Stress Reduction and Atherosclerotic CVD in Blacks
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases; Coronary Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): meditation
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment