Rationale and trial design of a randomized, controlled study on short-term psychotherapy after acute myocardial infarction: the STEP-IN-AMI trial (Short Term Psychotherapy in Acute Myocardial Infarction)

Abstract

Objective: A number of previous studies addressed the effect of psychological interventions in patients after acute myocardial infarction (AMI), but it is not known whether psychotherapy might be beneficial after medical and interventional therapy of AMI. We designed a randomized, controlled study to assess the effects of a short-term psychotherapy (STP) on the clinical outcomes of patients who underwent an emergency percutaneous coronary intervention after AMI.

Methods: One hundred consecutive patients undergoing an emergency percutaneous coronary intervention will be randomized 1 week after AMI to medical therapy (control group, C group) or to medical therapy and STP (STP group). Clinical follow-up visits are scheduled at 6 months, 1 and 5 years, whereas psychometric tests (Self-Evaluation test, Modified Maastricht Questionnaire, Social Support Questionnaire, Recent Life Change Questionnaire, Beck Depression Inventory, the MacNew Heart Disease Health-Related Quality of Life Questionnaire, Type D Personality test) are scheduled 1 week after AMI and at 1 year. The primary outcome measures of the study are the cumulative incidence of new cardiological events (myocardial reinfarction, death, stroke, life-threatening ventricular arrhythmias, and recurrence of angina) and the occurrence of new medical disorders. Secondary outcome measures are the incidence of rehospitalizations due to cardiological problems, the prevalence of patients with New York Heart Association class > or = II, left ventricular function, as assessed by echocardiography, and mean score of psychometric tests in the two groups at follow-up.

Conclusion: Our study has been planned to obtain an insight into how a STP influences clinical outcomes after interventional and medical treatment of AMI.