Research to compare the effect of three different psychological treatments for irritable bowel syndrome

ISRCTN	ISRCTN22888906
DOI	https://doi.org/10.1186/ISRCTN22888906
Protocol serial number	NL30698.041.10
Sponsor	University Medical Center Utercht (Netherlands)
Funder	University Medical Center Utrecht (The Netherlands)

Submission date: 14/04/2011
Registration date: 17/06/2011
Last edited: 27/11/2018

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

Not provided at time of registration

Contact information

Mrs Carla Flik
Scientific

Julius Center, Health Sciences and Primary Care
University Medical Center
Sratenum 6.131
Universiteitsweg 100
Utrecht
3584 CG
Netherlands

Phone	+31 88 756 8494
Email	c.e.flik@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Randomised placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Individual or group hypnotherapy in the treatment of irritable bowel syndrome in primary and secondary care
Study acronym	IMAGINE
Study objectives	1. At the end of therapy, patients in the hypnotherapy condition will report more adequate relief than in the educational supportive therapy condition (placebo treatment) 2. Hypnotherapy offered in a group format, is as effective as individual hypnotherapy
Ethics approval(s)	Medical Ethical Committee of the University Hospital Utrecht, 23/02/2011, METC-Protocol No. 10-201/O
Health condition(s) or problem(s) studied	Gastroenterology
Intervention	Patients will be randomly allocated to one of the following: 1. Six sessions of individual hypnotherapy (every 14 days) 2. Six sessions of hypnotherapy in a group consisting of 6 patients (every 14 days) 3. Six sessions of educational-supportive therapy (every 14 days) in a group consisting of 6 patients
Intervention type	Other
Primary outcome measure(s)	Responder rate for IBS symptoms based on a weekly assessment of Adequate Relief (AR) score.
Key secondary outcome measure(s)	1. Changes in the IBS Symptom Severity Score (IBS-SSS) and Quality of life (IBS-Qol) 2. Cognitions, self-efficacy, psychological complaints and direct and indirect costs of the disease, measured as the costs of visits to doctors and alernative healers, use of medicines and loss of labour productiveness
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	354
Key inclusion criteria	1. Patients aged 18-65 years 2. In primary and secondary care 3. Diagnosed with IBS (Rome III criteria)
Key exclusion criteria	1. Patients unable to understand the content of the sessions, because of insufficient command of the Dutch language 2. Patients unable to fill in the questionnaires 3. Patients unable (for example: too agressive) or unwilling to function in a group 4. Patients in whom a psychiatric condition needs attention first (for example severe depression or psychosis) 5. Patients who have IBS in addition to other chronic bowel diseases, as far as they are already diagnosed, such as ulcerative colitis, Crohn's disease or coeliac disease 6. Patients who have undergone major surgery to the lower gastrointestinal tract, such as partial or total colectomy, small bowel resection or partial or total gastrectomy
Date of first enrolment	01/05/2011
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

Netherlands

Study participating centre

Julius Center, Health Sciences and Primary Care

Utrecht
3584 CG
Netherlands

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?
Results article	1. results	20/12/2011		Yes	No
Results article	results	01/01/2019		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/11/2018: Publication reference added.
16/03/2016: Publication reference added.