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

Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in Treatment for Opioid Use Disorder - Phase I

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid Use
• Intervention / Treatment: Behavioral: Yoga classes

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02909
      • CODAC Behavioral Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

16

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Recruited	As this is a pilot study, a key outcome is number of participants recruited	4 months
Number of Yoga Teachers Trained to > 80% Fidelity to the Manual	As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity	7 months
Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected	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.)	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 202002-002-1; U01AT010863 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No