Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05492825
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2022-06-30
Brief Title:
IMPOWR-ME Project 1 Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
Randomized Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs for Patients With Chronic Back Pain and Opioid Use Disorder
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pragmatic open label randomized controlled trial with 111 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 345 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
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 teams 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 eg 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 111 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 115115115 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 teams 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 eg 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 111 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 115115115 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RM1DA055437 | NIH | None | httpsreporternihgovquickSearchRM1DA055437 |