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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
  Purpose
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.

Condition Intervention Phase
Coronary Heart Disease Cardiovascular Disease Behavioral: Transcendental Meditation Behavioral: Health Education Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Stress Reduction and Cardiovascular Disease Morbidity and Mortality

Resource links provided by NLM:


Further study details as provided by Maharishi University of Management:

Primary Outcome Measures:
  • composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke [ Time Frame: every six months for an average of 5.4 years ]

Secondary Outcome Measures:
  • 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 ]
  • psychosocial distress factors [ Time Frame: annually for an average of 5.4 years ]
    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 ]
    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 ]
    smoking, alcohol use, physical activity and dietary patterns were assessed by standard questionnaire. Body mass index was measured by balance and scale.


Enrollment: 201
Study Start Date: January 1998
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stress reduction
Stress reduction program utilizing the Transcendental Meditation (TM) technique
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
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.
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299935

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Maharishi University of Management
Medical College of Wisconsin
Investigators
Principal Investigator: Robert H Schneider, M.D. Maharishi University of Management
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Schneider, MD, FACC, Institute for Natural Medicine and Prevention, Maharishi University of Management
ClinicalTrials.gov Identifier: NCT01299935     History of Changes
Other Study ID Numbers: R01HL048107 ( US NIH Grant/Contract Award Number )
Study First Received: February 18, 2011
Last Updated: February 23, 2011

Keywords provided by Maharishi University of Management:
stress reduction
Transcendental Meditation technique
secondary prevention of coronary heart disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on June 28, 2017