The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.
The purpose of the study is to determine whether hypnotherapy can serve as an effective therapy for patients with Ulcerative Colitis (UC), a chronic, relapsing and remitting inflammatory bowel disease (IBD). The goal of this study is to determine if mind-body therapy is an effective complementary therapy for IBD, meaning a therapy to be used in conjunction with your standard treatment provided by your gastroenterologist. Standard treatment for UC often includes a combination approach and may include medications such as mesalamine, corticosteroids or immunomodulators. Mind-body therapy or hypnosis has been used to reduce stress and subsequent disease activity in patients with gastrointestinal diseases including IBD and Irritable Bowel Syndrome. It has also been shown to improve immune function and reduce inflammation in other health conditions such as cancer and arthritis. In this study, patients with inactive UC will be randomized to one of three groups. Two groups will undergo one of two mind-body therapies, which may include relaxation techniques or other techniques aimed at identifying the impact of UC on your psyche along with standard care for their UC. The other group will undergo 8 weeks of standard care without mind-body therapy. Clinical assessment measures will be repeated at 8 weeks, 12 weeks, 24 weeks and 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
55
8 weeks of gut-directed hypnotherapy
8 weeks of standard of care
8 weeks of mind-body therapy
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
feasibility
Time frame: 52 weeks
Estimated effect sizes
Time frame: 52 weeks
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