Condition category
Digestive System
Date applied
30/09/2011
Date assigned
10/01/2012
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Peter James Whorwell

ORCID ID

Contact details

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

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 measures

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

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

http://www.ccf.nihr.ac.uk/RfPB/Pages/home.aspx/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/03/2016: No publications found, verifying study status with principal investigator.