Hypnotherapy for irritable bowel syndrome: streamlining provision
| ISRCTN | ISRCTN61738583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61738583 |
| Protocol serial number | RfPB PB-PG-0906-10134 |
| Sponsor | National Institute for Health Research (UK) |
| Funder | National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit Programme ref: RfPB PB-PG-0906-10134 |
- Submission date
- 30/09/2011
- Registration date
- 10/01/2012
- Last edited
- 05/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Hypnotherapy has been shown to work as a treatment of irritable bowel syndrome (IBS). However, it has not been widely adopted by healthcare providers and this is probably because it is very time consuming and no set guidelines exist. It seems likely that hypnotherapy might be used more readily if it could be delivered over a shorter period of time and the technique better described so that therapists would find it easy to use the same methods.
This study aims to establish whether a short course of well described hypnotherapy works as well as conventional hypnotherapy where the sessions can be rather long and the content is dependent on the style of the therapist.
Who can participate?
The trial will be open to men and women between the ages of 18 and 65 who have irritable bowel syndrome without any other illnesses that could interfere with treatment.
What does the study involve?
A short course of six sessions of completely scripted hypnotherapy (like having a manual) will be compared with conventional hypnotherapy which involves twelve sessions of unscripted treatment.
What are the possible benefits and risks of participating?
All patients will receive one or other of the forms of hypnotherapy and should, therefore, experience benefit from the treatment. However, if the patients receiving the short form of treatment are seen to not do so well, they will be offered further treatment sessions in order to try and improve them further. Hypnotherapy has no side effects and never makes irritable bowel worse.
Where is the study run from?
Wythenshawe Hospital, Manchester (UK)
When is the study starting and how long is it expected to run for?
March 2010 to March 2013.
Who is funding the study?
National Institute for Health Research (UK).
Who is the main contact?
Professor PJ Whorwell
peter.whorwell@manchester.ac.uk
Contact information
Scientific
Education & Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised non-inferiority study comparing two forms of treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Hypnotherapy for irritable bowel syndrome: streamlining provision |
| Study objectives | Abbreviated, highly structured hypnotherapy for irritable bowel syndrome (IBS) is as effective as conventional hypnotherapy for this condition |
| Ethics approval(s) | South Manchester Local Research Ethics Committee, 5 December 2007 ref: 07/Q1403/108 |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome |
| Intervention | Patients are randomly assigned to either the hypnotherapy group or conventional therapy group for treatment of IBS. |
| Intervention type | Other |
| Primary outcome measure(s) |
Combined global outcome score and symptom severity scores |
| Key secondary outcome measure(s) |
1. Hospital Anxiety and Depression score |
| Completion date | 20/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Patients with refractory irritable bowel syndrome who are referred to the unit for hypnotherapy are eligible for this trial 2. Those with no other significant concomitant disease and agreeing to the study, having read the patient information details will be randomised to either of the treatment groups |
| Key exclusion criteria | Any significant concomitant disease that could interfere with the interpretation of the results |
| Date of first enrolment | 20/03/2010 |
| Date of final enrolment | 20/03/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
M23 9LT
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? |
|---|---|---|---|---|---|
| Abstract results | results presented at DDW | 01/04/2015 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/07/2018: Publication reference added.
04/07/2018: No publications found, verifying study status with principal investigator.
16/03/2016: No publications found, verifying study status with principal investigator.
