An Enhanced Mind-body Intervention to Reduce Disability and Pain in Veterans with PTSD

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Post-traumatic stress disorder (PTSD) continues to afflict thousands of Veterans and is associated with physical limitations, poor social function, and lower subjective well-being in addition to specific PTSD symptoms. Research also indicates that Veterans with PTSD are also more likely to report the presence of chronic pain, and they report greater pain severity and pain-related disability than those without PTSD. Notably, musculoskeletal conditions such as chronic low back pain (cLBP) and neck pain (cNP) are leading causes of disability among military personnel and Veterans. Mind-body interventions such as yoga and mantram repetition (MR) have very few side effects and are evidence-based non-pharmacological options for treating both chronic pain and PTSD. The objectives of the proposed project are to examine the feasibility of delivering a combined yoga and MR intervention to VA patients with PTSD and cLBP and/or cNP within a randomized controlled trial study design. MR enhances the active yoga intervention for this specific population by providing a portable tool for managing stress and anxiety, and improving mental and emotional functioning in situations of daily life. We will recruit and randomize 32 Veterans with PTSD to either enhanced yoga interventions or a relaxation/health education (R/HE) comparison intervention. The goal of the pilot randomized trial is to demonstrate the acceptability of the interventions, to study the feasibility of recruitment, retention, adherence, randomization, and assessments with military veterans with PTSD, and to measure any adverse events. Data will inform plans for a full-scale effectiveness RCT. Researchers and content experts will adapt and blend two manualized interventions (MR and yoga) into a single manualized and acceptable intervention. In addition, the existing yoga intervention and MR manuals will be adapted to provide a structured intervention guide for instructors. Next, we will recruit and screen 32 Veterans with PTSD. Eligible participants will be randomized to either the enhanced yoga interventions or the (R/HE) comparison intervention. Assessments will occur at baseline, 12-weeks, and again 6-weeks after the intervention ends (18-weeks). The enhanced yoga intervention will consist of 1x weekly instructor-led yoga sessions lasting approximately 75 minutes, augmented by home practice of yoga for 20 minutes/day. The R/HE control intervention will be manualized and will meet weekly for 12 weeks for approximately 75 minutes per week. Short homework assignments will be included. We will track and measure adverse events, recruitment rates, attendance and home practice rates, use of MR and yoga principles in daily life, attrition rates, and time to complete assessments. Questionnaires will assess pain-related function, pain, PTSD symptoms, insomnia/sleep, alcohol use, and quality of life. We will also conduct qualitative interviews with 12 study participants to examine acceptability, recommendations, and factors affecting attendance and attrition. We will target 7-8 yoga participants and 4-5 control participants. Data will be used to plan a full-scale RCT powered to detect differences in health outcomes.