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

Abstract 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.