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。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
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
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引用次数: 0

摘要

背景:以正念为基础的干预措施,如正念减压(MBSR),是有效的身心治疗慢性疼痛,尽管其适度的效果大小表明有改进的空间。值得注意的是,最近的研究表明,正念冥想不涉及内源性阿片系统,这在镇痛中起着重要作用。因此,探索基于正念的干预与激活该系统的非阿片类药物治疗的结合是有必要的。开放标签安慰剂(OLP)是一种没有欺骗的安慰剂,作为一种安全有效的镇痛药,研究表明其作用是由内源性阿片类药物的释放介导的。本研究旨在通过一项三组随机对照试验(RCT),评估正念减压与OLP联合治疗慢性疼痛的可行性和可接受性。方法:本研究将对慢性疼痛患者进行为期8周的三种治疗方法之一:单纯MBSR、单纯OLP或MBSR + OLP联合干预。参与者将参加四次面对面会议(基线评估、随机化会议、治疗中评估和治疗后评估),随后在3个月的随访中进行在线评估。MBSR课程将通过Zoom进行现场直播。OLP组的参与者将每天服用两次安慰剂,并使用电子药瓶盖和尿核黄素示踪剂测试来监测依从性。每日日记评估将在基线、治疗中、治疗后和3个月随访的7天时间内完成。讨论:这项单点可行性随机对照试验的结果将有助于完善和优化未来多点疗效试验所需的研究方案。试验注册:NCT06720909。12/06/2024注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Combining mindfulness intervention and open-label placebo treatment for chronic pain: a protocol for a feasibility study.

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.

Trial registration: NCT06720909 . Registered 12/06/2024.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
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.
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