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Ulcerative Colitis Relapse Prevention Trial, Hypnosis (UCRPT)
This study is currently recruiting participants.
Verified by National Center for Complementary and Alternative Medicine (NCCAM), August 2009
First Received: November 25, 2008   Last Updated: August 25, 2009   History of Changes
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
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: 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

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • feasibility [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimated effect sizes [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

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
Hypnotherapy: Active Comparator Behavioral: Hypnotherapy
8 weeks of gut-directed hypnotherapy
Standard care: Placebo Comparator Behavioral: Standard care
8 weeks of standard of care
Mind Body Therapy: Placebo Comparator Behavioral: Mind Body Therapy
8 weeks of mind-body therapy

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798642

Contacts
Contact: Jennifer Zinke, PhD 312-695-7086 j-zinke@northwestern.edu
Contact: Jason Bratten, BS, PMP 312-695-2742 j-bratten@northwestern.edu

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: Laurie Keefer, PhD Northwestern University
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Hypnotherapy
Ulcerative Colitis
Inflammatory Bowel Disease
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastroenteritis
Intestinal Diseases
Colitis

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

ClinicalTrials.gov processed this record on September 10, 2009