Ulcerative Colitis Relapse Prevention Trial, Hypnosis (UCRPT)

Northwestern University

Status

Completed

Conditions

Inflammatory Bowel Disease

Ulcerative Colitis

Treatments

Behavioral: Mind Body Therapy

Behavioral: Hypnotherapy

Behavioral: Standard care

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00798642

R21AT003204 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.

Full 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.

Enrollment

55 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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