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D-CIMT: Stress Reduction and Atherosclerotic CVD in African Americans

Sponsor
Maharishi International University (Other)
Overall Status
Completed
CT.gov ID
NCT05642936
Collaborator
Charles Drew University of Medicine and Science (Other)
197
Enrollment
2
Arms
67.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This was a randomized, single blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation program in reducing atherosclerotic CVD in 197 African American men and women with documented coronary artery disease (CAD) over a one-year treatment period. After baseline testing, participants were randomly assigned to either a stress reduction program (Transcendental Meditation) or a standard health education program.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: didactic health education control
  • Behavioral: Transcendental Meditation technique
 N/A

Detailed Description

This was a randomized, single blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation (TM) program in reducing atherosclerotic CVD in 197 African American men and women with documented coronary artery disease (CAD). This trial compared the efficacy of the TM program to health education over one year. All patients with minimum carotid artery wall thickness (>0.65mm women and >0.72 men) 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 clinical events, blood pressure, lipids, lifestyle, and psychosocial stress.

Study Design

Study Type:
Interventional
Actual Enrollment :
197 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This was a randomized, single blind, controlled, community-based clinical trialThis was a randomized, single blind, controlled, community-based clinical trial
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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 also blinded to the treatment assignments of their patients. Since participants were necessarily aware of their treatment status, this trial was a single-blind, randomized controlled trial design
Primary Purpose:
Treatment
Official Title:
Stress Reduction and Atherosclerotic CVD in African Americans Over One Year
Actual Study Start Date :
Oct 1, 2000
Actual Primary Completion Date :
Jul 1, 2003
Actual Study Completion Date :
May 31, 2006

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Carotid Intima Medial Thickness (CIMT) [12 months]

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

    Secondary Outcome Measures

    1. blood pressure [baseline, 3 and 12 months]

      systolic and diastolic BP measured manually with a mercury sphygmomanometer after five minutes sitting quietly without practicing any formal relaxation technique. The three readings were taken one minute apart and then averaged for that visit.

    2. lipid profile [baseline and 12 months]

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

    3. psychosocial stress and quality of life [baseline, 3 and 12 months]

      depression, anxiety, anger control and hostility, SF36 general health, coping, social support, life events

    4. lifestyle factors [baseline, 3 and 12 months]

      diet, exercise and substance use

    5. CVD mortality [12 months and 10 years]

      adverse clinical events of CVD mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 ---- at baseline screening. Other inclusion criteria in the absence of a minimum IMT score at baseline screening was diabetes, and/or myocardial infarction, coronary artery by-pass grafting (CABG) not within the last three months, and 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

    -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Maharishi International University
    • Charles Drew University of Medicine and Science

    Investigators

    • Principal Investigator: Robert H Schneider, M.D., Maharishi International University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Schneider, MD, Director and Dean, Maharishi International University
    ClinicalTrials.gov Identifier:
    NCT05642936
    Other Study ID Numbers:
    • HL51519B
    First Posted:
    Dec 8, 2022
    Last Update Posted:
    Dec 8, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Intracranial Arteriosclerosis
    Atherosclerosis

    Study Results

    No Results Posted as of Dec 8, 2022