Mindfulness meditation training for Irritable Bowel Syndrome

正念冥想训练治疗肠易激综合症

• 批准号: 10178443
• 负责人: John David Creswell
• 金额: $ 69.31万
• 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/10178443
• 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; 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 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.

项目概要/摘要 基于正念的干预（MBI）培训计划已被证明可以减轻压力并改善 初步随机对照试验 (RCT) 中显示了广泛的与压力相关的疾病结果。例如， 小型随机对照试验的初步证据表明，MBI 可减轻肠易激综合症 (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。 以 MBI 积极治疗要素的理论和概念模型为指导，称为监测和 接受理论（MAT），我们最近在两个发表的拆解 MBI 随机对照试验中表明，接受 技能培训对于推动健康、有压力的社区成年人的减压效果至关重要。具体来说， 具有注意力监测和接受技能培训的标准 MBI 计划在减少注意力方面表现出色 与不包括接受技能培训（或对照组）的平行 MBI 计划相关的压力 治疗后。我们观察到，各种干预措施的减轻压力效果一致 这两项拆除试验，使用为期 2 周的远程智能手机 MBI 或基于小组的 8 周 基于正念的减压 (MBSR) MBI 治疗方法。这里我们提出第一个 这种机械解释的转化试验，检查接受技能培训是否会带来压力 IBS 患者的恢复力和改善的症状结果。在规模最大、对照最完善的随机对照试验中 迄今为止 IBS 的 MBI 培训 (N=325)，我们将评估智能手机 MBI 计划是否有效（注意 监测和验收技能培训；监测+接受 (MA-MBI) 可减少日常生活压力和肠易激综合征 (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 取消技能培训（仅进行注意力监控技能培训；仅监控，MO-MBI）或主动 压力管理训练对照组（Coping Control，CC）。参与者不仅会提供临床医生 和患者在三个时间点评估 IBS 症状的测量值，但它们也会提供敏感的信息 对他们的压力和症状进行抽样评估（使用生态瞬时评估） 日常生活中的每个时间点。最后，作为探索性目标，参与者将提供粪便样本 基线和干预后，首次测试 MBI 是否可以改变肠道微生物组 肠易激综合症。在概念模型的指导下，拟议的研究将通过实验评估是否接受 技能培训是 IBS 患者减轻压力和健康益处的关键因素，并将提供 对高危人群的 MBI 积极治疗要素进行重要的机制重点评估 患者人群。我们相信，这次试验不仅可以帮助确定新的可访问且可扩展的 IBS 患者的循证治疗，但机制焦点也将有助于该领域取得更多进展 针对高危压力人群有效且高效的基于接受技能的正念训练方法 患者人群。