Examining the Effectiveness of Asynchronous Versus Synchronous Yoga for Veterans With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory Short Form (BPI-SF)
研究概览
简要总结
The goal of this clinical trial is to see if pre-recorded yoga videos are as helpful for chronic pain as online yoga sessions taught in real time. The main questions it aims to answer are:
Are pre-recorded yoga videos an acceptable and practical tool and could they be used more broadly?
Are pre-recorded yoga videos no worse than online yoga sessions taught in real time for managing chronic pain?
Researchers will compare changes in chronic pain, mental health, and quality of life outcomes for participants who attend pre-recorded yoga videos versus online yoga sessions taught in real time.
Over the course of 4 months, participants will:
Attend a 5-session virtual yoga course. Continue virtual yoga practice for 12-weeks on their own or in a VA online class. Complete 3 online assessments and a brief exit interview.
详细描述
The overarching goals of the proposed research are to pilot test feasibility and acceptability of a 5-session yoga primer to the mindful practice of pain-sensitive teleyoga and its impact on subsequent teleyoga practice delivered either synchronously or asynchronously. The research will also test the preliminary effectiveness of teleyoga practice on outcomes related to chronic pain, mental health, and quality of life.
- Aim 1: Assess acceptability and feasibility of trial methodology to inform future larger-scale trials.
- Aim 2: Use intent-to-treat analysis and random effect regression models to compare changes in pain interference, pain severity, physical function, quality of life, depression, and anxiety between participants who attend synchronous vs. asynchronous teleyoga.
The primary purpose of a pilot study is to assess feasibility of methods to inform future larger studies. However, inferential analyses may be appropriate to help ascertain estimates of variability for the primary and secondary outcomes that can be used to power larger trials. To that end, the investigators will use intent-to-treat procedures and random effect regression models to compare changes in the outcome variables between patients who receive asynchronous vs. synchronous teleyoga.
Hypothesis
The investigators predict that asynchronous teleyoga will be non-inferior to synchronous teleyoga in reducing the primary outcome of pain interference, as well as across secondary outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •U.S. Veteran enrolled at VAPORHCS and has established care with a VA medical or mental health provider.
- •Diagnosed with musculoskeletal pain, confirmed by electronic health record review and phone screening.
- •Has an average pain severity of at least 4 in the past 3 months, assessed by items 1-5 of the Brief Pain Inventory, Short Form.
- •Aged 18 or over.
- •Capable of using video teleconferencing to complete enrollment, assessment, and video interventions.
- •Meets physical readiness, assessed by questions during screening and approved for yoga participation by their primary care, physical therapy, or provider team.
- •Able to sit and stand from the floor without assistance
- •Able to ambulate community distances without an assistive device
- •Intact sensation in lower extremities below the knees
排除标准
- •Unable to read and write in English.
- •Unable to freely give informed consent.
- •Recent (past 3 months) psychotic symptoms consistent with a diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or other psychotic disorder and unrelated to PTSD. Assessed by medical record review and provider team.
- •Practicing yoga regularly defined as weekly or biweekly practice of 60 or more minutes for 6 months or more.
- •Recent (past 3 months) history of suicidal gesture related to physical pain or active suicidal ideation (plan, intent, means).
- •Concurrently enrolled in another research protocol involving a pain focused intervention.
- •Upcoming surgery that would impact yoga practice.
- •Active alcohol/other substance abuse or dependence, excluding tobacco/nicotine and marijuana (unless actively engaged in treatment). Assessed via the The Tobacco, Alcohol, prescription medication and other Substance use Tool (TAPS). A cutoff of 2 will be used to rule out.
- •Joint replacement within the past 12 months.
研究组 & 干预措施
Synchronous Teleyoga
Participants randomized to receive synchronous tele-yoga will be provided information so that they can attend VA Portland Health Care System (VAPORHCS) virtual yoga offerings. They will be encouraged to attend one class per week during the 12 weeks between randomization and follow-up assessment. Attendance may be tracked via a signed note in the medical record. Each session will last approximately 30-60 minutes.
干预措施: Pain-Sensitive Teleyoga Primer (Behavioral)
Synchronous Teleyoga
Participants randomized to receive synchronous tele-yoga will be provided information so that they can attend VA Portland Health Care System (VAPORHCS) virtual yoga offerings. They will be encouraged to attend one class per week during the 12 weeks between randomization and follow-up assessment. Attendance may be tracked via a signed note in the medical record. Each session will last approximately 30-60 minutes.
干预措施: Synchronous Teleyoga (Behavioral)
Asynchronous Teleyoga
Participants randomized to receive asynchronous teleyoga will be provided information so that they can access to the digital library of yoga videos on Ompractice, an existing partner with VA Medical Centers. Ompractice contains a suite of yoga video content, and participants will be encouraged to complete one class per week during the 12 weeks between randomization and follow-up assessment.
干预措施: Pain-Sensitive Teleyoga Primer (Behavioral)
Asynchronous Teleyoga
Participants randomized to receive asynchronous teleyoga will be provided information so that they can access to the digital library of yoga videos on Ompractice, an existing partner with VA Medical Centers. Ompractice contains a suite of yoga video content, and participants will be encouraged to complete one class per week during the 12 weeks between randomization and follow-up assessment.
干预措施: Asynchronous Teleyoga (Behavioral)
结局指标
主要结局
Brief Pain Inventory Short Form (BPI-SF)
时间窗: Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18
The Brief Pain Inventory Short Form (BPI-SF) is a widely used 9-item tool for assessing pain severity and pain interference. The primary outcome will be the Pain Interference Subscale of the BPI-SF. Scores are reported on a range of 0 - 10, with higher scores indicating more impairment due to pain.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- Brief Pain Inventory Short Form - Pain Severity Subscale (BPI-SF(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- PROMIS Physical Function 4-Item Short Form Instrument(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- Veterans RAND 12-Item Health Survey (VR-12)(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- Generalized Anxiety Disorder 7-Item Scale(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- Five-facet Mindfulness Questionnaire(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- Multidimensional Assessment of Interoceptive Awareness, Version 2 (Brief MAIA-2)(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- PTSD Checklist for DMS-5 (PCL-5)(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- Well-Being Signs(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- Pain Catastrophizing Scale(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
- Teleyoga Attendance and Engagement (EHR & Digital Well-Being Data Collection)(Baseline, Post 5-session Yoga Primer (Week 5/6), Week 18)
研究者
Belle Zaccari
Co-Principal Investigator
Portland VA Medical Center