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

Northwestern University At Chicago, Evanston IL

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Abstract

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