Persistence of Gastrointestinal Symptoms in Irritable Bowel Syndrome and Ulcerative Colitis: From Risk Factors to Modification (RU SOMACROSS)

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Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown aetiology. Results from a previous DFG-funded study and other studies indicate that, across both diseases, increased levels of illness anxiety and dysfunctional symptom expectations contribute to symptom persistence. Thus, comparing both disorders with regard to common and disease specific factors in the persistence and modification of gastrointestinal symptoms seems justified. In a pilot study, 15 patients with UC (mean age 44.1 plusminus 15.6 years, 80% female) and 20 patients with IBS (mean age 38.3 ± 13.6 years, 65% female), considered the topics "dealing with anxiety" and "improving expectations" highly important. They also indicated strong interest in undergoing an intervention addressing these topics in a short individual online-consultation format.Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies. Second, we hypothesise that additional biological, psychological and social factors contributing to the persistence of gastrointestinal symptoms in both UC and IBS can be identified. Third, in an explorative approach, we aim to compare risk-factors leading to symptom aggravation and persistence.To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, 3-arm randomised controlled proof-of-concept trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into 3 groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (intervention 1), non-specific supportive treatment in addition to standard care (intervention 2), or standard care only (control). Both active intervention groups will comprise 3 individual video consultation sessions and a booster session after 3 months. Primary outcome is baseline to post-interventional change in gastrointestinal symptom severity. The study will shed light onto the efficacy and action mechanisms of a targeted expectation management intervention for persistent gastrointestinal symptoms in patients with UC and IBS. Further, it will enable a better understanding of the development of persistent gastrointestinal symptoms and clarify which risk factors and mechanisms are disease-specific and which are effective across diseases. Eventually, this detailed analysis of the complex biopsychosocial mechanisms that lead to the persistence of gastrointestinal symptoms in UC and IBS will allow the development of evidence-based interventions to reduce distressing persistent symptoms.