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Ulcerative Colitis Relapse Prevention Trial, Hypnosis (UCRPT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00798642
First Posted: November 26, 2008
Last Update Posted: April 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Laurie Keefer, Northwestern University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Laurie Keefer, Northwestern University:

Primary Outcome Measures:
  • feasibility [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • Estimated effect sizes [ Time Frame: 52 weeks ]

Enrollment: 55
Study Start Date: July 2007
Study Completion Date: June 2012
Primary Completion Date: November 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

Detailed Description:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female patients between the ages of 18 and 70 of any ethnicity
  • endoscopy-confirmed (within the past 2 years) mild or moderately severe Ulcerative Colitis (at time of previous flare)
  • inactive disease at the time of recruitment:
  • Mayo score <2 with no subscale >1
  • no rectal bleeding
  • Physician Global Assessment Score (PGA) = 0
  • 2 weeks of baseline daily symptom diaries that support criteria for inactive disease
  • documented disease flare within the past 1.5 years to enhance the opportunity to observe differences between groups in a 1-year trial .
  • no medication or a stable dose of maintenance medication (i.e. mesalamine or sulfasalazine) for at least one month prior to enrollment.
  • If taking maintenance medication: an increase in dose will be considered a relapse
  • If taking no medication: initiation of any medication will be considered a relapse

Exclusion Criteria:

  • active disease
  • daily rectal bleeding for past 7 days
  • Mayo Score > 2, any subscale > 1
  • PGA score >0
  • history of severe or fulminant UC
  • most recent flare included > 6 bloody stools a day
  • history of of toxicity including fever, tachycardia, anemia or an elevated Erythrocyte sedimentation rate (ESR) ∙ history of continuous bleeding, blood transfusion requirement, abdominal tenderness and distension, and colonic dilation on abdominal plain films
  • other gastrointestinal conditions
  • Crohn's Disease (CD)
  • short-bowel syndrome
  • celiac sprue
  • irritable bowel syndrome (IBS)
  • renal or hepatic disease
  • positive stool exam (bacteria, ova, parasites)
  • C-difficile
  • history of colon resection
  • steroid-dependent, patients taking oral steroids within the past 30 days, topical steroids within the past week, quit smoking in the past 30 days given the known effects of smoking cessation on UC disease flare 23.
  • contraindications for hypnotherapy
  • unresolved history of physical or sexual abuse
  • a current or past dissociative disorder (i.e. Borderline PD, PTSD)
  • history of psychosis (including mania)
  • history of psychiatric hospitalization, including for self-harm or SI/HI
  • current substance abuse
  • severe psychiatric disorder
  • patients who are resistant to hypnosis as a result of religious or moral beliefs or any other reason
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798642


Locations
United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Laurie Keefer, PhD Northwestern University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laurie Keefer, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00798642     History of Changes
Other Study ID Numbers: R21AT003204 ( U.S. NIH Grant/Contract )
First Submitted: November 25, 2008
First Posted: November 26, 2008
Last Update Posted: April 2, 2014
Last Verified: April 2014

Keywords provided by Laurie Keefer, Northwestern University:
Hypnotherapy
Ulcerative Colitis
Inflammatory Bowel Disease
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes