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

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ClinicalTrials.gov Identifier: NCT00924456
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : November 30, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
High-normal Blood Pressure Psychological Stress Behavioral: Transcendental Meditation program Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults
Study Start Date : January 2006
Primary Completion Date : May 2007
Study Completion Date : May 2007
Arms and Interventions

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 Name: TM


Outcome Measures

Primary Outcome Measures :
  1. clinic systolic and diastolic blood pressure [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. psychological distress (anxiety, depression, anger/hostility) and coping (constructive thinking) [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924456


Locations
United States, District of Columbia
American University
Washington, District of Columbia, United States
Sponsors and Collaborators
Maharishi University of Management
American University
Abramson Family Foundation
Investigators
Principal Investigator: Robert H Schneider, M.D. Maharishi University of Management
More Information

Publications:
Responsible Party: Robert Schneider, M.D., Maharishi University of Management Research Institute
ClinicalTrials.gov Identifier: NCT00924456     History of Changes
Other Study ID Numbers: AF-0001
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: November 30, 2009
Last Verified: November 2009

Keywords provided by Maharishi University of Management:
Transcendental Meditation
blood pressure
psychological distress
high psychological distress

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms