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.

这是一项基于瑜伽练习（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）之间的康复，此处定义为精神分裂症（SZ）， 精神分裂症（SZA）和双相情感障碍（BP1）。 SMI是常见的，严重且毁灭性的 在世界范围内引起巨大残疾的条件。 SMI的许多功能都可以有效地处理，但是 在过去的一个世纪中，长期结果并没有太大改善。缺乏改进可能是由于 对SMI患者的功能缺陷的无效治疗，特别是在社区功能方面 在这里定义为社区中社交，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）疗法对治疗非常感兴趣 具有SMI的退伍军人，从而针对VA优先级。先前的研究表明短期 YE的好处可以改善SMI患者之间的认知缺陷和社区功能。而 已发表的研究令人鼓舞，YE的长期益处未经测试，特别是对于社区而言 功能。将接受和采用YE的SMI的退伍军人的个人资料也是未知的。我们有 使用短期，对印度SMI患者进行了试点研究和随机对照试验（RCT）， 简化的你们与药物结合。最近，我们还得出结论，辅助性 美国的退伍军人（PTSD）在美国（VA RR＆D优异奖，PI：L DAVIS，PSYD）。我们 发现我们所有研究都令人鼓舞，但我们的印度和我们的协议是不切实际的 与SMI的退伍军人。例如，对于有动机和/或 身体残疾。因此，在AIM 1中，我们将设计和评估印度和我们的适应 在非宗教上下文（正念，伸展，色调和呼吸练习）中的协议。我们将咨询我们的 印度和美国同事，我们与SMI的退伍军人及其VA治疗师为我们的SMI调整协议 人口。我们还将从最近的我们的控制状况，健康生活方式计划（WLP）调整 完成的缓解研究。在AIM 2中，我们将进行2臂RCT，其中同意与SMI的退伍军人 将随机分配给2个臂之一：YE和治疗 tau。与以前的短期Ye RCT不同，这两个武器将继续12个月，包括最初的12周训练 每周两次监督课程的期间，其次是一个为期12周的培训期，包括一个 每周有监督的会议，以及剩余6个月提供的每月刷新培训课程。我们 将符合YE和WLP的所有COVID-19相关要求。我们的混合1试验将比较功效 ye与WLP。主要结果是社区的自我报告和基于绩效的措施 功能；次要结果是认知和身体健康措施。我们目标3的目标是 了解具有SMI的退伍军人的人口/临床特征，他们更有可能接受并采用您 通过分析RCT数据（AIM 3A），启用长期康复。我们还将进行定性访谈 与有SMI并参加YE干预部门的退伍军人，推荐临床医生和瑜伽 识别实施障碍和促进者的讲师（AIM 3B）。因此，该项目旨在促进我们的 改善有SMI退伍军人生活质量的长期目标，并提供证据来指导家庭 - 基于和从长远来看，基于社区的实践，与《任务法》和《 VA》一致 战略计划。我们在进行25年以上的各种SMI研究方面的经验提供了强有力的支持 为了成功完成该提案。