Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stress Reduction and Atherosclerotic CVD in Blacks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000546
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : February 18, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE October 27, 1999
First Posted Date  ICMJE October 28, 1999
Last Update Posted Date February 18, 2016
Study Start Date  ICMJE March 1994
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress Reduction and Atherosclerotic CVD in Blacks
Official Title  ICMJE Not Provided
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Heart Diseases
  • Hypertension
  • Vascular Diseases
  • Coronary Disease
Intervention  ICMJE Behavioral: meditation
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE No eligibility criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000546
Other Study ID Numbers  ICMJE 90
R01HL051519 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Robert Schneider Maharishi International University
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP