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

This study has been completed.
Sponsor:
Collaborator:
Medical College of Wisconsin
Information provided by:
Maharishi University of Management
ClinicalTrials.gov Identifier:
NCT01299935
First received: February 18, 2011
Last updated: February 23, 2011
Last verified: February 2011

February 18, 2011
February 23, 2011
January 1998
June 2007   (final data collection date for primary outcome measure)
composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke [ Time Frame: every six months for an average of 5.4 years ] [ Designated as safety issue: Yes ]
all-cause mortality, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01299935 on ClinicalTrials.gov Archive Site
  • composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, coronary revascularization, and hospitalization for heart failure, unstable angina or ischemic heart disease - non-MI. [ Time Frame: every six months for average of 5.4 years ] [ Designated as safety issue: Yes ]
  • psychosocial distress factors [ Time Frame: annually for an average of 5.4 years ] [ Designated as safety issue: No ]
    psychometric factors included depression, hostility and anger using standardized psychometric instruments - Center for Epidemiological Depression Scale (CES-D), Cook-Medley Hostility Inventory (Ho), Anger Expression Scale (AX)
  • blood pressure [ Time Frame: every six months for an average of 5.4 years ] [ Designated as safety issue: Yes ]
    BP was assessed by standard clinical trial technique using multiple seated measurements in the research clinic
  • behavioral and lifestyle factors [ Time Frame: annually for an average of 5.4 years ] [ Designated as safety issue: Yes ]
    smoking, alcohol use, physical activity and dietary patterns were assessed by standard questionnaire. Body mass index was measured by balance and scale.
  • blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • psychosocial stress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Randomized Controlled Trial of Stress Reduction on Cardiovascular Morbidity and Mortality in African Americans
Stress Reduction and Cardiovascular Disease Morbidity and Mortality

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.

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, 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Coronary Heart Disease
  • Cardiovascular Disease
  • Behavioral: 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.
    Other Name: Transcendental Meditation technique, TM technique
  • 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.
    Other Name: lifestyle modification
  • Experimental: Stress reduction
    Stress reduction program utilizing the Transcendental Meditation (TM) technique
    Intervention: Behavioral: Transcendental Meditation
  • Active Comparator: 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: Behavioral: Health Education
Schneider RH, Grim CE, Rainforth MV, Kotchen T, Nidich SI, Gaylord-King C, Salerno JW, Kotchen JM, Alexander CN. Stress reduction in the secondary prevention of cardiovascular disease: randomized, controlled trial of transcendental meditation and health education in Blacks. Circ Cardiovasc Qual Outcomes. 2012 Nov;5(6):750-8. doi: 10.1161/CIRCOUTCOMES.112.967406. Epub 2012 Nov 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
July 2007
June 2007   (final data collection date for primary outcome measure)

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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Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01299935
RO1HL048107
Yes
Robert Schneider, MD, FACC, Institute for Natural Medicine and Prevention, Maharishi University of Management
Maharishi University of Management
Medical College of Wisconsin
Principal Investigator: Robert H Schneider, M.D. Maharishi University of Management
Maharishi University of Management
February 2011

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