Thomas Rutledge1, Sanford Nidich2, Robert H Schneider3, Paul J Mills4, John Salerno5, Pia Heppner6, Mayra A Gomez7, Carolyn Gaylord-King8, Maxwell Rainforth9. 1. 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. 2. Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: snidich@mum.edu. 3. Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: rschneider@mum.edu. 4. University of California, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: pmills@ucsd.edu. 5. Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: jsalerno@mum.edu. 6. 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. 7. Veterans Medical Research Foundation, 3350 La Jolla Village Drive, Building 13, San Diego, CA 92161, United States. Electronic address: Mayra.Gomez@va.gov. 8. Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: cking@mum.edu. 9. Maharishi University of Management Research Institute, 1000 North Fourth Street Fairfield, IA 52557, United States. Electronic address: rainforth@mum.edu.
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 AND DESIGN: 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 forPTSD 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). DISCUSSION: 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. Published by Elsevier Inc.
RCT Entities:
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 AND DESIGN: 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). DISCUSSION: 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. Published by Elsevier Inc.