Outcomes of a Holistic Yoga Program Designed to Relieve PTSD (RELIEVE trial)

描述（由申请人提供）： 背景：创伤后应激障碍在退伍军人的疾病负担中占很大比例。然而，目前的PTSD治疗并不是对所有人都有效，尽管有药物治疗和心理治疗，仍有相当多的人仍然有症状。因此，军队和退伍军人事务部对补充和替代医学方法（如瑜伽）的兴趣越来越大，以改善症状，而不需要直接对创伤进行口头处理。瑜伽提供了一种创新的方法来平静过度觉醒，减少麻木/回避，改善情绪的自我调节，同时培养身体和情绪的健康。由于这种独特的方法，创伤后应激障碍的生物，心理和社会层面，我们相信，瑜伽干预准备满足退伍军人更有效的创伤后应激障碍治疗方案的需求。最近的研究表明，瑜伽干预可以成功地提供给患有创伤后应激障碍的个人，并有可能减少临床医生评定和自我报告的整体创伤后应激障碍症状，抑郁和焦虑。然而，很少有研究评估瑜伽对创伤后应激障碍的影响，它们涉及的样本量很小，并且不是不受控制的，就是等待名单/常规护理控制的。此外，在瑜伽干预的风格和组成部分的研究之间存在很大差异。因此，迫切需要一项标准化，传统，整体瑜伽干预的随机对照试验，以告知VA政策制定者和临床医生瑜伽作为目前可用的PTSD治疗的辅助治疗的潜在益处。目的：该项目的总体目标是比较为期16周的整体瑜伽计划（HYP）与为期16周的健康生活方式计划（WLP）对PTSD和相关症状和结果的影响。本研究有三个具体目的：1）比较干预措施的效果（HYP与WLP）对总体PTSD症状严重程度的影响; 2）比较干预措施对PTSD特异性症状的影响（愤怒，睡眠），PTSD相关症状（抑郁、焦虑、疼痛）和相关结果（福利/生活质量）;第三章为有经验的瑜伽教师提供全人瑜伽课程和培训过程，为患有创伤后应激障碍的人提供HYP，以促进今后的研究和传播工作。方法：我们的研究样本将包括232名经临床医生确诊为PTSD的门诊患者，这些患者从Roudebush VA医疗中心以及大都会地区的心理健康诊所/临床医生和军事/退伍军人组织招募，他们将被随机分配接受整体瑜伽计划（HYP）或健康生活方式计划（WLP）。HYP将涉及一个标准化的16周干预，包括：1）由瑜伽联盟注册的瑜伽教练亲自教授至少200小时的瑜伽课程; 2）课程将包括瑜伽姿势，呼吸练习，深度肌肉收缩练习，放松练习，以及教师主导的讨论，以交流“经验教训”，并介绍瑜伽哲学的相关方面; 3）指导瑜伽姿势，呼吸和放松练习录音供家庭使用;和4）参与者手册，以加强在亲自会议期间教授的概念。WLP是一种注意力控制，包括低强度的身体活动和关于健康主题的教学法，还将鼓励家庭实践，并提供参与者手册，以加强在面对面会议期间教授的概念。

DESCRIPTION (provided by applicant): BACKGROUND: Posttraumatic Stress Disorder constitutes a substantial proportion of the burden of illness among veterans. However, current PTSD treatments are not effective for all, and a significant number remain symptomatic despite pharmacotherapy and psychotherapy. As a result, there has been increased interest within the military and VA in Complementary and Alternative Medicine approaches, such as yoga, to improve symptoms without requiring direct verbal processing of the trauma. Yoga provides an innovative approach to calming hyperarousal, reducing numbness/avoidance, and improving self-regulation of emotions, while cultivating physical and emotional well-being. Because of this unique approach to the biological, psychological, and social dimensions of PTSD, we believe that yoga interventions are poised to meet the demand for more effective PTSD treatment options for veterans. Recent research indicates that yoga interventions can be delivered successfully to individuals who have PTSD and have potential to reduce clinician rated and self-reported overall PTSD symptoms, depression and anxiety. However, few studies exist that have evaluated yoga for PTSD and they have involved small sample sizes and are either uncontrolled or waitlist/usual care controlled. Also, there is much variation among studies in the style and components of yoga interventions. Thus, a randomized controlled trial of a standardized, traditional, holistic yoga intervention is urgently needed to inform VA policy makers and clinicians of the potential benefits of yoga as an adjunct to currently available PTSD treatments. OBJECTIVE: The overall goal of this project is to compare the effects of a 16-week Holistic Yoga Program (HYP) with a 16-week Wellness Lifestyle Program (WLP) on PTSD and related symptoms and outcomes. This project has three specific aims: 1) to compare the effects of the interventions (HYP vs. WLP) on overall PTSD symptom severity; 2) compare the interventions' effects on PTSD-specific symptoms (anger, sleep), PTSD-related symptoms (depression, anxiety, pain) and related outcomes (well-being/quality of life); 3) to manualize the Holistic Yoga Program and training process for experienced yoga teachers to deliver HYP to individuals who have PTSD in order to facilitate future study and dissemination efforts. METHODS: Our study sample will include 232 outpatients with a clinician-confirmed diagnosis of PTSD, recruited from the Roudebush VA Medical Center as well as metropolitan area mental health clinics/clinicians and military/veterans' organizations, who will be randomly assigned to receive the Holistic Yoga Program (HYP) or the Wellness Lifestyle Program (WLP). The HYP will involve a standardized 16-week intervention consisting of: 1) in-person group yoga class taught by a yoga instructor registered through the Yoga Alliance at least at the 200 hour level; 2) classes will include yoga postures, breathing practices, deep muscle contraction practices, relaxation practices, and teacher-led discussions to exchange "lessons learned," and introduce relevant aspects of yoga philosophy; 3) guided yoga postures, breath and relaxation practice audio recordings for home-use; and 4) a Participant Handbook to reinforce concepts taught during in-person sessions. The WLP is an attention control comprised of low intensity physical activity and didactics about wellness topics that will also encourage home practice and provide a Participant Handbook to reinforce concepts taught during in- person sessions.