Trial By Error: Disastrous Results for Professor Crawley’s Pediatric Online CBT Trial

By David Tuller, DrPH

Pediatrician Esther Crawley, Bristol University’s methodologically and factually challenged grant magnet, has released what seem to be the first outcome results from her much-hyped but fatally flawed FITNET-NHS trial—and they are disastrous. The trial, a pediatric study of online CBT based on similar Dutch research that (falsely) claimed to have proven the effectiveness of the intervention, was granted around one million pounds by the UK’s National Institute for Health and Care Research.

The findings were presented in a poster presentation at a conference last month in Copenhagen. The title: “Cost-Effectiveness of Online Cognitive Behavioural Therapy for Children with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: FITNET-NHS.” The poster was published in the journal Value in Health this month. The conclusion was blunt: “FITNET-NHS (online CBT) is unlikely to be cost-effective compared to online Activity Management within the first 12-months.”

And here’s the larger take-home message: If you spend years over-interpreting unimpressive research findings and making inflated and grandiose claims about the rehabilitative powers of treatment with CBT/GET, regardless of whether the intervention is delivered individually or in groups, in person or online, accompanied by music therapy or not, naked or fully clothed (to ensure I don’t get accused of inaccuracy, I’ll point out this last point is a joke!), at some point your bullshit will come to light. This maxim applies in spades to Professor Crawley, a repeat violator of long-standing scientific standards.

A few years ago, after an investigation prompted by my complaints to the UK’s Health Research Agency, she was ordered to make corrections in the ethics statements of 11 different papers. Her 2017 study of the Lightning Process, which in my view constitutes research misconduct and arguably worse, now carries a 3,000-word correction and a 1,000-word editor’s note offering tortured explanations for why Professor Crawley and her colleagues were allowed to publish the exact same unreliable findings in the revised version of the paper.

Yet these and other black marks on Professor Crawley’s record, such as accusing me publicly of “libellous blogging” and then refusing to explain herself, haven’t prevented her from continuing to rake in public monies for her misguided experimentation—uh, “research”–on vulnerable children. That her work still commands institutional support is a disturbing commentary on the broken ethical compass that apparently guides decision-making at Bristol, UK funding agencies, and the major journals that have published her output.

I first covered Professor Crawley’s work in 2016 after the FITNET-NHS trial was announced, an event that took place at a high-profile press conference at the Science Media Centre (SMC). Despite its self-proclaimed dedication to objectivity, the SMC has always promoted the GET/CBT treatment paradigm for ME/CFS and has helped orchestrate negative press coverage of critics of this psycho-behavioral approach.

In the FITNET-NHS protocol, Professor Crawley and her colleagues promised to recruit more than 700 participants. Half each were to be assigned to the online CBT course and a standard intervention called “activity management.” The CBT program included 19 “psycho-educational and CBT online chapters for children and a parallel programme for parents.” In contrast, children in the activity management group “were supported to understand their baseline activity and to increase their activity amount each week” but were not offered CBT.

Like the bulk of research in this field, FITNET-NHS was an open-label trial relying on self-reported, subjective outcomes–a trial design fraught with the potential for an unknown amount of bias. The primary outcome for assessing the effectiveness of the intervention was physical function on the SF-36 questionnnaire—the same one used in PACE and related trials. To assess cost-effectiveness, the investigators relied on a specific quality-of-life instrument called the EQ-5D-5Y to calculate quality-adjusted life years (QALYs); the threshold for cost-effectiveness was set at £20,000 per QALY, a national standard.

The protocol offered high hopes:

“If FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions.”

Oops! Seems like the evidence–at least for cost-effectiveness is not what Professor Crawley expected. I wonder how she’s coping with this unequivocal failure.


FITNET-NHS recruitment efforts fell far behind the goals

After the SMC press conference, Professor Crawley was all over the media promoting FITNET-NHS. Despite this widespread exposure, the investigators fell far short of their recruitment goal, as they explained in a protocol amendment published in 2019 and in an “internal pilot” on recruitment conducted within the larger trial. Instead of the promised 734 participants, the investigators now planned to recruit just 314—less than half. According to the protocol amendment, this dramatically reduced target remained feasible despite the recruitment challenges, and the analysis would still be able to yield statistically significant albeit less robust findings.

