Hypnotherapy in inflammatory bowel disease. A randomised, placebo-controlled trial
| ISRCTN | ISRCTN37515330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37515330 |
| Secondary identifying numbers | N0515107957 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 07/01/2002 |
| 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 number of participants | 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
- England
- United Kingdom
Study participating centre
St Mark's Academic Institute Level 5X
Harrow
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
North West London Hospitals NHS Trust (UK) NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
27/02/2020: No publications found. All search options exhausted.
