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

• Sponsor: Butler Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04646148
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 20
• Locations: 2
• Arms: 16
• Actual Duration (Months): 8
• Patients Per Site: 10
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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;

1. randomize participants to intervention components and correctly administer components; d) run classes; and e) collect follow-up assessments.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 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 Treatment for Opioid Use Disorder - Phase I
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Nov 1, 2021
• Actual Study Completion Date: Nov 1, 2021

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: 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: 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 recieve prompting Text messages,	Behavioral: 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: 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: 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 financial Incentives to attend yoga classes and One-on-One individual sessions with a Yoga Instructor	Behavioral: 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 prompting Text messages and One-on-One individual sessions with a Yoga Instructor	Behavioral: 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 financial Incentives to attend yoga classes, prompting Text messages and One-on-One individual sessions with a Yoga Instructor	Behavioral: 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 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	Behavioral: 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 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	Behavioral: 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 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	Behavioral: 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: 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 One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos	Behavioral: 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 financial Incentives to attend yoga classes, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos	Behavioral: 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 prompting Text messages, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos	Behavioral: 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: Yoga classes; All participants are invited to attend weekly yoga classes.

Outcome Measures

Primary Outcome Measures

1. Number of participants recruited [4 months]

   As this is a pilot study, a key outcome is number of participants recruited

2. Percentage 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

3. Percent of outcome assessments completed [4 months]

   As this is a pilot study, an outcome is percentage of outcomes assessments completed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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.

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: NCT04646148
• Other Study ID Numbers: 202002-002-1; U01AT010863
• First Posted: Nov 27, 2020
• Last Update Posted: Jan 5, 2022
• Last Verified: Jan 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 Jan 5, 2022