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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)

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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.

Comparable studies

Other randomized controlled trials on PTSD, most cited first.

Study Year Design Participants
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Patients with severe PTSD, including those with comorbidities such as dissociation,... 2021 Randomized controlled trial n = 90
The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Patients with chronic post-traumatic stress disorder refractory to both psychotherapy... 2010 Randomized controlled trial n = 20
Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder Patients with chronic PTSD related to a range of trauma exposures 2014 Randomized controlled trial n = 41
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. Military veterans and first responders aged 18 or older with chronic PTSD lasting 6... 2018 Randomized, double-blind, dose-response, phase 2 clinical trial n = 26
A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD) Patients with treatment-resistant PTSD 2012 Randomized controlled trial n = 12

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Meditation PTSD Depression