Ulcerative Colitis Relapse Prevention Trial, Hypnosis
Completed · Not applicable
Conditions studied: Ulcerative Colitis, Inflammatory Bowel Disease
In brief
The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.
Key facts
- Study ID
- NCT00798642
- Run by
- Northwestern University
- People needed
- 55
- Starts
- 2007-07-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2014-04-02
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northwestern University, Feinberg School of Medicine — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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