Brief Summary
This is a pragmatic, open label, randomized controlled trial with 1:1:1 allocation to 12 weeks of: (1) onsite yoga at opioid treatment programs (OTPs), (2) onsite physical therapy (PT) at OTPs, or (3) treatment as usual (TAU). Participants will be 180 individuals with chronic back pain receiving treatment for opioid use disorder (OUD) in community-based OTPs. Through research visits at screening, baseline, and months 1, 2, 3, 6, and 9, the investigators will evaluate pain and opioid use outcomes and implementation outcomes.
Brief Title
IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
Detailed Description
This clinical trial will test yoga and physical therapy (PT) for individuals with concurrent opioid use disorder (OUD) and chronic pain (CP), onsite at community-based opioid treatment programs (OTPs). The investigators will focus on those who suffer from back pain, as it is the leading cause of CP among patients with OUD and will recruit individuals who are enrolled in treatment at OTPs in our health system in the Bronx, NY. Lack of integrated treatments addressing both OUD and CP has resulted in failed efforts to control the overdose epidemic. This project addresses this need by proposing to test on-site yoga and PT at OTPs.
The research team's proposed model is that CP from back pain among individuals with OUD leads to decreased physical function, decreased mood and anxiety symptoms, and increased opioid craving. To break this vicious cycle, the investigators propose to target both physical function (via PT or yoga) and mindfulness (via yoga).
Targeting physical function: Both yoga and PT are movement therapies which increase strength and flexibility, improving physical function and pain. Some movement therapies (e.g., exercise) have decreased substance use in individuals with alcohol and tobacco use disorders, but this is understudied in OUD.
Targeting mindfulness: As a mind-body approach, yoga advances overall well-being through practices of mindful breathing and mindfulness meditation. Improving mindfulness may reduce mood and anxiety symptoms, pain catastrophizing, pain intensity and interference, opioid craving and opioid use.
The investigators will test the overall hypothesis that yoga and PT provided onsite at OTPs will improve pain, opioid use, and quality of life among people with OUD and chronic back pain and will be cost effective. The investigators will conduct a hybrid type 1 effectiveness-implementation study, using a pragmatic, open label, three-arm (1:1:1) randomized controlled trial of: a) onsite yoga at OTPs, b) onsite PT at OTPs, and c) treatment as usual (TAU). The investigators will enroll 345 participants (115/115/115) with chronic, moderate or severe back pain in a 12-week intervention. Comprehensive assessments will be done at study enrollment and at months 1, 2, 3, 6, and 9. The investigators will assess pain intensity (primary outcome), pain interference, opioid use and craving, and quality of life.
Aim 1. To test the effectiveness of onsite yoga at OTPs in patients with OUD and CP at 6 months follow-up. H1a: Compared to TAU, on-site yoga will result in decreased pain intensity (primary pain outcome), pain interference, and illicit opioid use in the past 30 days (primary OUD outcome), and increased quality of life. H1b: Therapeutic improvement in H1a will be mediated by physical function and mindfulness.
Aim 2. To test the effectiveness of onsite PT at OTPs in patients with OUD and CP at 6 months follow-up. H2a: Compared to TAU, onsite PT will result in decreased pain intensity (primary pain outcome), pain interference, and illicit opioid use in the past 30 days (primary OUD outcome), and increased quality of life. H2b: Therapeutic improvement in H2a will be mediated by physical function.
Aim 3. To inform future implementation and dissemination efforts: 3a) Examine factors influencing Reach, Adoption, Implementation, and Maintenance (RE-AIM outcomes) of onsite yoga and PT at OTPs. The investigators will use qualitative and quantitative methods to describe multi-level factors influencing these domains, including qualitative interviews with 30 participants and 10 OTP stakeholders.
Exploratory Aim. The investigators will also explore the effectiveness of yoga compared to PT on outcomes and will examine complex patterns of predictors of pain and OUD outcomes with respect to each intervention, including alcohol and cannabis use, mood and anxiety symptoms, comorbidities, and social determinants of health.
The research team's proposed model is that CP from back pain among individuals with OUD leads to decreased physical function, decreased mood and anxiety symptoms, and increased opioid craving. To break this vicious cycle, the investigators propose to target both physical function (via PT or yoga) and mindfulness (via yoga).
Targeting physical function: Both yoga and PT are movement therapies which increase strength and flexibility, improving physical function and pain. Some movement therapies (e.g., exercise) have decreased substance use in individuals with alcohol and tobacco use disorders, but this is understudied in OUD.
