Chronic Pain, Opioid Use
Conditions
Brief summary
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.
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.
Interventions
BEHAVIORALYoga classes
All participants are invited to attend weekly yoga classes.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Yoga Teachers Trained to > 80% Fidelity to the Manual | 7 months | As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity |
| Number of Participants Recruited | 4 months | As this is a pilot study, a key outcome is number of participants recruited |
| Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 3 months | 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.) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Video/No One-on-One/No Text/No Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 0 |
| No Video/No One-on-One/No Text/Yes Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 1 |
| No Video/No One-on-One/Yes Text/No Incentive 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,
Yoga classes: All participants are invited to attend weekly yoga classes. | 0 |
| No Video/No One-on-One/Yes Text/Yes Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 1 |
| No Video/Yes One-on-One/No Text/No Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 1 |
| No Video/Yes One-on-One/No Text/Yes Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 2 |
| No Video/Yes One-on-One/Yes Text/No Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 1 |
| No Video/Yes One-on-One/Yes Text/Yes Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 2 |
| Yes Video/No One-on-One/No Text/No Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 1 |
| Yes Video/No One-on-One/No Text/Yes Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 2 |
| Yes Video/No One-on-One/Yes Text/No Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 1 |
| Yes Video/No One-on-One/Yes Text/Yes Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 2 |
| Yes Video/Yes One-on-One/No Text/No Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 1 |
| Yes Video/Yes One-on-One/No Text/Yes Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 1 |
| Yes Video/Yes One-on-One/Yes Text/No Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 2 |
| Yes Video/Yes One-on-One/Yes Text/Yes Incentive 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
Yoga classes: All participants are invited to attend weekly yoga classes. | 2 |
| Total | 20 |
Baseline characteristics
| Characteristic | No Video/No One-on-One/No Text/Yes Incentive | Total | Yes Video/Yes One-on-One/Yes Text/Yes Incentive | Yes Video/Yes One-on-One/Yes Text/No Incentive | Yes Video/Yes One-on-One/No Text/Yes Incentive | Yes Video/Yes One-on-One/No Text/No Incentive | Yes Video/No One-on-One/Yes Text/Yes Incentive | Yes Video/No One-on-One/Yes Text/No Incentive | Yes Video/No One-on-One/No Text/Yes Incentive | Yes Video/No One-on-One/No Text/No Incentive | No Video/Yes One-on-One/Yes Text/Yes Incentive | No Video/Yes One-on-One/Yes Text/No Incentive | No Video/Yes One-on-One/No Text/Yes Incentive | No Video/Yes One-on-One/No Text/No Incentive | No Video/No One-on-One/Yes Text/Yes Incentive |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 0 | 48.5 years STANDARD_DEVIATION 11.94 | 49 years STANDARD_DEVIATION 1 | 55 years STANDARD_DEVIATION 10 | 59 years STANDARD_DEVIATION 0 | 35 years STANDARD_DEVIATION 0 | 51 years STANDARD_DEVIATION 9 | 50 years STANDARD_DEVIATION 0 | 54.5 years STANDARD_DEVIATION 1.5 | 59 years STANDARD_DEVIATION 0 | 52.5 years STANDARD_DEVIATION 18.5 | 46 years STANDARD_DEVIATION 0 | 48.5 years STANDARD_DEVIATION 12.5 | 32 years STANDARD_DEVIATION 0 | 38 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 18 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 10 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 20 participants | 2 participants | 2 participants | 1 participants | 1 participants | 2 participants | 1 participants | 2 participants | 1 participants | 2 participants | 1 participants | 2 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 12 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 8 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 | 0 / 0 | 0 / 1 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 0 | 0 / 1 | 0 / 0 | 1 / 1 | 0 / 1 | 0 / 2 | 0 / 1 | 1 / 2 | 0 / 1 | 1 / 2 | 0 / 1 | 1 / 2 | 1 / 1 | 1 / 1 | 2 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 | 0 / 0 | 0 / 1 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 2 | 0 / 2 |
Outcome results
Primary
Number of Participants Recruited
As this is a pilot study, a key outcome is number of participants recruited
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Entire Study | Number of Participants Recruited | 20 Participants |
Primary
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
Population: 5 yoga teachers trained and taught classes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Entire Study | Number of Yoga Teachers Trained to > 80% Fidelity to the Manual | 4 Participants |
Primary
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
Population: By design, no one was assigned to group 1 or 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Video/No One-on-One/No Text/Yes Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| No Video/No One-on-One/Yes Text/Yes Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| No Video/Yes One-on-One/No Text/No Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 8.3 percentage of weeks | Standard Deviation 0 |
| No Video/Yes One-on-One/No Text/Yes Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 62.5 percentage of weeks | Standard Deviation 53.03 |
| No Video/Yes One-on-One/Yes Text/No Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| No Video/Yes One-on-One/Yes Text/Yes Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 58.3 percentage of weeks | Standard Deviation 58.92 |
| Yes Video/No One-on-One/No Text/No Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| Yes Video/No One-on-One/No Text/Yes Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| Yes Video/No One-on-One/Yes Text/No Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| Yes Video/No One-on-One/Yes Text/Yes Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| Yes Video/Yes One-on-One/No Text/No Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| Yes Video/Yes One-on-One/No Text/Yes Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| Yes Video/Yes One-on-One/Yes Text/No Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 100 percentage of weeks | Standard Deviation 0 |
| Yes Video/Yes One-on-One/Yes Text/Yes Incentive | Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected | 12.5 percentage of weeks | Standard Deviation 17.68 |