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

加强身心干预，减少患有创伤后应激障碍 (PTSD) 退伍军人的残疾和疼痛

• 批准号: 9922133
• 负责人: Erik J Groessl
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2021-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9922133
• 关键词: Address; Adherence; Adult; Adverse event; Affect; Alcohol consumption; Anxiety; Area; Chronic low back pain; Chronic neck pain; Clinical; Data; Effectiveness; Emotional; Feasibility Studies; Future; Goals; Health; Health education; Home environment; Hybrids; Impairment; Integrative Medicine; Intervention; Intervention Studies; Interview; Life; Manuals; Measures; Meditation; Military Personnel; Mind-Body Intervention; Musculoskeletal; Musculoskeletal Diseases; Neck Pain; Noise; Outcome; Overdose; Pain; Pain management; Participant; Patients; Personal Satisfaction; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Post-Traumatic Stress Disorders; Preparation; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Recommendation; Relaxation; Reporting; Research; Research Design; Research Personnel; Risk; Severities; Sleep; Sleeplessness; Social Functioning; Stress; Structure; Symptoms; System; Time; Training; Transportation; Veterans; Yoga; addiction; adverse outcome; base; body-mind; chronic back pain; chronic pain; chronic painful condition; comparison group; comparison intervention; design; disability; effective therapy; eligible participant; emotional functioning; evidence base; experience; functional disability; health difference; high risk; improved; improved functioning; innovation; instructor; mental function; mild traumatic brain injury; mindfulness-based stress reduction; opioid epidemic; opioid therapy; opioid use; pain patient; pain reduction; phrases; portability; programs; randomized trial; recruit; side effect; stress management; stress related disorder; tool; user-friendly

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.

创伤后应激障碍（PTSD）继续困扰数千名退伍军人，并与 除特定的PTSD外，身体局限性，社会功能差和较低的主观福祉 症状。研究还表明，具有PTSD的退伍军人也更有可能报告 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没有PTSD的残疾更大。 值得注意的是，肌肉骨骼状况，例如慢性下背部疼痛（CLBP）和颈部疼痛（CNP） 军事人员和退伍军人的残疾原因。心身干预，例如瑜伽和 Mantram重复（MR）几乎没有副作用，并且是基于证据的非药理学选择 治疗慢性疼痛和PTSD。 拟议项目的目标是检查提供合并瑜伽和MR的可行性 在随机对照研究设计中，干预PTSD和CLBP和/或CNP的VA患者的干预。 MR通过提供一种用于管理的便携式工具来增强该特定人群的主动瑜伽干预 压力和焦虑，并在日常生活的情况下改善心理和情感功能。我们将招募 并随机将32名用PTSD的退伍军人随机增强瑜伽干预措施或放松/健康教育 （R/HE）比较干预。飞行员随机试验的目的是证明 干预措施，以研究招聘，保留，依从性，随机化和评估的可行性 与有PTSD的退伍军人一起，衡量任何不良事件。数据将为全面计划提供信息 有效性RCT。 研究人员和内容专家将调整并将两种手动干预措施（MR和瑜伽）融入一个 单手册和可接受的干预。此外，现有的瑜伽干预和MR手册将 适用于为讲师提供结构化干预指南。接下来，我们将招募和屏幕32 具有PTSD的退伍军人。合格的参与者将被随机分配到增强的瑜伽干预措施或 （R/HE）比较干预。评估将在基线，12周以及在此之后再次进行6周 干预结束（18周）。增强的瑜伽干预将包括1倍每周的讲师主导瑜伽 会议持续约75分钟，通过瑜伽的家庭练习增强了20分钟/天。这 R/HE控制干预措施将进行手动，每周开会12周，约75分钟 每周。将包括简短的作业。我们将跟踪和测量不良事件， 招聘率，出勤率和家庭执业率，日常生活中MR和瑜伽原则的使用 费率和完成评估的时间。问卷将评估与疼痛有关的功能，疼痛，PTSD 症状，失眠/睡眠，饮酒和生活质量。我们还将与12进行定性访谈 研究参与者检查可接受性，建议以及影响出勤率和流失的因素。 我们将针对7-8个瑜伽参与者和4-5个对照参与者。数据将用于计划全面的RCT 有动力检测健康结果的差异。