Trial Details

Not Recruiting
Basic Information
Clinical ID c3369
Identifier ISRCTN37515330
Trial Title Hypnotherapy in inflammatory bowel disease. A randomised, placebo-controlled trial
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Digestive System: Inflammatory bowel disease Digestive System _ 1. Crohn's disease_ 2. Ulcerative colitis_
Interventions We plan to recruit sixty patients who will be randomised into one of the four arms of our study. There will be a complex stratification given the many parameters that may effect quality of life issues. This will include age, sex, disease type (Crohn's or ulcerative colitis), use of immunosuppressants, and presence/absence of stoma. The first group (n=15) will have 6 gastroenterological input sessions (one session per week) conducted by a Gastroenterology Registrar at St Mark's Hospital. These sessions will consist of a 20 minute consultation with each individual on different issues concerning the patient's gastroenterological problems. The rationale of this control group is to permit the assessment of the possible superiority of hypnotherapy over informal psychological therapy. The third and fourth (placebo) group (n=30) will receive no treatment during the first 6 week-period of the study, however they will then be randomised into either the hypnotherapy or gastroenterological input therapy which will both be administered for the subsequent six weeks. The primary end-point of the study will be a change in the patient's quality of life assessment by the disease specific inflammatory bowel disease questionnaire (IBDQ). Secondary end-points will include improvements in the EuroQol quality of life index, and (depending on the underlying inflammatory bowel disease) either the modified Crohn's disease activity index (mCDAI) or the ulcerative colitis scoring system Crohn's disease (unless clinically indicated) The IBDQ and EuroQol will be administered at weeks 0, 6, 12 and 18. The mCDAI or UCSS will be assessed at weeks 0,6,12 and 18, with the exception of sigmoidoscopy (needed for the UCSS) which will only be performed twice or three times in patients with ulcerati
Participant Information
Sponsor Department of Health
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2005-03-31