title: Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD.
abstract: BACKGROUND
  Although meditation therapies such as the Transcendental Meditation (TM) technique are commonly used to assist with stress and stress-related diseases, there remains a lack of rigorous clinical trial research establishing the relative efficacy of these treatments overall and for populations with psychiatric illness. This study uses a comparative effectiveness design to assess the relative benefits of TM to those obtained from a gold-standard cognitive behavioral therapy for posttraumatic stress disorder (PTSD) in a Veteran population.
  
  
  METHODS
  This paper describes the rationale and design of an in progress randomized controlled trial comparing TM to an established cognitive behavioral treatment - Prolonged Exposure (PE) - and an active control condition (health education [HE]) for PTSD. This trial will recruit 210 Veterans meeting DSM-IV criteria for PTSD, with testing conducted at 0 and 3 months for PTSD symptoms, depression, mood disturbance, quality of life, behavioral factors, and physiological/biochemical and gene expression mechanisms using validated measures. The study hypothesis is that TM will be noninferior to PE and superior to HE on changes in PTSD symptoms, using the Clinician Administered PTSD Scale (CAPS).
  
  
  CONCLUSIONS
  The described study represents a methodologically rigorous protocol evaluating the benefits of TM for PTSD. The projected results will help to establish the overall efficacy of TM for PTSD among Veterans, identify bio-behavioral mechanisms through which TM and PE may improve PTSD symptoms, and will permit conclusions regarding the relative value of TM against currently established therapies for PTSD.
authors: VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: Thomas.Rutledge@va.gov.
authors: Thomas
authors: T
authors: Rutledge
authors: Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: snidich@mum.edu.
authors: Sanford
authors: S
authors: Nidich
authors: Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: rschneider@mum.edu.
authors: Robert H
authors: RH
authors: Schneider
authors: University of California, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: pmills@ucsd.edu.
authors: Paul J
authors: PJ
authors: Mills
authors: Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: jsalerno@mum.edu.
authors: John
authors: J
authors: Salerno
authors: VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: psantiago@ucsd.edu.
authors: Pia
authors: P
authors: Heppner
authors: Veterans Medical Research Foundation, 3350 La Jolla Village Drive, Building 13, San Diego, CA 92161, United States. Electronic address: Mayra.Gomez@va.gov.
authors: Mayra A
authors: MA
authors: Gomez
authors: Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: cking@mum.edu.
authors: Carolyn
authors: C
authors: Gaylord-King
authors: Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: rainforth@mum.edu.
authors: Maxwell
authors: M
authors: Rainforth
mesh_terms: D002140:California; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D057186:Comparative Effectiveness Research; D006801:Humans; D019122:Meditation / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D013313:Stress Disorders, Post-Traumatic / Q000628:therapy*; D014728:Veterans / Q000523:psychology*
keywords: Cognitive behavioral therapy; Meditation; Posttraumatic stress disorder; Prolonged exposure; Transcendental meditation