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

Not Applicable

Completed

• Conditions: Chronic Pain; Opioid Use
• Interventions: Behavioral: Yoga classes

• Registration Number: NCT04646148
• Lead Sponsor: Butler Hospital

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.

Study Timeline

• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-27
• Study Start: 2021-03-01
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Results First Submitted: 2022-07-21
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-19
• Last Update Submitted: 2022-08-19
• Results First Posted: 2022-09-14
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
No Video/No One-on-One/Yes Text/No Incentive	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 recieve prompting Text messages,
No Video/Yes One-on-One/No Text/No Incentive	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/No One-on-One/No Text/No Incentive	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
No Video/No One-on-One/Yes Text/Yes Incentive	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/Yes One-on-One/Yes Text/Yes Incentive	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
No Video/Yes One-on-One/No Text/Yes Incentive	Yoga classes	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
No Video/No One-on-One/No Text/Yes Incentive	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/Yes One-on-One/Yes Text/No Incentive	Yoga classes	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
Yes Video/No One-on-One/Yes Text/Yes Incentive	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/No One-on-One/No Text/No Incentive	Yoga classes	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
Yes Video/No One-on-One/No Text/Yes Incentive	Yoga classes	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
Yes Video/Yes One-on-One/No Text/Yes Incentive	Yoga classes	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
No Video/Yes One-on-One/Yes Text/Yes Incentive	Yoga classes	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
Yes Video/No One-on-One/Yes Text/No Incentive	Yoga classes	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
Yes Video/Yes One-on-One/No Text/No Incentive	Yoga classes	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
Yes Video/Yes One-on-One/Yes Text/No Incentive	Yoga classes	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

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.)

Trial Locations

Locations (2)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

CODAC Behavioral Healthcare; 🇺🇸 Providence, Rhode Island, United States