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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00798642 |
The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.
Condition | Intervention |
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Ulcerative Colitis Inflammatory Bowel Disease |
Behavioral: Hypnotherapy Behavioral: Standard care Behavioral: Mind Body Therapy |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | National Center for Complementary & Alternative Medicine, The Role of Gut-Directed Hypnotherapy in Relapse Prevention for Ulcerative Colitis |
Estimated Enrollment: | 190 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Hypnotherapy: Active Comparator |
Behavioral: Hypnotherapy
8 weeks of gut-directed hypnotherapy
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Standard care: Placebo Comparator |
Behavioral: Standard care
8 weeks of standard of care
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Mind Body Therapy: Placebo Comparator |
Behavioral: Mind Body Therapy
8 weeks of mind-body therapy
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Zinke, PhD | 312-695-7086 | j-zinke@northwestern.edu |
Contact: Jason Bratten, BS, PMP | 312-695-2742 | j-bratten@northwestern.edu |
United States, Illinois | |
Northwestern University, Feinberg School of Medicine | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Jennifer Zinke, PhD 312-695-7086 j-zinke@northwestern.edu | |
Contact: Jason Bratten, BS, PMP 312-695-2742 j-bratten@northwestern.edu | |
Principal Investigator: Laurie Keefer, PhD | |
Sub-Investigator: Jennifer Zinke, PhD | |
Sub-Investigator: Terrance Barrett, MD |
Principal Investigator: | Laurie Keefer, PhD | Northwestern University |
Responsible Party: | Feinberg School of Medicine, Northwestern University ( Laurie Keefer, PhD, Director, Center for Psychosocial Research in GI ) |
Study ID Numbers: | R21 AT003204 |
Study First Received: | November 25, 2008 |
Last Updated: | August 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00798642 History of Changes |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
Hypnotherapy Ulcerative Colitis Inflammatory Bowel Disease Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Colonic Diseases |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Gastroenteritis Intestinal Diseases Colitis |
Pathologic Processes Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Gastroenteritis Intestinal Diseases Colitis |