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

这是一个混合1，有效性实施研究的瑜伽为基础的运动（YE）作为一种辅助工具， 严重精神疾病（SMI）患者的康复，此处定义为精神分裂症（SZ）， 情感障碍（SZA）和双相I型障碍（BP 1）。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条件。SMI的许多特征可以有效治疗，但 在过去的世纪，长期结果没有多大改善。缺乏改善可能是由于 SMI患者的功能缺陷治疗无效，特别是在社区功能方面， 在这里被定义为在社区中发挥作用的社交、休闲、就业和生活技能。互补 因此，改善社区功能的中西医结合（CIM）疗法对治疗 退伍军人与SMI，从而针对一个高度优先领域的VA。此前的研究表明， YE对改善SMI患者的认知缺陷和社区功能的益处。而 尽管已发表的研究令人鼓舞，但YE的长期益处尚未得到验证，特别是对社区而言 功能退伍军人与SMI谁将接受和采用YE的配置文件也是未知的。我们有 进行了试点研究和随机对照试验（RCT）的个人与SMI在印度使用短期， 简化的YE结合药物治疗。最近，我们还总结了RELIEVE，这是一项针对YE的随机对照试验， 退伍军人与创伤后应激障碍（PTSD）在美国（VA RR&D优异奖，PI：L戴维斯，心理学博士）。我们 从我们所有的研究中发现了令人鼓舞的改进，但是我们的印度和美国YE协议对于 患有严重精神分裂症的退伍军人。例如，有些姿势可能对有动机的老年退伍军人和/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的适应性 非宗教背景下的协议（正念、伸展、调节和呼吸练习）。我们将咨询我们的 印度和美国同事、我们患有SMI的退伍军人及其VA治疗师，以调整我们SMI的方案 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RELIEVE研究。在目标2中，我们将进行一项双臂随机对照试验，其中同意SMI的退伍军人 将被随机分配至2组之一：YE和常规治疗（TAU，任何处方治疗）或WLP+ τ的与之前的短期YE RCT不同，两组将持续12个月，包括最初的12周培训 一个为期12周的培训期，包括每周两次监督培训， 每周提供有监督的课程，其余6个月每月提供复习培训课程。我们 将符合YE和WLP的所有COVID-19相关要求。我们的混合1号试验将比较 YE对WLP主要成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。我们的目标3是 了解患有SMI的退伍军人的人口统计学/临床特征，他们更有可能接受并采用YE， 通过分析RCT数据，实现长期康复（目标3A）。我们还会进行定性访谈 与退伍军人谁有SMI，并参加了YE干预手臂，指临床医生，和瑜伽 教员确定实施的障碍和促进因素（目标3B）。因此，该项目旨在促进我们的 改善患有SMI的退伍军人的生活质量的长期目标，并提供证据指导回家- 基于社区的YE实践，与《使命法》和《退伍军人管理法》相一致 战略计划。我们在开展各种SMI研究方面超过25年的经验提供了强有力的支持 成功完成提案。

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.