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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00798642 |
Purpose
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 |
|---|---|
|
Ulcerative Colitis Inflammatory Bowel Disease |
Behavioral: Hypnotherapy Behavioral: Standard care Behavioral: Mind Body Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
|---|---|
| Active Comparator: Hypnotherapy |
Behavioral: Hypnotherapy
8 weeks of gut-directed hypnotherapy
Other Name: HYP
|
| Placebo Comparator: Standard care |
Behavioral: Standard care
8 weeks of standard of care
Other Name: SC
|
| Placebo Comparator: Mind Body Therapy |
Behavioral: Mind Body Therapy
8 weeks of mind-body therapy
Other Name: MB
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Northwestern University, Feinberg School of Medicine | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Laurie Keefer, PhD | Northwestern University |
More Information
| Responsible Party: | Laurie Keefer, PhD, Director, Center for Psychosocial Research in GI, Feinberg School of Medicine, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00798642 History of Changes |
| Other Study ID Numbers: | R21 AT003204, R21AT003204 |
| Study First Received: | November 25, 2008 |
| Last Updated: | April 6, 2011 |
| 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 |
|
Colitis Colitis, Ulcerative Inflammatory Bowel Diseases Intestinal Diseases Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |