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Stepped Care for Patients to Optimize Whole Recovery
Sponsor: Yale University
Summary
This is a prospective, randomized clinical trial of 204 patients with opioid use disorder (OUD) and chronic pain (CP) to test the effectiveness of treatment as usual compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce pain interference (Aim 1) and decrease illicit opioid use, alcohol use, anxiety, depression, and stress, and improve sleep (Aim 2). Eligible participants will begin medications for opioid use disorder (MOUD) and will be randomized to receive SC-POWR (i.e., cognitive behavioral therapy (CBT), MOUD, and onsite groups for exercise \[Wii Fit, Tai Chi\] and stress reduction \[relaxation training, auricular acupuncture\] for 24 weeks. Participants will be followed for another 24 weeks to evaluate durability of treatment response on pain interference illicit opioid use, alcohol use, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2023-06-28
Completion Date
2026-08-31
Last Updated
2025-09-16
Healthy Volunteers
No
Conditions
Interventions
SC-POWR
Patients assigned to SC-POWR receive 12 Cognitive Behavioral Therapy (CBT) sessions over 24 weeks.
Locations (2)
APT Foundation
New Haven, Connecticut, United States
APT Foundation
North Haven, Connecticut, United States