Abstract Background Managing fatigue, pain and urgency/ faecal incontinence (FI) represents a key unmet need in holistic treatment of IBD. The IBD-BOOST programme was a 5-year programme evaluating the burden and treatment of these symptoms. Methods A national survey was conducted 1, followed by development and feasibility testing of a checklist for nurse-led optimisation of modifiable causes of symptoms 2. Following this, IBD-BOOST, a digital, interactive, facilitator-supported, self-management intervention to address fatigue, pain and FI was assessed in a multi-centre, two-arm, parallel-group, randomised controlled trial 3. The web-based programme combined educational, behavioural and cognitive strategies delivered through a cognitive behavioural framework. Patients who rated impact of fatigue, pain, and/or FI as ≥ 5/10 in the national survey were invited. The intervention was 6 months access to the online IBD-BOOST programme supported by a facilitator; the control group received are as usual (CAU). Primary outcomes were UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief (GRSR) at 6 months. A cost-effectiveness analysis was performed. Results From the national survey (8486 responses; 54% reporting FI, 24% fatigue and 21% pain)1, 780 participants were recruited to the RCT. At 6 months, there were no statistically significant between-arm differences for UK-IBDQ (mean difference = -1.67 (95%CI = -4.13, 0.80), p = 0.19) and GRSR (mean difference = 0.44 (95%CI = -0.56, 1.44), p = 0.39), but positive trends across outcomes were observed. Engagement with the programme was variable, with 57% of participants completing the minimum “dose” of four sessions. Importantly, complier-averaged causal effects analysis demonstrated that participants who complied with the intervention reported better UK-IBDQ scores than ‘would-be’ compliers receiving CAU alone (mean difference = -2.39 (95%CI = -4.34, -0.45), p = 0.02). Serious adverse events were similar between the intervention and CAU. The intervention was found to be cost-effective, improving generic health-related QoL (EQ-5D-5L) with high probability (90%) of being cost-effective at conventional willingness-to-pay thresholds. Cost savings were -£28,633 (95% CI: -51,555; 18,764) and -£33,568 (-64,421; 26,198) per QALY gained with IBD-BOOST from health services and societal perspectives, respectively. Conclusion The IBD BOOST programme represents an in-depth body of work in holistic IBD care. The RCT is the largest trial of a psychological intervention in IBD fatigue, pain and FI. Although the primary outcome endpoints were not met, patients who engaged with the intervention derived benefit and the intervention was cost-effective. References: 1. Fatigue, pain and faecal incontinence in adult inflammatory bowel disease patients and the unmet need: a national cross-sectional survey. BMC Gastroenterology, 2024. 24: p. https://doi.org/10.1186/s12876-024-03570-8. 2. Optimising fatigue, abdominal pain and faecal incontinence in people with inflammatory bowel disease (IBD-BOOST Optimise): feasibility study of a checklist and algorithm for initial nurse-led management. BMJ Open Gastroenterology, 2024. doi:10.1136/bmjgast-2024-001585. 3. Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial. Trials. 2021 Aug 3;22(1):516. doi: 10.1186/s13063-021-05466-4 Conflict of interest: Hart, Ailsa: Grant: Takeda Personal Fees: Abbvie, Amgen, Arena, AZ, Falk, Celltrion, Eli Lilly, Ferring, Genentech/ Roche, GSK, Pfizer, Takeda, Napp, Pharmacosmos, Janssen (J & J), Bristol-Myers Squibb, Gilead, Galapagos Norton, Christine: Personal Fees: Janssen: lecture fee WebMD lecture fee Medscape symposium fee Merck Pharmaceuticals lecture fee Pfizer advisory board fee Moss-morris, Rona: No conflict of interest Mihaylova, Borislava: No conflict of interest Cléirigh Büttner, Fionn: No conflict of interest Hamborg, Thomas: No conflict of interest Miller, Laura: No conflict of interest Roukas, Chris: None Stagg, Imogen: No conflict of interest Aziz, Qasim: Grant: Classado Pharmaceuticals Takeda Pharmaceuticals Other: My Health Chart - Med Tech Czuber-Dochan, Wladyslawa: Grant: National Institute of Health Research, Bristol Myers Squibb, and Crohn’s and Colitis UK Personal Fees: Dr Falk Pharma UK and PharmaCosmos Dibley, Lesley: No conflict of interest McGuiness, Serena: No conflict of interest Pollok, Richard: I have no potential Conflict of Interest in the past 3 years including grants, honoraria, shares, paid positions, advisory boards, personal fees or non-financial support Saxena, Sonia: No conflict of interest Sweeney, Louise: No conflict of interest Taylor, Stephanie: No conflict of interest Wileman, Vari: No conflict of interest Lindsay, James: Investigator Initiated Research Grant: Takeda, Abbvie, Gilead Personal Fees: I have received fees for speaking and may have received support to attend academic conferences from: Abbvie UK/Global, Bristol Myers Squib, Cornerstones US, Gilead, Galapagos, Lilly, MSD UK, Ferring UK, Ferring Intl., Celltrion, Takeda, Pfizer, Janssen, Tillotts, Other: I serve of the advisory board of Abbvie UK/Global, Alpini, Astra Zeneca, Engytix, Galapagos, Gilead, GSK, Lily, MSD, Ferring UK, Ferring Intl., Celltrion, Takeda, Pfizer, Janssen, Shattucks Laboratory,
Hart et al. (Thu,) studied this question.