RCT of Meditation and Health Education on CIMT and MACE in Black Women and Men

NCT ID: NCT05642936

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2014-12-31

Brief Summary

This was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation program on carotid intima-media thickness and major adverse cardiovascular events in 197 African American men and women at risk for atherosclerotic CVD. After baseline testing, participants were randomly assigned to either a stress reduction program (Transcendental Meditation) or a standard health education program. Follow up was conducted over one year and 12 years.

Detailed Description

This was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation (TM) program carotid intima-media thickness and major adverse cardiovascular events (MACE) in 197 African American men and women at high risk for ASCVD. This trial compared the efficacy of the TM program to health education over one year on cIMT. Eligible participants were randomly allocated to either the TM program or health education (HE). The primary outcome was carotid intima-media thickness (IMT) assessed by B-mode ultrasonography at baseline and 12 months. Secondary outcomes were blood pressure, lipids, lifestyle, psychosocial stress and MACE. Fatal and nonfatal clinical events were assessed over one year, and mortality after 12 years.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Transcendental Meditation

The TM technique is a simple, natural, effortless mental procedure that is practiced 20 minutes twice a day while sitting comfortably with the eyes closed. During the practice, it is reported that ordinary thinking processes settle down, and a distinctive "wakeful hypometabolic" state characterized by neural coherence and physiological rest is gained. The TM technique was taught in a 7-step course of instruction consisting of six 1.5-2 hour individual and group meetings taught by a certified instructor.

Group Type: EXPERIMENTAL

Transcendental Meditation technique

Intervention Type: BEHAVIORAL

a mental technique derived from the Vedic tradition of ancient India and practiced by anyone for 20 minutes twice a day sitting

Health Education

The control intervention was a cardiovascular health education program designed to match the format of the experimental intervention for instructional time, instructor attention, participant expectancy, social support, and other nonspecific factors. The classroom content was based on standard, published materials. The instructors were professional health educators.

Group Type: ACTIVE_COMPARATOR

didactic health education control

Intervention Type: BEHAVIORAL

didactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component

Interventions

didactic health education control

didactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component

Intervention Type: BEHAVIORAL

Transcendental Meditation technique

a mental technique derived from the Vedic tradition of ancient India and practiced by anyone for 20 minutes twice a day sitting

Intervention Type: BEHAVIORAL

Other Intervention Names

lifestyle modification; TM program

Eligibility Criteria

Inclusion Criteria

race/ethnicity: African American, self-identified, age: no upper limit, gender: male or female, minimum carotid artery intima medial thickness (IMT) of at least .72 mm for men and .65 mm for women or long-term history of diabetes, myocardial infarction, coronary artery revascularization or coronary angiography indicating at least one vessel with 50% stenosis.

Exclusion Criteria

myocardial infarction, unstable angina, CABG, percutaneous transluminal coronary angioplasty (PTCA), or stroke within the previous three months, carotid artery endarterectomy, arrhythmia - atrial fibrillation, second or third degree AV block, congestive heart failure - class III or IV or ejection fraction less than 30 %, clinically significant valvular heart disease, clinically significant hepatic or renal failure, major psychiatric disorders, current alcohol or other drug abuse dependency disorder, non-cardiac life-threatening illness, and participating in a formal stress management program

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

College of Medicine, Charles R. Drew University of Medicine and Science

UNKNOWN

Sponsor Role: collaborator

Barbara Streisand Women's' Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California

UNKNOWN

Sponsor Role: collaborator

Maharishi International University

OTHER

Sponsor Role: lead

Responsible Party

Robert Schneider, MD

Director and Professor, Institute for Natural Medicine and Prevention

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert H Schneider, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maharishi International University

References

Norris KC, Salerno J, Bairey Merz CN, Kaushik V, Gelleta S, Castillo A, Nidich S, Gaylord-King C, Schneider RH. A randomized controlled trial of meditation and health education on carotid intima-media thickness and major adverse cardiovascular events in Black men and women. Front Med (Lausanne). 2025 Mar 19;12:1513699. doi: 10.3389/fmed.2025.1513699. eCollection 2025.

Reference Type: DERIVED

PMID: 40177279 (View on PubMed)

Other Identifiers

HL51519B

Identifier Type: -

Identifier Source: org_study_id