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.

Introduction: Chronic pain increases the risk of prescription opioid misuse or opioid use disorder (OUD). Non-pharmacological treatments are needed to dually address pain and opioid risks. The purpose of the Mobile and Online-Based Interventions to Lessen Pain (MOBILE Relief) study is to compare a one-session, video-based, on-demand digital pain relief skills intervention for chronic pain ('Empowered Relief' (ER); tailored to people at risk for opioid misuse or with opioid misuse/OUD) to a one-session digital health education intervention ('Living Better'; no pain management skills).
Methods and Analysis: MOBILE Relief is an international online randomised controlled clinical trial. Study participants are adults with chronic, non-cancer pain (≥6 months) with daily pain intensity ≥3/10, taking ≥10 morphine equivalent daily dose and score ≥6 on the Current Opioid Misuse Measure. Participants are recruited through clinician referrals and clinic advertisements. Study procedures include electronic eligibility screening, informed consent, automated 1:1 randomisation to the treatment group, baseline measures, receipt of assigned digital treatment and six post-treatment surveys spanning 3 months. Study staff will call participants at baseline and 1-month and 3 months post-treatment to verify the opioid prescription. The main statistical analyses will include analysis of covariance and mixed effects model for repeated measurements regression.
Main Outcomes: Primary outcomes are self-reported pain catastrophising, pain intensity, pain interference, opioid craving and opioid misuse at 1-month and 3 months post-treatment. We will determine the feasibility of ER (≥50% participant engagement, ≥70% treatment appraisal ratings). We hypothesise the ER group will be superior to the Living Better group in the reduction of multiprimary pain outcomes at 1-month post-treatment and opioid outcomes at 1-month and 3 months post-treatment.
Ethics and Dissemination: The study protocol was approved by the Stanford University School of Medicine Institutional Review Board (IRB 61643). We will publish results in peer-reviewed journals; National Institute of Drug Abuse (funder) and MOBILE Relief participants will receive result summaries.
Trial Registration Number: NCT05152134.
Competing Interests: Competing interests: Stanford University receives fees for continuing medical education ER clinician certification workshops; BD receives no personal monies for the ER certification workshops, nor for dissemination or adoption of ER. BD is the Chief Science Advisor at Applied VR, and her consulting role with this company (personal fees) is unrelated to the current research. BD receives royalties for four pain treatment books she has authored or coauthored. She is the principal investigator for two pain research awards from the Patient-Centered Research Outcomes Research Institute, one of which involves the study of ER. BD is the principal investigator for two NIH grants that are investigating the efficacy of ER (one is the MOBILE Relief study). BD serves on the Board of Directors for the Institute for Brain Potential (which is licensed by Stanford University to offer ER clinician certification workshops), and is on the Medical Advisory Board for the Facial Pain Association. BD is a scientific member of the NIH Interagency Pain Research Coordinating Committee, a former member of the Centers for Disease Control and Prevention Opioid Workgroup (2020–2021), and a current member of the Pain Advisory Group of the American Psychological Association. SM receives research funding from the NIH, Food and Drug Administration and Patient-Centered Outcomes Research Institute (administered through Stanford University). He is an unpaid advisor to both ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities and Networks) on their oversight committee and the American Chronic Pain Association (ACPA) for their scientific oversight. All other authors report no disclosures or conflicts of interest.
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