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

Results WOB procedure grant award by ZonMw to ReCOVer research
(Internet Cognitive Behavioral Therapy) in patients with long COVID (ReCOver).

"The British NICE has determined that the quality of the scientific evidence for this treatment is low to very low.

It is also clear from Dutch and foreign empirical studies that this form of CBT does not help the majority of patients and that it leads to deterioration in some.

We would like to prevent this, also for long COVID patients."

The answers by Hans Knoop are quite something...

English version here:
 
No treatment protocol available because "The treatment must first be tested in research."

Where to begin with that one? :jawdrop:

(For starters he stated that it definitely would work and that it was just a matter of timing on the recruitment page: "We already know that chronic fatigue can succesfully be treated with cognitive behaviour therapy. We wonder if cognitive behaviour therapy can also help prevent that fatigue after COVID-19 becomes chronic.")


I really need to do some other stuff first, but will come back to read the rest for more horrortainment later.


Good you are going after this @Grigor
 
Yes, thanks to those trying to engage on this, and for sharing the document @Grigor. Knoop's responses to some questions start on page 8 - I too find them incredible.

I thought this response from Knoop about the actimetry measurement was interesting:

4. The study design shows that actometry is not a primary or secondary outcome measure
is considered to. Actometry does take place. What will be done with the results
of the actometer?
(Knoop) The actometer is only used to monitor patients prior to treatment
divide into an active group and a less active group.
Click to expand...
 
Hutan said:
Yes, thanks to those trying to engage on this, and for sharing the document @Grigor. Knoop's responses to some questions start on page 8 - I too find them incredible.

I thought this response from Knoop about the actimetry measurement was interesting:
Click to expand...

What was unsaid is perhaps more interesting. (the fact that they haven't found improvement on actimetry in other patient groups).
 
Hutan said:
Yes, thanks to those trying to engage on this, and for sharing the document @Grigor. Knoop's responses to some questions start on page 8 - I too find them incredible.

I thought this response from Knoop about the actimetry measurement was interesting:
Click to expand...

I haven't read the above so this is speculation---

[Knoop] "The actometer is only used to monitor patients prior to treatment divide into an active group and a less active group."
Incredible seems reasonable. Actimetry is OK to select participants, but it's not OK to measure the outcome --- seems illogical.

Surely the more obvious answer is Knoop doesn't use actimetry, as an outcome indicator, because it indicates the intervention doesn't work. As others have pointed out on this site, these folks [Knoop, Garner ---] know their interventions work, so the actimetry measurements must be unreliable - since it doesn't confirm improvement!

These folks shouldn't receive a cent of public [taxpayers] money for their shoddy work. This crap should be relegated to nonsense individuals are free to believe/not believe but have no place in public decisions - like publicly funded health care.
 
Hutan said:
Yes, thanks to those trying to engage on this, and for sharing the document @Grigor. Knoop's responses to some questions start on page 8 - I too find them incredible.

I thought this response from Knoop about the actimetry measurement was interesting:
Click to expand...
@dave30th wrote in his blog that they do but not at 6 months follow up. I heard the same from patients who participated in the trial and did have the actigraph at the end of the treatment as well.

The study does include one objective measure—participants will wear actigraphs, a wrist monitor that measure activity, for 14 days at baseline and 14 days at the end of treatment.
Click to expand...

https://www.virology.ws/2022/01/07/...long-covid-patients/?utm_source=pocket_mylist
 
Last edited:
So Knoop's reply that the actimetry is only used at the beginning of the trial to divide patients into two groups based on activity level seems to be quite wrong then.

I wonder if he made a mistake due to not being very familiar with the protocol and implementation of his own trial, or if he is starting to redefine the protocol already? Certainly, the actimetry results will be something to watch. @Grigor, did the participant you know say anything more about her experience in the trial? Did she have a measured increase in activity over the course of the intervention, and does she think the reported activity levels reflected her actual physical capacity?

Thanks to @dave30th for his blog on this. There are some good comments under it too, some mentioning that it can be relatively easy to increase measured physical activity for a two week period.
 
Hutan said:
So Knoop's reply that the actimetry is only used at the beginning of the trial to divide patients into two groups based on activity level seems to be quite wrong then.

I wonder if he made a mistake due to not being very familiar with the protocol and implementation of his own trial, or if he is starting to redefine the protocol already? Certainly, the actimetry results will be something to watch. @Grigor, did the participant you know say anything more about her experience in the trial? Did she have a measured increase in activity over the course of the intervention, and does she think the reported activity levels reflected her actual physical capacity?

Thanks to @dave30th for his blog on this. There are some good comments under it too, some mentioning that it can be relatively easy to increase measured physical activity for a two week period.
Click to expand...
I pretty assume it's the PACE strategy: if good, they publish and boast like it's a magical cure, if not good they will simply bury and pretend they didn't even do it. It worked for PACE, no reason why this successful formula wouldn't get used again and again.

