Pilot-RCT of an integrative group therapy for patients with refractory irritable bowel syndrome (ISRCTN02977330)

Objective: Different forms of psychotherapeutic treatments have been proven effective in irritable bowel syndrome (IBS), but disorder-oriented and integrative concepts are still rare. Therefore, we implemented and evaluated an integrative group therapeutic concept within an interdisciplinary tertiary care clinic for functional gastrointestinal disorders (FGIDs). Aims: present our integrative group concept, assess feasibility issues, and evaluate efficacy. Methods: A pilot-RCT with a randomized controlled wait-listed group design was conducted. The treatment concept was a disorder-oriented multicomponent group therapy (12 90-min weekly sessions) integrating interactive psychoeducation, gut-directed hypnotherapy, and open group phases. All patients received enhanced medical care and completed a short online diary as an active wait-listed control condition. Inclusion criteria: refractory IBS diagnosed as somatoform autonomic dysfunction of the lower gastrointestinal tract (SAD). Primary outcome: IBS symptom severity (IBS-SSS). Results: Of 294 patients, 220 had IBS (ROME III), 144 were diagnosed as SAD (ICD-10), 51 were eligible regarding inclusion/exclusion criteria, and 30 consented to participate (group intervention: n = 16, wait-listed control condition: n = 14). Only 1 patient dropped out. Intention-to-treat-analysis with repeated-measures mixed ANOVA showed that the group intervention was not significantly superior to the wait-listed control condition. Nevertheless, the calculated effect size for the between-group difference in IBS-SSS at the end of treatment (post) was moderate (d = 0.539). Conclusion: Our disorder-oriented integrative group intervention for IBS proved to be acceptable and feasible in an interdisciplinary tertiary care setting. There is promise in this intervention, but a larger RCT may be needed to investigate efficacy.