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

Primary Purpose

Opioid Use, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly 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 MMT or 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
  • Homeless, defined as any time in the past month sleeping in a shelter or on the street.

Sites / Locations

  • Boston Medical CenterRecruiting
  • CODAC Behavioral HealthcareRecruiting

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 receive 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 One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes

This group does not receive Personal Practice Videos or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor and prompting Text messages

This group does not receive Personal Practice Videos, but DOES receive One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes

This group does not receive One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos

This group does not receive One-on-One individual sessions with a Yoga Instructor or prompting Text messages, but DOES receive Personal Practice Videos and financial Incentives to attend yoga classes

This group does not receive One-on-One individual sessions with a Yoga Instructor or financial Incentives to attend yoga classes, 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 Personal Practice Videos and One-on-One individual sessions with a Yoga Instructor

This group does not receive prompting Text messages, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes

This group does not receive financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor and prompting Text messages

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

Yoga Dosage
Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
April 4, 2023
Sponsor
Butler Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04641221
Brief Title
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
Acronym
YOGAMAT-II
Official Title
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

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 2 - Multiphase Optimization Strategy (MOST) Optimization Phase: To conduct a factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. We will enroll a total n=192. All participants will receive the core yoga intervention, with random assignment to the four intervention components outlined above. Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage. Examine mechanisms by which components are hypothesized to work.
Detailed Description
In Phase 2, we will conduct a fully powered optimization trial. We will enroll 192 participants, planning to role approximately equal numbers of participants in both sites. In both phases, all participants will receive the core yoga intervention (12 weeks of weekly manualized yoga classes), with random assignment to the 4 key intervention components. Participants will be patients enrolled in methadone (MMT) or buprenorphine/naloxone (BUP) treatment with chronic pain. Enrollment period for this phase will last approximately 2 years.

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
192 (Anticipated)

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 receive 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 One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes
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 One-on-One individual sessions with a Yoga Instructor and prompting Text messages
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 One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes
Arm Title
Yes Video/No One-on-One/No Text/No Incentive
Arm Type
Active Comparator
Arm Description
This group does not receive One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes, 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 One-on-One individual sessions with a Yoga Instructor or prompting Text messages, but DOES receive Personal Practice Videos and financial Incentives to attend yoga classes
Arm Title
Yes Video/No One-on-One/Yes Text/No Incentive
Arm Type
Active Comparator
Arm Description
This group does not receive One-on-One individual sessions with a Yoga Instructor or financial Incentives to attend yoga classes, 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 Personal Practice Videos and One-on-One individual sessions with a Yoga Instructor
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 Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes
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 Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor and prompting Text messages
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)
Weekly Yoga Classes
Intervention Description
All participants are invited to attend weekly yoga classes.
Primary Outcome Measure Information:
Title
Yoga Dosage
Description
Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview
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 MMT or 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 No access to a reasonably safe, reliable place to engage in personal yoga practice and a private space to participate in online yoga classes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Uebelacker, PhD
Phone
401-455-6200
Email
luebelacker@butler.org
First Name & Middle Initial & Last Name or Official Title & Degree
Donnell Vannoppen
Phone
4014556652
Email
dvannoppen@butler.org
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Lorin
Facility Name
CODAC Behavioral Healthcare
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Kirshy

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 II

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