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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain; Opioid Use Disorder; Opioid Misuse and Addiction
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Pain Self-Management

Detailed Description

This is randomized trial of a pain self-management (PSM) intervention for chronic pain tailored to individuals with opioid misuse or opioid use disorder (OUD) as compared to usual care. The investigators hypothesize that PSM will be effective in improving both reducing pain and improving MOUD engagement among individuals with co-occurring opioid misuse/OUD and chronic pain.

This is a multisite trial recruiting from primary care clinics located in Pennsylvania, West Virginia and Maryland.

Interventions: Participants will be randomized to either PSM or Usual Care.

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.

Usual Care (UC): Usual care or "treatment as usual" refers to the standard of care that patient participants receive at their primary care clinic. The standard of care for patients is to discuss issues related to chronic pain and opioid use with their providers and to receive clinical care for these conditions.

Study Duration: ~27 months (18 months of recruitment + 9 months follow-up) Participant Duration: 9 months

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Comprehensive Care Practice
  • Pennsylvania
    • Allison Park, Pennsylvania, United States, 15101
      • Renaissance Family Practice - Hampton Office
    • Blawnox, Pennsylvania, United States, 15238
      • Renaissance Family Practice - RIDC Office
    • Glenshaw, Pennsylvania, United States, 15223
      • Renaissance Family Practice - Glenshaw Office
    • Pittsburgh, Pennsylvania, United States, 15209
      • Renaissance Family Practice - Millvale Office
    • Pittsburgh, Pennsylvania, United States, 15213
      • Community Medicine, Inc.
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC General Internal Medicine-Montefiore
    • Pittsburgh, Pennsylvania, United States, 15215
      • Renaissance Family Practice - Aspinwall Office
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC General Internal Medicine-Shadyside (Shea Medical Center)
    • Pittsburgh, Pennsylvania, United States, 15238
      • Renaissance Family Practice - Harmarville Office
    • Turtle Creek, Pennsylvania, United States, 15145
      • UPMC General Internal Medicine-Turtle Creek
    • Verona, Pennsylvania, United States, 15147
      • Renaissance Family Practice - Penn Hills Office
    • West Mifflin, Pennsylvania, United States, 15122
      • UPMC General Internal Medicine-South
  • West Virginia
    • Buckhannon, West Virginia, United States, 26201
      • St. Joseph's Rural Health Clinic (WVU Medicine)
    • Harpers Ferry, West Virginia, United States, 25425
      • Harpers Ferry Family Medicine (WVU Medicine)
    • Morgantown, West Virginia, United States, 26501
      • WVU Medicine University Town Centre
    • Shepherdstown, West Virginia, United States, 25419
      • WVU Medicine Primary Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

1. Adults at least 18 years old
2. Ability to speak, read, and understand English
3. Capable of providing informed consent
4. Access to phone and/or internet
5. 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

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

   1. OUD Misuse Screening score of 3 or more (sometimes or more) on at least one of the questions
   2. Meets criteria for DSM-5 Opioid Use Disorder on MINI-J
   3. Documented diagnosis of Opioid use Disorder (OUD)
7. Have bothersome (Grade 2) or high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Under 18 years of age
2. Have cancer-related pain
3. 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
4. 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
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Usual care refers to the standard of care that patients receive at their primary care clinic.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline	The Pain, Enjoyment, and General Activity (PEG) Scale is a validated, self-report 3-item tool assessing pain intensity and interference over the past week. The PEG scale consists of 3 separate numerical scales. Each scale has ratings ranging from 0-10. The PEG score is calculated by averaging the three numbers; a higher score indicates greater pain. Change = 3 month score - baseline score	Baseline, 3 Months
Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline	The Pain Catastrophizing Scale is a validated, self-report 6-item tool assessing assess pain catastrophizing for chronic pain. The PCS-6 uses a 5-point scale, ranging from 0 (not at all) to 4 (all the time). The total score ranges from 0 to 24, with higher score representing greater catastrophic thinking. Change = 3 month score - baseline score	Baseline, 3 Months
Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline	The modified ASI is a validated, self-report tool which includes questions from the Addiction Severity Index section on drug and alcohol use and includes questions about specific opioids used. The number of days in the last 30 that a participant reports using heroin, fentanyl, and/or opioid analgesics (percocet, oxycodone, oxycontin, vicodin, dilaudid, hydrocodone, hydromorphone, morphine, or codeine) will be summed for the outcome "Number of days non-prescribed opioids were used in the past 30 days." Number of days may range from 0 to 90.	3 Months
Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline	The IMPOWR Opioid Misuse Screening scale is an exploratory, self-report scale consisting of 4 questions about the use of prescribed pain medications. Each question response ranges from Never (0) to Almost Always (4) with a possible summed score ranging from 0 to 16, with higher scores indicating more severe misuse.	3 Months
Proportion of Participants that Engage in MOUD Treatment at 3 months Post-baseline	Proportion of individuals who self-reported having filled a prescription for or were administered or dispensed any MOUD (methadone, buprenorphine, naltrexone)	Baseline, 3 Months
Number of Days Participants took MOUD at 6-months Post-baseline	MOUD: methadone, buprenorphine, naltrexone. Measured by self-report and medical chart extraction.	6 Months
Change from Baseline in Self-Efficacy at 3 months Post-baseline	Change in self-efficacy for managing symptoms as measured by the Pain Self-Efficacy Questionnaire (PSEQ). The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. The PSEQ is applicable to all persisting pain presentation. It enquires into the level of self-efficacy regarding a range of functions, including household chores, socializing, work, as well as coping with pain without medication. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain. High scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients. Change = 3 month score - baseline score	Baseline, 3 Months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Erin Winstanley, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: opioid; pain; primary care; behavioral health
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Opioid-Related Disorders; Chronic Pain; Behavior, Addictive
• Other Study ID Numbers: STUDY24080167; RM1DA055311 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No