Opioid Use, Chronic Pain
Conditions
Brief summary
Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase: 1. 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. 2. Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage. 3. 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.
Interventions
BEHAVIORALWeekly Yoga 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yoga Dosage | 3 months | Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview |
Countries
United States
Participant flow
Recruitment details
For these purposes, we defined completion as completing the BPI at Month 3 or Month 12
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 | 12 |
| 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 | 12 |
| 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 receive prompting Text messages | 12 |
| 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 | 12 |
| 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 | 12 |
| 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 One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes | 12 |
| 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 One-on-One individual sessions with a Yoga Instructor and prompting Text messages | 12 |
| No Video/Yes One-on-One/Yes Text/Yes Incentive 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 | 12 |
| Yes Video/No One-on-One/No Text/No Incentive 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 | 12 |
| Yes Video/No One-on-One/No Text/Yes Incentive 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 | 12 |
| Yes Video/No One-on-One/Yes Text/No Incentive 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 | 12 |
| 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 | 12 |
| 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 Personal Practice Videos and One-on-One individual sessions with a Yoga Instructor | 12 |
| Yes Video/Yes One-on-One/No Text/Yes Incentive 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 | 12 |
| Yes Video/Yes One-on-One/Yes Text/No Incentive 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 | 12 |
| 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 | 12 |
| Total | 192 |
Baseline characteristics
| Characteristic | 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 | Total | 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 | No Video/No One-on-One/No Text/No Incentive | Yes Video/Yes One-on-One/Yes Text/No Incentive | Yes Video/Yes One-on-One/Yes Text/Yes Incentive |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 43.0 Years STANDARD_DEVIATION 8.6 | 41.8 Years STANDARD_DEVIATION 8.1 | 45.7 Years STANDARD_DEVIATION 8.9 | 43.1 Years STANDARD_DEVIATION 10.1 | 47.0 Years STANDARD_DEVIATION 13.5 | 43.8 Years STANDARD_DEVIATION 11 | 47.2 Years STANDARD_DEVIATION 10.4 | 42.4 Years STANDARD_DEVIATION 8.9 | 44.8 Years STANDARD_DEVIATION 10.4 | 49.4 Years STANDARD_DEVIATION 10.5 | 39.9 Years STANDARD_DEVIATION 9.7 | 45.8 Years STANDARD_DEVIATION 11.2 | 43.2 Years STANDARD_DEVIATION 9.5 | 43.9 Years STANDARD_DEVIATION 10.6 | 44.8 Years STANDARD_DEVIATION 11.7 | 48.0 Years STANDARD_DEVIATION 10.8 | 48.4 Years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 19 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 11 Participants | 12 Participants | 12 Participants | 11 Participants | 11 Participants | 11 Participants | 173 Participants | 10 Participants | 10 Participants | 11 Participants | 12 Participants | 11 Participants | 11 Participants | 10 Participants | 11 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 | 0 Participants | 0 Participants |
| Medication for Addiction Treatment Buprenorphine | 9 Participants | 7 Participants | 4 Participants | 7 Participants | 4 Participants | 6 Participants | 4 Participants | 5 Participants | 96 Participants | 7 Participants | 6 Participants | 6 Participants | 7 Participants | 6 Participants | 5 Participants | 6 Participants | 7 Participants |
| Medication for Addiction Treatment Methadone | 3 Participants | 5 Participants | 8 Participants | 5 Participants | 8 Participants | 6 Participants | 8 Participants | 7 Participants | 96 Participants | 5 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 7 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 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 | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 19 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 13 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 8 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 9 Participants | 9 Participants | 9 Participants | 10 Participants | 8 Participants | 10 Participants | 12 Participants | 146 Participants | 8 Participants | 9 Participants | 7 Participants | 9 Participants | 11 Participants | 10 Participants | 9 Participants | 9 Participants |
