Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
YOGAMAT-II
2 other identifiers
interventional
192
1 country
2
Brief Summary
Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase:
- 1.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.
- 2.Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage.
- 3.Examine mechanisms by which components are hypothesized to work.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedStudy Start
First participant enrolled
February 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedResults Posted
Study results publicly available
November 20, 2025
CompletedNovember 20, 2025
October 1, 2025
2.7 years
November 16, 2020
October 8, 2025
November 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Yoga Dosage
Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview
3 months
Study Arms (16)
No Video/No One-on-One/No Text/No Incentive
ACTIVE COMPARATORThis 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/No Text/Yes Incentive
ACTIVE COMPARATORThis 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/No One-on-One/Yes Text/No Incentive
ACTIVE COMPARATORThis 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
No Video/No One-on-One/Yes Text/Yes Incentive
ACTIVE COMPARATORThis 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
No Video/Yes One-on-One/No Text/No Incentive
ACTIVE COMPARATORThis 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/Yes One-on-One/No Text/Yes Incentive
ACTIVE COMPARATORThis 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
No Video/Yes One-on-One/Yes Text/No Incentive
ACTIVE COMPARATORThis 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
No Video/Yes One-on-One/Yes Text/Yes Incentive
ACTIVE COMPARATORThis 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
Yes Video/No One-on-One/No Text/No Incentive
ACTIVE COMPARATORThis 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
Yes Video/No One-on-One/No Text/Yes Incentive
ACTIVE COMPARATORThis 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
Yes Video/No One-on-One/Yes Text/No Incentive
ACTIVE COMPARATORThis 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
Yes Video/No One-on-One/Yes Text/Yes Incentive
ACTIVE COMPARATORThis 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/Yes One-on-One/No Text/No Incentive
ACTIVE COMPARATORThis 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
Yes Video/Yes One-on-One/No Text/Yes Incentive
ACTIVE COMPARATORThis 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
Yes Video/Yes One-on-One/Yes Text/No Incentive
ACTIVE COMPARATORThis 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
Yes Video/Yes One-on-One/Yes Text/Yes Incentive
ACTIVE COMPARATORThis group receives Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes
Interventions
All participants are invited to attend weekly yoga classes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Boston Medical Center
Boston, Massachusetts, 02118, United States
CODAC Behavioral Healthcare
Providence, Rhode Island, 02909, United States
Related Publications (1)
Uebelacker LA, Braun TD, Taylor LE, Saper R, Baldwi M, Abrantes A, Tremont G, Toribio A, Kirshy S, Koch R, Lorin L, Van Noppen D, Anderson B, Roseen EJ, Stein MD. Evaluation of intervention components to maximize yoga practice among people with chronic pain taking opioid agonist therapy: A factorial experiment using the multiphase optimization strategy framework. Contemp Clin Trials. 2024 Feb;137:107411. doi: 10.1016/j.cct.2023.107411. Epub 2023 Dec 14.
PMID: 38103784DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Uebelacker, PhD
- Organization
- Butler Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2020
First Posted
November 23, 2020
Study Start
February 20, 2022
Primary Completion
November 15, 2024
Study Completion
August 31, 2025
Last Updated
November 20, 2025
Results First Posted
November 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share