Hypnotherapy for irritable bowel syndrome: streamlining provision

ISRCTN	ISRCTN61738583
DOI	https://doi.org/10.1186/ISRCTN61738583
Secondary identifying numbers	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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Peter James Whorwell
Scientific

Education & Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Study information

Study design	Randomised non-inferiority study comparing two forms of treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	20/03/2010
Completion date	20/03/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Education & Research Centre

Manchester
M23 9LT
United Kingdom

Sponsor information

National Institute for Health Research (UK)
Government

Research for Patient Benefit Programme
Grange House
15 Church Street
Twickenham
TW1 3NL
United Kingdom

Website	http://www.ccf.nihr.ac.uk/RfPB/Pages/home.aspx/
"ROR"	https://ror.org/0187kwz08

Funders

Funder type

Government

National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit Programme ref: RfPB PB-PG-0906-10134

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	results presented at DDW	01/04/2015		No	No

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.