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.
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