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

Maharishi International University

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Behavioral: didactic health education control; Behavioral: Transcendental Meditation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05642936

HL51519B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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197 participants in 2 patient groups

Transcendental Meditation

Experimental group

Description:

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.

Treatment:

Behavioral: Transcendental Meditation technique

Health Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: didactic health education control