Moss-Morris, Rona, Norton, Christine, Hart, Ailsa, Büttner, Fionn Cléirigh, Hamborg, Thomas, Miller, Laura, Stagg, Imogen, Aziz, Quasim, Czuber-Dochan, Wladyslawa, Dibley, Lesley ORCID: https://orcid.org/0000-0001-7964-7672, English-Stevens, Megan, Flowers, Julie, McGuinness, Serena, Mihaylova, Borislava, Pollock, Richard CG, Roukas, Chris, Saxena, Sonia, Sweeney, Louise, Taylor, Stephanie and Wileman, Vari (2025) Digital cognitive behavioural self-management programme for fatigue, pain and faecal incontinence in inflammatory bowel disease: the IBD-BOOST randomised controlled trial. Lancet Digital Health. ISSN 2589-7500 (Online) (In Press)

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Abstract

Background: Fatigue, pain, and urgency/faecal incontinence (FI) are common, debilitating symptoms in inflammatory bowel disease (IBD). We developed IBD-BOOST, a digital, interactive, facilitator-supported, self-management intervention to address these symptoms.
Methods: Objective: to assess the effects of IBD-BOOST compared with care as usual (CAU) in relieving symptoms and improving QoL in people with IBD experiencing fatigue, pain and/or urgency/FI. A multi-centre, two-arm, parallel-group, individually randomised controlled trial with computer-generated randomisation maintaining allocation concealment, was conducted. Patients with IBD who rated the impact of fatigue, pain, and/or FI as ≥5/10 in a UK national survey were invited. The intervention was 6 months access to the online IBD-BOOST programme; the control group received CAU. Primary outcomes were UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief (GRSR) at 6 months post-randomisation. Pre-specified subgroup analyses investigated the influence of irritable bowel syndrome, depression, anxiety, and active IBD at baseline on the effect of the trial intervention on each primary outcome.
Findings: Participants (N=780) were randomised to the IBD-BOOST intervention (n=391) or CAU alone (n=389). 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). Complier-averaged causal effects analysis demonstrated that participants who complied with the intervention reported lower/better UK-IBDQ scores than ‘would-be’ compliers receiving CAU alone (mean difference=-2.39 (95%CI=-4.34, -0.45), p=0.02). Subgroup analyses did not identify any statistically significant treatment effect modifiers. Serious adverse events were similar between the intervention (n=55, 14%) and CAU (n=79, 20%).
Interpretation: IBD-BOOST did not significantly improve disease-specific QoL or global rating of symptom relief in IBD patients with fatigue, pain, and/or urgency/FI compared to CAU. People who complied with the intervention appeared to derive benefit.
Funding: NIHR(RP-PG-0216-20001)
Trial registration: https://www.isrctn.com/ISRCTN71618461

Item Type:	Article
Uncontrolled Keywords:	fatigue, pain, urgency, inflammatory bowel disease, online inetrvention, self-management
Subjects:	R Medicine > R Medicine (General) R Medicine > RB Pathology T Technology > T Technology (General)
Faculty / School / Research Centre / Research Group:	Faculty of Education, Health & Human Sciences Faculty of Education, Health & Human Sciences > Institute for Lifecourse Development Faculty of Education, Health & Human Sciences > Institute for Lifecourse Development > Centre for Chronic Illness and Ageing Faculty of Education, Health & Human Sciences > School of Health Sciences (HEA)
Last Modified:	22 Jul 2025 11:40
URI:	https://gala.gre.ac.uk/id/eprint/50845

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