Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
24/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alastair Forbes

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515107957

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/01/2002

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

07/01/2002

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mark's Academic Institute Level 5X
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

North West London Hospitals NHS Trust (UK) NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes