Protocol ReCOVer: A RCT testing the efficacy of CBT for preventing chronic post-infectious fatigue among patients diagnosed with COVID-19.

[Grigor]

Very troubling study by prof Knoop et al.

"ONDERZOEKSVRAAG

To investigate whether delivering timely Cognitive Behavioural Therapy [CBT], an evidence-based treatment for chronic fatigue, is effective in preventing the development of post-COVID-19 chronic fatigue.

URGENTIE

A substantial subgroup of COVID-19 patients is expected to develop post-COVID-19 chronic fatigue, i.e. severe fatigue persisting for more than 6 months with accompanying detrimental effects on patient health, functioning and societal participation.
Quickly gathering evidence on the efficacy of internet based CBT (iCBT) to prevent post-COVID-19 chronic fatigue and its possible consecutive implementation is a unique opportunity to help to alleviate the pandemic’s negative impact on patient health and on the wider society.

HYPOTHESE

It is hypothesized that timely offering iCBT for fatigue, i.e. 3 to 6 months after COVID-19 diagnosis or hospital discharge, will lead to a significant and clinically relevant reduction in fatigue severity (primary outcome) following the intervention, will reduce the proportion of patients who progress to chronic fatigue at follow-up and foster patients’ work ability, physical and social functioning and reduce other somatic symptoms as compared to care as usual.

PLAN VAN AANPAK

We propose a 2-arm randomised controlled trial l in which patients who have recovered from acute COVID-19 but suffer from ongoing severe and debilitating fatigue are randomised to either iCBT or care as usual. The project will be conducted within 24 months. Primary outcome is patients’ fatigue severity, as assessed with the CIS-fatigue at follow up (T1, T2). A sample of 114 patients (57 in each arm) will suffice to identify clinical relevant differences in fatigue severity. Recruitment will be conducted within existing COVID-19 cohorts, among outpatient clinics of participating hospitals, from referrals of general practitioners or self-referrals. Offering CBT as internet-based intervention fits within the current social distancing measures."

https://www.zonmw.nl/nl/over-zonmw/...acy-of-cognitive-behavioural-therapy-for-pre/

 

[Saz94]

Oh fuck off

(Not you, Grigor )

 

[Hoopoe]

How much of an effect can internet CBT possibly have? I think the most likely result is no meaningful effect, although it could pressure patients back to work sooner, which could also be counterproductive.

 

[Wonko]

Tired old response but;

What 'evidence' is referred to in the phrase 'Cognitive Behavioural Therapy [CBT], an evidence-based treatment for chronic fatigue'?

 

[Denise]

Very troubling study by prof Knoop et al.

"ONDERZOEKSVRAAG

To investigate whether delivering timely Cognitive Behavioural Therapy [CBT], an evidence-based treatment for chronic fatigue, is effective in preventing the development of post-COVID-19 chronic fatigue.

URGENTIE

A substantial subgroup of COVID-19 patients is expected to develop post-COVID-19 chronic fatigue, i.e. severe fatigue persisting for more than 6 months with accompanying detrimental effects on patient health, functioning and societal participation.
Quickly gathering evidence on the efficacy of internet based CBT (iCBT) to prevent post-COVID-19 chronic fatigue and its possible consecutive implementation is a unique opportunity to help to alleviate the pandemic’s negative impact on patient health and on the wider society.

HYPOTHESE

It is hypothesized that timely offering iCBT for fatigue, i.e. 3 to 6 months after COVID-19 diagnosis or hospital discharge, will lead to a significant and clinically relevant reduction in fatigue severity (primary outcome) following the intervention, will reduce the proportion of patients who progress to chronic fatigue at follow-up and foster patients’ work ability, physical and social functioning and reduce other somatic symptoms as compared to care as usual.

PLAN VAN AANPAK

We propose a 2-arm randomised controlled trial l in which patients who have recovered from acute COVID-19 but suffer from ongoing severe and debilitating fatigue are randomised to either iCBT or care as usual. The project will be conducted within 24 months. Primary outcome is patients’ fatigue severity, as assessed with the CIS-fatigue at follow up (T1, T2). A sample of 114 patients (57 in each arm) will suffice to identify clinical relevant differences in fatigue severity. Recruitment will be conducted within existing COVID-19 cohorts, among outpatient clinics of participating hospitals, from referrals of general practitioners or self-referrals. Offering CBT as internet-based intervention fits within the current social distancing measures."

https://www.zonmw.nl/nl/over-zonmw/...acy-of-cognitive-behavioural-therapy-for-pre/

So someone has figured out how to identify people who will develop chronic fatigue (of any sort) which then allows them to administer CBT to prevent it? I guess I missed that news.
I guess I don't really understand this study - they initially say they can identify people who will develop chronic fatigue but then say they are studying people who have fatigue after acute COVID-19 infection or hospital discharge (were those who were in hospital dx'd with COVID-19or is it just anyone post-hospitalization who has fatigue?)

 

[Hutan]

Primary outcome is patients’ fatigue severity, as assessed with the CIS-fatigue at follow up (T1, T2). A sample of 114 patients (57 in each arm) will suffice to identify clinical relevant differences in fatigue severity. Recruitment will be conducted within existing COVID-19 cohorts, among outpatient clinics of participating hospitals, from referrals of general practitioners or self-referrals.

I wonder if there is some way to put pressure on the researchers to measure objective things assuming they aren't already e.g. have participants wear an activity monitor (all the time); work hours?

And what are the followup T1 and T2 times? Are they long enough?

Two of the problems with CBT trials is that they recruit selectively and attempt to convince participants that they will recover if they do the work. Maybe there is a way to 'increase the equipoise' - by encouraging a less biased sample and increasing information in the media about the problems with the evidence base for CBT?

