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

• Sponsor: Butler Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04641221
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 192
• Locations: 2
• Arms: 16
• Anticipated Duration (Months): 37.3
• Patients Per Site: 96
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use; Chronic Pain	Behavioral: Weekly Yoga Classes	N/A

Detailed Description

In Phase 2, we will conduct a fully powered optimization trial. We will enroll 192 participants, planning to role approximately equal numbers of participants in both sites. In both phases, all participants will receive the core yoga intervention (12 weeks of weekly manualized yoga classes), with random assignment to the 4 key intervention components. Participants will be patients enrolled in methadone (MMT) or buprenorphine/naloxone (BUP) treatment with chronic pain. Enrollment period for this phase will last approximately 2 years.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
• Actual Study Start Date: Feb 20, 2022
• Anticipated Primary Completion Date: Dec 30, 2024
• Anticipated Study Completion Date: Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly 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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly 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 receive prompting Text messages	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly 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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
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 One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
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 One-on-One individual sessions with a Yoga Instructor and prompting Text messages	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
Active Comparator: No Video/Yes One-on-One/Yes Text/Yes Incentive This 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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/No One-on-One/No Text/No Incentive This 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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/No One-on-One/No Text/Yes Incentive This 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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/No One-on-One/Yes Text/No Incentive This 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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly 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 Personal Practice Videos and One-on-One individual sessions with a Yoga Instructor	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
Active Comparator: Yes Video/Yes One-on-One/No Text/Yes Incentive This 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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
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 Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor and prompting Text messages	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.
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	Behavioral: Weekly Yoga Classes; All participants are invited to attend weekly yoga classes.

Outcome Measures

Primary Outcome Measures

1. Yoga Dosage [3 months]

   Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

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

• Homeless, defined as any time in the past month sleeping in a shelter or on the street.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118
2	CODAC Behavioral Healthcare	Providence	Rhode Island	United States	02909

Sponsors and Collaborators

• Butler Hospital
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Butler Hospital
• ClinicalTrials.gov Identifier: NCT04641221
• Other Study ID Numbers: 202002-002-2; U01AT010863
• First Posted: Nov 23, 2020
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Mar 23, 2022