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.? ?
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