Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II

Conditions
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Opioid Use, Chronic Pain

Intervention / Treatment
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* Behavioral: Weekly Yoga Classes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Video/No One-on-One/No Text/No Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: No Video/No One-on-One/No Text/Yes Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: No Video/No One-on-One/Yes Text/No Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: No Video/No One-on-One/Yes Text/Yes Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: No Video/Yes One-on-One/No Text/No Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: No Video/Yes One-on-One/No Text/Yes Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: No Video/Yes One-on-One/Yes Text/No Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: No Video/Yes One-on-One/Yes Text/Yes Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: Yes Video/No One-on-One/No Text/No Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: Yes Video/No One-on-One/No Text/Yes Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: Yes Video/No One-on-One/Yes Text/No Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: Yes Video/No One-on-One/Yes Text/Yes Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: Yes Video/Yes One-on-One/No Text/No Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: Yes Video/Yes One-on-One/No Text/Yes Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: Yes Video/Yes One-on-One/Yes Text/No Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|
| Active Comparator: Yes Video/Yes One-on-One/Yes Text/Yes Incentive<br>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 | Behavioral: Weekly Yoga Classes<br>* All participants are invited to attend weekly yoga classes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yoga Dosage | Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview | 3 months |