Mindfulness for Irritable Bowel Syndrome

描述(申请人提供)：肠易激综合征(IBS)是一种常见的致残功能障碍，其特征是严重的腹部不适和排便障碍。它影响了超过10%的美国成年人(14%的女性，8%的男性)，导致严重残疾、生活质量受损和严重的医疗负担。IBS的常规治疗对一些患者只有部分有效，包括使用药物、行为调整、饮食方法以及改变生活方式，如锻炼和减压。尽管认知行为疗法和催眠等行为疗法一直是最有效的疗法之一，但它们的实施成本很高。 正念冥想是一种以小组形式教授的补充/替代医学(CAM)疗法，是一种独特的自我调节、心身结合的方法，在这种方法中，练习者学习关注当下的体验，放弃对负面情绪和过去和未来想法的执着。已发现它在减轻慢性疼痛和压力以及改善与IBS相似的疾病方面有效，包括纤维肌痛、头痛和抑郁。 这项针对患有IBS的女性的探索性、先导性研究的总体目标是，在一项小型随机对照临床试验中，将正念冥想训练与患者支持组(一种先前证实的对照条件)进行比较，以评估更大规模、决定性试验的可行性。具体目标是评估主要和次要结果衡量标准，评估受益预期和衡量正念程度(过程衡量标准)，并确定在我们的环境下进行此类试验的障碍。60名符合罗马II IBS诊断标准的女性将被随机分配到两种治疗方法中的一种--正念冥想训练或支持组--并将接受每周8次的小组治疗，外加一次为期一天的治疗。主要的结果测量是从治疗前到治疗结束，以及在3、6和12个月的随访中，验证的肠易激症状严重程度量表的改善。其他变量涉及可供选择的终点(例如，IBS症状的适当缓解、特定疾病的生活质量)和治疗效果的机制(例如，应对量表、心理症状、内脏敏感性量表)。多学科研究团队包括医生、心理学家和教育工作者。

DESCRIPTION (provided by applicant): Irritable bowel syndrome (IBS) is a common and disabling functional disorder characterized by significant abdominal discomfort and disturbed defecation. It affects over 10% of U.S. adults (14% women, 8% men), resulting in major disability, impaired quality of life, and a significant health-care burden. Conventional management of IBS is only partially effective in some patients and includes use of medications, behavioral modification, dietary approaches, and lifestyle changes such as exercise and stress reduction. Although behavioral treatments such as cognitive behavioral therapy and hypnosis have been among the most effective treatments, they are costly to deliver. Mindfulness meditation, a complementary/alternative medicine (CAM) therapy taught in groups, is a unique self-regulatory, mind-body approach in which practitioners learn to attend to present-moment experiences, letting go of fixation on negative emotions and thoughts of past and future. It has been found to be effective in reducing chronic pain and stress and in ameliorating disorders with similarities to IBS, including fibromyalgia, headache, and depression. The overall goals of this exploratory, pilot study of women with IBS are to compare mindfulness meditation training to a patient support group (a previously validated control condition) in a small, randomized controlled clinical trial, in order to assess the feasibility of a larger, definitive trial. Specific aims are to evaluate primary and secondary outcome measures, to assess expectancy of benefit and scales measuring mindfulness (process measures), and to identify barriers to conducting such a trial in our setting. Sixty women meeting Rome II diagnostic criteria for IBS will be randomly assigned to one of two treatments - mindfulness meditation training or a support group - and will undergo 8 weekly group sessions plus a single day-long session. The primary outcome measure is improvement on the validated Irritable Bowel Symptom Severity Scale from pretreatment to the end of treatment, with follow-up at 3, 6, and 12 months. Additional variables address alternative endpoints (e.g., Adequate Relief of IBS symptoms, disease specific quality of life) and mechanism of treatment effects (e.g., coping scales, psychological symptoms, Visceral Sensitivity Scale). The multidisciplinary research team includes physicians, psychologists, and educators.