Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD.
Thomas Rutledge, Sanford Nidich, Robert H Schneider, Paul J Mills, John Salerno, Pia Heppner, Mayra A Gomez, Carolyn Gaylord-King, Maxwell Rainforth
Contemporary Clinical Trials September 1, 2014 DOI: 10.1016/j.cct.2014.07.005 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 210 |
| Population | Veterans meeting DSM-IV criteria for PTSD |
| Interventions | Transcendental Meditation Prolonged Exposure Health education |
| Duration | 3-month testing period |
| Topics | Meditation PTSD |
| Keywords | Cognitive behavioral therapy Posttraumatic stress disorder Prolonged exposure Transcendental meditation |
| Key findings | The study hypothesizes that Transcendental Meditation will be noninferior to Prolonged Exposure and superior to health education for reducing PTSD symptoms in Veterans. |
Abstract
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. 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). 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.