{"doi":"10.1136/bmjopen-2024-086889","title":"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","abstract":"<jats:sec>\n                    <jats:title>Introduction</jats:title>\n                    <jats:p>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).</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis</jats:title>\n                    <jats:p>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.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcomes</jats:title>\n                    <jats:p>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.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination</jats:title>\n                    <jats:p>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.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number</jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05152134\">NCT05152134</jats:ext-link>\n                      .\n                    </jats:p>\n                  </jats:sec>","journal":"BMJ Open","year":2024,"id":635200,"datarank":0.31191623125197543,"base_score":2.0794415416798357,"endowment":2.0794415416798357,"self_citation_contribution":0.31191623125197543,"citation_network_contribution":0.0,"self_endowment_contribution":0.31191623125197543,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":7,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":973382,"name":"Paige Palenski","orcid":null,"position":1,"is_corresponding":false},{"id":445246,"name":"Luzmercy Perez","orcid":"0000-0002-1423-7901","position":2,"is_corresponding":false},{"id":1647885,"name":"Dokyoung Sophia You","orcid":null,"position":3,"is_corresponding":false},{"id":1647886,"name":"Maisa S Ziadni","orcid":null,"position":4,"is_corresponding":false},{"id":871942,"name":"Corinne Jung","orcid":null,"position":5,"is_corresponding":false},{"id":899273,"name":"Emma Adair","orcid":null,"position":6,"is_corresponding":false},{"id":1036910,"name":"Lu Tian","orcid":"0000-0002-9113-3073","position":7,"is_corresponding":false},{"id":840880,"name":"Sean C Mackey","orcid":null,"position":8,"is_corresponding":false},{"id":1647887,"name":"Beth D Darnall","orcid":null,"position":9,"is_corresponding":false},{"id":1104022,"name":"Karlyn A. Edwards","orcid":"0000-0002-5821-3733","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"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","abstract":"<jats:sec>\n                    <jats:title>Introduction</jats:title>\n                    <jats:p>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).</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis</jats:title>\n                    <jats:p>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.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcomes</jats:title>\n                    <jats:p>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.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination</jats:title>\n                    <jats:p>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.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number</jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05152134\">NCT05152134</jats:ext-link>\n                      .\n                    </jats:p>\n                  </jats:sec>","is_dataset_classified":null,"base_score":0.0,"endowment":0.0,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"39122392","pmcid":"PMC11332006","openalex_id":null,"authors":[],"funders":[{"funder_name":"National Institute of Neurological Disorders and Stroke","grant_id":"K24NS126781","title":null},{"funder_name":"National Institute of Neurological Disorders and Stroke","grant_id":"R61NS11865","title":null},{"funder_name":"National Institute on Drug Abuse","grant_id":"K12DA050607","title":null},{"funder_name":"National Institute on Drug Abuse","grant_id":"K23DA047473","title":null},{"funder_name":"National Institute on Drug Abuse","grant_id":"K23DA048972","title":null},{"funder_name":"National Institute on Drug Abuse","grant_id":"K24DA053564","title":null},{"funder_name":"National Institute on Drug Abuse","grant_id":"T32DA035165","title":null},{"funder_name":"National Institutes of Health","grant_id":"2T32DA035165-11A1","title":"Interdisciplinary Research Training in Pain and/or Substance Use Disorders"},{"funder_name":"National Institutes of Health","grant_id":"1K24NS126781-01","title":"Mentoring in Discovery and Validation of Clinical Chronic Pain Biomarkers"},{"funder_name":"National Institutes of Health","grant_id":"5K23DA047473-02","title":"Single Session Pain Catastrophizing Class: Efficacy & Mechanisms for Reducing Opioid Use Among Chronic Pain Patients"},{"funder_name":"National Institutes of Health","grant_id":"5K24DA053564-03","title":"Research and Mentoring in Innovative Patient Oriented Pain and Opioid Science"},{"funder_name":"National Institutes of Health","grant_id":"5K12DA050607-05","title":"University of Pittsburgh Collaboration in Addiction Training Scholars (PittCATS) Program"},{"funder_name":"National Institutes of Health","grant_id":"5K23DA048972-02","title":"Effect of pain catastrophizing on prescription opioid craving"}],"total_grants":13,"fwci":null,"citation_percentile":null,"influential_citations":0,"citation_trend":[],"oa_status":"gold","license":"cc-by-nc","oa_locations":[{"url":"https://bmjopen.bmj.com/content/bmjopen/14/8/e086889.full.pdf","host_type":"publisher"},{"url":"https://syndication.highwire.org/content/doi/10.1136/bmjopen-2024-086889","host_type":"publisher"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11332006/pdf/bmjopen-14-8.pdf","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC11332006","host_type":"Europe_PMC"},{"url":"https://europepmc.org/articles/PMC11332006?pdf=render","host_type":"Europe_PMC"},{"url":"https://doi.org/10.1136/bmjopen-2024-086889","host_type":""},{"url":"https://pubmed.ncbi.nlm.nih.gov/39122392","host_type":""},{"url":"http://dx.doi.org/10.1136/bmjopen-2024-086889","host_type":""},{"url":"https://doaj.org/article/9a9ac0326c7240279161c10935c2eac5","host_type":""}],"fields_of_study":["03 medical and health sciences","0302 clinical medicine"],"mesh_terms":["Humans","Opioid-Related Disorders","Analgesics, Opioid","Telemedicine","Adult","Female","Male","Randomized Controlled Trials as Topic","Pain Management","Chronic Pain","Prescription Drug Misuse"],"keywords":["Behavior","Cognition","Chronic pain","Substance Misuse","Telemedicine","Psychosocial Intervention","Adult","Male","R","Opioid-Related Disorders","Analgesics, Opioid","Mental Health","Medicine","Humans","Pain Management","Female","Prescription Drug Misuse","Randomized Controlled Trials as Topic"],"sdg_mappings":[{"sdg_number":3,"sdg_label":"3. 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