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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Adults at least 18 years old

• Ability to speak, read, and understand English

• Capable of providing informed consent

• Access to phone and/or internet

• Current (defined as at least 1 primary care visit in the past 3 years) or new (confirmed appointment) primary care patient at a participating clinic

• Must meet criteria for OUD or opioid misuse based on at least one of the following:

‣ OUD Misuse Screening score of 3 or more (sometimes or more) on at least one of the questions

⁃ Meets criteria for DSM-5 Opioid Use Disorder on MINI-J

⁃ Documented diagnosis of Opioid use Disorder (OUD)

• Have bothersome (Grade 2) or high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)

Locations
United States
Pennsylvania
Renaissance Family Practice - Hampton Office
RECRUITING
Allison Park
Renaissance Family Practice - RIDC Office
RECRUITING
Blawnox
Renaissance Family Practice - Glenshaw Office
RECRUITING
Glenshaw
Community Medicine, Inc.
RECRUITING
Pittsburgh
Renaissance Family Practice - Aspinwall Office
RECRUITING
Pittsburgh
Renaissance Family Practice - Harmarville Office
RECRUITING
Pittsburgh
Renaissance Family Practice - Millvale Office
RECRUITING
Pittsburgh
UPMC General Internal Medicine-Montefiore
RECRUITING
Pittsburgh
UPMC General Internal Medicine-Shadyside (Shea Medical Center)
RECRUITING
Pittsburgh
UPMC General Internal Medicine-Turtle Creek
RECRUITING
Turtle Creek
Renaissance Family Practice - Penn Hills Office
RECRUITING
Verona
UPMC General Internal Medicine-South
RECRUITING
West Mifflin
West Virginia
St. Joseph's Rural Health Clinic (WVU Medicine)
NOT_YET_RECRUITING
Buckhannon
Harpers Ferry Family Medicine (WVU Medicine)
NOT_YET_RECRUITING
Harpers Ferry
WVU Medicine University Town Centre
NOT_YET_RECRUITING
Morgantown
WVU Medicine Primary Care
NOT_YET_RECRUITING
Shepherdstown
Contact Information
Primary
Melessa Salay, MPH
TREETOP@pitt.edu
412-648-7896
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 204
Treatments
Active_comparator: Usual Care
Usual care refers to the standard of care that patients receive at their primary care clinic.
Experimental: Pain Self-Management (PSM)
PSM is a manualized pain self-management behavioral intervention tailored to patients with chronic pain and opioid misuse/OUD. PSM consists of 10 intervention sessions delivered via phone or web-based communication platform. Sessions will be led by a staff interventionist.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: University of Pittsburgh

This content was sourced from clinicaltrials.gov