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.

 

[rvallee]

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).

Even by the standards of "Imagine a world"-based medicine, this is a new low. "Imagine a group of controls who would have done what we wanted them to do". How did they determine controls who would have? With our friends: lies, damned lies, and statistics:

Latent mixture modelling was undertaken to identify participants who would adhere in the care as usual group using the following predictors that were selected a priori: age, gender, education level, employment status, relationship status, and symptom scores for pain, fatigue, and incontinence.

Why would a serious medical journal publish nonsense like this? The Lancet seems not much interested in being serious.

The care as usual group knew that they would be offered access to the intervention (without a facilitator) after returning 12-month outcome measures.

They don't appear to include the numbers who did, which suggests that probably none did.

IBD-BOOST is a 12-session, interactive, digital, facilitator-supported intervention based on a theoretically informed logic model of gut–brain psychological mechanisms that contribute to symptom maintenance

"A theoretically informed logic model" is some grade A bullshit when you can't use theoretical because there is no actual theory behind this, just wild speculation. How does crap like this even get published?

The IBD-BOOST group received access to the IBD-BOOST programme for 6 months.

388 (99%) of 391 participants completed registration, 346 (89%) completed session 1, and 45 (12%) did not complete any sessions.

221 (57%) of 391 participants in the IBD-BOOST group completed the pre-defined adherence dose of four sessions

They defined 'compliance' as 4 sessions. The program is designed for 12. This is terrible adherence.

Participants in the IBD-BOOST group had better quality of life according to the EQ-5D utility score than did the care as usual group at 6 months (table 2), but a significant difference was not observed at 12 months.

This is almost a universal pattern, and it has been massively abused on the fiction of needing 'boosters', when in fact it's just a reflection of the bias in the trials.

And, see, they simply decided that it didn't work because of low adherence, so they simply have to figure out how to get people to adhere/comply and job's done:

As with many digital interventions, adherence to IBD-BOOST was low. Only 221 (57%) of 391 participants in the IBD-BOOST group completed the pre-defined adherence dose of four sessions. Complier-averaged causal effects analysis suggested that participants who complied with IBD-BOOST reported significantly higher UK-IBDQ than participants who would have complied in the care as usual group. This finding suggests that the null effects could relate to insufficient uptake of IBD-BOOST, although the same effects were not found for Global Rating of Symptom Relief.

I don't know if this is the first time it's happened or I just happened to notice, but the framing of compliance, rather than adherence, is very odd. Especially as they switch back and forth as if they are equivalent.

And of course you have to imagine a totally different health care system that could provide such a thing, which they acknowledge it does not support their wild fantasy that they simply need to do more to get the compliance they assume would magically work:

The decision to use non-CBT-trained facilitators for IBD-BOOST was pragmatic as few gastroenterology services in the UK have access to trained CBT therapists, but nearly all have IBD nurses. The choice of only one 30-min session with a facilitator alongside on-site messaging once per week was based on interviews, which suggested IBD nurses would not have time for more support.26 This amount of time might have been insufficient to maximise uptake.

So this is very much like the delusional PACE model, which even Wessely acknowledged was not feasible for requiring resources that simply don't exist. But they got away with it. In both cases out of null result.

The ideology can never fail, it can only be failed. What a complete waste of resources. The people in charge of medical research are doing a terrible job for encouraging junk like this. All this money could have gone to real research instead, but it's completely wasted.