Exercise-based Program for Rehabilitation of Veterans with Severe Mental Illness

这是一项以瑜伽为基础的锻炼(YE)作为辅助工具的混合1，有效性实施研究 严重精神疾病(SMI)患者的康复，在这里定义为精神分裂症(SZ)， 分裂情感障碍(SZA)和双相情感障碍(BP1)。SMI是常见的、严重的和毁灭性的 在世界范围内造成巨大残疾的疾病。SMI的许多功能都可以有效地处理，但 在过去的一个世纪里，长期结果并没有太大的改善。没有改善的原因可能是 对SMI患者功能缺陷的治疗不力，特别是在社区功能方面， 这里的定义是在社区中发挥作用的社交、休闲、就业和生活技能。互补性 因此，改善社区功能的中西医结合(CIM)疗法对治疗非常有兴趣 SMI的退伍军人，从而为退伍军人管理局瞄准一个高度优先的领域。先前的研究表明，短期内 YE对改善SMI患者认知缺陷和社区功能的益处。而当 已发表的研究令人鼓舞，YE的长期好处未经检验，特别是对社区而言 功能正常。患有SMI的退伍军人接受和收养Ye的情况也是未知的。我们有 对印度的SMI患者进行了试验性研究和随机对照试验(RCT)， 简化叶合用药。最近，我们还结束了Release，一个助词Ye For的RCT 美国创伤后应激障碍(PTSD)退伍军人(VA RR&D功勋奖，PI：L·戴维斯，精神病学)。我们 从我们所有的研究中发现了令人鼓舞的改进，但我们的印度和美国的YE协议对于 SMI的退伍军人。例如，一些姿势可能对有运动能力和/或 身体残疾。因此，在目标1中，我们将设计和评估印度和美国YE的改编 在非宗教背景下的礼仪(正念、伸展、调理和呼吸练习)。我们将咨询我们的 印度和美国的同事，我们患有SMI的退伍军人和他们的VA治疗师为我们的SMI调整方案 人口。我们还将调整我们的控制条件，健康生活方式计划(WLP)，从我们最近的 完成了解脱学习。在目标2中，我们将进行一项双臂RCT，其中同意退伍军人与SMI 将被随机分配到2个手臂中的一个：YE和照常治疗(TAU，任何处方治疗)或WLP+ 陶先生。与之前的短期Ye RCT不同，这两支部队将持续12个月，包括最初12周的训练 为期12周的训练期，每周由两次监督课程组成，之后是一次 每周有监督课程，其余6个月每月提供进修课程。我们 将符合所有与新冠肺炎相关的YE和WLP要求。我们的混合1号试验将比较疗效 叶诗文与WLP的对决。主要结果是社区的自我报告和基于绩效的衡量标准 功能；次要结果是认知和身体健康措施。我们在目标3中的目标是 了解患有SMI的退伍军人的人口统计学/临床特征，他们更有可能接受和采用YE 通过分析循证医学研究数据实现长期康复(目标3A)。我们还将进行定性采访 与患有SMI并参与YE干预的退伍军人一起，推荐临床医生和瑜伽 指导员确定实施的障碍和促进者(目标3B)。因此，该项目旨在推进我们的 改善患有SMI的退伍军人生活质量的长期目标，并提供证据指导回家- 符合《使命法》和《退伍军人事务部》的长期和基于社区的YE实践 战略规划。我们进行各种SMI研究超过25年的经验为我们提供了强有力的支持 为顺利完成该提案。

This is a Hybrid 1, effectiveness-implementation study of yoga-based exercise (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI), defined here as schizophrenia (SZ), schizoaffective disorder (SZA) and bipolar I disorder (BP1). SMIs are common, severe and devastating conditions that cause enormous disability world-wide. Many features of SMI can be treated effectively, yet the long-term outcome has not improved much over the past century. The lack of improvement may be due to ineffective treatment of functional deficits in SMI patients, particularly in terms of community functioning, defined here as social, leisure, employment, and life skills functioning in the community. Complementary and Integrative Medicine (CIM) therapies that improve community functions are thus of great interest for treating Veterans with SMI and thereby target an area of high priority for the VA. Prior studies have shown short-term benefits of YE for improving cognitive deficits and community functions among persons with SMI. While the published studies are encouraging, the longer-term benefits of YE are untested, particularly for community functioning. The profile of Veterans with SMI who will accept and adopt YE is also unknown. We have conducted pilot studies and a randomized controlled trial (RCT) for individuals with SMI in India using short-term, simplified YE combined with medications. Recently, we also concluded RELIEVE, a RCT of adjunctive YE for Veterans with post-traumatic stress disorder (PTSD) in the USA (VA RR&D Merit award, PI: L Davis, PsyD). We found encouraging improvements from all our studies, but our Indian and US YE protocols are impractical for Veterans with SMI. For example, some postures may be difficult for older Veterans with amotivation and/or physical disabilities. Therefore, in Aim 1, we will design and evaluate adaptations of the Indian and US YE protocols in a non-religious context (mindfulness, stretching, toning and breathing exercises). We will consult our Indian and US colleagues, our Veterans with SMI and their VA therapists to adapt the protocol for our SMI population. We will also adapt our control condition, the Wellness Lifestyle Program (WLP), from our recently completed RELIEVE study. In Aim 2, we will conduct a 2-armed RCT in which consenting Veterans with SMI will be randomly assigned to one of 2 arms: YE and treatment as usual (TAU, any prescribed treatment) or WLP+ TAU. Unlike prior short-term YE RCTs, the two arms will continue 12 months, including an initial 12-week training period consisting of two supervised sessions per week, followed by a 12-week training period consisting of one supervised session per week, and monthly refresher training sessions offered for the remaining 6 months. We will conform to all COVID-19 related requirements for YE and WLP. Our Hybrid 1 trial will compare the efficacy of YE versus WLP. Primary outcomes are self-report and performance-based measures of community functioning; secondary outcomes are cognition and physical fitness measures. Our goals in Aim 3 are to understand demographic/clinical features of Veterans with SMI who are more likely to accept and adopt YE to enable long-term rehabilitation, by analysis of the RCT data (Aim 3A). We will also conduct qualitative interviews with Veterans who have SMI and participated in the YE intervention arm, referring clinicians, and the Yoga instructor to identify barriers and facilitators for implementation (Aim 3B). The project thus aims to advance our long-term goals for improving the quality of life for Veterans with SMI and to provide evidence to guide home- based and over the longer term, community-based YE practice, consistent with the Mission Act and the VA Strategic Plan. Our experience in conducting a variety of SMI research for over 25 years offers strong support for successful completion of the proposal.