PMID- 37362184 OWN - NLM STAT- Publisher LR - 20230928 IS - 1868-8527 (Print) IS - 1868-8535 (Electronic) IS - 1868-8527 (Linking) DP - 2023 May 24 TI - Zoom-Based Mindfulness-Oriented Recovery Enhancement Plus Just-in-Time Mindfulness Practice Triggered by Wearable Sensors for Opioid Craving and Chronic Pain. PG - 1-17 LID - 10.1007/s12671-023-02137-0 [doi] AB - OBJECTIVE: The opioid crisis in the USA remains severe during the COVID-19 pandemic, which has reduced access to evidence-based interventions. This Stage 1 randomized controlled trial (RCT) assessed the preliminary efficacy of Zoom-based Mindfulness-Oriented Recovery Enhancement (MORE) plus Just-in-Time Adaptive Intervention (JITAI) prompts to practice mindfulness triggered by wearable sensors (MORE + JITAI). METHOD: Opioid-treated chronic pain patients (n = 63) were randomized to MORE + JITAI or a Zoom-based supportive group (SG) psychotherapy control. Participants completed ecological momentary assessments (EMA) of craving and pain (co-primary outcomes), as well as positive affect, and stress at one random probe per day for 90 days. EMA probes were also triggered when a wearable sensor detected the presence of physiological stress, as indicated by changes in heart rate variability (HRV), at which time participants in MORE + JITAI were prompted by an app to engage in audio-guided mindfulness practice. RESULTS: EMA showed significantly greater reductions in craving, pain, and stress, and increased positive affect over time for participants in MORE + JITAI than for participants in SG. JITAI-initiated mindfulness practice was associated with significant improvements in these variables, as well as increases in HRV. Machine learning predicted JITAI-initiated mindfulness practice effectiveness with reasonable sensitivity and specificity. CONCLUSIONS: In this pilot trial, MORE + JITAI demonstrated preliminary efficacy for reducing opioid craving and pain, two factors implicated in opioid misuse. MORE + JITAI is a promising intervention that warrants investigation in a fully powered RCT. PREREGISTRATION: This study is registered on ClinicalTrials.gov (NCT04567043). CI - (c) The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2023, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. FAU - Garland, Eric L AU - Garland EL AD - University of Utah, 395 South, 1500 East, Salt Lake City, UT 84112 USA. GRID: grid.223827.e. ISNI: 0000 0001 2193 0096 AD - Salt Lake VA Medical Center, Salt Lake City, USA. GRID: grid.413886.0 FAU - Gullapalli, Bhanu T AU - Gullapalli BT AD - University of California-San Diego, San Diego, USA. GRID: grid.266100.3. ISNI: 0000 0001 2107 4242 FAU - Prince, Kort C AU - Prince KC AD - University of Utah, 395 South, 1500 East, Salt Lake City, UT 84112 USA. GRID: grid.223827.e. ISNI: 0000 0001 2193 0096 FAU - Hanley, Adam W AU - Hanley AW AD - University of Utah, 395 South, 1500 East, Salt Lake City, UT 84112 USA. GRID: grid.223827.e. ISNI: 0000 0001 2193 0096 FAU - Sanyer, Mathias AU - Sanyer M AD - Utah State University, Logan, USA. GRID: grid.53857.3c. ISNI: 0000 0001 2185 8768 FAU - Tuomenoksa, Mark AU - Tuomenoksa M AD - Illumivu, Asheville, NC USA. FAU - Rahman, Tauhidur AU - Rahman T AD - University of California-San Diego, San Diego, USA. GRID: grid.266100.3. ISNI: 0000 0001 2107 4242 LA - eng SI - ClinicalTrials.gov/NCT04567043 GR - R01 AT011772/AT/NCCIH NIH HHS/United States GR - R01 DA042033/DA/NIDA NIH HHS/United States PT - Journal Article DEP - 20230524 PL - United States TA - Mindfulness (N Y) JT - Mindfulness JID - 101518348 PMC - PMC10205566 OTO - NOTNLM OT - Chronic pain OT - Craving OT - JITAI OT - Machine learning OT - Opioid misuse OT - mHealth COIS- Conflict of InterestEric Garland, PhD, LCSW is the Director of the Center on Mindfulness and Integrative Health Intervention Development. The Center provides Mindfulness-Oriented Recovery Enhancement (MORE), mindfulness-based therapy, and cognitive behavioral therapy in the context of research trials for no cost to research participants; however, Dr. Garland has received payment for delivering lectures, and teaching engagements (related to training clinicians in mindfulness) sponsored by institutions of higher education, government agencies, and medical centers. Dr. Garland also receives royalties from the sale of books related to MORE. Dr. Garland is a licensor to BehaVR, LLC. Mark Tuomenoksa is the Chief Technology Officer of Illumivu. No other authors have any related conflicts of interest to disclose. EDAT- 2023/06/26 19:07 MHDA- 2023/06/26 19:07 PMCR- 2023/05/24 CRDT- 2023/06/26 13:02 PHST- 2023/04/15 00:00 [accepted] PHST- 2023/06/26 19:07 [pubmed] PHST- 2023/06/26 19:07 [medline] PHST- 2023/06/26 13:02 [entrez] PHST- 2023/05/24 00:00 [pmc-release] AID - 2137 [pii] AID - 10.1007/s12671-023-02137-0 [doi] PST - aheadofprint SO - Mindfulness (N Y). 2023 May 24:1-17. doi: 10.1007/s12671-023-02137-0.