A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
Technical Report,30 Sep 2015,29 Sep 2016
Veterans Medical Research Foundation San Diego United States
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This study consists of a comparative effectiveness trial of Transcendental Meditation TM compared to Prolonged Exposure PE and education control EC groups in Veterans diagnosed with clinically significant PTSD by way of a validated structured interview methodology over a treatment period of three months. Two hundred and ten veterans will participate in this three-arm trial. Testing will be conducted at 0 and 3 months for PTSD symptoms, psychological distress, depression, quality of life, behavioral factors, and physiologicalbiochemical mechanisms using validated interview, self-report, and biological measures. Recruitment began in June of 2013. We hypothesize that TM will be non-inferior to PE on the primary outcome of the study and superior to EC on PTSD study outcomes. This will be a multidisciplinary, collaborative research project comprising investigators from the San Diego VA Healthcare System, the University of California at San Diego and Maharishi University of Management Research Institute. Given a sample of 210 patients, an alpha level of .05 for declaring statistical significance, equal standard deviations, and an attrition rate of 20, estimated power levels are -.90.
- Medicine and Medical Research