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

Primary Purpose

High-normal Blood Pressure, Psychological Stress

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transcendental Meditation program
Sponsored by
Maharishi International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High-normal Blood Pressure focused on measuring Transcendental Meditation, blood pressure, psychological distress, high psychological distress

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • American University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transcendental Meditation program

Wait list control

Arm Description

a natural effortless mental technique practiced sitting quietly 20 minutes twice a day

student subjects on wait list control

Outcomes

Primary Outcome Measures

clinic systolic and diastolic blood pressure

Secondary Outcome Measures

psychological distress (anxiety, depression, anger/hostility) and coping (constructive thinking)

Full Information

First Posted
June 18, 2009
Last Updated
April 5, 2022
Sponsor
Maharishi International University
Collaborators
American University, Abramson Family Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00924456
Brief Title
A Clinical Trial of the Transcendental Meditation (TM) Program on Blood Pressure, Psychological Distress, and Coping
Acronym
AU
Official Title
A Randomized Controlled Trial of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi International University
Collaborators
American University, Abramson Family Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-normal Blood Pressure, Psychological Stress
Keywords
Transcendental Meditation, blood pressure, psychological distress, high psychological distress

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcendental Meditation program
Arm Type
Experimental
Arm Description
a natural effortless mental technique practiced sitting quietly 20 minutes twice a day
Arm Title
Wait list control
Arm Type
Placebo Comparator
Arm Description
student subjects on wait list control
Intervention Type
Behavioral
Intervention Name(s)
Transcendental Meditation program
Other Intervention Name(s)
TM
Intervention Description
a natural effortless mental technique
Primary Outcome Measure Information:
Title
clinic systolic and diastolic blood pressure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
psychological distress (anxiety, depression, anger/hostility) and coping (constructive thinking)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H Schneider, M.D.
Organizational Affiliation
Maharishi International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University
City
Washington
State/Province
District of Columbia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19798037
Citation
Nidich SI, Rainforth MV, Haaga DA, Hagelin J, Salerno JW, Travis F, Tanner M, Gaylord-King C, Grosswald S, Schneider RH. A randomized controlled trial on effects of the Transcendental Meditation program on blood pressure, psychological distress, and coping in young adults. Am J Hypertens. 2009 Dec;22(12):1326-31. doi: 10.1038/ajh.2009.184. Epub 2009 Oct 1.
Results Reference
result
PubMed Identifier
18854202
Citation
Travis F, Haaga DA, Hagelin J, Tanner M, Nidich S, Gaylord-King C, Grosswald S, Rainforth M, Schneider RH. Effects of Transcendental Meditation practice on brain functioning and stress reactivity in college students. Int J Psychophysiol. 2009 Feb;71(2):170-6. doi: 10.1016/j.ijpsycho.2008.09.007. Epub 2008 Sep 30.
Results Reference
result
PubMed Identifier
21559213
Citation
Haaga DA, Grosswald S, Gaylord-King C, Rainforth M, Tanner M, Travis F, Nidich S, Schneider RH. Effects of the Transcendental Meditation Program on Substance Use among University Students. Cardiol Res Pract. 2011 Mar 21;2011:537101. doi: 10.4061/2011/537101.
Results Reference
result

Learn more about this trial

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

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