Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase I
Purpose
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.
Conditions
- Opioid Use
- Chronic Pain
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator No Video/No One-on-One/No Text/No Incentive |
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 |
|
|
Active Comparator No Video/No One-on-One/No Text/Yes Incentive |
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 |
|
|
Active Comparator No Video/No One-on-One/Yes Text/No Incentive |
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, |
|
|
Active Comparator No Video/No One-on-One/Yes Text/Yes Incentive |
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 |
|
|
Active Comparator No Video/Yes One-on-One/No Text/No Incentive |
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 |
|
|
Active Comparator No Video/Yes One-on-One/No Text/Yes Incentive |
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 |
|
|
Active Comparator No Video/Yes One-on-One/Yes Text/No Incentive |
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 |
|
|
Active Comparator No Video/Yes One-on-One/Yes Text/Yes Incentive |
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 |
|
|
Active Comparator Yes Video/No One-on-One/No Text/No Incentive |
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 |
|
|
Active Comparator Yes Video/No One-on-One/No Text/Yes Incentive |
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 |
|
|
Active Comparator Yes Video/No One-on-One/Yes Text/No Incentive |
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 |
|
|
Active Comparator Yes Video/No One-on-One/Yes Text/Yes Incentive |
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 |
|
|
Active Comparator Yes Video/Yes One-on-One/No Text/No Incentive |
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 |
|
|
Active Comparator Yes Video/Yes One-on-One/No Text/Yes Incentive |
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 |
|
|
Active Comparator Yes Video/Yes One-on-One/Yes Text/No Incentive |
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 |
|
|
Active Comparator Yes Video/Yes One-on-One/Yes Text/Yes Incentive |
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 |
|
More Details
- Status
- Completed
- Sponsor
- Butler Hospital
Study Contact
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.