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

Ah yes, agree. I read your statement as suggesting trackers added additional bias to simple subjective records.

However, I think that a longer period of using a tracker would mean that any increase, caused by some optimistic bias on the part of the patient, would be unsustainable over say a 3 month period. I suspect it might be sustainable over 6 weeks or so. (I base that on my early cycles of crashing after six weeks of apparent “improvement”.)

Further, the magnitude of the improvement could be better measured. Subjective measures are easily skewed by interpretations advantageous to those wanting to prove their pet therapy. Trackers would better demonstrate the degree of improvement.

 

This is why long term follow up studies need to look for regression to the mean. Like they found in the PACE trial.

 

Yep, medical politics and the defense of the indefensible.

 

You could always give patients step counters without a screen. So they can't see their own steps. That would give a less biased sample, if that's your worry?

 

On the question of keeping a diary of activity. I am sure that I have seen something from the early days, and I was quite surprised by it, that the purpose is not the information which it provides as to activity. It is the act of keeping the diary which alters behaviour and forms part of the therapy.

 

I find such things 'extremely disruptive'.

Every erg of 'spare' capacity goes into them, as well as some core capacity (i.e diaries/logs etc. impact my ability to do the basics, by which I don't just mean things like hoovering/cleaning, acquiring food, or even washing (myself), I mean food/drinks, the consumption of.)

Everything becomes about the diary/log, virtually every minute - as these things normally involve acting/recording at set times I have to be aware, all of the time - or it doesn't happen.

This leaves me with insufficient cognitive capacity to do, or even notice, other things.

So, yeah, they do 'alter behaviour', and not in a good way.

 

i can't tell if the actimeter data are considered actual outcomes. Where do you see that this will not be measured at the very end?

 

They listed it under 'Other study outcomes':

They say: "At T0 and T1, data on physical activity level and sleep are also gathered by using an actigraph and completing a sleep diary."

They also had this table on outcomes and when they are to be measured:

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05569-y/tables/3

 

Ah, thanks!

 

Do actigraphs accrue a time-based data log that can subsequently be analysed / graphed, as their name suggests?

 

Interesting. I think other studies generally average over the seven days (I think it's usually that, not 14 days, in these studies) and do not break down the changes across the time period. Or maybe they do?

 

That is the goal, yes.

 

Trial By Error: Dutch CBT Trial Targets “Dysfunctional Beliefs About Fatigue” in Long Covid Patients

"So the intervention addresses all the mechanisms through which patients, per the investigators, are bringing this fatigue on themselves. Neat! However, it is important to note that the protocol presents no evidence that the fatigue experienced by Covid-19 patients has anything to do with “dysfunctional beliefs about fatigue,” “perceived low social support,” “fears and worries regarding COVID-19,” or the other itemized factors. These speculations are apparently based on the beliefs of the researchers. Since they favorably cite results from the discredited PACE trial as part of the evidence base, their judgement can be questioned."

https://www.virology.ws/2022/01/07/...beliefs-about-fatigue-in-long-covid-patients/

 

It's rather misleading that the title states this is a controlled randomised trial.

Patients in the control group receive no intervention from the researchers but only the standard medical care they manage to gather themselves from their treating physicians, GP or other therapists. So the care, attention and contact time of CBT therapists isn't controlled for at all and could explain any improvements the trial might show, given that all listed primary and secondary outcomes measures are subjective measurements (actigraphy is mentioned but it is not clear if it will be used as an outcome measures or a mediation variable)

As @Arvo clarified, the website describes Fit after COVID (CBT) as the intervention while the other group is explicitly described as the control group. The website claims that they already know CBT is effective for fatigue, that they hope it will also work for patients with long COVID. Patients in the control group will receive the intervention after the trial ends.

Clearly this is a very biased way of setting up a trial and it is not "controlled" in the way this term is normally used. It is unclear how the trial could give us meaningful results.

 

Apparently, one has to pay €1065 to submit a letter to the journal to point out some of the problems with this trial.
https://trialsjournal.biomedcentral.com/about

 

Exactly. it can't.

 

Right. it's listed as an outcome but doesn't seem to be one of the formal outcome measurements, especially because they are using it only at end-of-treatment, not at the follow-up point.