Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase I
Status
Completed
Conditions
Chronic Pain
Opioid Use
Treatments
Behavioral: Yoga classes
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
20 patients
Sex
All
Ages
18+ years old
Volunteers
No 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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
Double Blind
20 participants in 16 patient groups
No Video/No One-on-One/No Text/No Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
No Video/No One-on-One/No Text/Yes Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
No Video/No One-on-One/Yes Text/No Incentive
Active Comparator group
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,
Treatment:
Behavioral: Yoga classes
No Video/No One-on-One/Yes Text/Yes Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
No Video/Yes One-on-One/No Text/No Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
No Video/Yes One-on-One/No Text/Yes Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
No Video/Yes One-on-One/Yes Text/No Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
No Video/Yes One-on-One/Yes Text/Yes Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
Yes Video/No One-on-One/No Text/No Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
Yes Video/No One-on-One/No Text/Yes Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
Yes Video/No One-on-One/Yes Text/No Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
Yes Video/No One-on-One/Yes Text/Yes Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
Yes Video/Yes One-on-One/No Text/No Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
Yes Video/Yes One-on-One/No Text/Yes Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
Yes Video/Yes One-on-One/Yes Text/No Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
Yes Video/Yes One-on-One/Yes Text/Yes Incentive
Active Comparator group
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
Treatment:
Behavioral: Yoga classes
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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