No oversight means anything goes, this isn't something that happens every now and then, it's the plain formula for the entire field.
 
Trial By Error: More on the Dutch CBT Long Covid Trial; Finnish Study of “Amygdala Retraining” Program

"I have written a couple of times about a Dutch trial of internet-delivered cognitive behavior therapy to prevent severe fatigue in long Covid patients. The goal is to address factors like “dysfunctional beliefs about fatigue,” “perceived low social support, “problems with processing the acute phase of COVID-19, and “fears and worries regarding COVID-19″ that are purportedly driving the prolonged symptoms. My posts—here and here–were not favorably disposed toward the research and suggested the design was biased toward producing positive results.

Last month, advocates from three Dutch patient organizations published their own report about the study. The researchers, from the Dutch Knowledge Center for Chronic Fatigue (NKCV), were awarded €308,000 by ZonMw, a major independent health care funding agency. The lead investigator, psychologist Hans Knoop, is a well-known proponent of the CBT/GET treatment paradigm for ME/CFS. In 2011, he and a Dutch colleague wrote a commentary for The Lancet that accompanied the PACE trial and declared that participants had met “a strict criterion of recovery”—a demonstrably untrue statement."

https://www.virology.ws/2022/02/04/...finnish-study-of-amygdala-retraining-program/
 
Dr Tuller's (excellent) blog highlights one of the points Knoop made:
Professor Knoop’s argument that medical researchers are “moving away from objective outcomes” is a new one to me.
Click to expand...
Not new. This argument was also made by RCPsych in their responses to the NICE consultation (p1035 of the first comments table), where they say that "the general direction of travel is more in the opposite direction" - i.e. away from objective outcome measures and towards greater adoption of PROMs.
RCPsych said:
His point is that patients who main symptoms are self- reported do not give an accurate account of those symptoms after any intervention which is non-blinded. For that reason objective measures, such as biomarkers, exercise testing and so on, which are superior to self-report measures, could be used.

We do not accept this.

Indeed, the general direction of travel is more in the opposite direction – for example in responding to the views of patients about what matters to them, NICE and others have steadily increased, not decreased, the importance of self-reported outcomes
Click to expand...

In some other areas of medicine there has also been a push towards greater use of PROMs, especially with diseases where there is only a weak correlation between the currently available objective measurements of disease and functional status (e.g. in MS, the correlation between radiological assessment of demyelinating lesions and patients' self-report of impairment is quite weak).
 
Hutan said:
did the participant you know say anything more about her experience in the trial? Did she have a measured increase in activity over the course of the intervention, and does she think the reported activity levels reflected her actual physical capacity?
Click to expand...
She gave me this answer. She didn't want her case to be recognizable. Still an interesting to read. CC: @dave30th

The sleep-wake rhythm module is sleeping and getting up at the same times every day, which you register daily in an app. Also daytime naps are not allowed. With the activity building module you could choose between walking or cycling 4 or 5 times a day (you can choose yourself). Per day 4 (or 5) x 1 extra min and within a week you can skip 1 day and 1 day no build-up (hold). So you can take an extra walk 4 (or 5) x 5 min per day per week. So after 2 weeks you are at 4 (or 5) x 10 min, etc. In case of complaints, the motivation was mainly to continue, or at least to hold on to what you could (which could be several days) and especially not to think/talk about the complaints (the CBT principles…). You also registered these minutes in the app on a daily basis. It was indicated in advance to keep the activities you did daily as much as possible before the start. After e.g. 15 min you could exchange 1 of the 4 (or 5) walks for a daily activity that you want to do, e.g. cleaning for 15 min daily. Then you walk 3 (or 4) x 16 min etc, which you could later exchange for other activities. But you do not register this activity, only the remaining 3 (or 4)x walks. The intensity of your other activities is not tracked anywhere. Even if you skip your daily activities in order to maintain the walks, it is not stated anywhere (it was not the intention to reduce your daily activities that you already could and have built up, but it happens in practice). Not even if you walk at a different pace. You also do not register this anywhere (actigraph is only used before and after completion, not during treatment). There is, however, the option to report this to the practitioner in the chat (this was not indicated whether that was the intention, but I think he did little with it). If you do that (often), then I think they see that you are too busy with your complaints… ‍♀️


At the end of the treatment, you look back and sum up what you can do with extra daily activities in a day.


Summarized:


With the practical modules you register the sleep and waking time every day, and the duration of the walk per day per walk, but everything you do next to it or have exchanged for a walk (and therefore walk less) is not registered, either. the intensity/speed of walks or activities and also not the complaints you get due to the accumulated activities. At the end you sum up what you have achieved: which daily activities you can do (extra).
Click to expand...
 
You must log in or register to reply here.
Back
Top Bottom