Research to compare the effect of three different psychological treatments for the Irritable Bowel Syndrome.

Rationale:

Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care. IBS is a chronic functional gastro-intestinal disorder, characterized by recurrent periods of abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is weak. Several reviews have been written on the effectiveness of psychological therapeutic interventions for these complaints. According to the Clinical practice guideline from the National Institute for Health and Clinical Excellence(NICE), Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy are useful options for patients with refractory IBS in secondary care and for this group of patients the therapies are cost-effective. Hypnotherapy may be considered a promising intervention for IBS, but the evidence is still too limited. Further research is recommended, with special focus on the potential of this intervention as a first line therapy option, with long term follow-up.



Objective:

This study has two main objectives:

1. To assess the efficacy of hypnotherapy on symptoms and quality of life in IBS patients;

2. To compare the efficacy of individual hypnotherapy with a group application of hypnotherapy in IBS treatment.



Study design:

We propose a randomised placebo-controlled trial to evaluate the effects of individual - and group hypnotherapy in the treatment of IBS patients in primary and secondary care. To this end we assess the efficacy of hypnotherapy compared to control therapy and compare the efficacy of group-hypnotherapy to individual hypnotherapy. Follow-up for all patients is 9 months post treatment. In the study period of two years a total of 354 IBS patients will be included in primary and secondary care.



Study population:

Primary care and secondary care patients (aged 18-65) with IBS, consulting their general practitioner, the medical specialist or gastroenterologist.



Intervention:

Patients will be randomly allocated to 6 sessions of individual hypnotherapy, 6 sessions of group-hypnotherapy or 6 sessions of educational-supportive therapy in a group (placebo).



Main study parameters/endpoints:

The primary efficacy parameter is the responder rate for IBS symptoms based on a weekly assessment of Adequate Relief (AR) score. Secondary efficacy parameters are changes in the IBS Symptom Severity Score (IBS-SSS) and Quality of Life (IBS-Qol), cognitions, psychological complaints, self-efficacy and direct and indirect costs of the disease, measured as the costs of visits to doctors and alternative healers, use of medicines and loss of labour productiveness.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

The patient will visit the therapist 7 times (intake + 6 sessions) during treatment, as well as being asked to fill in questionnaires. No adverse events of hypnotherapy in literature have been reported.

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.

Assessments:
1. Prior to start of treatment;

2. End of treatment (after 12 weeks);

3. 9 months after treatment (follow-up).

Patients will be randomly allocated to:

1. 6 sessions of individual hypnotherapy (every 14 days);

2. 6 sessions of hypnotherapy in a group (6 patients)(every 14 days);

3. 6 sessions of educational-supportive therapy (every 14 days) in a group (6 patients).