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RECRUITING
NCT05155163
NA

Stepped Care for Patients to Optimize Whole Recovery

Sponsor: Yale University

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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