Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
Not Applicable
Active, not recruiting
- Conditions
- Chronic PainOpioid Use
- Interventions
- Behavioral: Weekly Yoga Classes
- Registration Number
- NCT04641221
- Lead Sponsor
- Butler Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 192
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description No Video/Yes One-on-One/No Text/Yes Incentive Weekly Yoga Classes This group does not receive Personal Practice Videos or prompting Text messages, but DOES receive One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes No Video/Yes One-on-One/Yes Text/No Incentive Weekly Yoga Classes This group does not receive Personal Practice Videos or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor and prompting Text messages No Video/No One-on-One/No Text/Yes Incentive Weekly Yoga Classes This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, but DOES receive financial Incentives to attend yoga classes No Video/No One-on-One/Yes Text/Yes Incentive Weekly Yoga Classes This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, but DOES receive prompting Text messages and financial Incentives to attend yoga classes Yes Video/No One-on-One/No Text/No Incentive Weekly Yoga Classes This group does not receive One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos No Video/No One-on-One/No Text/No Incentive Weekly Yoga Classes 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 Yes Video/No One-on-One/Yes Text/Yes Incentive Weekly Yoga Classes This group does not receive One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos, prompting Text messages, and financial Incentives to attend yoga classes Yes Video/Yes One-on-One/No Text/No Incentive Weekly Yoga Classes This group does not receive prompting Text messages or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos and One-on-One individual sessions with a Yoga Instructor No Video/No One-on-One/Yes Text/No Incentive Weekly Yoga Classes This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or financial Incentives to attend yoga classes, but DOES receive prompting Text messages No Video/Yes One-on-One/No Text/No Incentive Weekly Yoga Classes This group does not receive Personal Practice Videos or prompting Text messages or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor No Video/Yes One-on-One/Yes Text/Yes Incentive Weekly Yoga Classes This group does not receive Personal Practice Videos, but DOES receive One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes Yes Video/No One-on-One/No Text/Yes Incentive Weekly Yoga Classes This group does not receive One-on-One individual sessions with a Yoga Instructor or prompting Text messages, but DOES receive Personal Practice Videos and financial Incentives to attend yoga classes Yes Video/No One-on-One/Yes Text/No Incentive Weekly Yoga Classes This group does not receive One-on-One individual sessions with a Yoga Instructor or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos and prompting Text messages Yes Video/Yes One-on-One/No Text/Yes Incentive Weekly Yoga Classes This group does not receive prompting Text messages, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes Yes Video/Yes One-on-One/Yes Text/No Incentive Weekly Yoga Classes This group does not receive financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor and prompting Text messages Yes Video/Yes One-on-One/Yes Text/Yes Incentive Weekly Yoga Classes This group receives Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes
- Primary Outcome Measures
Name Time Method Yoga Dosage 3 months Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CODAC Behavioral Healthcare
🇺🇸Providence, Rhode Island, United States