support (LPSS) after myocardial infarction (MI) are associated with higher morbidity and mortality, but little was known about whether this excess risk can be reduced through treatment.
The 2,481 MI patients (1,084 women and 1,397 men) were recruited from 73 hospitals affiliated with 8 clinical centers. All patients with an acute MI admitted to the participating hospitals were considered for enrollment. Exclusion criteria included patients with acute MI following percutaneous coronary intervention (PNI) or coronary artery bypass graft (CABG) surgery or those receiving psychotherapy for depression. Prior to April 1998, patients were excluded if they were taking any antidepressant medication and after April 1998 they were included if taking an antidepressant for longer than 14 days but remained depressed. Patients were also excluded if they had noncardiac conditions likely to be fatal within 1 year, were too ill to participate, were participating in another research protocol that posed a significant logistic burden or that might confound evaluation of the (ENRICHD) intervention, had major psychiatric comorbidity (including schizophrenia, bipolar disorder, severe dementia, or active substance abuse), were at imminent risk for suicide, refused to participate or their attending physician disallowed participation, could not be enrolled within 28 days of the acute event, or were inaccessible for intervention or follow-up.
The patients were diagnosed with major or minor depression 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). Patients were randomly assigned to usual medical care or CBT-based psychosocial 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.
The intervention did not increase event-free survival. However, 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.
Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N, for the ENRICHD Investigators. Effects of Treating Depression and Low Perceived Social Support on Clinical Events After Myocardial Infarction: The Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA 2003;289:3106-3116.