Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
Completed · Not applicable
Conditions studied: Opioid Use, Chronic Pain
In brief
Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase: 1. 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. 2. Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage. 3. Examine mechanisms by which components are hypothesized to work.
Key facts
- Study ID
- NCT04641221
- Run by
- Butler Hospital
- People needed
- 192
- Starts
- 2022-02-20
- Expected to finish
- 2025-08-31
- Last updated by the study team
- 2025-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Boston Medical Center — Boston, Massachusetts, United States
- CODAC Behavioral Healthcare — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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