Exercise-based Program for Rehabilitation of Veterans With Severe Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Quality of Life Scale (QOL)
研究概览
简要总结
This is a hybrid1, effectiveness-implementation study of yoga-based exercises (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI). The two-arm randomized controlled trial will compare the efficacy of YE compared to the Wellness Lifestyle Program (WLP). Primary outcomes of the study will be self-report and performance-based measures of community functioning, defined in the investigators study as social, leisure, employment, and life skills functioning in the community. Secondary outcomes will include cognition and physical fitness measures.
详细描述
This study will examine Yoga-based Exercise (YE) as a rehabilitation tool for Veterans with Severe Mental Illness (SMI), defined as schizophrenia (SZ), schizoaffective disorder (SZA), and Bipolar 1 disorder (BP1), with or without co-morbid history of alcohol use disorders (AUD) or substance use disorders (SUD). The study will evaluate factors associated with engagement in and uptake of YE among Veterans with SMI. This is a randomized controlled trial of YE that will examine factors that could facilitate or impede implementation of YE among Veterans with SMI.
Aim 1. Adapt YE protocols for Veterans with SMI. The investigators will design and evaluate adaptions of previously used Indian and US-based YE protocols in a non-religious context (mindfulness, stretching, toning and breathing exercises). The investigators will consult Indian and US colleagues, Veterans with SMI, and their VA therapists to adapt the protocol for SMI population. The investigators will also adapt control condition, the Wellness Lifestyle Program (WLP), from the recently completed RELIEVE study.
Aim 2. Study the efficacy of long-term YE among Veterans with SMI with a 2-armed RCT. The investigators 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 or WLP and treatment as usual. Unlike prior short-term YE RCTs, the two arms will continue for 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 sessions for the remaining 6 months. The investigators will compare the efficacy of YE versus WLP. The primary outcomes are self-report and performance-based measures of community functioning. Secondary outcomes are cognition and physical fitness measures.
Aim 3. Study factors associated with YE acceptance, adoption and implementation. The investigators goal for Aim 3 is 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 (Aim3A). The investigators 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research staff conducting assessments will not be informed as to which group each participant has been assigned. Additionally, investigators will be be masked to groups, except for Dr. Bramoweth. Dr. Bramoweth will be conducting qualitative interviews with participants enrolled in the YE group only. He will be masked to all other participants except those participating in the qualitative interviews.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent;
- •age 18-70 years;
- •DSM-5 diagnosis of
- •schizophrenia,
- •schizoaffective disorder,
- •bipolar 1 disorder,
- •DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder including those with a co-morbid
- •alcohol use disorder or substance use disorder;
- •clinically stable;
- •clinical global impression-severity (CGI-S) scores mild to moderately ill
排除标准
- •Unable to provide written informed consent;
- •intellectual disability (i.e., severe enough to impact understanding of yoga-based exercises) based on chart or IQ<80 on the Wechslet Abbreviated Scale of Intelligence-II (WASI-II);
- •disability or illness precluding yoga-based exercises or wellness lifestyle program, e.g.,
- •current or recent angina (<6 months),
- •history of myocardial infarction in the past year (unless permission is obtained from the primary care physician),
- •uncontrolled hypertension or hypotension;
- •neurological illness complicating diagnosis / cognitive evaluation, e.g.,
- •dementia,
- •stroke or head injury;
- •physical problems that preclude training for yoga-based exercises / wellness lifestyle program, e.g.,
- •severely impaired vision;
- •ongoing treatment that includes more than one hour per week of relaxation and mind-body based stress reduction strategies related to yoga
研究组 & 干预措施
Yoga-based Exercise (YE)
The Yoga-based Exercise (YE) intervention is a series of yoga-based poses that consists of sitting, standing, kneeling, and lying postures as well as breathing exercises. The duration of the intervention will be 12 months. Participants will engage in yoga-based exercise sessions lasting 60 minutes twice a week for the first 12 weeks (3 months) of the project. The following 12 weeks, participants will engage in yoga-based exercises once a week. The remainder of the study (6 months), participants will engage in yoga-based exercises once a month.
干预措施: Yoga-based Exercise (YE) (Other)
Wellness Lifestyle Program (WLP)
The Wellness Lifestyle Program (WLP) is a comprehensive lifestyle program that consists of 30 minutes of educational information covering various topics, such as nutrition, healthy living, stress reduction, and more will be followed by 30 minutes of low-intensity exercise such as walking. The duration of the intervention will be 12 months. Participants will engage in the 60 minute WLP session twice a week for the first 12 weeks (3 months) of the project. The following 12 weeks, participants will engage in WLP sessions once a week. The remainder of the study (6 months), participants will engage in WLP sessions once a month.
干预措施: Wellness Lifestyle Program (WLP) (Other)
结局指标
主要结局
Quality of Life Scale (QOL)
时间窗: 12 months
The Quality of Life Scale (QOL) will be used to measure interpersonal, social and occupational functioning. The QOL scale is a 16-item scale ranging from 1-7. 1= Terrible, 2 = Unhappy, 3 = Mostly dissatisfied, 4= Mixed, 5 = Mostly satisfied, 6 = Pleased, 7= Delighted
Social Functioning Scale (SFS)
时间窗: 12 months
The Social Functioning Scale (SFS) is a self-report measure of social functioning, and is widely used in adults with psychosis.
Patient-Reported Outcomes Measurements Information Systems (PROMIS)
时间窗: 12 months
Patient-Reported Outcomes Measurements Information System's (PROMIS) Satisfaction with Participation in Social Roles and Activities will be used to assess participant's perceived satisfaction with their social roles and activities as part of the community and social functioning outcome. The PROMIS scale is an 8-item short form. The scale for each item is: Not at all, a little bit, somewhat, quite a bit, very much.
次要结局
- Clinical Global Impression-Severity (CGI-S)(12 months)
- 2-minute walk(12 months)
- Brief Assessment of Cognition (BAC)(12 month)
- RAND 36-Item Short Form Survey (SF-36)(12 months)
- Patterns of utilization(12 months)
- Brief Psychiatric Rating Scale (BPRS)(12 months)
- The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(12 months)
- Multidimensional Assessment of Interoceptive Awareness, 2nd Edition (MAIA2)(12 months)