The poster on cost-effectiveness doesn’t mention the study’s failure to meet its initial recruitment expectations. But it nonetheless presents a bleak picture—at least for CBT proponents. The online program included 19 “psycho-educational and CBT online chapters for children and a parallel programme for parents.” In contrast, children in the activity management group “were supported to understand their baseline activity and to increase their activity amount each week.”

The mean cost of the online CBT intervention—£2826–was £1048 more than the mean cost of activity management. Yet the mean benefit from the CBT intervention over activity management was just 0.002 QALYs–a miniscule difference. In other words, the possibility that the online CBT is cost-effective is so remote that calling it merely “unlikely”—as in the poster’s conclusions—actually seems to be sugar-coating these pathetic results.

The poster strained mightily to glean some positive nuggets from the overall wreckage. The best it could find was a glimmer of a possibility that the online CBT might seem to have some effect on those who also had psychiatric diagnoses. A subgroup analysis, noted the poster, “indicated that there is a higher probability of FITNET-NHS being cost-effective for children with comorbid anxiety/depression.” Hm. Given the abysmal findings for the overall sample, having a “higher probability” of being cost-effective is not an impressive standard. Even so, the poster noted that “there is considerable uncertainty in these findings.” Translation: These findings are essentially meaningless and certainly not actionable.

In the conclusions, the investigators portrayed their work—laughably–as an important addition to medical science, to wit: “Our study makes a novel contribution to the CFS/ME literature. To our knowledge, it is the first study to assess cost-effectiveness of online CBT for children with ME/ CFS, as well as being the first study to assess cost-effectiveness of CFS/ME treatment for children with comorbid anxiety/ depression.”

These boasts appear to demonstrate a remarkable lack of self-awareness on the part of Professor Crawley and her team. Null results are generally useful. But anyone examining this body of research with an objective eye should have recognized long ago that it is plagued by unreliable findings, and that throwing more money to investigate new iterations of these same interventions over and over again is a measure of insanity—or at least scientific illiteracy. This poster once again reveals the intellectual bankruptcy at the core of the ongoing project to prove that the CBT/GET approach leads to major benefits and recovery for ME and/or CFS patients.

11 thoughts on “Trial By Error: Disastrous Results for Professor Crawley’s Pediatric Online CBT Trial”

  1. If there hadn’t been such scrutiny on her research and calls for amendments to errors in her calculations, I fear that this paper as well would have skewed the results in her favour.
    So well done for the continued pressure which has now had effect on current studies and therefore might mean that less money is given to these shoddy projects

  2. The tide is slowly turning against these intellectually challenged, morally contemptible purveyors of scientific merde. And through your unremitting efforts over the years you’ve done a good deal of the heavy lifting David. Thanks once again!

  3. The continuing travesty is that the UK NIH funds this nonsense while really sick children languish and die from lack of knowledgable treatment. Thank you, David, for your ongoing work that exposes the pseudo-science of Dr. Crawley and her “colleagues.”

  4. Thank you David. Forever grateful for your capacity and veracity for telling it like it is.

    Her harms against children should leave a breadcrumb trail back to the corrupt funding and pre emptive care pathways the status quo are attempting to create / maintain.

    The mere ideology of her study keeps the MUS to IAPT gravy boat flowing for biopsychosocial therapies / upholds current paradigm. Dismissing the updated 2021 NHS guidelines. How is this not criminal?

    And we all know who benefits from their own individual investments in the telemed shift. If only these people weren’t presidents of the Royal Collages, of Physicians and GPs here in UK – as well making NHS board member earlier this year. Does he still hold shares / is he still on the board of the Science Media Centre..?

    The previous president of the royal college of psychiatry?

    None of them stand alone. And their crimes against humanity (that was supposed to be classified for future decades..) have finally been made publicly available to society -both Crawley and Weasley and all the others hiding under the same rock should be named, shamed and outed for their crimes.

