A study to describe the burden of mental ill health in inflammatory bowel disease patients using advanced therapies, and to identify any associations between common mental health problems and the efficacy of such advanced therapies

Research question Is there a longitudinal relationship in IBD patients that require advanced therapy to suggest that anxiety, depression and perceived stress predisposes to failure of advanced therapy for IBD? Background IBD is most commonly diagnosed in the 2nd and 3rd decades of life, often with debilitating symptoms. IBD and mental illness often co-exist in patients with associated poorer IBD outcomes compared to patients without mental illness. It is unknown whether mental illness impacts the effectiveness or longevity of IBD treatment. We hypothesise that unrecognised or inadequately treated anxiety, depression and perceived stress is a factor that makes advanced therapies less likely to maintain remission of IBD. Aims and Objectives Primary objective: 1. To describe any longitudinal association between IBD activity and symptoms of anxiety, depression and perceived stress in patients using an advanced therapy for IBD. Secondary Objectives: 2. To describe the rate of anxiety, depression and perceived stress in patients using advanced therapies for IBD. 3. To describe the proportion of patients that experience disease activity while using advanced therapies for IBD with pre-existing diagnoses of anxiety and depression compared to those without. Methods Patients receiving Infliximab or vedolizumab attend the infusion unit every 4-8 weeks. Prior to their attendance at the infusion unit, they will be sent a participant information sheet. On the day of their biologic infusion they will be offered the opportunity to participate. This strategy is replicated from the CLARITY study, a highly successful study of COVID in IBD patients that recruited large numbers of patients over a short time period. Once consented, patients contact details will be passed to the Birmingham Centre for Observational and Prospective Studies (BiCOPS) team, who will arrange for them to receive study questionnaires. Baseline demographics including medical and psychological history will be collected. At 4 weekly intervals for 52 weeks, patients will complete validated tools to measure anxiety, depression, perceived stress and IBD disease activity. Statistical analysis will identify the influence of mental health on IBD activity and to describe longitudinal relationships between them. Timelines for delivery REC approval within first month of project start date 1st site (lead trust) open in month 4 All nine planned trusts open by end of month 6 Last patient recruited by end of Month 8 Anticipated Impact and Dissemination Our research is endorsed by Crohn s and Colitis UK, with whom we plan to partner to disseminate our research to key public stakeholders. Our research will be submitted to both national and international conferences as an abstract to present and provoke discussion. Our research will be published in full in a peer reviewed journal. The research will be published by open access to maximize the readership of our work and the potentially impact. The anticipated impact of this research is to design a trial to evaluate treatment for anxiety, depression and perceived stress in patients receiving advanced treatment for IBD to improve outcomes from IBD. Such a study would be a future project, utilizing this research to inform study feasibility and design.