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

Overview

Journal BMJ Open

Specialty General Medicine

Date 2024 Aug 9

PMID 39122392

Authors

Karlyn A Edwards

Paige Palenski

Luzmercy Perez

Dokyoung Sophia You

Maisa S Ziadni

Corinne Jung

Emma Adair

Lu Tian

Sean C Mackey

Beth D Darnall

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Recent advances in the treatment of chronic pain and substance use disorders.

Edwards K, Buonora M, Merlin J, Liebschutz J Curr Opin Psychol. 2024; 62:101977.

PMID: 39705790 PMC: 11867877. DOI: 10.1016/j.copsyc.2024.101977.

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