Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RfPB PB-PG-0906-10134
Study information
Scientific title
Hypnotherapy for irritable bowel syndrome: streamlining provision
Acronym
Study hypothesis
Abbreviated, highly structured hypnotherapy for irritable bowel syndrome (IBS) is as effective as conventional hypnotherapy for this condition
Ethics approval
South Manchester Local Research Ethics Committee, 5 December 2007 ref: 07/Q1403/108
Study design
Randomised non-inferiority study comparing two forms of treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Irritable bowel syndrome
Intervention
Patients are randomly assigned to either the hypnotherapy group or conventional therapy group for treatment of IBS.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Combined global outcome score and symptom severity scores
Secondary outcome measures
1. Hospital Anxiety and Depression score
2. Quality of life score
3. Non colonic symptom score
4. EQ5D
Overall trial start date
20/03/2010
Overall trial end date
20/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
Any significant concomitant disease that could interfere with the interpretation of the results
Recruitment start date
20/03/2010
Recruitment end date
20/03/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Education & Research Centre
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
National Institute for Health Research (UK)
Sponsor details
Research for Patient Benefit Programme
Grange House
15 Church Street
Twickenham
TW1 3NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit Programme ref: RfPB PB-PG-0906-10134
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
Basic results (scientific)
Publication list
2015 results presented at DDW 2015 https://www.gastrojournal.org/article/S0016-5085(15)32244-7/abstract