One-year results of the randomized, controlled, short-term psychotherapy in acute myocardial infarction (STEP-IN-AMI) trial

Abstract Background Previous studies on cognitive and interpersonal interventions have yielded inconsistent results in ischemic heart disease patients. Methods 101 patients aged ≤70years, and enrolled one week after complete revascularization with urgent/emergent angioplasty for an AMI, were randomized to standard cardiological therapy plus short-term humanistic–existential psychotherapy (STP) versus standard cardiological therapy only. Primary composite end point was: one-year incidence of new cardiological events (re-infarction, death, stroke, revascularization, life-threatening ventricular arrhythmias, and the recurrence of typical and clinically significant angina) and of clinically significant new comorbidities. Secondary end points were: rates for individual components of the primary outcome, incidence of re-hospitalizations for cardiological problems, New York Heart Association class, and psychometric test scores at follow-up. Results 94 patients were analyzed at one year. The two treatment groups were similar across all baseline characteristics. At follow-up, STP patients had had a lower incidence of the primary endpoint, relative to controls (21/49 vs. 35/45 patients; p=0.0006, respectively; NNT=3); this benefit was attributable to the lower incidence of recurrent angina and of new comorbidities in the STP group (14/49 vs. 22/45 patients, p=0.04, NNT=5; and 5/49 vs. 25/45, p Conclusion Adding STP to cardiological therapy improves cardiological symptoms, quality of life, and psychological and medical outcomes one year post AMI, while reducing the need for re-hospitalizations. Larger studies remain necessary to confirm the generalizability of these results. Clinical trial registration ClinicalTrial.gov: NCT00769366