SOMA.GUT

Persistence of gastrointestinal Symptoms in Irritable Bowel Syndrome and Ulcerative Colitis: From Risk Factors to Modification

Background

Ulcerative colitis (UC) and irritable bowel syndrome (IBS) are distressing chronic diseases associated with abdominal pain and altered bowel habits of unknown origin. Results from a DFG funded study and other previous studies indicate that, across both diseases, increased levels of illness-related 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 CU (44.1 ± 15.6 years, 80% female) and 20 patients with IBS (38.3 ± 13.6 years, 65% female) identified "dealing with anxiety" and "improving expectations" as particularly relevant. They expressed great interest in an intervention that addresses these in a brief individual online format.

Aims

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. Moreover, we expect to identify further biological, psychological, and social factors that contribute to the persistence of gastrointestinal symptoms. Finally, in an exploratory approach, we will compare risk factors as well as aggravating and maintaining factors for gastrointestinal symptom persistence in CU and IBS.

Working programme

To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, nationwide, 3-arm randomised controlled proof-of-concept trial. A total of 117 patients with UC and 117 patients with IBS will be randomly allocated 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 online consultation sessions and a booster session after 3 months. The primary outcome is baseline to post-interventional change in gastrointestinal symptom severity.

Expected impact

The study will shed light onto the efficacy and mechanisms of action of a targeted expectation management intervention for persistent gastrointestinal symptoms in patients with UC and IBS. The study will clarify which risk factors and mechanisms of symptom persistence are disease-specific and which are valid across diseases. Further, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies for persistent somatic symptoms.