Ulcerative Colitis Clinical Trial
Official title:
National Center for Complementary & Alternative Medicine, The Role of Gut-Directed Hypnotherapy in Relapse Prevention for Ulcerative Colitis
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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