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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2007-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Heart Disease Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Stress reduction

Stress reduction program utilizing the Transcendental Meditation (TM) technique

Group Type EXPERIMENTAL

Transcendental Meditation

Intervention Type BEHAVIORAL

The Transcendental Meditation program is the principal mind-body approach of Maharishi Ayurveda, originating from the ancient Vedic tradition and introduced 50 years ago by Vedic scholar and teacher Maharishi Mahesh Yogi. The Transcendental Meditation technique is described as a simple and natural procedure that is practiced 20 minutes twice a day while sitting comfortably with the eyes closed. Practice of the Transcendental Meditation technique does not require any changes in personal beliefs, philosophy or lifestyle. During the practice a unique state of restful alertness is gained. Acute and chronic physiological effects have been documented. The course is taught by instructors certified by Maharishi Foundation - USA.

health education

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.

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

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.

Interventions

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Transcendental Meditation

The Transcendental Meditation program is the principal mind-body approach of Maharishi Ayurveda, originating from the ancient Vedic tradition and introduced 50 years ago by Vedic scholar and teacher Maharishi Mahesh Yogi. The Transcendental Meditation technique is described as a simple and natural procedure that is practiced 20 minutes twice a day while sitting comfortably with the eyes closed. Practice of the Transcendental Meditation technique does not require any changes in personal beliefs, philosophy or lifestyle. During the practice a unique state of restful alertness is gained. Acute and chronic physiological effects have been documented. The course is taught by instructors certified by Maharishi Foundation - USA.

Intervention Type BEHAVIORAL

Health Education

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Transcendental Meditation technique, TM technique lifestyle modification

Eligibility Criteria

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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.

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Eligible Sex

ALL

Accepts Healthy Volunteers

No