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

Andy

Senior Member (Voting rights)
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
 
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.

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.
 
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.
 
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:

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

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

"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?



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

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:

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:

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.


"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."

These aren't therefore just nurses being asked to give a pill at the right time to someone and then if the experiment shows it didn't work they go away unchanged. Or learning to keep a straight face for 10secs even wilst they deliver a lie, fully knowing this is a lie that may or may not work for the purposes of an experiment (so don't take it on board too much). They are getting trained in something that is intended to embed and inbue itself on how they look at their entire patient cohort from this point forward. Claiming it's 'therapy'. And the experiment bit is just forgotten.

They'll forever now think differently and probably think that's 'a therapy' even though this sort of thing proving it neither works nor doesn't harm means it isn't a 'therapy' because it doesn't help and now can't be said that's what is foreseeable from doing it to someone. We need a new term for things that are just meddling 'interventions' that never had any benefit at all, and require people like the authors above to call themselves 're-thinking techniques that might cause harm' until it is proven otherwise with every single person they train in it, so they don't go around misinformed and using it on people under the false pretence it does good by using that inaccurate term of therapy.

I'm not being cynical in also thinking that of course even if the therapy turns out to not just be useless in what it claims it will do, but harmful in its intention ('have you tried thinking your way out of fecal incontinence' is required before someone gives adjustments or signs it off as a disability)

The main reason for training nurses and staff in these clinics is actually to change their mindset. And then even when it turns out to be BS and harmful they don't and can't remove what is effectively nonsense-thinking out of their head and deprogramme them. SO they then have really done what might well have been the intention all along which is to convert people who are supposed to have been trained in medicine and facts based on the illness in their propagandic manifesto of the opposite.

If you'd just had x number of days of being corrected and forced to now communicate with people in a certain way - trouble enough, and should not be sneaking its way into healthcare to use CBT style - and in 'ideas' even if they are as evidenced as spoon-bending that maybe thinking will change people's symptoms so those with bad symptoms maybe aren't working on their thinking enough. Then most won't just 'drop it' and be able to shake it off and go back to who they were before.

SO they've now been trained in a certain attitude to patients and a certain distorted filter for hearing them or seeing straight on symptoms.

Even when post-hoc the claim of 'it might work' has been proven to be nonsense. So was used as an excuse to get the foot in the door and all of these people have now had their minds distorted, people who are on the front line and who are hearing what a patient says, does or their symptoms and translates that into what actually goes into their notes and history.

ANd of course even if those licensed in these areas so they had oversight and regulation on delivering these 'therapies', so that if it turns out one was dangerous you'd hope the licensing organisation of the CBT people would require them to deprogramme themselves and stop doing it, even if it was them that let them be trained, they are picking on focusing on spreading it out specifically to those who aren't regulated or licensed for this. SO that never happens.

I just see this kind of thing as a weapon/mechanism that allows propagandic training that somehow they aren't responsible for either the consequences of or undoing. Just like the fake research is. But worse. And it needs to be stopped being left open as a loophole.
 
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