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

Butler Hospital20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Opioid Use Chronic Pain

Interventions

Yoga classesBEHAVIORAL

All participants are invited to attend weekly yoga classes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Boston Medical Center

Boston, Massachusetts, United States

CODAC Behavioral Healthcare

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Number of Participants Recruited

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

Time frame: 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

Time frame: 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.)

Time frame: 3 months

Data from ClinicalTrials.gov

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