Evidence map›Paper›PMID 41206261›Full record

Trial reportThe Lancet. Digital health2025

Digital cognitive behavioural self-management programme for fatigue, pain, and faecal incontinence in inflammatory bowel disease (IBD-BOOST): a multicentre, parallel, randomised controlled trial.

Rona Moss-Morris, Christine Norton, Ailsa Hart, Fionn Cléirigh Büttner, Thomas Hamborg, Laura Miller, Imogen Stagg, Qasim Aziz, Wladyslawa Czuber-Dochan, Lesley Dibley and 10 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The Lancet. Digital health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Rona Moss-MorrisDepartment of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London Bridge, London, UK.
Christine NortonFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. Electronic address: christine.norton@kcl.ac.uk.
Ailsa HartSt Mark's Hospital Central Middlesex, London, UK.
Fionn Cléirigh BüttnerPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Thomas HamborgPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Laura MillerUnit for Social and Community Psychiatry, Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University of London, Newham Centre for Mental Health, London, UK.
Imogen StaggSt Mark's Hospital Central Middlesex, London, UK.
Qasim AzizBlizard Institute, Centre for Neuroscience, Surgery and Trauma, Wingate Institute, Queen Mary University of London, UK.
Wladyslawa Czuber-DochanFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.
Lesley DibleyInstitute for Lifecourse Development, Faculty of Education, Health and Human Sciences, University of Greenwich, Eltham, London, UK.
Megan English-StevensCambridge, UK.
Julie FlowersBristol, UK.
Serena McGuinnessLearning & Research Building, Southmead Hospital, Bristol, UK.
Borislava MihaylovaHealth Economics and Policy Research Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Richard PollokSt George's University of London and NHS Trust, Department of Gastroenterology, St George's Hospital, London, UK.
Chris RoukasHealth Economics and Policy Research Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Sonia SaxenaSchool for Public Health, Imperial College London, London, UK.
Louise SweeneyDepartment of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London Bridge, London, UK.
Stephanie TaylorWolfson Institute of Population Health, Queen Mary University of London, London, UK.
Vari WilemanDepartment of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London Bridge, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFatigue, pain, and faecal urgency or incontinence are common, debilitating symptoms in inflammatory bowel disease (IBD). We developed IBD-BOOST, a digital, interactive, facilitator-supported, self-management intervention, and aimed to assess its effects compared with care as usual in relieving these symptoms and improving quality of life.

methodsThis multicentre, parallel, randomised controlled trial was conducted online in the UK, with allocation concealment maintained. Participants aged 18 years or older with IBD who rated the impact of fatigue, pain, and faecal urgency or incontinence as 5 or more on a 0-10 scale in a UK national survey were invited. Participants were randomly assigned (1:1) to the online IBD-BOOST programme or care as usual for 6 months via computer-generated randomisation. Primary outcomes were UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and Global Rating of Symptom Relief at 6 months post-randomisation. All randomly assigned participants were included in the intention-to-treat and harms analysis. This trial is registered with ISRCTN.com (ISRCTN71618461) and is closed.

findingsBetween Jan 20, 2020, and July 27, 2022, 4449 participants were invited to participate, and 780 participants were randomly assigned: 391 to IBD-BOOST and 389 to care as usual. 524 (67%) of 780 participants were female and 253 (32%) were male. At 6 months, there were no statistically significant differences for UK-IBDQ between the care as usual group (unadjusted mean 62·09 [SD 14·42]) and the IBD-BOOST group (unadjusted mean 60·85 [SD 16·08]; treatment effect estimate: adjusted mean difference -1·67 [95% CI -4·13 to 0·80], p=0·19) or for Global Rating of Symptom Relief (unadjusted mean 3·65 [2·75] vs 4·13 [2·81]; adjusted mean difference 0·44 [95% CI -0·56 to 1·44], p=0·39). Complier-averaged causal effects analysis demonstrated that participants who complied with IBD-BOOST reported lower UK-IBDQ scores than those who would have complied in the care as usual group (mean difference -2·39 [95%CI -4·34 to -0·45], p=0·016). Adverse events and serious adverse events were similar between the IBD-BOOST group (55 [14%] of 391) and care as usual group (79 [20%] of 389). There was one possible treatment-related serious adverse event in the IBD-BOOST group (recurrent sleep disorder) and no deaths.

interpretationIBD-BOOST did not statistically significantly improve disease-specific quality of life or Global Rating of Symptom Relief in patients with IBD with fatigue, pain, or faecal urgency or incontinence compared with care as usual. People who complied with the intervention appeared to derive benefit. Future research should focus on enhancing compliance with interventions and targeting them to individuals most likely to benefit.

fundingUK National Institute for Health and Care Research.

Indexed as

Cognitive Behavioral TherapyFatigueFecal IncontinenceInflammatory Bowel DiseasesPainPain ManagementSelf-ManagementAdultAgedFemaleHumansMaleMiddle AgedQuality of LifeSurveys and QuestionnairesUnited Kingdom

Identifiers

PMID41206261

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.