Pain Self-Management and Treatment Engagement for Patients Taking Opioids
TREETOP
Pain Self-Management Intervention to Reduce Pain & Improve MOUD Engagement in Primary Care: A Randomized Trial
2 other identifiers
interventional
204
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Nov 2024
Typical duration for not_applicable chronic-pain
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2024
CompletedFirst Submitted
Initial submission to the registry
February 26, 2025
CompletedFirst Posted
Study publicly available on registry
March 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 11, 2026
May 1, 2026
1.7 years
February 26, 2025
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline
The PROMIS Pain Interference - Short Form 4a is a validated, self-report 4-item tool assessing pain interference over the past 7 days. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (not at all) to 5 (very much). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. That is, a person has more problems with pain hindering activities. By comparison, a pain interference T-score of 40 is one SD better than average. Change = 3 month score - baseline score
Baseline, 3 Months
Secondary Outcomes (7)
Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline
Baseline, 3 Months
Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline
Baseline, 3 Months
Proportion of Participants that Engage in MOUD Treatment at 3 months Post-baseline
Baseline, 3 Months
Number of Days Participants took MOUD at 6-months Post-baseline
6 Months
Change from Baseline in Self-Efficacy at 3 months Post-baseline
Baseline, 3 Months
- +2 more secondary outcomes
Study Arms (2)
Usual Care
ACTIVE COMPARATORUsual care refers to the standard of care that patients receive at their primary care clinic.
Pain Self-Management (PSM)
EXPERIMENTALPSM 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Under 18 years of age
- Have cancer-related pain
- Are currently in jail, prison, overnight/residential facility as required by court of law or have pending legal action that could prevent participation in study activities
- Have received prescribed, administered, or dispensed MOUD (buprenorphine, methadone, naltrexone) as maintenance treatment for OUD (excluding acute or short-term (\< 7 days) use of these medications to manage opioid withdrawal or pain management) within the past 90 days
- Had an intentional suicide attempt within the past 3 months
- The investigators will not exclude individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (17)
Comprehensive Care Practice
Baltimore, Maryland, 21224, United States
Renaissance Family Practice - Hampton Office
Allison Park, Pennsylvania, 15101, United States
Renaissance Family Practice - RIDC Office
Blawnox, Pennsylvania, 15238, United States
Renaissance Family Practice - Glenshaw Office
Glenshaw, Pennsylvania, 15223, United States
Renaissance Family Practice - Millvale Office
Pittsburgh, Pennsylvania, 15209, United States
Community Medicine, Inc.
Pittsburgh, Pennsylvania, 15213, United States
UPMC General Internal Medicine-Montefiore
Pittsburgh, Pennsylvania, 15213, United States
Renaissance Family Practice - Aspinwall Office
Pittsburgh, Pennsylvania, 15215, United States
UPMC General Internal Medicine-Shadyside (Shea Medical Center)
Pittsburgh, Pennsylvania, 15232, United States
Renaissance Family Practice - Harmarville Office
Pittsburgh, Pennsylvania, 15238, United States
UPMC General Internal Medicine-Turtle Creek
Turtle Creek, Pennsylvania, 15145, United States
Renaissance Family Practice - Penn Hills Office
Verona, Pennsylvania, 15147, United States
UPMC General Internal Medicine-South
West Mifflin, Pennsylvania, 15122, United States
St. Joseph's Rural Health Clinic (WVU Medicine)
Buckhannon, West Virginia, 26201, United States
Harpers Ferry Family Medicine (WVU Medicine)
Harpers Ferry, West Virginia, 25425, United States
WVU Medicine University Town Centre
Morgantown, West Virginia, 26501, United States
WVU Medicine Primary Care
Shepherdstown, West Virginia, 25419, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Winstanley, PhD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 26, 2025
First Posted
March 4, 2025
Study Start
November 25, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 11, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- De-identified data will be made available within 18 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Access to trial IPD may be made available to individuals that submit a request along with the required documents to the IMPOWR data committee. Data access requires approval by the IMPOWR data committee and the individual must agree to comply with the data sharing policies of IMPOWR and HEAL.
This study will comply with the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy) and data for this study will be available to the public through the IMPOWR Dissemination Education and Coordination Center (IDEA-CC) (https://heal.nih.gov/research/clinical-research/integrative-management-chronic-pain).