Targeting mindfulness: As a mind-body approach, yoga advances overall well-being through practices of mindful breathing and mindfulness meditation. Improving mindfulness may reduce mood and anxiety symptoms, pain catastrophizing, pain intensity and interference, opioid craving and opioid use.
The investigators will test the overall hypothesis that yoga and PT provided onsite at OTPs will improve pain, opioid use, and quality of life among people with OUD and chronic back pain and will be cost effective. The investigators will conduct a hybrid type 1 effectiveness-implementation study, using a pragmatic, open label, three-arm (1:1:1) randomized controlled trial of: a) onsite yoga at OTPs, b) onsite PT at OTPs, and c) treatment as usual (TAU). The investigators will enroll 345 participants (115/115/115) with chronic, moderate or severe back pain in a 12-week intervention. Comprehensive assessments will be done at study enrollment and at months 1, 2, 3, 6, and 9. The investigators will assess pain intensity (primary outcome), pain interference, opioid use and craving, and quality of life.
Aim 1. To test the effectiveness of onsite yoga at OTPs in patients with OUD and CP at 6 months follow-up. H1a: Compared to TAU, on-site yoga will result in decreased pain intensity (primary pain outcome), pain interference, and illicit opioid use in the past 30 days (primary OUD outcome), and increased quality of life. H1b: Therapeutic improvement in H1a will be mediated by physical function and mindfulness.
Aim 2. To test the effectiveness of onsite PT at OTPs in patients with OUD and CP at 6 months follow-up. H2a: Compared to TAU, onsite PT will result in decreased pain intensity (primary pain outcome), pain interference, and illicit opioid use in the past 30 days (primary OUD outcome), and increased quality of life. H2b: Therapeutic improvement in H2a will be mediated by physical function.
Aim 3. To inform future implementation and dissemination efforts: 3a) Examine factors influencing Reach, Adoption, Implementation, and Maintenance (RE-AIM outcomes) of onsite yoga and PT at OTPs. The investigators will use qualitative and quantitative methods to describe multi-level factors influencing these domains, including qualitative interviews with 30 participants and 10 OTP stakeholders.
Exploratory Aim. The investigators will also explore the effectiveness of yoga compared to PT on outcomes and will examine complex patterns of predictors of pain and OUD outcomes with respect to each intervention, including alcohol and cannabis use, mood and anxiety symptoms, comorbidities, and social determinants of health.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-920-5379
Central Contact Email
SNAHVI@montefiore.org
Central Contact Role
Contact
Central Contact Phone
608-335-3481
Central Contact Email
mary.hribar@einsteinmed.edu
Completion Date
Completion Date Type
Estimated
Conditions
Substance Use Disorders
Chronic Pain
Opioid Use Disorder
Back Pain Lower Back Chronic
Eligibility Criteria
Inclusion Criteria:
1. age ≥18 years old
2. English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
3. receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days
4. Chronic low or mid back pain, with at least moderate pain severity (score of ≥4 on the Pain, Enjoyment of Life and General Activity (PEG) Scale)
5. Willingness to participate in all study components
6. ability to provide informed consent, assessed using consent teach-back
Exclusion Criteria:
1. severe disabling conditions that could make participation in yoga or PT hazardous (e.g., spinal canal stenosis; severe scoliosis; vertebral fracture, history of spine surgery, or joint surgery in the past six months; severe or progressive neurological deficits, or cardiovascular or neurological disease requiring hospitalization in the past six months; unable to stand for at least 60 seconds; regular use of a wheelchair or motorized scooter, or regular use of a walker and inability to walk at least 4 steps without it; 3 or more falls in the prior year with at least one being non-mechanical;; or other severe disabling conditions deemed by the study clinician or MPI to preclude safe or adequate participation in the study)
2. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis)
3. cancer pain related to malignancy
4. yoga practice or PT in the prior 60 days
1. age ≥18 years old
2. English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
3. receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days
4. Chronic low or mid back pain, with at least moderate pain severity (score of ≥4 on the Pain, Enjoyment of Life and General Activity (PEG) Scale)
5. Willingness to participate in all study components
6. ability to provide informed consent, assessed using consent teach-back
Exclusion Criteria:
1. severe disabling conditions that could make participation in yoga or PT hazardous (e.g., spinal canal stenosis; severe scoliosis; vertebral fracture, history of spine surgery, or joint surgery in the past six months; severe or progressive neurological deficits, or cardiovascular or neurological disease requiring hospitalization in the past six months; unable to stand for at least 60 seconds; regular use of a wheelchair or motorized scooter, or regular use of a walker and inability to walk at least 4 steps without it; 3 or more falls in the prior year with at least one being non-mechanical;; or other severe disabling conditions deemed by the study clinician or MPI to preclude safe or adequate participation in the study)
2. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis)
3. cancer pain related to malignancy
4. yoga practice or PT in the prior 60 days
Inclusion Criteria
Inclusion Criteria:
1. age ≥18 years old
2. English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
3. receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days
4. Chronic low or mid back pain, with at least moderate pain severity (score of ≥4 on the Pain, Enjoyment of Life and General Activity (PEG) Scale)
5. Willingness to participate in all study components
6. ability to provide informed consent, assessed using consent teach-back
1. age ≥18 years old
2. English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
3. receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days
4. Chronic low or mid back pain, with at least moderate pain severity (score of ≥4 on the Pain, Enjoyment of Life and General Activity (PEG) Scale)
5. Willingness to participate in all study components
6. ability to provide informed consent, assessed using consent teach-back
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05492825
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2021-13320
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Randomized Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs for Patients With Chronic Back Pain and Opioid Use Disorder
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change in Pain Intensity
Outcome Time Frame
From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Description
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.
