Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Pain Self-Management Intervention to Reduce Pain & Improve MOUD Engagement in Primary Care: A Randomized Trial
University of Pittsburgh
204 participants
Nov 25, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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)
Exclusion Criteria7
- 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.
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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.
Locations(16)
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NCT06855732