 

[Grigor]

I already asked Knoop on LinkedIn if they'll only use subjective measures. He will not answer of course.

 

[InitialConditions]

What a blatant waste of money.

 

[NelliePledge]

Abra ca bloody dabra

 

[Peter T]

Tired old response but;

What 'evidence' is referred to in the phrase 'Cognitive Behavioural Therapy [CBT], an evidence-based treatment for chronic fatigue'?

I have come to profoundly distrust the phrase ‘evidence-based treatment’, as it generally seems to be bad or misleading evidence.

 

[Grigor]

I have come to profoundly distrust the phrase ‘evidence-based treatment’, as it generally seems to be bad or misleading evidence.

His whole title is off. Evidence based?

On November 24 2016 clinical psychologist J.A.(Hans) Knoop has been appointed as professor of Evidence-based psychological and behavioral interventions for medical conditions and somatic symptoms.

https://www.amsterdamresearch.org/w...l-psychology-amc-appointed-as-professor.-.htm

 

[Snow Leopard]

How much of an effect can internet CBT possibly have? I think the most likely result is no meaningful effect, although it could pressure patients back to work sooner, which could also be counterproductive.

The usual "effect", meaning response biases.

Notice how they're not considering hours worked as an outcome measure.

 

[Amw66]

Paul Garner's thoughts would be interesting on this one.

 

[Invisible Woman]

We propose a 2-arm randomised controlled trial l in which patients who have recovered from acute COVID-19 but suffer from ongoing severe and debilitating fatigue are randomised to either iCBT or care as usual. The project will be conducted within 24 months

Apart from the usual "chronic fatigue" - what exactly is chronic fatigue here? Fatigue, fatigueability, a bit knackered but can still lead a mostly normal life? Etc, etc...

Participants will have had "acute covid" and suffering ongoing symptoms. So this will most likely pick up people who were hospitalised and possibly spent time in intensive care and may also be suffering from difficulties associated with being post intensive care treatment.

If there is any improvement how are they going to tell whether changes in questionnaire responses are due to addressing issues with post intensive care patients vs after effects of covid vs training them how to fill in a questionnaire?

If those patients are also having other therapy to address lung and heart issues and that therapy is helping them might that not also affect the way they fill in questionnaires? So the questionnaires may pick up improvements based on other therapies that have nothing to do with CBT.

Am I wrong, or does it seem that the majority of those suffering with long term post covid effects didn't need hospital treatment? In that case the research is recruiting the wrong cohort.

 

[MSEsperanza]

That was quick:

Trial By Error: And Now–No Surprise–CBT for Post-Covid Fatigue
by David Tuller

https://www.virology.ws/2020/08/08/trial-by-error-and-now-no-surprise-cbt-for-post-covid-fatigue/

Old habits die hard. So do bad ideas. Especially when these old habits and bad ideas have formed the basis for prominent academic and medical careers in the UK and the Netherlands.

In the Netherlands, the Dutch health research agency ZonMw has proposed a welcome and long-overdue investment of almost $30 million (€25 million) over ten years in biomedical research into ME/CFS (more about that later). At the same time, the agency has also announced support for another effort by Professor Hans Knoop in his longstanding campaign to promote cognitive behavior therapy. His new study, highlighted along with dozens of others about Covid-19 on the ZonMw website, is called: ReCOVer: Can Cognitive Behavioral Therapy via the Internet prevent the fatigue symptoms of COVID-19 patients from becoming chronic? A controlled and randomized trial

Here we go again.

 

[chrisb]

I have come to profoundly distrust the phrase ‘evidence-based treatment’, as it generally seems to be bad or misleading evidence.

The beauty of the phrase is that it is wholly devoid of content. There are no rules as to the quality or admissability of the evidence or the standard which it must reach. It means whatever the user wants it to mean. Have any of them read Popper?

 

[Barry]

How much of an effect can internet CBT possibly have? I think the most likely result is no meaningful effect, although it could pressure patients back to work sooner, which could also be counterproductive.

But even if less likely, a negative effect on people's health could be hugely impactful.

I have come to profoundly distrust the phrase ‘evidence-based treatment’, as it generally seems to be bad or misleading evidence.

Always puts me in mind of the much-used politicians' trope, "There is no evidence to suggest that ...". The notion of evidence-based has to embrace the idea of evidence without significant omission. If you specifically avoid seeking evidence you don't want to find, then it amounts to malpractice.

That was quick:

Trial By Error: And Now–No Surprise–CBT for Post-Covid Fatigue
by David Tuller

https://www.virology.ws/2020/08/08/trial-by-error-and-now-no-surprise-cbt-for-post-covid-fatigue/

I've added a comment there, awaiting moderation.

 

[Mike Dean]

I have come to profoundly distrust the phrase ‘evidence-based treatment’, as it generally seems to be bad or misleading evidence.

The beauty of the phrase is that it is wholly devoid of content. There are no rules as to the quality or admissability of the evidence or the standard which it must reach. It means whatever the user wants it to mean. Have any of them read Popper?

It's a rhetorical device meant to confer authority on the person who utters it.

 

[Barry]

I've added a comment there, awaiting moderation.

A pity you can't edit those comments, 'cos there's an amendment I would like to have made.

ETA: When my comment appears, where I've written:

"The presumption of deconditioning, without strong safeguards for those not suffering from it"

What I should have better written is:

"The presumption of deconditioning, without strong safeguards for those not primarily suffering from it"

 

[NelliePledge]

Agree @Barry I would say that just because something is internet based doesn’t make it less likely to be harmful

- people are subject to online bullying and get groomed into all sorts of unpleasant activities

- even if there’s no engagement with a live person at the other end in some ways people may even take stuff that’s in writing seriously than a less formal chat.