Outcome Measure
Illicit opioid use
Outcome Time Frame
Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Secondary Ids
Secondary Id
RM1DA055437
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Measure
Change in Pain Interference - Brief Pain Inventory (BPI)
Outcome Description
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.
Outcome Time Frame
Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Measure
Heroin Use
Outcome Description
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.
Outcome Time Frame
Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Measure
Fentanyl Use
Outcome Description
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.
Outcome Time Frame
Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Measure
Unprescribed Prescription Opioid Analgesic Use
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months
Outcome Measure
Health-related quality of life (HRQoL)
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months
Outcome Measure
Pain Catastrophizing
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months
Outcome Measure
Opioid Craving
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Outcome Measure
Physical Activity - International Physical Activity Questionnaire Short Form (IPAQ-SF)
Outcome Description
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.
Outcome Time Frame
1 month, 2 months, 3 months, and 9 months
Outcome Measure
Global Impression of Change
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Outcome Measure
Depressive Symptoms
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Outcome Measure
Anxiety Symptoms
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Measure
Positive urine test for non-prescribed opioids
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Measure
Physical Function Assessments - Fingertip-to-floor test
Outcome Description
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.
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Measure
Physical Function Tests - Short Physical Performance Battery (SPPB)
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 3 months, 6 months, and 9 months
Outcome Measure
Physical Function, self-reported
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Outcome Measure
Back Pain-related Disability
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Outcome Measure
Fear Avoidance
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Measure
Mindfulness
Outcome Description
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.
Outcome Time Frame
3 months
Outcome Measure
Intervention Session Attendance
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
Outcome Measure
Retention in Medications for Opioid Use Disorder (MOUD)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joanna Starrels
Investigator Email
joanna.starrels@einsteinmed.edu
Investigator Department
Medicine
Investigator Division
General Internal Medicine
Investigator Sponsor Organization
Einstein
Study Department
Medicine
Study Division
General Internal Medicine
Categories Mesh Debug
Substance Use and Addiction --- SUBSTANCE-RELATED DISORDERS
Substance Use and Addiction --- CHRONIC PAIN
Substance Use and Addiction --- OPIOID-RELATED DISORDERS
Substance Use and Addiction --- CHEMICALLY-INDUCED DISORDERS
Child Development & Autism --- MENTAL DISORDERS
Mental Health & Behavioral Research --- MENTAL DISORDERS
Psychiatry & Behavioral Sciences --- MENTAL DISORDERS
Substance Use and Addiction --- MENTAL DISORDERS
Brain, Spinal Cord & Nervous System --- PAIN
Headaches & Migraine --- PAIN
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NARCOTIC-RELATED DISORDERS
MeSH Terms
SUBSTANCE-RELATED DISORDERS
CHRONIC PAIN
OPIOID-RELATED DISORDERS
CHEMICALLY-INDUCED DISORDERS
MENTAL DISORDERS
PAIN
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
NARCOTIC-RELATED DISORDERS
YOGA
PHYSICAL THERAPY MODALITIES
THERAPEUTICS
MIND-BODY THERAPIES
COMPLEMENTARY THERAPIES
SPIRITUAL THERAPIES
EXERCISE MOVEMENT TECHNIQUES
REHABILITATION