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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Use, Chronic Pain

Intervention / Treatment
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* Behavioral: Yoga classes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 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.

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: 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: 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 recieve prompting Text messages, | Behavioral: 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: 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: 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 financial Incentives to attend yoga classes and One-on-One individual sessions with a Yoga Instructor | Behavioral: 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 prompting Text messages and One-on-One individual sessions with a Yoga Instructor | Behavioral: 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 financial Incentives to attend yoga classes, prompting Text messages and One-on-One individual sessions with a Yoga Instructor | Behavioral: 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 financial Incentives to attend yoga classes, prompting Text messages or One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos | Behavioral: 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 prompting Text messages or One-on-One individual sessions with a Yoga Instructor, but DOES receive financial Incentives to attend yoga classes and Personal Practice Videos | Behavioral: 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 financial Incentives to attend yoga classes, or One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos and prompting Text messages | Behavioral: 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: 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 One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos | Behavioral: 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 financial Incentives to attend yoga classes, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos | Behavioral: 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 prompting Text messages, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos | Behavioral: 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: 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 |
| --- | --- | --- |
| Number of Participants Recruited | As this is a pilot study, a key outcome is number of participants recruited | 4 months | 
| Number of Yoga Teachers Trained to > 80% Fidelity to the Manual | As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity | 7 months | 
| Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | As this is a pilot study, an outcome is percentage of weeks where data on amount of yoga personal practice were collected. The total number of weeks possible = 12. These data are most important as they will be used to derive the primary outcome in the next phase of this research (total amount of yoga practice.) | 3 months |