Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
234 participants
INTERVENTIONAL
2023-08-23
2025-08-15
Brief Summary
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Detailed Description
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The intervention, Empowered Relief On-Demand, will include roughly 80 minutes of interactive digital pain education and pain management skills content with multimedia features and an App. The investigators will conduct a fully online 2-arm RCT of digital Empowered Relief in a national sample of people with comorbid chronic pain and opioid misuse compared to a digital health education control (HE).
The investigators will implement The MOBILE Relief Study, an international (United States, Canada, United Kingdom, and Australia) 2-arm online feasibility RCT of Empowered Relief to reduce pain intensity, pain interference, pain-related distress (pain outcomes) and opioid outcomes (opioid craving and misuse) in people with prescription opioid misuse and chronic pain. They will compare Empowered Relief On Demand to an interactive digital health education (HE) intervention that is devoid of pain management skills ("Living Better") in community-based individuals with comorbid chronic pain and prescription opioid misuse (N=220). Completion of the brief post-treatment survey (received immediately following treatment completion) is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with five items (overall satisfaction with treatment, ease of understanding, relevance, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, and months 1, 2, and 3. At post-treatment weeks 1 and 2, electronic surveys will measure opioid craving, pain intensity, pain catastrophizing (distress), and pain interference.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Empowered Relief On Demand
Empowered Relief On-Demand will include roughly 80 minutes of interactive and multimedia pain educational content that targets pain and stress self-regulation, pain medication misuse, a personalized plan for relief and an audio App for daily use.
Empowered Relief On-Demand
Tailored interactive digital health treatment for chronic pain
Health Education (HE; "Living Better")
The HE arm is an interactive digital general health education intervention called "Living Better" that is devoid of specific content on pain, psychological skills, and has no active strategies or worksheets.
Health Education
The HE digital intervention is roughly 65 minutes with content discussing pain and health topics generally; it is devoid of pain education, psychological skills, and has no active strategies, worksheets, or supportive tools.
Interventions
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Empowered Relief On-Demand
Tailored interactive digital health treatment for chronic pain
Health Education
The HE digital intervention is roughly 65 minutes with content discussing pain and health topics generally; it is devoid of pain education, psychological skills, and has no active strategies, worksheets, or supportive tools.
Eligibility Criteria
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Inclusion Criteria
* Chronic non-cancer pain (at least 6 months in duration)
* Average pain intensity of at least 3 on the PROMIS SFV1.0 Pain Intensity 1a
* Daily prescription opioid use (at least 10 morphine milliequivalent daily dose; MEDD) for at least 3 months
* Opioid misuse (at least 6 on the Current Opioid Misuse Measure; COMM)
* English fluency
* Internet access
Exclusion Criteria
* Inability to complete study electronic surveys
* Cannot currently be enrolled in a study or trial with Empowered Relief as a treatment/intervention
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Stanford University
OTHER
Responsible Party
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Beth Darnall
Principal Investigator
Locations
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Stanford University
Palo Alto, California, United States
Countries
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References
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Edwards KA, Palenski P, Perez L, You DS, Ziadni MS, Jung C, Adair E, Tian L, Mackey SC, Darnall BD. Protocol for a randomised trial of a self-directed digital pain management intervention (Empowered Relief) tailored to adults with chronic pain and prescription opioid misuse/disorder: the MOBILE Relief study. BMJ Open. 2024 Aug 9;14(8):e086889. doi: 10.1136/bmjopen-2024-086889.
Other Identifiers
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61643
Identifier Type: -
Identifier Source: org_study_id