Stress Reduction and Atherosclerotic CVD in Blacks
Stress Reduction and Atherosclerotic CVD in Blacks
To evaluate the effectiveness of stress reduction with Transcendental Meditation (TM) on left
 ventricular hypertrophy, left ventricular function, blood pressure, psychosocial stress and
 quality of life, and cardiovascular disease risk factors.
BACKGROUND:

 Blacks in the United States have disproportionately high rates of cardiovascular disease and
 mortality. Left ventricular hypertrophy, the primary manifestation of hypertensive heart
 disease and a major independent predictor of cardiovascular mortality, is twice as prevalent
 in Blacks with hypertension as in whites. Research has implicated chronic socio-environmental
 and psychological stress in the etiology of hypertension and left ventricular hypertrophy in
 Blacks. The trial seeks to investigate directly the impact of stress reduction programs for
 treating hypertensive heart disease in Blacks, since conventional antihypertensive drug
 therapies are less successful than expected. Moreover, these therapies frequently have
 adverse side effects on quality of life, and have low compliance rates, particularly in
 minorities.

 DESIGN NARRATIVE:

 The first study conducted between 1994 and 1999 used transcendental meditation for stress
 reduction in hypertensive heart disease. The study was randomized and blind. Subjects were
 randomized to practice TM for twelve months or to receive health education. The following
 measurements were obtained: left ventricular mass and function using echocardiography; clinic
 blood pressure and ambulatory blood pressure monitoring; urinary sodium excretion; alcohol
 consumption, weight, physical activity, cigarette smoking, and previous use of
 antihypertensive medication; various quality of life measures including physical functioning,
 psychosocial functioning, subjective symptoms, trait anger and anger-expression, stress
 impact scale, personal efficacy and health locus of control, social supports, ego
 development, and social desirability.

 The trial was part of the Collaborative Projects on Minority Health, an Institute- initiated
 program to foster collaborative clinical research that focused on new and improved approaches
 for diagnosis, management, and prevention of cardiovascular, lung, and blood diseases in
 minorities. The trial was part of a two-grant collaboration on Nonpharmacologic Treatments
 for Managing Hypertension in African American Adults. Ernest Johnson (R01HL50516),the Program
 Coordinator collaborated with Robert Schneider (R01HL51519). The objectives of their studies
 were complementary and the collaborative arrangements allowed them to determine the
 effectiveness of different approaches to stress management in comparison with a control group
 that was comparable at both sites. In addition, the treatment schedules in both studies
 resulted in identical contact time, length of interventions, expectations regarding treatment
 effectiveness, and follow-up assessment periods. As a result, a considerable degree of
 pooling of data for analysis was possible.

 Dr. Schneider's study was renewed in FY 1999 to conduct a randomized, single-blind,
 controlled, community-based trial involving 184 African American subjects with known coronary
 heart disease. Male and female subjects are enrolled at the on-going field site, Martin
 Luther King-Drew Medical Center in inner city Los Angeles. After baseline testing, subjects
 are randomized to either active stress reduction with TM or health education control-both in
 addition to usual medical care-and posttested after 12 months. The primary outcome is carotid
 artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography.
 Secondary measures include traditional CVD risk factors (blood pressure, lipids, smoking,
 exercise), psychosocial stress, quality of life and cost effectiveness.

 The study completion date listed in this record was obtained from the "End Date" entered in
 the Protocol Registration and Results System (PRS) record.
No eligibility criteria