Hypnotherapy in inflammatory bowel disease. A randomised, placebo-controlled trial

ISRCTN	ISRCTN37515330
DOI	https://doi.org/10.1186/ISRCTN37515330
Protocol serial number	N0515107957
Sponsor	Department of Health
Funder	North West London Hospitals NHS Trust (UK) NHS R&D Support Funding

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 27/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alastair Forbes
Scientific

St Mark's Academic Institute Level 5X
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Hypnotherapy in inflammatory bowel disease. A randomised, placebo-controlled trial
Study objectives	Patients with chronic inflammatory bowel disease have an impaired quality of life compared to healthy controls. The most prevalent problems are not only disease related symptoms (e.g. diarrhoea and abdominal pain), but also worries about subsequent exacerbations, surgery, cancer, social restrictions and sexual dysfunction. These symptoms are often in considerable disparity to apparent disease activity. Hypnosis is an altered state of consciousness, trying to focus the mind's inner unconscious resources to activate or inhibit a psychological or a physiological response. Hypnotherapy has been used successfully as an aid to treat many conditions of medical and psychological origin. In gastroenterology, hypnotherapy has been shown by previous studies to be highly effective in the treatment of refractory irritable bowel syndrome and has also been tried in organic disorders. To our knowledge, hypnotherapy has not been formally assessed in patients with inflammatory bowel disease. We hypothesise that hypnotherapy has the ability to improve quality of life in symptomatic patients with inflammatory bowel disease when offered as an adjunct to conventional therapy. We propose to study the efficacy of individual hypnotherapy in the symptomatic treatment of patients with inflammatory bowel disease. It will be a randomised, placebo-controlled trial comparing individual hypnotherapy, 'gastroenterological input' therapy and placebo.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Digestive System: Inflammatory bowel disease
Intervention	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 ulcerative colitis at 0 and 6 weeks, or at 0, 6 and 12 weeks in those in the delayed are) and not at all in patients with Crohn's disease (unless clinically indicated).
Intervention type	Other
Primary outcome measure(s)	The primary end-point of the study will be a change in the patients' perception of their overall status as assessed by the disease specific inflammatory bowel disease questionnaire (IBDQ). The secondary end-point of the study will be the improvement of the inflammatory bowel disease activity indices: modified Crohn's disease activity index (CDAI) and ulcerative colitis scoring system (UCSS). Hypnotherapy is a psychological treatment of uncertain mechanism of action. We would expect it to target mainly quality of life problems and functional symptoms related to inflammatory bowel disease rather than the inflammatory process itself. Nevertheless, there is evidence in favour of the concept that brain-gut interaction can modify inflammatory intestinal responses as well
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	Total number 60, hypnotherapy group 15, gastrointestinal input group 15 delayed treated (placebo) group 30 (delayed hypnotherapy 15, delayed gastroenterological input therapy 15. The age range will be 18-80 years.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	07/01/2002
Date of final enrolment	31/03/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St Mark's Academic Institute Level 5X

Harrow
HA1 3UJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/02/2020: No publications found. All search options exhausted.