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

溃疡性结肠炎(UC)和肠易激综合征(IBS)是与腹痛和不明原因的排便习惯改变相关的令人苦恼的慢性疾病。之前DFG资助的一项研究和其他研究的结果表明，在这两种疾病中，疾病焦虑水平的增加和功能障碍的症状预期有助于症状的持久性。因此，比较这两种疾病在胃肠道症状的持续性和改良性方面的共同因素和疾病特异性因素似乎是合理的。在一项初步研究中，15名UC患者(平均年龄44.1岁+15.6岁，女性占80%)和20名IBS患者(平均年龄38.3±13.6岁，女性占65%)认为“应对焦虑”和“提高期望”这两个主题非常重要。他们还表示有强烈的兴趣接受干预，以简短的个人在线咨询形式解决这些问题。我们的主要假设是，UC和IBS的持续性胃肠道症状可以通过使用期望管理策略修改功能障碍症状预期和疾病相关焦虑来改善。其次，我们假设UC和IBS持续存在胃肠道症状的其他生物、心理和社会因素是可以识别的。第三，在探索性方法中，我们旨在比较导致症状加重和持续的危险因素。为了评估成人UC和IBS患者持续躯体症状的可修改程度，我们将进行一项观察者盲法、三臂随机对照概念验证试验。共有117名UC患者和117名IBS患者将被随机分为3组，规模相等：在标准护理(干预1)的基础上进行旨在减少疾病相关焦虑和功能障碍症状预期的有针对性的期望管理(干预1)，在标准护理(干预2)的基础上进行非特异性支持性治疗(干预2)，或仅进行标准护理(对照)。这两个积极干预组将包括3个单独的视频咨询会议和3个月后的助推器会议。主要结果是介入治疗后胃肠道症状严重程度的基线变化。这项研究将阐明有针对性的期望管理干预对UC和IBS患者持续胃肠道症状的疗效和作用机制。此外，这将有助于更好地了解持续性胃肠道症状的发展，并澄清哪些风险因素和机制是特定于疾病的，哪些是跨疾病有效的。最终，对导致UC和IBS胃肠道症状持续存在的复杂生物-心理-社会机制的详细分析将使循证干预措施的发展成为可能，以减少令人痛苦的持续症状。

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.