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.