Status:
COMPLETED
Ulcerative Colitis Relapse Prevention Trial, Hypnosis
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Ulcerative Colitis
Inflammatory Bowel Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00798642
Start Date
July 1 2007
End Date
June 1 2012
Last Update
April 2 2014
Active Locations (1)
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1
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611