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.

项目摘要/摘要 基于正念的干预(MBI)训练计划已被证明可以减轻压力并提高 在最初的随机对照试验(RCT)中，与应激相关的疾病结局的广泛范围。例如, 来自小型随机对照试验的初步证据表明，MBIS可以减轻肠易激综合征(IBS)的症状。 病人。然而，我们对正念训练的潜在积极治疗机制知之甚少。 以MBIS主动治疗要素的理论和概念模型为指导，称为监视器和 接受理论(MAT)，我们最近在两个已发表的拆解MBI RCT中展示了接受 技能培训对于推动社区健康成人的压力缓解效果至关重要。具体来说， 标准的MBI计划加上注意力监测和接受技能培训，在减少 与不包括验收技能培训(或控制组)的并行MBI计划相关的压力 后处理。我们观察到干预交付方法在以下方面具有一致的减压效果 这两个拆解试验，要么使用为期2周的远程智能手机MBI，要么使用为期8周的小组 基于正念的压力减轻(MBSR)MBI治疗方法。在这里，我们提出第一个 对这一机械解释的翻译试验，考察接受技能培训是否会导致压力 IBS患者的恢复力和改善的症状结果。在规模最大、控制最好的RCT中 IBS的MBI培训到目前为止(N=325)，我们将评估是否有智能手机的MBI计划(注意 监测和验收技能培训；监测+接受，MA-MBI)减少日常生活压力和IBS 治疗后的症状和两个月的随访，与接受的匹配的MBI计划相关 技能培训已删除(仅限注意力监控技能培训；仅限监控，MO-MBI)或对活动的 压力管理训练对照组(应对控制，CC)。参与者不仅将为临床医生提供 和患者在三个时间点对IBS症状的评估，但它们也将提供敏感的 对他们的压力和症状的体验抽样评估(使用生态瞬时评估) 在日常生活中的每一个时间点。最后，作为一个探索性的目标，参与者将提供粪便样本 基线和干预后提供有史以来第一次测试MBIS是否可以改变肠道微生物群 IBS。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 技能培训是缓解IBS患者压力和健康益处的关键因素，并将提供 针对高危人群的MBIS积极治疗要素的重要机械重点评估 患者群体。我们相信，这一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，但机械聚焦也将帮助该领域取得更大进展 在高危压力人群中基于接受技能的有效正念训练方法 患者群体。