Digital cognitive behavioural self-management programme for fatigue, pain, and faecal incontinence in [IBD]... 2025 Moss-Morris, Norton et al

[Andy]

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

Summary​

Background​

Fatigue, 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.

Methods​

This 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.

Findings​

Between 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.

Interpretation​

IBD-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.

Open access

 

[Andy]

Despite the obvious failure I'm sure this won't derail the CBT gravy train in any way.

 

[Utsikt]

As usual, it’s never the intervention’s fault that it failed, it’s the inflexible patients that refuse to engage with BS programmes..

It’s notable that the effect of this programme was substantially lower than the average effect in a Cochran review.

Spoiler: Cochrane

A 2025 Cochrane review of all individual and cluster-randomised controlled trials of psychological interventions for IBD identified the IBD-BOOST study as the first randomised trial of a psychotherapy intervention to treat fatigue, pain, and faecal urgency or incontinence in IBD. This is the largest randomised controlled trial (n=780) in IBD to date. The Cochrane review included 21 psychotherapy trials (n=1678).

Like IBD-BOOST, most psychotherapy interventions included elements of cognitive behavioural therapy, but only one of these studies was a digital intervention. Most provided face-to-face therapy or remote delivered therapy with a health-care professional. In line with IBD-BOOST, 11 of these studies used UK-IBDQ as an outcome.

The combined standardised mean difference in the Cochrane review was 0·19 (95% CI 0·06 to 0·33), corresponding to a difference in UK-IBDQ of 4·40 (1·09 to 7·70), which is larger than the difference found in IBD-BOOST (mean difference –1·67 [95% CI –4·13 to 0·80]).

This suggests that digitally delivered psychotherapy, and/or psychotherapy that focuses on managing IBD symptoms, is less effective at improving quality of life in IBD than other forms of delivery or interventions specifically targeting quality of life.

Alternatively, IBD-BOOST might have been negatively affected by poor engagement in digital sessions. A complier-averaged causal effects analysis among participants who completed four or more sessions of IBD-BOOST showed larger improvements in UK-IBDQ scores than those who completed care as usual.

As is customary, there is no mention of the issue caused by combining lack of blinding with subjective outcomes.