| Region of Enrollment United States Massachusetts | 10 Participants | 5 Participants | 5 Participants | 8 Participants | 3 Participants | 8 Participants | 8 Participants | 6 Participants | 110 Participants | 7 Participants | 6 Participants | 7 Participants | 7 Participants | 6 Participants | 9 Participants | 9 Participants | 6 Participants |
| Region of Enrollment United States Ohio | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States Rhode Island | 2 Participants | 6 Participants | 7 Participants | 4 Participants | 7 Participants | 4 Participants | 4 Participants | 5 Participants | 76 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 9 Participants | 11 Participants | 6 Participants | 6 Participants | 8 Participants | 10 Participants | 124 Participants | 6 Participants | 10 Participants | 8 Participants | 10 Participants | 5 Participants | 7 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 3 Participants | 1 Participants | 6 Participants | 6 Participants | 4 Participants | 2 Participants | 68 Participants | 6 Participants | 2 Participants | 4 Participants | 2 Participants | 7 Participants | 5 Participants | 5 Participants | 4 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 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 9 / 12 | 9 / 12 | 6 / 12 | 7 / 12 | 5 / 12 | 8 / 12 | 10 / 12 | 5 / 12 | 8 / 12 | 9 / 12 | 7 / 12 | 8 / 12 | 8 / 12 | 6 / 12 | 7 / 12 | 8 / 12 |
| serious Total, serious adverse events | 4 / 12 | 3 / 12 | 3 / 12 | 2 / 12 | 3 / 12 | 1 / 12 | 2 / 12 | 1 / 12 | 2 / 12 | 1 / 12 | 2 / 12 | 4 / 12 | 1 / 12 | 1 / 12 | 3 / 12 | 1 / 12 |
Outcome results
Primary
Yoga Dosage
Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Video/No One-on-One/No Text/No Incentive | Yoga Dosage | 164.5 Total yoga Minutes |
| No Video/No One-on-One/No Text/Yes Incentive | Yoga Dosage | 99.4 Total yoga Minutes |
| No Video/No One-on-One/Yes Text/No Incentive | Yoga Dosage | 139.1 Total yoga Minutes |
| No Video/No One-on-One/Yes Text/Yes Incentive | Yoga Dosage | 102.2 Total yoga Minutes |
| No Video/Yes One-on-One/No Text/No Incentive | Yoga Dosage | 116.6 Total yoga Minutes |
| No Video/Yes One-on-One/No Text/Yes Incentive | Yoga Dosage | 154.8 Total yoga Minutes |
| No Video/Yes One-on-One/Yes Text/No Incentive | Yoga Dosage | 84.5 Total yoga Minutes |
| No Video/Yes One-on-One/Yes Text/Yes Incentive | Yoga Dosage | 185.6 Total yoga Minutes |
| Yes Video/No One-on-One/No Text/No Incentive | Yoga Dosage | 89.7 Total yoga Minutes |
| Yes Video/No One-on-One/No Text/Yes Incentive | Yoga Dosage | 90.9 Total yoga Minutes |
| Yes Video/No One-on-One/Yes Text/No Incentive | Yoga Dosage | 111.4 Total yoga Minutes |
| Yes Video/No One-on-One/Yes Text/Yes Incentive | Yoga Dosage | 122.3 Total yoga Minutes |
| Yes Video/Yes One-on-One/No Text/No Incentive | Yoga Dosage | 145.8 Total yoga Minutes |
| Yes Video/Yes One-on-One/No Text/Yes Incentive | Yoga Dosage | 144.9 Total yoga Minutes |
| Yes Video/Yes One-on-One/Yes Text/No Incentive | Yoga Dosage | 167.0 Total yoga Minutes |
| Yes Video/Yes One-on-One/Yes Text/Yes Incentive | Yoga Dosage | 117.2 Total yoga Minutes |
Comparison: There were four potential intervention components. This study used a 2x2x2x2 factorial design. Thus, we analyzed main and interaction effects for the four potential intervention components.p-value: 0.02890% CI: [1.02, 1.18]zero-inflated negative-binomial (ZINB)
Comparison: There were four potential intervention components. This study used a 2x2x2x2 factorial design. Thus, we analyzed main and interaction effects for the four potential intervention components.p-value: 0.03990% CI: [1.02, 1.17]zero-inflated negative binomial
Comparison: There were four potential intervention components. This study used a 2x2x2x2 factorial design. Thus, we analyzed main and interaction effects for the four potential intervention components.p-value: 0.00190% CI: [0.8, 0.93]Zero-inflated negative binomial