The primary objective of this multicenter trial is to evaluate the effects of psychosocial interventions on the cardiac-related morbidity and mortality of MI patients at high psychosocial risk. High psychosocial risk is defined as the presence of depression and/or social isolation. The study design will compare a psychosocial intervention group, in which patients are provided with social support and psychological treatment designed to decrease social isolation and depression, with a health education control and a standard medical care group, using a combined endpoint of CHD death + reinfarction. Secondary endpoints include health- related quality of life; adherence to medications and health-promoting behaviors; and ischemic events, measured by ambulatory electrocardiogram (AECG) and exercise tolerance testing (ETT). To accomplish its objective, this program proposes to recruit approximately eight Clinical Units for patient accession, intervention, and data collection, as well as a Clinical Coordinating Center for coordinating all data collection, storage of data, analysis activities, reviewing the medical progress of the study, and for organizing the Steering Committee and the Data and Safety Monitoring Board meetings. It is anticipated that a total of 3,000 patients, or approximately 375 patients shall be enrolled per Clinical Unit. In order to assure that the study will provide meaningful data on women and diverse racial/ethnic groups, the overall goal will be to recruit 50% women and 50% minorities. The numbers of women and minority patients may vary from clinic to clinic depending on local population composition and other characteristics that influence access to care.
NIH ExPorter
NIH ExPorter