Ulcerative Colitis Relapse Prevention Trial, Hypnosis (UCRPT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laurie Keefer, Northwestern University
ClinicalTrials.gov Identifier:
NCT00798642
First received: November 25, 2008
Last updated: April 1, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

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 ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798642

Locations
United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Laurie Keefer, PhD Northwestern University
  More Information

Additional Information:
No publications provided by Northwestern University

Additional 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: R21 AT003204, R21AT003204
Study First Received: November 25, 2008
Last Updated: April 1, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014