The primary objective of this multicenter trial is to evaluate the effects of psychosocial interventions on the cardiac-related morbidity and mortatity of MI patients at high psychosocial rib. 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 healthrelated quality of life; adherence to medications and health- promoting behaviors; and ischemic events, measured by ambulatory e!ectrocardiogram (AECG) and exercise toleaance 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 373 patients shall be enrolled per Clinical Unit. In order to assure that the study will provide meaningrul 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.

Project Start
1995-09-29
Project End
2001-09-28
Budget Start
1995-09-29
Budget End
1996-09-28
Support Year
Fiscal Year
1995
Total Cost
Indirect Cost
Name
Duke University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
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Wu, Colin O; Tian, Xin; Jiang, Wenhua (2011) A shared parameter model for the estimation of longitudinal concomitant intervention effects. Biostatistics 12:737-49
Lett, Heather S; Blumenthal, James A; Babyak, Michael A et al. (2009) Dimensions of social support and depression in patients at increased psychosocial risk recovering from myocardial infarction. Int J Behav Med 16:248-58
Saab, Patrice G; Bang, Heejung; Williams, Redford B et al. (2009) The impact of cognitive behavioral group training on event-free survival in patients with myocardial infarction: the ENRICHD experience. J Psychosom Res 67:45-56

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