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

NCT01299935 | Completed Phase 2 DMC

• 1 other identifier: R01HL048107
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease; Cardiovascular Disease

Keywords

stress reduction; Transcendental Meditation technique; secondary prevention of coronary heart disease

Outcome Measures

Primary Outcomes (1)

• composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke

  every six months for an average of 5.4 years

Secondary Outcomes (4)

• composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, coronary revascularization, and hospitalization for heart failure, unstable angina or ischemic heart disease - non-MI.

  every six months for average of 5.4 years

• psychosocial distress factors

  annually for an average of 5.4 years

• blood pressure

  every six months for an average of 5.4 years

• behavioral and lifestyle factors

  annually for an average of 5.4 years

Study Arms (2)

Stress reduction

EXPERIMENTAL

Stress reduction program utilizing the Transcendental Meditation (TM) technique

Behavioral: Transcendental Meditation

health education

ACTIVE COMPARATOR

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

Interventions

Transcendental Meditation BEHAVIORAL

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.

Also known as: Transcendental Meditation technique, TM technique

Stress reduction

Health Education BEHAVIORAL

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.

Also known as: lifestyle modification

health education

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maharishi International University: lead
• Medical College of Wisconsin: collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 23149426 RESULT

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases

Interventions

Meditation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert H Schneider, M.D.

  Maharishi International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Natural Medicine and Prevention

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 21, 2011
• Study Start: January 1, 1998
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

US (1)