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Open Access Study protocol

A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study)

Carla E Flik1*, Yanda R van Rood2, Wijnand Laan3, André JPM Smout4, Bas LAM Weusten5, Peter J Whorwell6 and Niek J de Wit7

Author Affiliations

1 Julius Centre for Health Sciences and Primary Care, University Medical Centre, Universiteitsweg 100, 3584 CG Utrecht, The Netherlands

2 Psychiatric policlinic, Leids University Medical Centre, Post box: 9600, 2300 RC Leiden, The Netherlands

3 Julius Centre for Health Sciences and Primary Care, University Medical Centre, Universiteitsweg 100, 3584 CG Utrecht, The Netherlands

4 Department of Gastroenterology and Hepatology, Academic Medical Centre, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

5 St. Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands

6 Education and Research Centre, Wythenshawe Hospital, Manchester, M23 9LT, UK

7 Julius Centre for Health Sciences and Primary Care, University Medical Centre, Universiteitsweg 100, 3584 CG Utrecht, The Netherlands

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BMC Gastroenterology 2011, 11:137  doi:10.1186/1471-230X-11-137

Published: 20 December 2011

Abstract

Background

Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition.

Methods/Design

The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65) with IBS (Rome-III criteria). Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo), with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy.

Discussion

If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs.

Trial registration number

ISRCTN: ISRCTN22888906