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RECRUITING
NCT06855732
NA

Pain Self-Management and Treatment Engagement for Patients Taking Opioids

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

Summary

The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder (OUD) The main questions it aims to answer are: * Does PSM help participants manage their chronic pain more effectively? * Does PSM help participants engage in treatment for opioid use? Researchers will compare PSM to standard care to see if PSM is effective in managing chronic pain and engagement in treatment. Participants will: * Take part in the PSM program or receive standard care for 12 weeks after enrolling in the study * Complete surveys every 3 months for 9 months (total of 4 visits) Participants will receive compensation for participating in the study. There are risks associated with participating in the study, including breach of confidentiality and psychological distress caused by discussing difficult topics.

Official title: Pain Self-Management Intervention to Reduce Pain & Improve MOUD Engagement in Primary Care: A Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2024-11-25

Completion Date

2026-12-31

Last Updated

2025-10-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Usual Care

Usual care refers to the standard of care that patients receive at their primary care clinic. The standard of care for patients is to discuss chronic pain with their providers at their discretion, and for providers to offer buprenorphine for OUD and/or provide referrals to specialty addiction treatment programs in the local community. Participants will continue to have access to usual care for chronic pain, which could include pain clinic visits, physical therapy, medication (e.g., gabapentin), and/or seeing a counselor, psychiatrist, or psychologist. The study protocol will not interfere with usual clinical care.

BEHAVIORAL

Pain Self-Management

PSM is a manualized behavioral intervention tailored to patients in primary care with opioid misuse/OUD. The PSM intervention that consists of ten sessions/modules. Participants will be offered a total of 10 PSM sessions, delivered weekly over a 12-week intervention period starting from the date of study enrollment. A trained staff interventionist will lead the 60-minute sessions using a participant study manual that outlines the content for all 10 sessions. The first two sessions, "Introduction" and "Navigating Conversations About Opioids", are mandatory. Participants can choose the order of the remaining 8 sessions, prioritizing those they are most interested in. Additional session topics are: Stress Management and Your Pain, Relaxation Techniques to Help Your Pain, Thinking Differently About Your Pain, Sleeping Better to Help Your Pain, Physical Activity and Your Pain, Mood and Your Pain, and Communicating with Others.

Locations (16)

Renaissance Family Practice - Hampton Office

Allison Park, Pennsylvania, United States

Renaissance Family Practice - RIDC Office

Blawnox, Pennsylvania, United States

Renaissance Family Practice - Glenshaw Office

Glenshaw, Pennsylvania, United States

Renaissance Family Practice - Millvale Office

Pittsburgh, Pennsylvania, United States

Community Medicine, Inc.

Pittsburgh, Pennsylvania, United States

UPMC General Internal Medicine-Montefiore

Pittsburgh, Pennsylvania, United States

Renaissance Family Practice - Aspinwall Office

Pittsburgh, Pennsylvania, United States

UPMC General Internal Medicine-Shadyside (Shea Medical Center)

Pittsburgh, Pennsylvania, United States

Renaissance Family Practice - Harmarville Office

Pittsburgh, Pennsylvania, United States

UPMC General Internal Medicine-Turtle Creek

Turtle Creek, Pennsylvania, United States

Renaissance Family Practice - Penn Hills Office

Verona, Pennsylvania, United States

UPMC General Internal Medicine-South

West Mifflin, Pennsylvania, United States

St. Joseph's Rural Health Clinic (WVU Medicine)

Buckhannon, West Virginia, United States

Harpers Ferry Family Medicine (WVU Medicine)

Harpers Ferry, West Virginia, United States

WVU Medicine University Town Centre

Morgantown, West Virginia, United States

WVU Medicine Primary Care

Shepherdstown, West Virginia, United States