Structure of the programme
The overarching aim of this programme was to improve the quality of life (QoL) of people living with inflammatory bowel disease (IBD) by reducing the burden of their most common and troublesome chronic symptoms of fatigue, pain and urgency/faecal incontinence (FI). We aimed to achieve this by working closely with people living with IBD to develop and test tools to identify these symptoms, and help optimise medical management, and by developing and evaluating an online, facilitator-supported self-management intervention based on cognitive behavioural (CB) principles. Figure 1 shows the structure of the programme, divided into three main work packages (WPs), with additional work to that originally proposed completed in each WP, plus dissemination threaded throughout the programme.
FIGURE 1 Structure of the IBD-BOOST programme. (Figure not reproduced here; see the original article.)
Rationale for the inflammatory bowel disease-BOOST research programme
Inflammatory bowel disease includes predominantly Crohn’s disease (CD) and ulcerative colitis (UC), and is increasing worldwide, with a prevalence approaching 1% of the population in countries following a ‘Western’ diet.1 IBD affects over 500,000 people in the UK, causing unpredictable bouts of gut inflammation, with acute illness, diarrhoea and pain. The cause has yet to be fully defined, but it is a combination of genetic and environmental factors, with the gut microbiota likely playing an important role. There is no current cure for IBD, which often starts in childhood or as a young adult. The primary aim of medical management is tight control of inflammation using a variety of medications, and most previous IBD research has focused on this.
Despite advances in treatments, even when disease activity appears to be under control, people often experience debilitating symptoms, in particular fatigue, pain and urgency/FI. These symptoms have a major impact on people’s QoL and ability to work and socialise.2 Patients report that these symptoms are not taken seriously by health professionals and report that little help is given.3–5 An IBD research priority-setting consensus placed fatigue, pain and FI in the top 10 issues that IBD patients and clinicians want addressed by research.6
Our programme, shaped by the concerns of our patient and clinician stakeholders, focused on mapping the problems and developing and testing a supported online self-management intervention for these symptoms.
Changes to the programme as originally planned
The most significant changes made to the programme since our application were adjustments to the impact of the coronavirus disease discovered in 2019 (COVID-19) pandemic. Generally, we were well placed, as the majority of our work, including the intervention and collection of outcome measures, already were or could be moved online. However, the pandemic necessitated these changes:
- Prolonging the programme for 1 year.
- Adding to the sample for our survey from an unselected population recruited from clinical and other unselected databases by including participants self-selected via social media advertising.
- Reducing the sample size for the Optimise checklist and algorithm from 1000 to 200 (as a feasibility study) as most NHS clinical sites were unable to recruit for us (sites reduced from 20 to 4). This limited our ability to draw clinical or QoL conclusions from this study.
- Because of the limited sample size for Optimise, we were unable to follow the planned flow of participants from Survey to Optimise to the randomised controlled trial (RCT) and so were not able to test if optimising symptoms prior to the RCT had an effect.
- IBD nurses were often redeployed, and few were able to act as facilitators for our IBD-BOOST intervention. We therefore trained psychology graduates as additional facilitators (and compared their performance with the nurses who we did manage to train).
- Adding a survey into the process evaluation of the RCT to gauge the impact of the pandemic on participant engagement with the RCT intervention.
In addition, we were further delayed by a cyber security incident which affected our data safe haven during which we had no access to our data, delaying our final analyses by a further 4 months (necessitating a further no-cost extension). We are confident that there has been no damage to our data.
Throughout the programme, we have undertaken additional work not anticipated in the original application. This is summarised in Figure 1 as added-value work and reported throughout this report as additional work.
