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.

项目摘要/摘要 基于正念的干预措施（MBI）培训计划已被证明可以减轻压力并改善 在初始随机对照试验（RCT）中，与压力相关的疾病结果广泛。例如， 有小型RCT的最初证据表明，MBI减少了肠易激综合征（IBS）的症状 患者。但是，我们对正念训练的潜在主动治疗机制知之甚少。 在MBI的主动处理元素的理论和概念模型的指导下，称为Monitor和 接受理论（MAT），我们最近在两个已发表的拆除MBI RCT中表明接受了 技能培训对于在健康压力社区成年人中推动减轻压力的影响至关重要。具体来说， 通过注意监测和接受技能培训的标准MBI计划在减少方面表现出色 相对于平行MBI计划的压力，该计划不包括接受技能培训（或对照组） 治疗后。我们观察到跨干预输送方法的一致压力减轻效应 这两个拆卸试验，使用2周的远程智能手机MBI或8周基于组的试验 基于正念的压力减轻（MBSR）MBI治疗方法。在这里，我们提出了第一个 该机械账户的翻译试验，检查接受技能培训是否驱动压力 IBS患者的韧性和改善的症状结果。在最大，最控制的RCT中 IBS迄今为止的MBI培训（n = 325），我们将评估是否智能手机MBI计划（注意 监视和接受技能培训；监视+接受，MABI）减轻了日常生活压力和IBS 相对于匹配的MBI计划，治疗后的症状和两个月随访的症状 消除了技能培训（仅在注意力监测技能方面培训；仅监视，MO-MBI）或积极的 压力管理培训对照组（Coping Control，CC）。参与者不仅会提供临床医生 患者在三个时间点评估了IBS症状的措施，但也将提供敏感的 经验抽样评估（使用生态时刻评估）的压力和症状 在每个时间点的日常生活中。最后，作为探索性目的，参与者将在 基线和干预后，提供了有史以来第一次测试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，拟议的研究将实验评估是否接受 技能培训是减轻压力和健康益处的关键因素，并将提供 对AT风险强调的MBI的主动治疗元素的重要机械重点评估 患者人群。我们认为，该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，但机械重点也将帮助该领域进步 高风险强调的有效，有效的接受技能的正念培训方法 患者人群。