A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
Abstract
This single-blinded, RCT will: 1) evaluate effects of Transcendental Meditation (TM) vs. Prolonged Exposure (PE) and PTSD health education control (EC), using the Clinician Administered PTSD Scale (CAPS) (primary outcome); 2) evaluate effects of TM vs. controls on PTSD symptoms (PCL-M), depressive symptoms and other psychological distress measures, quality of life, and physiological/biochemical stress markers; and 3) evaluate treatment compliance. The study will enroll 210 subjects (70 per group). The VA San Diego is the field site with testing conducted at 0 and 3 months The research will provide data on the feasibility and efficacy of TM as an alternative therapy for PTSD. Our collaborative group (Maharishi University of Management Research Institute, VA San Diego Healthcare System, University of California at San Diego) has made excellent progress in year one. Since securing IRB and DoD human subjects approvals the end of May 2012, we completed hiring all staff, finalized procedures for conducting the study, are currently on target for randomization, with 24 subjects randomized over the first four-months (target of 23) and have good treatment compliance, with over 80% treatment sessions attended. Our first Data Safety and Monitoring Board Meeting, chaired by our medical monitor, was held July 2013.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2013
- Accession Number
- ADA589691
Entities
People
- Sanford Nidich
- Thomas Rutledge