This synopsis summarises the 22 papers produced by the IBD-BOOST programme. These can be found in Table 1. All works from the programme are published or submitted for publication.
| WP and paper number | Authors | Journal and doi | Open access manuscript |
|---|---|---|---|
| WP1a, Paper 1: Patient strategies for managing the vicious cycle of fatigue, pain and urgency in Inflammatory Bowel Disease: impact, planning and support7 | Dibley, Khoshaba, Artom, Van Loo, Sweeney, Syred, Windgassen, Moffatt, Norton and members of the IBD-BOOST PPI team | Dig Dis Sci 2021;66:3330–42https://doi.org/10.1007/s10620-020-06698-1 | https://kclpure.kcl.ac.uk/portal/en/publications/patient-strategies-for-managing-the-vicious-cycle-of-fatigue-pain |
| WP1a, Paper 2: Developing an online program for self-management of fatigue, pain, and urgency in Inflammatory Bowel Disease: patients’ needs and wants8 | Fawson, Dibley, Smith, Batista, Artom, Windgassen, Syred, Moss-Morris, Norton | Dig Dis Sci 2022;67:2813–26https://doi.org/10.1007/s10620-021-07109-9 | https://kclpure.kcl.ac.uk/portal/en/publications/developing-an-online-programme-for-self-management-of-fatigue-pai |
| WP1a, Paper 3: Inflammatory bowel disease nurses’ views on taking on a new role to support an online self-management programme for symptoms of fatigue, pain and urgency: a qualitative study to maximise intervention acceptance9 | Matthias, Fawson, Yan, Sweeney, Moss- Morris, Norton | Gastrointest Nurs 2021;19:28–35https://doi.org/10.12968/gasn.2021.19.9.28 | https://kclpure.kcl.ac.uk/portal/en/publications/inflammatory-bowel-disease-nurses-views-on-taking-on-a-new-role-t |
| WP1b, Paper 4: Targets for interventions for faecal incontinence in inflammatory bowel disease: a systematic review10 | Proudfoot, Norton, Artom, Didymus, Kubasiewicz and Khoshaba | Scand J Gastroenterol 2018;53:1476–83 https://doi.org/10.1080/00365521.2018.1543451 | https://kclpure.kcl.ac.uk/portal/en/publications/targets-for-interventions-for-faecal-incontinence-in-inflammatory |
| WP1b, Paper 5: A novel digital self-management intervention for symptoms of fatigue, pain, and urgency in inflammatory bowel disease: describing the process of development11 | Sweeney, Windgassen, Artom, Norton, Fawson, Moss-Morris | JMIR Form Res 2022;6:e33001https://doi.org/10.2196/33001 | https://kclpure.kcl.ac.uk/portal/en/publications/a-novel-digital-self-management-intervention-for-symptoms-of-fati |
| WP1c, Paper 6: Pain management in inflammatory bowel disease: feasibility of an online therapist supported CBT-based self-management intervention12 | Sweeney, Moss-Morris, Czuber-Dochan, Norton | Pilot Feasibility Stud 2021;7:95https://doi.org/10.1186/s40814-021-00829-9 | https://kclpure.kcl.ac.uk/portal/en/publications/pain-management-in-inflammatory-bowel-disease-feasibility-of-an-o |
| WP1: Paper 7: Development and test–retest reliability of a new, self-report questionnaire assessing healthcare use and personal costs in people with inflammatory bowel disease: the Inflammatory Bowel Disease Resource Use Questionnaire (IBD-RUQ)13 | Roukas, Syred, Gordeev, Norton, Hart, Mihaylova | Frontline Gastroenterol 2022;14:flgastro-2022https://doi.org/10.1136/flgastro-2022-102182 | https://kclpure.kcl.ac.uk/portal/en/publications/development-and-test-retest-reliability-of-a-new-self-report-ques |
| WP2b. Paper 8: Fatigue, pain and faecal incontinence in adult inflammatory bowel disease patients and the unmet need: a national cross-sectional survey14 | Hart, Miller, Cléirigh-Büttner, Hamborg, Saxena, Pollok, Stagg, Wileman, Tzorovili, Aziz, Czuber-Dochan, Dibley, Mihaylova, Moss-Morris, Roukas, McGuiness, Norton | BMC Gastroenterol 2024;24:481https://doi.org/10.1186/s12876-024-03570-8Published abstract: https://doi.org/10.1093/ecco-jcc/jjac190.0099 | Open access from the journal |
