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

NCT05642936 | Completed DMC

• 1 other identifier: HL51519B
• Study Type: interventional
• Target: 197
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Carotid Intima Medial Thickness (CIMT)

  This measure of wall thickness of the carotid artery was assessed by B-mode ultrasonography

  12 months

Secondary Outcomes (5)

• blood pressure

  baseline, 3 and 12 months

• lipid profile

  baseline and 12 months

• lifestyle factors

  baseline, 3 and 12 months

• major adverse cardiovascular events (MACE) - fatal and nonfatal

  one year

• major adverse cardiovascular events (MACE) - fatal

  12 years

Study Arms (2)

Transcendental Meditation

EXPERIMENTAL

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.

Behavioral: Transcendental Meditation technique

Health Education

ACTIVE COMPARATOR

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.

Behavioral: didactic health education control

Interventions

didactic health education control BEHAVIORAL

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

Also known as: lifestyle modification

Health Education

Transcendental Meditation technique BEHAVIORAL

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

Also known as: TM program

Transcendental Meditation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maharishi International University: lead
• College of Medicine, Charles R. Drew University of Medicine and Science: collaborator
• Barbara Streisand Women's' Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California: collaborator

Related Publications (1)

• 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.

  PMID: 40177279 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Robert H Schneider, M.D.

  Maharishi International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigators and clinic staff were blinded to treatment assignment, except the project manager who did not collect data from participants. Primary care physicians were blinded to the treatment assignments of their patients. Since participants were necessarily aware of their treatment status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Institute for Natural Medicine and Prevention

Model Details: This was a randomized controlled community-based clinical trial

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: October 1, 2000
• Primary Completion: July 1, 2005
• Study Completion: December 31, 2014
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: once the study is published (i.e., in print)