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

Maharishi International University197 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

197

Conditions

Cardiovascular Disease

Interventions

didactic health education controlBEHAVIORAL

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

Transcendental Meditation techniqueBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 \-

Outcomes

Primary Outcomes

Carotid Intima Medial Thickness (CIMT)

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

Time frame: 12 months

Secondary Outcomes

blood pressure

systolic and diastolic BP technique. The three readings were taken one minute apart and then averaged for that visit.

Time frame: baseline, 3 and 12 months

lipid profile

blood tests or panel for cholesterol, LDL, HDL, and triglycerides

Time frame: baseline and 12 months

lifestyle factors

diet, exercise and substance use

Time frame: baseline, 3 and 12 months

major adverse cardiovascular events (MACE) - fatal and nonfatal

adverse clinical events - fatal and non-fatal

Time frame: one year

major adverse cardiovascular events (MACE) - fatal

deaths

Time frame: 12 years

Data from ClinicalTrials.gov

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