Integrated Services for Pain: Interventions to Reduce Pain Effectively
CompletedNot applicableNCT03454555
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States. Clinicians often prescribe opioids which can help ease pain in the short term, but evidence does not support their effectiveness over the long term. For some people, long-term opioid use can lead to addiction and overdose. People need effective options and support to help maintain or improve their function and quality of life. This study compared two programs for helping people living with long-term pain who have been prescribed opioids for 3 or more months. This study was done at primary care and pain care clinics at 3 health systems in the Southeastern United States. The study team assigned people by chance to one of two study programs: (1) individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) or (2) patient-clinician shared decision making. In the MI+CBT program, the patient learned strategies to better cope with chronic pain. In the SDM program, the patient and clinician worked together through enhanced communication to make decisions that aligned with values and preferences of the patient. The study team compared the two programs by looking at changes in opioid dosage, physical functioning, and pain interference over time. They collected information about prescribed opioid dosage from electronic health records and patients completed surveys at the start of the study and 6 and 12 months later. The study team worked with an advisory group that included patients, advocates, clinicians, and pain experts. The advisory group met with the study team two to three times per year to provide input on the study.
Study details
- Official title
- Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain
- Conditions
- Interventions
- Behavioral: Shared Decision Making
- Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain
- Sponsor
- RTI International
- Collaborators
- Patient-Centered Outcomes Research Institute; University of North Carolina Health Care System; Duke Health; Vanderbilt University Medical Center
- Start date
- 2019-06-26
- Primary completion
- 2023-09-30
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Aged 18 to 85 years * History of chronic non-cancer pain (CNCP) * Receiving chronic opioid therapy for CNCP as evidenced by current or most recent prescription of an average daily prescribed dosage of 20 milligrams of morphine equivalents * Receiving care at a participating clinic from a participating provider, as evidenced by at least 1 in-person visit within the past 12 months. Exclusion Criteria: * Not meeting the above inclusion criteria * Opioid use is for pain directly related to an active cancer diagnosis * Opioid use is for maintenance treatment of an opioid use disorder * Suicide attempt within the past 3 years * Active suicidal ideation * Currently receiving Cognitive-Behavioral Therapy (CBT) * Non-English speaking * Other reason at the discretion of the investigator
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03454555