IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs

Change in Pain Intensity on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain intensity subscale. The BPI pain intensity subscale consists of 4 items which asks patients to rate their worst pain, least pain, average pain, and current pain using a 0-10 numeric rating scale (NRS), where 0 represents "No pain" and 10 represents "Pain as bad as you can imagine" such that higher scores are associated with greater pain intensity. Scores from the four items are averaged to obtain a mean score. Results will be summarized by study arm using basic descriptive statistics.

Illicit opioid use will be a composite outcome defined by self-reported opioid use days over the past 30 days using items from a modified Addiction Severity Index questionnaire. It is defined by the maximum number of days of use of: a) heroin, b) fentanyl [unprescribed], and c) prescription opioids [unprescribed]. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.

Change in Pain interference on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain interference subscale. The BPI pain interference subscale consists of 7 items which asks patients to rate how much pain has interfered with mood, walking ability, work, relations with others, sleep, enjoyment of life, and general activity using a 0-10 numeric rating scale (NRS), where 0 represents "Does not interfere" and 10 represents "Completely interferes" such that higher scores are associated with greater pain interference. Scores from the seven items are averaged to obtain a mean score. Results will be summarized by study arm using basic descriptive statistics.

Heroin use will be defined by self-reported heroin use days over the past 30 days using an item from a modified Addiction Severity Index questionnaire. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.

Fentanyl use will be defined by self-reported, unprescribed, fentanyl use days over the past 30 days using an item from a modified Addiction Severity Index questionnaire. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.

Unprescribed prescription opioid analgesic use will be defined by self-reported number of days of prescription opioid analgesic use that is not prescribed, over the past 30 days, using items from a modified Addiction Severity Index questionnaire. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.

HRQoL will be assessed using a utility score from the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) scoring system. PROPr summarizes several PROMIS domains into a single, preference-based score. PROPr is a health utility score which aggregates scores from 7 PROMIS domains: Cognitive Function/Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. PROPr scores are calculated using a multiplicative multiattribute utility function that combines the individual PROMIS domain scores into a single score. The PROPr score is expressed as a health utility index value on a scale between 0 (the utility of being dead) and 1 (utility of full health) such that higher scores are indicative of better perceived overall health utility. Scores will be summarized by study arm using basic descriptive statistics.

Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS) short form. The PCS short form is a 6-item scale which examines the subscales of rumination, magnification, and helplessness related to pain. The six items on the PCS short form are rated on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("All the time") yielding an overall possible score of 0-24 such that higher scores are indicative of a greater degree of pain catastrophizing. Scores will be summarized by study arm using basic descriptive statistics.

Opioid craving will be assessed using the Opioid Medication Craving Scale. The Opioid Medication Craving Scale is a 3-item form in which participants are asked to provide responses on a 100 point scale as to how strong their desire to use opioids was over the past 24 hours; the likelihood they would use opioids if placed in the same environment of previous use; and how strong urges are for opioids when something in the environment reminds them of it. The 1st and 3rd items are rated on a scale from 0 ("No Desire") to 100 ("Strong Desire"). The 2nd item is rated on a scale from 0 ("No likelihood of use") to 100 ("Strong likelihood of use"). An overall score is obtained by averaging the three ratings with higher scores being associated with more intense cravings. Results will be summarized by study arm using basic descriptive statistics.

Physical Activity will be assessed using the IPAQ-SF. The IPAQ consists of four items which query as to the number of days in which four types of activities were performed over the past 7 days: vigorous activity, moderate activity, walking, and sedentary activity. Participants respond as to the number of days per week spent on each type or category of physical activity described. The number of days of physical activity will be categorically summarized by study arm using basic descriptive statistics.

Global Impression of change from the beginning of the study will be evaluated using the Patient Global Impression of Change (PGIC) assessment. The PGIC consists of a single item which asks the participant "Since the start of the study (treatment), my overall pain is..." and asks the participant to rate the pain on a 7-point Likert scale ranging from 0 ("Very much improved") to 6 ("Very much worse"), such that lower scores are associated with an overall impression of improvement since the start of the study. Results will be summarized by study arm using basic descriptive statistics.

Depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ assessment is a self-report scale which consists of 9 items that measure the frequency of mood-related symptoms experienced over the prior 2-week period. The 9 combined items are scored on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), yielding an overall possible scoring range of 0-27, wherein higher scores are indicative of a greater frequency of mood-related symptoms. Results will be summarized by study arm using basic descriptive statistics.

