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

Primary Purpose

Opioid Use, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga classes
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Medical Center
  • CODAC Behavioral Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

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

Arm Description

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

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

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,

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants Recruited
As this is a pilot study, a key outcome is number of participants recruited
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
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.)

Secondary Outcome Measures

Full Information

First Posted
November 12, 2020
Last Updated
August 19, 2022
Sponsor
Butler Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04646148
Brief Title
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase I
Acronym
YOGAMAT-II
Official Title
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in Treatment for Opioid Use Disorder - Phase I
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 1 - MOST Preparation Phase: To conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20. Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Chronic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Video/No One-on-One/No Text/No Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
No Video/No One-on-One/No Text/Yes Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
No Video/No One-on-One/Yes Text/No Incentive
Arm Type
Active Comparator
Arm Description
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,
Arm Title
No Video/No One-on-One/Yes Text/Yes Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
No Video/Yes One-on-One/No Text/No Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
No Video/Yes One-on-One/No Text/Yes Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
No Video/Yes One-on-One/Yes Text/No Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
No Video/Yes One-on-One/Yes Text/Yes Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
Yes Video/No One-on-One/No Text/No Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
Yes Video/No One-on-One/No Text/Yes Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
Yes Video/No One-on-One/Yes Text/No Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
Yes Video/No One-on-One/Yes Text/Yes Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
Yes Video/Yes One-on-One/No Text/No Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
Yes Video/Yes One-on-One/No Text/Yes Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
Yes Video/Yes One-on-One/Yes Text/No Incentive
Arm Type
Active Comparator
Arm Description
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
Arm Title
Yes Video/Yes One-on-One/Yes Text/Yes Incentive
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Yoga classes
Intervention Description
All participants are invited to attend weekly yoga classes.
Primary Outcome Measure Information:
Title
Number of Participants Recruited
Description
As this is a pilot study, a key outcome is number of participants recruited
Time Frame
4 months
Title
Number of Yoga Teachers Trained to > 80% Fidelity to the Manual
Description
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
Title
Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
CODAC Behavioral Healthcare
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02909
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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