| WP2b, Paper 9: Impact of fatigue, pain, and bowel incontinence on the quality of life of people living with Inflammatory Bowel Disease: a UK cross-sectional survey15 | Roukas, Miller, Cléirigh Büttner, Hamborg, Stagg, Hart, Gordeev, Lindsay, Moss-Morris, Norton, Mihaylova | United Eur Gastroenterol J 2025;13:364–75https://doi.org/10.1002/ueg2.12668Published abstract: https://doi.org/10.1093/ecco-jcc/jjac190.0063 | Open access from the journal |
| WP2a and WP2c, Paper 10: Optimising fatigue, abdominal pain, and faecal incontinence in people with Inflammatory Bowel Disease. Feasibility study of a checklist and algorithm for initial nurse-led management: the IBD-BOOST Optimise study16 | Stagg, Cléirigh Büttner, Hart, Fikree, McLaughlin, LeBlanc, Bouri, Hamborg, Miller, Norton | BMJ Open Gastroenterol 2024;11:e001585https://doi.org/10.1136/bmjgast-2024-001585 | Open access from the journal |
| WP3b, Paper 11: Supported online self-management vs. 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 trial17 | Norton, Syred, Kerry, Artom, Sweeney, Hart, Czuber-Dochan, Taylor, Mihaylova, Roukas, Aziz, Miller, Pollok, Saxena, Stagg, Terry, Zenasni, Dibley and Moss-Morris | Trials 2021;22:516https://doi.org/10.1186/s13063-021-05466-4An update for increased sample size was also published in Trials:18 https://doi.org/10.1186/s13063-023-07095-5 | Open access from the journal |
| WP3b, Paper 12: Digital cognitive behavioural self-management programme for fatigue, pain and faecal incontinence in inflammatory bowel disease: the IBD-BOOST randomised controlled trial19 | Moss-Morris, Norton, Hart, Cléirigh Büttner, Hamborg, Miller, Stagg, Aziz, Czuber-Dochan, Dibley, English-Stevens, Flowers, McGuinness, Mihaylova, Pollok, Roukas, Saxena, Sweeney, Taylor, Wileman | Lancet Digit Health 2025;7:e100906 https://doi.org/10.1016/j.landig.2025.100906Published abstract20https://academic.oup.com/ecco-jcc/article/18/Supplement_1/i1240/7586952 | Open access from journal |
| WP3c, Paper 13: Economic evaluation of a digital behavioural self-management intervention for pain, fatigue and faecal incontinence in inflammatory bowel disease: the IBD-BOOST randomised controlled trial | Roukas, Miller, Cléirigh Büttner, Hamborg, Stagg, Hart, Gordeev, Lindsay, Moss-Morris, Norton, Mihaylova | Planned external publication | |
| WP3d, Paper 14: Process evaluation findings contradict RCT results of the IBD-BOOST digital self-management intervention for fatigue, pain and faecal urgency in inflammatory bowel disease: a mixed methods study of patient perspectives21 | Czuber-Dochan, Wileman, Dibley, Paramasivan, Alawi, Moss-Morris, Norton, Taylor | Br J Health Psycholhttps://doi.org/10.1111/bjhp.70035Published abstract https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i2305/7971981 | Open access from the journal |
| WP3d, Paper 15: Supporting patients using a digital self-management Intervention for symptoms of fatigue, pain, and urgency/incontinence in Inflammatory Bowel Disease: a mixed methods process evaluation of trial facilitators22 | Wileman, Moss-Morris, Czuber-Dochan, Dibley, Miller, Stagg, Sweeney, Tze-Yu, McGuiness, Miller, Norton, Taylor | PLOS ONE2026;21https://doi.org/10.1371/journal.pone.0350560 | In press |
| WP3, Paper 16: What is the impact on recruitment of a shortened compared with a standard-length participant information leaflet? PROMETHEUS in IBD BOOST: study within a trial (SWAT), a decentralised randomised controlled trial23 | Miller, Hart, Cléirigh Büttner, Arundel, Hamborg, McGuinness, Moss-Morris, Parker, Relton, Stagg, Sweeney, Wileman, Zenasni, Norton | Trials 2025;26:211 https://doi.org/10.1186/s13063-025-08931-6 | Open access from the journal |