    Because it isn’t just insane watching history repeat itself. It’s inhumane.

    And the world wants to know why, and who’s to blame for the abysmal lack of effective treatments for ME – now we’ve been obliterated by the tsunami of Long Covid disability.

    Professor Leonard Jason just released his paper. Acknowledging the true findings and up-to-date figures and facts regarding the prevalence of ME in a subtype of long covid patients – Prepandemic, the figures are 250,000 ME patients – Currently there are nine million ME patients in the US alone Post Covid. Costing their economy over 350billion dollars annually!

    Where is the science media centres messaging on that?

    Where is the will, and where is the urgency?

    Why do they keep pouring the funding into the biopsychosocial ideologies?

    They clearly keep falling on their own swords….. So, Yeah. Maybe it is high time for a criminal investigation.

    Enough ME patients have died avoidable deaths because of researchers just like her And the institutional corruption that maintains her activities.

    We can’t thank you enough for your bravery and commitment to highlighting, resolving and dissolving these core issues.

    Gotta uproot the rot from the core.

    It’s brutal living in Bristol. Aware of all of this. 10 years of medical mismanagement. Witnessing patients suffering needlessly and endlessly, globally, while these same players carry on in the arrogant fashion that led the world to the mess its in, with every single sector failing because the population are too disabled to work.

    We want our lives back. Our loved ones who have passed on to feel peace, claim justice. We want our children to have futures.

    Stop funding BPS research for ME. Prioritise large scale biomedical trials. Find and approve the effective treatments.

    Enough is enough.

    The World, is waiting.

  5. I’ll just make one observation: I wonder what the likes of Mike VanElzakker could have done with ONE MILLION POUNDS? A drop in the ocean wrt to funding for other diseases, but I’d wager it could have moved the dial toward something very useful for pwme.

  6. Jenny Charlesworth

    Thank you David – it is astounding that one million pounds was wasted on such a flawed exercise – not scientific research – it is heartbreaking the suffering this woman and her ilk have caused around the world including to my daughter’s 28 years of suffering since age of 12 here in South Africa. Thank you so much for your dedication in exposing these charlatans.

  7. Thank you for your continued reporting and especially for the humor. Sometimes we’ve gotta laugh or we’ll cry.

  8. The UK government needs to stop funding biopsychosocial research and strategies and get back to biology. The other day I read about an initiative to attempt to get sick people back to work - I don’t think this plan will succeed when doctors have been told that up to a half of outpatient clinic referrals will have medically unexplained symptoms (MUS) that don’t require biomedical management, meaning that millions of outpatients may not be receiving the medical care that they should be getting. Government ministers seem to be missing the point – the reason that people aren’t working is likely not because they need some persuading to be more active but because they’re really sick and have been failed by the NHS’s use of a flawed cost-cutting model in medicine. Gardening clubs or whatever, although I’m sure great fun, are not going to help with that. Our government should scrutinize the science rather than listening to those who tell it what it wants to hear. To my mind, a pie-in-the sky theory that physical healthcare spend can be slashed by managing unexplained symptoms with cheap psychotherapy does not represent a sustainable solution to the NHS’s predicament. CBT might help some people with mental health problems but it seems it’s not cost effective for ME/CFS, and probably not for a whole host of other physical health disorders either. It’s time to stop this madness and to start investigating and treating all patients properly, not just those whose diagnosis and treatment is relatively straightforward. (We all pay in, after all, so should expect equality of care.) If it isn’t stopped then I fear that the dumbing down of UK medicine under the MUS and FND/’functional’ banners will continue to erode the health and prosperity of our nation.

    But on a plus side, it seems that not all UK doctors have fallen for the MUS/FND/functional spiel so I live in hope that things will change. If only our Chancellor of the Exchequer would engage their apparent high regard for science and scrutinize the science. It’s a far safer strategy I think than accepting and adopting what they’re told by those purporting to be experts in the field. Politics in medicine? Surely not? Who could conceive of such a thing?!

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