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

患有严重精神疾病的退伍军人的基于运动的康复计划

• 批准号: 10415301
• 负责人: GRETCHEN L HAAS
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10415301
• 关键词: Adopted; Adoption; Affect; Area; Award; Bipolar I; Breathing Exercises; COVID-19; Characteristics; Clinic; Clinical; Cognition; Cognitive deficits; Communities; Community Integration; Complementary Medicine; Consent; Consolidated Framework for Implementation Research; Consult; Data; Disease; Elements; Employment; Ensure; Exercise; Family; Frequencies; Goals; Health; Health Personnel; Healthcare; Home; Hybrids; Impaired cognition; Impairment; India; Individual; Integrative Medicine; Intervention; Interview; Leisures; Life; Life Style; Measures; Mental Health; Mission; Muscle Contraction; Outcome; Participant; Patient Self-Report; Patients; Pattern; Persons; Pharmaceutical Preparations; Physical Fitness; Pilot Projects; Population; Post-Traumatic Stress Disorders; Posture; Prevalence; Protocols documentation; Publishing; Quality of life; Randomized; Randomized Controlled Trials; Recording of previous events; Refractory; Regulation; Rehabilitation therapy; Relaxation; Research; Research Design; Role; Rural Community; Safety; Schedule; Schizoaffective Disorders; Schizophrenia; Services; Social Functioning; Socialization; Strategic Planning; Stretching; Substance Use Disorder; Suicide prevention; Supervision; Symptoms; Techniques; Testing; Time; Training; Veterans; Yoga; alcohol use disorder; arm; base; cognitive benefits; comorbidity; comparative efficacy; cost; design; disability; effectiveness implementation study; efficacy study; exercise intervention; exercise program; exercise training; experience; future implementation; implementation efforts; implementation facilitators; improved; ineffective therapies; instructor; interest; long-term rehabilitation; mindfulness; performance based measurement; physically handicapped; primary outcome; programs; secondary outcome; severe mental illness; skills; social; study characteristics; tool; treatment arm; treatment as usual; uptake; virtual

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.

这是一项混合 1、以瑜伽为基础的运动 (YE) 作为辅助工具的有效性实施研究 严重精神疾病（SMI）患者的康复，这里定义为精神分裂症（SZ）， 分裂情感性障碍 (SZA) 和 I 型双相情感障碍 (BP1)。 SMI 很常见、严重且具有破坏性 在世界范围内造成巨大残疾的情况。 SMI 的许多特征都可以得到有效治疗，但 过去一个世纪以来，长期成果并没有太大改善。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， 这里定义为在社区中发挥作用的社交、休闲、就业和生活技能。补充 因此，改善社区功能的综合医学（CIM）疗法对于治疗 患有 SMI 的退伍军人因此成为 VA 高度优先考虑的领域。先前的研究表明短期 YE 对改善 SMI 患者的认知缺陷和社区功能的益处。虽然 已发表的研究令人鼓舞，YE 的长期效益尚未经过测试，特别是对于社区而言 发挥作用。接受并收养 YE 的 SMI 退伍军人的情况也不得而知。我们有 使用短期、 简化 YE 与药物相结合。最近，我们还完成了 RELIEVE，一项针对 YE 辅助治疗的 RCT 美国患有创伤后应激障碍 (PTSD) 的退伍军人（VA RR&D 优异奖，PI：L Davis，心理学博士）。我们 我们所有的研究都发现了令人鼓舞的进步，但我们的印度和美国 YE 协议对于 患有 SMI 的退伍军人。例如，对于缺乏积极性和/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、塑身和呼吸练习）。我们将咨询我们的 印度和美国同事、我们的 SMI 退伍军人以及他们的 VA 治疗师为我们的 SMI 调整了协议 人口。我们还将调整我们的控制条件，即健康生活方式计划 (WLP)， 完成 RELIEVE 研究。在目标 2 中，我们将进行一项 2 组 RCT，其中同意患有 SMI 的退伍军人 将被随机分配到 2 个组之一：YE 和照常治疗（TAU，任何规定的治疗）或 WLP+ TAU。与之前的短期 YE RCT 不同，两组将持续 12 个月，包括最初的 12 周训练 为期 12 周的培训期包括每周两次监督课程，随后是为期 12 周的培训期，其中包括一次 每周有监督课程，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 Hybrid 1 试验将比较疗效 YE 与 WLP 的比较。主要成果是自我报告和基于绩效的社区衡量标准 发挥作用；次要结果是认知和身体健康指标。我们目标 3 的目标是 了解患有 SMI 的退伍军人的人口统计/临床特征，他们更有可能接受并采用 YE 通过分析 RCT 数据（目标 3A），实现长期康复。我们还将进行定性访谈 与患有 SMI 并参加 YE 干预部门的退伍军人、转诊临床医生和瑜伽 指导员识别实施的障碍和促进因素（目标 3B）。因此，该项目旨在推进我们的 改善患有 SMI 的退伍军人的生活质量的长期目标，并提供证据来指导家庭 基于并从长远来看，基于社区的 YE 实践，符合《使命法》和《退伍军人事务部》 战略计划。我们超过 25 年进行各种 SMI 研究的经验提供了强有力的支持 以确保提案的顺利完成。