| WP3, Paper 17: The impact of COVID-19 on trial participants’ engagement with IBD-BOOST: a digital cognitive behavioural intervention24 | Honzlova, Sweeney, Norton, Moss-Morris, Wileman | Gastrointest Nurs 2024;22https://doi.org/10.12968/gasn.2024.22.2.114 | Open access from the journal or via https://kclpure.kcl.ac.uk/portal/en/publications/the-impact-of-covid-19-on-trial-participants-engagement-with-ibd- |
| WP3, Paper 18: Development and preliminary evaluation of a suicidal risk assessment protocol in a randomised controlled trial using the Patient Health Questionnaire (PHQ‑9)25 | Wileman McGuinness, Sweeney, Norton, Miller, Stagg, O’Carroll, Moss-Morris | Trials 2024;25:476https://doi.org/10.1186/s13063-024-08276-6 | Open access from the journal |
| WP3, Paper 19: Modifiable psychological factors are associated with symptom clusters of pain, fatigue and faecal incontinence in inflammatory bowel disease: a latent profile analysis26 | Wileman, Chilcot, Norton, Hart, Miller Stagg, Seaton, Moss-Morris | J Crohn’s Colitis 2025;19:jjae183 https://doi.org/10.1093/ecco-jcc/jjae183 | Open access from the journal |
| WP3, Paper 20: The relationships between depression, inflammation and self-reported IBD activity and their impact on healthcare usage27 | Seaton, Wileman, Norton, Moss-Morris | BMC Gastroenterol 2025;25:140 https://doi.org/10.1186/s12876-025-03691-8 | Open access from journal |
| WP4 (dissemination), Paper 21: Chronic abdominal pain in inflammatory bowel disease – a practical guide28 | Baillie, Norton, Saxena, Pollok | Frontline Gastroenterol 2024;15:144–53https://doi.org/10.1136/flgastro-2023-102471 | https://kclpure.kcl.ac.uk/portal/en/publications/chronic-abdominal-pain-in-inflammatory-bowel-disease-a-practical- |
| WP4 (dissemination), Paper 22: What did we learn from the IBD-BOOST research programme?29 | Norton | Gastrointestinal Nurs 2025;23 https://doi.org/10.12968/gasn.2024.0122 | https://kclpure.kcl.ac.uk/portal/en/publications/what-did-we-learn-from-the-ibd-boost-research-programme/ |
Patient and public involvement in the programme
Patient and public involvement (PPI) was a key feature of our programme from the outset and has remained central throughout. People living with IBD were crucial in:
- developing our proposal and framing our research questions
- acting as co-applicants
- chairing and participating in our Programme Steering Committee (PSC: three members throughout)
- active members of our Programme Management committee (two members throughout)
- developing our interventions, surveys and all patient-facing material (such as the intervention, the survey, Optimise checklist and all participant information sheets)
- developing interview schedules and coanalysing all qualitative data
- coauthoring publications and writing plain English summaries for the public
- presenting our findings, including a joint presentation at the European Crohn’s and Colitis Organisation international meeting in 2023.
To achieve this, we worked very closely with Crohn’s and Colitis UK (CCUK) our charity partner; two of their staff were co-applicants. The charity’s contribution was invaluable as they advertised all PPI opportunities for us and helped us interview and select PPI leads when our original lead left the programme, as well as finding replacements for PSC members who left. We worked with our PPI leads and attended patient-facing meetings to spread the word about our programme and seek feedback.
Principal findings of the programme of research
Table 1 summarises the WPs and gives links to the resulting publications.