NCT04641221已完成不适用
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 4
- 主要终点
- Yoga Dosage
研究概览
简要总结
Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase:
- To conduct a factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. We will enroll a total n=192. All participants will receive the core yoga intervention, with random assignment to the four intervention components outlined above.
- Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage.
- Examine mechanisms by which components are hypothesized to work.
详细描述
In Phase 2, we will conduct a fully powered optimization trial. We will enroll 192 participants, planning to role approximately equal numbers of participants in both sites. In both phases, all participants will receive the core yoga intervention (12 weeks of weekly manualized yoga classes), with random assignment to the 4 key intervention components. Participants will be patients enrolled in methadone (MMT) or buprenorphine/naloxone (BUP) treatment with chronic pain. Enrollment period for this phase will last approximately 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Enrolled in MMT or BUP treatment for > 3 months
- •Plan to continue treatment for next 6 months
- •Chronic pain, defined as pain for at least half the days over the previous three months, a mean score of 4 or higher on the Brief Pain Interference Scale (BPI; with reference to chronic pain), and pain severity of 4 or higher on a Visual Analog Scale (0-10) indicating "worst pain in the last week." Pain severity score will also refer to the areas of their body in which they have chronic pain.
- •Aged > 18
- •Proficiency in English sufficient to engage in informed consent in English, understand classes taught in English, and read short sentences
- •Available at least one of the times study classes are offered.
排除标准
- •Currently taking yoga classes or practicing yoga at home once per week or more often.
- •Medical conditions that would make participation in yoga unsafe or not possible, including active malignancy treatment, fracture, recent joint surgery, use of assistive ambulatory devices other than a cane. . (In cases where this is unclear, site PI will make final determination based on available evidence.)
- •Severe or progressive neurologic deficits. (In cases where this is unclear, site PI will make final determination based on available evidence.)
- •Other severe disabling chronic medical and/or psychiatric comorbidities deemed by the site PI on a case-by-case basis to prevent safe or adequate participation in the study (e.g., cognitive impairment that prevents a participant from understanding assessments; history of disruptive behavior in medical settings; severe disabling heart failure or lung disease)
- •Surgery requiring overnight hospitalization planned in the next 3 months
- •Pregnancy
- •No access to a reasonably safe, reliable place to engage in personal yoga practice and a private space to participate in online yoga classes
结局指标
主要结局
Yoga Dosage
时间窗: 3 months
Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview
次要结局
未报告次要终点
研究者
研究点 (4)
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