A Randomized Controlled Trial of Stress Reduction on Cardiovascular Morbidity and Mortality in African Americans (Milw)

Maharishi International University

Status and phase: Completed; Phase 2

Conditions: Coronary Heart Disease; Cardiovascular Disease

Treatments: Behavioral: Health Education; Behavioral: Transcendental Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT01299935

R01HL048107

Details and patient eligibility

About

This randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the Transcendental Meditation program will reduce all-cause mortality, myocardial infarction and stroke in African American patients with coronary heart disease. Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure and psychosocial stress.

Full description

The overall objective of this randomized controlled trial is to conduct a long-term evaluation of the effects of the Transcendental Meditation (TM) program compared to health education (HE) on secondary prevention of clinical events in African American men and women with coronary artery disease (CAD). Patients (N=201; mean age 59 yrs) were enrolled with documented CAD (i.e., coronary angiogram showing at least one artery with > 50% stenosis). Patients were pretested at baseline and every 6-12 months for the duration of the study for incidence of clinical events, BP, BMI, medication usage, lifestyle behaviors, psychosocial stress factors and intervention compliance. Subjects were followed for a maximum of 9.2 years (mean 5.4 years). The investigators hypothesize that a selected stress reduction intervention, the TM program compared with a health education control may significantly reduce risk for death, myocardial infarction (MI) and stroke in African American men and women with CHD. If successful, the Transcendental Meditation program may be clinically useful in the secondary prevention of cardiovascular disease in a high-risk population.

Enrollment: 201 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

African American men and women with documented coronary heart disease defined a coronary angiogram demonstrating the presence of one more coronary arteries with > or = 50% stenosis.

Exclusion criteria

acute MI, stroke or coronary revascularization within the previous three months; symptomatic heart failure with EF < 20%; dementia or other cognitive impairment determined clinically; and non-cardiac life threatening illness.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 2 patient groups

Stress reduction

Experimental group

Description:

Stress reduction program utilizing the Transcendental Meditation (TM) technique

Treatment:

Behavioral: Transcendental Meditation

health education

Active Comparator group

Description:

health education is taught in a clinical setting using standard AHA recommendations for proper diet, exercise and control of substance usage but without a stress management component.

Treatment:

Behavioral: Health Education