A Randomized Controlled Trial of Stress Reduction on Cardiovascular Morbidity and Mortality in African Americans
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Stress Reduction and Cardiovascular Disease Morbidity and Mortality |
- 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 ]
- 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.
| 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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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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Contacts and Locations| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Robert H Schneider, M.D. | Maharishi University of Management |
More Information
Additional Information:
No publications provided by Maharishi University of Management
Additional 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: | RO1HL048107 |
| Study First Received: | February 18, 2011 |
| Last Updated: | February 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Maharishi University of Management:
|
stress reduction Transcendental Meditation technique secondary prevention of coronary heart disease |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease |
Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013