Randomized, unmasked trial
The purpose of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients Study is to conduct a multi-center clinical trial to determine the effects of psychosocial intervention, designed to increase social support and alleviate depression, on the combined endpoint of all cause mortality and nonfatal infarction in patients with recently diagnosed acute MI who are at high psychosocial risk, that is, who are depressed and/or have low social support. Secondary medical endpoints include all cause mortality; cardiovascular mortality; recurrent nonfatal MI; revascularization procedures; cardiovascular hospitalizations; and changes in risk factor profiles. Secondary psychosocial endpoints include severity of depression; degree of lack of social support; and health-related quality of life. A pilot phase was conducted which involved assessment of the feasibility of recruiting and retaining post-MI patients for the trial. On the basis of the pilot phase, the trial was warranted to accrue sufficient numbers of patients to evaluate the effects of the intervention on mortality and reinfarction.