THE ROLE OF GUT-DIRECTED HYPNOTHERAPY IN RELAPSE PREVENTION FOR ULCERATIVE COLITI

描述(申请人提供)：目标1是确定肠导催眠疗法，一种已建立的针对心理应激的CAM干预措施，是否可行并可被溃疡性结肠炎(UC)患者接受。目的2是评估肠导催眠疗法预防UC复发和其他临床疾病结果的效果大小。这个项目是朝着我们的长期目标迈出的一步，即帮助患有炎症性肠病的患者 (IBD)使用行为自我管理技术，以获得更好的疾病控制，减少 突发事件的频率、严重性和持续时间，并提高生活质量。介绍了 对于部分患者来说，维持性药物对于延长间隔时间是至关重要的 但预防复发的方法是有限的。IBD患者和他们的医生认为压力是一种常见的 引发复发。肠导催眠疗法可能通过提高对UC的依从性和注意力来影响UC 积极的生活方式因素和改变与压力相关的生理和心理过程 与疾病爆发和生活质量有关。88名缓解期UC患者将随机接受8周的肠道指导治疗 催眠治疗+标准护理(HYP)，b)8周时间/注意力控制+标准护理(TA)或c) 单独标准护理(SCA)。在基线、8周(治疗后)、20周、36周重复评估 两周和52周。目标1终点：1)在试用期内保留的患者比例 与那些没有完成/进入试验的人进行比较。我们预计，HYP将是可行的，并 至少一部分非活动期UC患者可以接受；2)登记的参与者之间的差异 以及那些因人口统计、疾病特征、依从性和 感觉到的压力。我们预计不同集团之间会有差异：Hyp&>TA&GT；SCA。目标2 终点：1)每个治疗组在52周时仍处于缓解状态的参与者的比例，如 由每日症状日记和医生评估确定。我们希望HYP在使用时 与标准护理相结合，可能会增加1年仍处于缓解状态的患者的比例 比TA或SCA更多的随访，证明了催眠疗法可能是积极的 复发的影响风险；2)平均复发天数、首次复发的特征、生活质量、 知觉控制、知觉压力和坚持：HY P&GT；TA&GT；SCA。

DESCRIPTION (provided by applicant): Aim 1 is to determine whether gut-directed hypnotherapy, an established CAM intervention that targets psychological stress, is feasible and acceptable to patients with Ulcerative Colitis (UC). Aim 2 is to estimate effect sizes for gut-directed hypnotherapy on relapse prevention and other clinical disease outcomes in UC. This project is a step towards our long-term goal, which is to help patients with Inflammatory Bowel Diseases (IBD) employ behavioral self-management techniques in order to obtain better disease control, reduce the frequency, severity and duration of flare-ups and achieve improved quality of life. The introduction of maintenance medications has been critical for a portion of patients with respect to increasing time between flares, but relapse prevention methods are limited. IBD patients and their doctors cite stress as a common trigger for relapse. Gut-directed hypnotherapy may impact UC by improving adherence and attention to positive lifestyle factors and altering stress-related physiological and psychological processes that contribute to disease flare and quality of life. 88 UC patients in remission will be randomized to a) 8 weeks of gut directed hypnotherapy + standard care (HYP), b) 8 weeks time/attention control + standard care (TA) or c) standard care alone (SCA). Assessments are repeated at baseline, 8 weeks (post-treatment), 20 weeks, 36 weeks and 52 weeks. Aim 1 Endpoints: 1) proportion of patients who are retained over the trial period in comparison to those who did not complete/enter the trial. We expect that HYP will be feasible and acceptable to at least a subset of patients with inactive UC; 2) differences between participants who enroll and those who decline enrollment/drop-out on demographics, disease characteristics, adherence and perceived stress. We expect that there will be differences between groups: HYP > TA > SCA. Aim 2 Endpoints: 1) the proportion of participants in each treatment group that are still in remission at 52 weeks, as determined by daily symptom diaries and physician evaluation. We expect that HYP, when used in conjunction with standard care, may increase the proportion of patients who remain in remission at 1-year follow-up more than either TA or SCA, demonstrating proof of concept that hypnotherapy may positively impact risk of relapse; 2) mean number of days to relapse, characteristics of first flare, quality of life, perceived control, perceived stress and adherence: HY P>TA>SCA.