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

This study has been completed.
Sponsor:
Collaborators:
American University
Abramson Family Foundation
Information provided by:
Maharishi University of Management
ClinicalTrials.gov Identifier:
NCT00924456
First received: June 18, 2009
Last updated: November 27, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
High-normal Blood Pressure
Psychological Stress
Behavioral: Transcendental Meditation program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Maharishi University of Management:

Primary Outcome Measures:
  • clinic systolic and diastolic blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • psychological distress (anxiety, depression, anger/hostility) and coping (constructive thinking) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 296
Study Start Date: January 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 18, 2009
Last Updated: November 27, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 15, 2014