RCT of Meditation and Health Education on CIMT and MACE in Black Women and Men (SR-CIMT)

A Randomized Controlled Trial of Meditation and Health Education on Carotid Intima-Media Thickness and Major Adverse Cardiovascular Events in Black Women and Men

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Transcendental Meditation technique; Behavioral: didactic health education control

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.

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other Names: TM program
Active Comparator: 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.	Behavioral: didactic health education control; didactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component; Other Names: lifestyle modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid Intima Medial Thickness (CIMT)	This measure of wall thickness of the carotid artery was assessed by B-mode ultrasonography	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lipid profile	blood tests or panel for cholesterol, LDL, HDL, and triglycerides	baseline and 12 months
lifestyle factors	diet, exercise and substance use	baseline, 3 and 12 months
blood pressure	systolic and diastolic BP technique. The three readings were taken one minute apart and then averaged for that visit.	baseline, 3 and 12 months
major adverse cardiovascular events (MACE) - fatal and nonfatal	adverse clinical events - fatal and non-fatal	one year
major adverse cardiovascular events (MACE) - fatal	deaths	12 years

Collaborators and Investigators

• Sponsor: Maharishi International University
• Collaborators: College of Medicine, Charles R. Drew University of Medicine and Science; Barbara Streisand Women's' Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California
• Investigators: Principal Investigator: Robert H Schneider, M.D., Maharishi International University

Publications and helpful links

General Publications

• Salerno J, Schneider R, Rainforth M, Myers H and Gaylord- King C. Stress Reduction and Atherosclerotic CVD in African Americans. Journal of Psychosomatic Medicine. 2010;72:A-149.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2000
• Primary Completion (Actual): July 1, 2005
• Study Completion (Actual): December 31, 2014

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Cardiovascular Diseases
• Other Study ID Numbers: HL51519B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: upon request to the study investigators, an outside researcher may inquire for permission to obtain the IPD (deidentified) on an MS excel and Access databases.
• IPD Sharing Time Frame: once the study is published (i.e., in print)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No