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

创伤后应激障碍(PTSD)继续困扰着成千上万的退伍军人，并与 身体缺陷，社会功能差，主观幸福感较低，以及特定的创伤后应激障碍 症状。研究还表明，患有创伤后应激障碍的退伍军人也更有可能报告说 慢性疼痛，他们报告的疼痛严重程度和与疼痛相关的残疾比那些没有创伤后应激障碍的人更严重。 值得注意的是，肌肉骨骼疾病，如慢性下腰痛(CLBP)和颈部疼痛(CNP)是主要的 军事人员和退伍军人致残原因。身心干预，如瑜伽和 Mantram重复(MR)副作用很少，是基于证据的非药物治疗方案 治疗慢性疼痛和创伤后应激障碍。 拟议项目的目标是研究提供瑜伽和MR相结合的可行性。 在随机对照试验设计中对患有创伤后应激障碍和cLBP和/或CNP的VA患者进行干预。 MR为这一特定人群提供了一种便携式的管理工具，从而增强了对这一特定人群的积极瑜伽干预 压力和焦虑，以及改善日常生活中的精神和情绪功能。我们将招募 让32名患有创伤后应激障碍的退伍军人随机接受强化瑜伽干预或放松/健康教育 (R/HE)对照干预。试点随机试验的目标是证明 干预措施，研究招募、保留、坚持、随机化和评估的可行性 与患有创伤后应激障碍的退伍军人进行合作，并衡量任何不良事件。数据将为全范围的 有效性RCT。 研究人员和内容专家将调整并将两种手动干预(MR和瑜伽)整合为 单一的人工干预和可接受的干预。此外，现有的瑜伽干预和先生手册将 进行调整，为教师提供结构化干预指南。接下来，我们将招募和筛选32名 患有创伤后应激障碍的退伍军人。符合条件的参与者将随机接受强化瑜伽干预或 (R/HE)对照干预。评估将在基线、12周和6周后再次进行 干预结束(18周)。强化的瑜伽干预将包括每周1次由教练指导的瑜伽 每次持续约75分钟，同时每天在家练习20分钟的瑜伽。这个 R/HE控制干预将手动进行，并将在12周内每周举行一次会议，约75分钟 每周。短小的家庭作业将包括在内。我们将跟踪和衡量不良事件， 招聘率、出勤率和家庭实习率、日常生活中MR和瑜伽原则的使用、自然减员 利率和完成评估的时间。调查问卷将评估疼痛相关功能、疼痛、创伤后应激障碍 症状、失眠/睡眠、饮酒和生活质量。我们还将对12名学生进行定性采访 研究参与者检查可接受性、建议，以及影响出席率和自然减员的因素。 我们的目标是7-8名瑜伽参与者和4-5名对照参与者。数据将用于规划全面的RCT 有能力检测健康结果的差异。

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.