Chung Jung Mun, Estrella Contreras, Yushu Xiao, Ryan Eckert, Alexandra Harting, Sathvika Damera, Iosef Perez, Hemant K Pandey, Aram S Mardian, Frank LoVecchio, Luana Colloca, Kelly E Dunn, Michael Todd, Roger B Fillingim, Mary C Davis
{"title":"结合正念干预和开放标签安慰剂治疗慢性疼痛:可行性研究方案。","authors":"Chung Jung Mun, Estrella Contreras, Yushu Xiao, Ryan Eckert, Alexandra Harting, Sathvika Damera, Iosef Perez, Hemant K Pandey, Aram S Mardian, Frank LoVecchio, Luana Colloca, Kelly E Dunn, Michael Todd, Roger B Fillingim, Mary C Davis","doi":"10.1186/s40814-025-01692-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR), are efficacious mind-body treatments for chronic pain, though their modest effect sizes suggest room for improvement. Notably, recent studies indicate that mindfulness meditation does not engage the endogenous opioid system, which plays an important role in analgesia. Therefore, exploring the combination of a mindfulness-based intervention with a non-opioid treatment that activates this system is warranted. Open-label placebo (OLP), a placebo that is given to a participant without deception, has shown significant promise as a safe and potentially effective analgesic, with studies indicating its effects are mediated by the release of endogenous opioids. This study aims to evaluate the feasibility and acceptability of combining MBSR and OLP treatment compared to each intervention alone for chronic pain in a three-arm randomized controlled trial (RCT).</p><p><strong>Methods: </strong>This study will include an 8-week exposure to one of three treatments for individuals with chronic pain: MBSR-only, OLP-only, or a combined MBSR + OLP intervention. Participants will attend four in-person sessions (baseline assessment, randomization session, mid-treatment assessment, and posttreatment assessment), followed by an online assessment at a 3-month follow-up. MBSR sessions will be conducted live via Zoom. Participants in OLP groups will take placebo pills twice daily, with adherence monitored using an electronic pill bottle cap and urine riboflavin tracer testing. Daily diary assessments will be completed over 7-day periods at baseline, mid-treatment, post-treatment, and 3-month follow-up.</p><p><strong>Discussion: </strong>Findings from this single-site feasibility RCT will help refine and optimize study protocols needed for a future, fully powered multi-site efficacy trial.</p><p><strong>Trial registration: </strong>NCT06720909 . Registered 12/06/2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"111"},"PeriodicalIF":1.6000,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12366083/pdf/","citationCount":"0","resultStr":"{\"title\":\"Combining mindfulness intervention and open-label placebo treatment for chronic pain: a protocol for a feasibility study.\",\"authors\":\"Chung Jung Mun, Estrella Contreras, Yushu Xiao, Ryan Eckert, Alexandra Harting, Sathvika Damera, Iosef Perez, Hemant K Pandey, Aram S Mardian, Frank LoVecchio, Luana Colloca, Kelly E Dunn, Michael Todd, Roger B Fillingim, Mary C Davis\",\"doi\":\"10.1186/s40814-025-01692-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR), are efficacious mind-body treatments for chronic pain, though their modest effect sizes suggest room for improvement. Notably, recent studies indicate that mindfulness meditation does not engage the endogenous opioid system, which plays an important role in analgesia. Therefore, exploring the combination of a mindfulness-based intervention with a non-opioid treatment that activates this system is warranted. Open-label placebo (OLP), a placebo that is given to a participant without deception, has shown significant promise as a safe and potentially effective analgesic, with studies indicating its effects are mediated by the release of endogenous opioids. This study aims to evaluate the feasibility and acceptability of combining MBSR and OLP treatment compared to each intervention alone for chronic pain in a three-arm randomized controlled trial (RCT).</p><p><strong>Methods: </strong>This study will include an 8-week exposure to one of three treatments for individuals with chronic pain: MBSR-only, OLP-only, or a combined MBSR + OLP intervention. 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Combining mindfulness intervention and open-label placebo treatment for chronic pain: a protocol for a feasibility study.
Background: Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR), are efficacious mind-body treatments for chronic pain, though their modest effect sizes suggest room for improvement. Notably, recent studies indicate that mindfulness meditation does not engage the endogenous opioid system, which plays an important role in analgesia. Therefore, exploring the combination of a mindfulness-based intervention with a non-opioid treatment that activates this system is warranted. Open-label placebo (OLP), a placebo that is given to a participant without deception, has shown significant promise as a safe and potentially effective analgesic, with studies indicating its effects are mediated by the release of endogenous opioids. This study aims to evaluate the feasibility and acceptability of combining MBSR and OLP treatment compared to each intervention alone for chronic pain in a three-arm randomized controlled trial (RCT).
Methods: This study will include an 8-week exposure to one of three treatments for individuals with chronic pain: MBSR-only, OLP-only, or a combined MBSR + OLP intervention. Participants will attend four in-person sessions (baseline assessment, randomization session, mid-treatment assessment, and posttreatment assessment), followed by an online assessment at a 3-month follow-up. MBSR sessions will be conducted live via Zoom. Participants in OLP groups will take placebo pills twice daily, with adherence monitored using an electronic pill bottle cap and urine riboflavin tracer testing. Daily diary assessments will be completed over 7-day periods at baseline, mid-treatment, post-treatment, and 3-month follow-up.
Discussion: Findings from this single-site feasibility RCT will help refine and optimize study protocols needed for a future, fully powered multi-site efficacy trial.
期刊介绍:
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.