NCT00924456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

June 18, 2009

Last Update Submit

April 5, 2022

Conditions

High-normal Blood PressurePsychological Stress

Keywords

Transcendental Meditationblood pressurepsychological distresshigh psychological distress

Outcome Measures

Primary Outcomes (1)

  • clinic systolic and diastolic blood pressure

    3 months

Secondary Outcomes (1)

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

    3 months

Study Arms (2)

Transcendental Meditation program

EXPERIMENTAL

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

Behavioral: Transcendental Meditation program

Wait list control

PLACEBO COMPARATOR

student subjects on wait list control

Behavioral: Transcendental Meditation program

Interventions

Transcendental Meditation programBEHAVIORAL

a natural effortless mental technique

Also known as: TM
Transcendental Meditation programWait list control

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University

Washington D.C., District of Columbia, United States

Location

Related Publications (3)

  • 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.

    PMID: 19798037RESULT

  • 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.

    PMID: 18854202RESULT

  • 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.

    PMID: 21559213RESULT

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Robert H Schneider, M.D.

    Maharishi International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Dean

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 19, 2009

Study Start

January 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

US(1)