Clinical trial NCT00924456: A Clinical Trial of the Transcendental Meditation (TM) Program on Blood Pressure, Psychological Distress, and Coping
Official title: A Randomized Controlled Trial of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: High-normal Blood Pressure
Psychological Stress
Keywords: Transcendental Meditation
blood pressure
psychological distress
high psychological distress
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: American University
name: Abramson Family Foundation
First posted: 2009-06-19
Enrollment: 296
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: clinic systolic and diastolic blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: psychological distress (anxiety, depression, anger/hostility) and coping (constructive thinking)
timeFrame: 3 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: American University
state: District of Columbia
Study officials:
affiliation: Maharishi International University
name: Robert H Schneider, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.