Stress Reduction and Atherosclerotic CVD in African American Women and Men

Study Overview
=================
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.

Official Title
-----------------
Stress Reduction and Atherosclerotic CVD in African American Women and Men

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Behavioral: didactic health education control
* Behavioral: Transcendental Meditation technique


Participation Criteria
=================
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 -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This was a randomized, single blind, controlled, community-based clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcendental Meditation<br>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<br>* a mental technique derived from the Vedic tradition of ancient India and practiced by anyone for 20 minutes twice a day sitting<br>* Other names: TM program;|
| Active Comparator: Health Education<br>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<br>* didactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component<br>* 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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |