Mindfulness meditation training for Irritable Bowel Syndrome

正念冥想训练治疗肠易激综合症

• 批准号: 10401442
• 负责人: John David Creswell
• 金额: $ 67.09万
• 依托单位: CARNEGIE-MELLON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-04 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10401442
• 关键词: Abdominal Pain; Adopted; Adult; Affect; Aftercare; Attention; Attitude; Automobile Driving; Behavior Therapy; Brain; Cellular Phone; Communities; Control Groups; Data; Disease; Disease Outcome; Distress; Ecological momentary assessment; Educational Intervention; Elements; Emergency Situation; Enrollment; Evaluation; Event; Evidence based intervention; Evidence based treatment; Expectancy; Fostering; Functional Gastrointestinal Disorders; Functional disorder; Habits; Health; Health Benefit; Intervention; Intestines; Irritable Bowel Syndrome; Learning; Life; Life Stress; Link; Measures; Mediating; Mindfulness Training; Modeling; Monitor; Outcome; Participant; Pathway interactions; Patient Self-Report; Patients; Persons; Physicians; Play; Publishing; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Role; Sample Size; Sampling; Stress; Symptoms; Testing; Time; Training; Training Programs; Translational trial; active method; arm; base; coping; experience; follow-up; gut microbiome; gut microbiota; improved; instructor; interest; intervention delivery; intervention program; metabolomics; mindfulness; mindfulness intervention; mindfulness meditation; mindfulness-based stress reduction; patient population; post intervention; programs; reduce symptoms; response; skills; skills training; stool sample; stress management; stress reduction; stress resilience; stress symptom; symptomatic improvement; theories; volunteer

PROJECT SUMMARY/ABSTRACT Mindfulness-Based Intervention (MBI) training programs have been shown to reduce stress and improve a broad range of stress-related disease outcomes in initial randomized controlled trials (RCTs). For example, there is initial evidence from small RCTs that MBIs reduce symptoms in Irritable Bowel Syndrome (IBS) patients. Yet we know little about the underlying active treatment mechanisms of mindfulness training. Guided by a theoretical and conceptual model of the active treatment elements of MBIs, called Monitor and Acceptance Theory (MAT), we recently showed in two published dismantling MBI RCTs that acceptance skills training is critical for driving stress reduction effects in healthy stressed community adults. Specifically, standard MBI programs with attention monitoring and acceptance skills training were superior in reducing stress relative to parallel MBI programs that did not include acceptance skills training (or to control groups) at post-treatment. We observed consistent stress reduction effects across intervention delivery approaches in these two dismantling trials, using either a 2-week remote smartphone MBI or with an 8-week group-based Mindfulness-Based Stress Reduction (MBSR) MBI treatment approach. Here we propose the first translational trial of this mechanistic account, examining whether acceptance skills training drives stress resilience and improved symptom outcomes in IBS patients. In the largest and most well-controlled RCT of MBI training in IBS to-date (N=325), we will evaluate whether a smartphone MBI program (with attention monitoring and acceptance skills training; Monitor+Accept, MA-MBI) reduces daily life stress and IBS symptoms at post-treatment and two-month follow-up, relative to a matched MBI program with acceptance skills training removed (training in attention monitoring skills only; Monitor Only, MO-MBI) or to an active stress management training control group (Coping Control, CC). Participants will not only provide clinician and patient assessed measures of IBS symptoms at the three time points, but they will also provide sensitive experience sampling assessments (using Ecological Momentary Assessment) of their stress and symptoms in daily life at each time point. Finally, as an exploratory aim, participants will provide stool samples at baseline and post-intervention to provide the first ever test of whether MBIs can alter the gut microbiome in IBS. Guided by a conceptual model, the proposed study will experimentally evaluate whether acceptance skills training is a key ingredient for stress reduction and health benefits in IBS patients, and will provide an important mechanistically-focused evaluation of the active treatment elements of MBIs for at risk stressed patient populations. We believe that this trial not only can help identify a new accessible and scalable evidence-based treatment for IBS patients, but the mechanistic focus will also help the field advance more effective and efficient acceptance skills-based mindfulness training approaches among at-risk stressed patient populations.

项目总结/摘要 基于正念的干预（MBI）训练计划已被证明可以减轻压力，改善生活质量。 在最初的随机对照试验（RCT）中广泛的压力相关疾病结局。比如说， 有来自小型随机对照试验的初步证据表明，MBIs可减轻肠易激综合征（IBS）的症状 患者然而，我们对正念训练的潜在积极治疗机制知之甚少。 在MBIs的积极治疗要素的理论和概念模型（称为监测和 接受理论（MAT），我们最近在两个发表的拆除MBI RCT中显示，接受 技能培训对健康的有压力的社区成年人的减压效果至关重要。具体地说， 标准的MBI项目与注意力监测和接受技能培训在上级 压力相对于平行的MBI计划，不包括接受技能培训（或对照组）， 后处理。我们观察到，在不同的干预实施方法中， 这两个拆除试验，使用2周的远程智能手机MBI或8周的基于组的MBI， 正念减压（MBSR）MBI治疗方法。在这里，我们提出了第一个 这种机械解释的翻译试验，检验接受技能训练是否会导致压力 恢复力和改善IBS患者的症状结果。在最大和控制最好的RCT中， MBI培训IBS的日期（N=325），我们将评估是否智能手机MBI计划（注意 监测和接受技能培训;监测+接受，MA-MBI）减少日常生活压力和IBS 治疗后和两个月随访时的症状，相对于接受的匹配MBI计划 删除技能培训（仅注意力监测技能培训;仅监测，MO-MBI）或激活 应激管理训练对照组（Coping Control，CC）。参与者不仅将提供临床医生 和患者在三个时间点评估IBS症状的措施，但他们也将提供敏感的 经验抽样评估（使用生态瞬时评估）他们的压力和症状 在日常生活中，在每个时间点。最后，作为探索性目的，参与者将提供粪便样本， 基线和干预后，提供了有史以来第一次测试MBIs是否可以改变肠道微生物组， IBS.在概念模型的指导下，拟议的研究将通过实验评估接受是否 技能培训是IBS患者减轻压力和健康益处的关键因素， 对MBIs的积极治疗元素进行重要的机制性评价， 患者人群。我们相信，这项试验不仅可以帮助确定一个新的可访问和可扩展的 IBS患者的循证治疗，但机制的重点也将有助于该领域的进一步发展 有效和高效的接受技能为基础的正念训练方法在风险强调 患者人群。