Anxiety symptoms will be assessed using derivatives of the Generalized Anxiety Disorder-7 (GAD-7). The GAD assessment is a self-report scale which consists of 7 items that measure the frequency of anxiety-related symptoms experienced over the prior 2-week period. The 7 combined items are scored on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), yielding an overall possible scoring range of 0-21, wherein higher scores are associated with a greater frequency of anxiety-related symptoms. Results will be summarized by study arm using basic descriptive statistics.

Positive urine test for non-prescribed opioids will be assessed using point of care urine drug testing. It is a dichotomous variable (yes/no) wherein yes is indicative of a positive test for oxycodone, fentanyl, or other opiates that were not indicated by participant as prescribed. Results will be summarized by study arm.

The fingertip-to-floor test measures the ability of the participant to bend to the floor from a standing position. The participant is asked to remove shoes and, without bending the knees, to bend forward at the waist and reach towards the floor with fingertips, keeping arms and knees extended. The distance in centimeters (cm) from the tip of the middle finger to the floor is measured. This can be repeated up to 3 times per participant and the best trial will be used/recorded. Shorter distances from the floor are indicative of greater flexibility. Results will be summarized by study arm using basic descriptive statistics.

SPPB measures lower extremity function and mobility in 3 areas: Balance (side-by-side stand, semi-tandem stand, and tandem stand); Gait speed (3 meter walk test); and Strength (5 chair stands).

Balance (side-by-side and semi-tandem stand): 1 point (pt) for each test they can hold for >=10 seconds (s), and 0 pts for <10s Balance (tandem stand): 2 pts for holding for >=10s, 1 pt for holding from 3-9.99s, and 0 pts for holding <3s

Gait speed (time): 4 pts for < 3.62s, 3 pts for 3.62-4.65s, 2 pts for 4.66-6.52s, 1 pt for > 6.52s

Strength: 4 pts for completing 5 chair stands in <=11.19s, 3 pts for 11.20-13.69s, 2 pts for 13.70-16.69s, and 1 pt for >=16.70s. 0 pts given if a participant is unable to complete 5 chair stands in <60s or could not/would not attempt task

Scores from the 3 areas are summed for an overall range of 1-12 with higher scores indicating better lower extremity function/mobility. Results will be summarized by study arm using basic descriptive statistics.

General physical function will be measured using the PROMIS Physical Functioning Scale. This assessment consists of 6 items rated on a 5-point Likert scale ranging from 1 = "Unable to do the task" to 5 = "Able to do the task without difficulty or limitations" yielding an overall possible scoring range of 6-30, wherein higher scores are associated with better, self-reported, physical functioning. Results will be summarized by study arm using basic descriptive statistics.

Back pain-related disability will be measured with the Oswestry Low Back Pain Disability Questionnaire, a self-report scale which consists of 10 items that measure low back pain intensity and functional impact. Responses are scored on a 6-point Likert scale where 0 represents no functional limitation and 5 represents the most severe functional limitation, yielding an overall possible scoring range of 0-50. Results will be converted to a percentage of points score (=Score/50*100) and summarized by study arm.

The Fear Avoidance Beliefs Questionnaire-Physical Activity component (FABQ-PA) is a four-item questionnaire that assesses how participants believe and expect different physical activities would impact pain. Items are rated on a 7-point Likert scale ranging from 0 to 6, where 0 = "Completely disagree" to 6 = "Completely agree." Scores for the 4 items will be summed, to yield an overall possible score of 0 to 24. Higher scores are indicative of a greater fear-avoidance belief about physical activity. Scores will be summarized by study arm using basic descriptive statistics.

Mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS). The MAAS is a 15-item scale which measures mindful awareness using a 6-point Likert scale ranging from 1 = "Almost always" to 6 = "Almost never." The summary score is the mean of the 15 items, yielding an overall possible score ranging from 1-6, with higher scores indicating greater mindful awareness. Results will be summarized by summarized by study arm using basic descriptive statistics.

For participants randomized to one of the intervention arms (yoga or PT), the number of intervention sessions attended, ranging from 0 to 12, will be determined. Mean attendance will be summarized by arm.

Retention in MOUD is defined by whether the participant was still enrolled in care at the OTP AND received methadone or buprenorphine (yes/no). This will be assessed by electronic medical record review. Results will be summarized by study arm using basic descriptive statistics.