Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in Treatment for Opioid Use Disorder - Phase I

Butler Hospital2 个研究点分布在 1 个国家目标入组 20 人开始时间: 2021年3月1日最近更新: 2022年9月14日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Butler Hospital
入组人数: 20
试验地点: 2
主要终点: Number of Yoga Teachers Trained to > 80% Fidelity to the Manual

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Phase 1 - MOST Preparation Phase:

To conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20.
Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial.
Demonstrate our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer components; d) run classes; and e) collect follow-up assessments.

详细描述

In Phase 1, we will enroll 10 participants at each recruitment site (n=20). The purpose of Phase 1 (MOST Preparation Phase) is to allow us to establish and refine procedures at these new sites and document aspects of feasibility, including our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer these components; d) run classes; and e) collect follow-up assessments. Enrollment period for this phase will last approximately 4 months.

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 methadone maintenance (MMT) or buprenorphine/naloxone (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
•Plan to move out of the area within 6 months.
•Homeless, defined as any time in the past month sleeping in a shelter or on the street.

研究组 & 干预措施

No Video/No One-on-One/No Text/No Incentive

Active Comparator

This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes