Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Department of Psychology, Helmut Schmidt University, University of the Federal Armed Forces, Hamburg, Germany.
BMJ Open. 2022 Jun 14;12(6):e059529. doi: 10.1136/bmjopen-2021-059529.
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 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. 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.
To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). Both active intervention groups will comprise three individual online consultation sessions and a booster session after 3 months. The primary outcome is baseline to postinterventional change in gastrointestinal symptom severity.
The study was approved by the Ethics Committee of the Hamburg Medical Association (2020-10198-BO-ff). 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. Furthermore, the detailed analysis of the complex biopsychosocial mechanisms will allow the further advancement of aetiological models and according evidence-based intervention strategies.
ISRCTN30800023.
溃疡性结肠炎（UC）和肠易激综合征（IBS）是两种令人痛苦的慢性疾病，其特征为腹部疼痛和排便习惯改变，病因不明。先前的研究结果表明，在这两种疾病中，与疾病相关的焦虑水平升高和功能性症状预期的改变会导致症状持续存在。因此，比较这两种疾病在胃肠道症状持续存在和改变方面的共同和疾病特异性因素是合理的。我们的主要假设是，通过使用预期管理策略来改变 UC 和 IBS 患者中与疾病相关的焦虑和功能性症状预期，可以改善持续性胃肠道症状。
为了评估在 UC 和 IBS 成年患者中，持续性躯体症状在多大程度上可以通过改变功能性症状预期和与疾病相关的焦虑来改善，我们将进行一项观察者盲、三臂随机对照试验。共有 117 例 UC 患者和 117 例 IBS 患者将被随机分为三组，每组人数相等：除标准护理（SC）外，还针对目标进行预期管理，以降低与疾病相关的焦虑和功能性症状预期（干预 1）；除 SC 外，还进行非特异性支持性治疗（干预 2）或仅 SC（对照组）。两组干预组都将包括三次在线个别咨询和 3 个月后的一次强化咨询。主要结局是胃肠道症状严重程度从基线到干预后的变化。
该研究已获得汉堡医学协会伦理委员会的批准（2020-10198-BO-ff）。该研究将阐明针对 UC 和 IBS 患者持续性胃肠道症状的靶向预期管理干预的疗效和作用机制。此外，对复杂的生物心理社会机制的详细分析将允许进一步推进病因学模型和相应的循证干预策略。
ISRCTN30800023。
