A Clinical Trial of the Transcendental Meditation (TM) Program on Blood Pressure, Psychological Distress, and Coping (AU)

April 5, 2022 updated by: Robert Schneider, MD, Maharishi International University

A Randomized Controlled Trial of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults

The purpose of this trial is to show that the Transcendental Meditation program can decrease blood pressure in young adults (college students) and is associated with decreased psychological distress and coping ability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Psychological distress contributes to the development of hypertension in young adults. This was a randomized controlled trial of 296 university students randomly allocated to either the Transcendental Meditation® program or wait-list control. At baseline and after three months posttest, systolic and diastolic blood pressure, psychological distress (total mood disturbance, anxiety, depression, anger/hostility) and coping ability (global constructive thinking) were measured.

Study Type

Interventional

Enrollment (Actual)

296

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States
        • American University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female
  • currently enrolled in an undergraduate or graduate program through August 2006

Exclusion Criteria:

  • history of:

    • hypertension
    • hypoglycemia
    • chronic fainting
    • coronary heart disease
    • current systolic/diastolic blood pressure above 140/90 mm Hg or below 90/60 mm Hg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcendental Meditation program
a natural effortless mental technique practiced sitting quietly 20 minutes twice a day
Behavioral: Transcendental Meditation program
a natural effortless mental technique
Other Names:
  • TM
Placebo Comparator: Wait list control
student subjects on wait list control
Behavioral: Transcendental Meditation program
a natural effortless mental technique
Other Names:
  • TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinic systolic and diastolic blood pressure
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
psychological distress (anxiety, depression, anger/hostility) and coping (constructive thinking)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharishi International University

Collaborators

American University
Abramson Family Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

June 18, 2009

First Posted (Estimate)

June 19, 2009

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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