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

NCT04646148 | Completed Results DMC

• 2 other identifiers: 202002-002-1U01AT010863
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Phase 1 - MOST Preparation Phase:

1. 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. 2.Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial.
3. 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.

Conditions

Opioid Use; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (16)

No Video/No One-on-One/No Text/No Incentive

ACTIVE COMPARATOR

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

No Video/No One-on-One/No Text/Yes Incentive

ACTIVE COMPARATOR

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

No Video/No One-on-One/Yes Text/No Incentive

ACTIVE COMPARATOR

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

No Video/No One-on-One/Yes Text/Yes Incentive

ACTIVE COMPARATOR

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

No Video/Yes One-on-One/No Text/No Incentive

ACTIVE COMPARATOR

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

No Video/Yes One-on-One/No Text/Yes Incentive

ACTIVE COMPARATOR

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

No Video/Yes One-on-One/Yes Text/No Incentive

ACTIVE COMPARATOR

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

No Video/Yes One-on-One/Yes Text/Yes Incentive

ACTIVE COMPARATOR

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

Yes Video/No One-on-One/No Text/No Incentive

ACTIVE COMPARATOR

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

Yes Video/No One-on-One/No Text/Yes Incentive

ACTIVE COMPARATOR

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

Yes Video/No One-on-One/Yes Text/No Incentive

ACTIVE COMPARATOR

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

Yes Video/No One-on-One/Yes Text/Yes Incentive

ACTIVE COMPARATOR

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

Yes Video/Yes One-on-One/No Text/No Incentive

ACTIVE COMPARATOR

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

Yes Video/Yes One-on-One/No Text/Yes Incentive

ACTIVE COMPARATOR

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

Yes Video/Yes One-on-One/Yes Text/No Incentive

ACTIVE COMPARATOR

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

Yes Video/Yes One-on-One/Yes Text/Yes Incentive

ACTIVE COMPARATOR

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

Interventions

Yoga classes BEHAVIORAL

All participants are invited to attend weekly yoga classes.

No Video/No One-on-One/No Text/No Incentive; No Video/No One-on-One/No Text/Yes Incentive; No Video/No One-on-One/Yes Text/No Incentive; No Video/No One-on-One/Yes Text/Yes Incentive; No Video/Yes One-on-One/No Text/No Incentive; No Video/Yes One-on-One/No Text/Yes Incentive; No Video/Yes One-on-One/Yes Text/No Incentive; No Video/Yes One-on-One/Yes Text/Yes Incentive; Yes Video/No One-on-One/No Text/No Incentive; Yes Video/No One-on-One/No Text/Yes Incentive; Yes Video/No One-on-One/Yes Text/No Incentive; Yes Video/No One-on-One/Yes Text/Yes Incentive; Yes Video/Yes One-on-One/No Text/No Incentive; Yes Video/Yes One-on-One/No Text/Yes Incentive; Yes Video/Yes One-on-One/Yes Text/No Incentive; Yes Video/Yes One-on-One/Yes Text/Yes Incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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
• 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.

Sponsors & Collaborators

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

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

CODAC Behavioral Healthcare

Providence, Rhode Island, 02909, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a pilot study that was designed to assess feasibility of the proposed design prior to starting a larger trial.

Results Point of Contact

• Title: Dr. Lisa Uebelacker
• Organization: Butler Hospital

luebelacker@butler.org

401-455-6381

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 12, 2020
• First Posted: November 27, 2020
• Study Start: March 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 14, 2022
• Results First Posted: September 14, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)