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

Not Applicable

Completed

Brief Summary: Phase 1 - MOST Preparation Phase:

1. To conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20.

2. Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial.

3. 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: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Recruited	4 months	As this is a pilot study, a key outcome is number of participants recruited
Number of Yoga Teachers Trained to > 80% Fidelity to the Manual	7 months	As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity
Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected	3 months	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.)

Secondary Outcome Measures

Name	Time	Method

Locations (2): Boston Medical Center
🇺🇸
Boston, Massachusetts, United States
CODAC Behavioral Healthcare
🇺🇸
Providence, Rhode Island, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States