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

1) I tried a similar thing on my own about 20 years ago. Cycling on the hometrainer, adding a minute every week I think it was. (Or maybe every x days?) For me (Late Stage Lyme but I could possibly also be considered as having ME as a comorbity from reactivated herpesvirus) it meant a shuffle around of activity, not improvement. If I cycled on the hometrainer it meant not being able to do something else. And I quit because of that and because overall I deteriorated from it, plus hitting a plateau of say 8 minutes and then crashing. I remember I got to a point that if I had cycled, I wasn't able to brush my teeth in the evening. It basically meant I swapped cycling for being able to take minimum care for myself.

2)Could be me being severely ill, but a minute a day extra sounds like a lot, let alone 4 or 5 times an extra minute per day. Does this mean that the severely ill are left out? The buildup also sounds very....theoretical/thought of behind a desk to me. What happens if someone gets POTS, or low grade fevers, or purpleblue toes or fingers, or crashes, or deteriorates? You know, real life LC stuff. Are there instructions for that? "Hold on to what you can and just don't think about it" doesn't really cut it.

3) As usual when actually looking at what this stuff entails in practise, I'm struck by the simplicity of it, and the baffling arrogant assumption that people need "treatment" in the form of telling them to go to bed on time and practise every day while expanding that a bit every time. That's at best a leaflet, and what patients, who are often grown adults, try at first anyway. I find it very insulting the way patients are treated like they are five years old and have to be parented.


Also a reminder that the premise of CBT is change of unwanted behaviour via the Operant Conditioning principle (meaning that the effect of forced behaviour change is that it will lead to more, and spontaneous, behaviour change towards the desired behaviour, I explained about that here*), supported by cognitive reframing of "unhelpful" thoughts and views that keep the "undesired" behaviour in place.

Patients should after a short while do the desired behaviour on their own accord because the operant conditioning kicks in.

Of course the whole notion of treating sickness as a "behaviour" that can be modified is messed up to begin with, but following this patient description above it would mean that after a couple of weeks patients should blossom into wellness and expansion of activity because they notice that they can do more and the symptoms go away*: Presented Positive and Omitted Negative. If Presented Positive and Omitted Negative don't actually happen, then the therapy has failed.
(And what people like Knoop do is papering over the OC effect not happening by temporarily influencing questionnnaire entries. They basically influence the patient into reporting that the PP and ON are happening. And Knoop also acts like the PP and ON don't even matter anymore. CBT for ME is not just a failure in terms of applying a psychiatric therapy for neurosis on a serious multisystemic illness, but also in terms of its own aims.)




*Only the last "Omitted Negative" should be "Omitted Positive", but I can't edit the post anymore
*Also keep in mind that part of the group will improve anyway because they are within the 18 month window where that can happen spontaneously.

 

Good one. Or cut corners, saying you did 4x8 minutes while it was actually more like 7, 6.5, 7, and 8-but-with-a-break-because-whew minutes, just like last week, but you don't want to disappoint your therapist or give the impression you were slack. (People pleasing/embarrasment drive.)

You'd think with an app involved that it could be linked to a step counter/ activity device of some sort that checks entries of activity against activity measured.

 

I just created a thread about a paper that is applicable to Knoop and this trial (and others).

Registration and primary outcome reporting in behavioral health trials, 2022, Taylor & Gorman | Science for ME (s4me.info)

 

This is a patient who took part in the trial explaining her experience or what she had to do.

 

How do those unfortunate people who can't teleport even do a 5 minute walk with the suggested level of accuracy?

How do they get home, without more walking?

It's all very well saying walk 5 minutes and stop, but that would leave me outside, until my next scheduled 5 minute walking session, which could be used to get home, nearly, as there are upward stairs to get back in, which take longer than downward stairs.

Or do they expect people do do maths, after exercise, and walk 2 minutes and then turn around and come back.

Nowhere exists that is 2 (or 5) minutes away, so pointless, non useful, activity, possibly with added advanced maths and alarm recognition/processing.

 

@Wonko That can be solved with a phone timer. Put it on 2.5 minutes and when it says beep you turn back.

I do agree with it being pointless activity when you are already limited. Like I mentioned earlier they also seem to completely leave out the effort rerouting. (wee, you can walk for 8 minutes 4 times a day, but if that means not putting the clean laundry away, making easy food instead of cooking a decent meal, not washing your hair and not phoning a friend then what is the use?) Non-walking/cycling activities are not tracked anywhere. Which is a notable omission, as effort rerouting is a typical thing to happen, and they are not ME/CFS noobs.

Plus Life Happens. What are these trial participants supposed to do when the cat has stepped into its own aromatic creation and shared it with the living room floor and furniture, they have to make an unexpected but imporant lengthy phone call to their kid's school, kid's morning routine takes longer then expected, the garbage bag or a glass broke due to a mishap etc.? This trial seems to assume that people are living in a bell jar, or on a shelf somewhere. Especially women are expected to take care of domestic stuff, kids and parents, and every little energy they have will be put into their basic self care, their children and domestic needs first. Do they have an understanding partner that will cook all this time without complaints, or are they expected to put dinner on the table? But if that starts to get strained because of these turns on the hometrainer/walks, then what?

It's so...wereldvreemd (quixotic). Like I said earlier, like someone behind a desk decided this should work.

 

Oh that's way too risky, it could reveal that it's all a sham. Can't risk that. Along with using Orwellian language, knowing not to risk measuring anything is basically the only thing learned in a century of psychosomatic medicine. Although they did get away with it in PACE, but you probably have to be eminent enough to get away with it.

 

Setting a timer doesn't prevent the likelihood of needing to stop before one returns home.

 

You are probably much more on the money that I am. My mind initially went to even more cynical assumptions. Goodness knows why they need a less and more active group if they aren't going to measure their level of activity at any point other than the start. I wonder if he's spotted something useful in the past as the reason for his quite specific but unusual 'approach'. I noticed this KNoop paper was a reference in the Jul 2021 Chalder was part of: https://www.sciencedirect.com/science/article/pii/S0022399913002663?via=ihub#s0075

You'll have to tell me if I can screenshot just the 2 graphs in results section that happen, weirdly to be sat side-by-side: Perceived activity and Objective activity (actimeter). I just find this presentation astounding. They've broken people down into 4 groups POST-HOC (my next point) based on whether they were 'fast responders>non-responders' on 'the fatigue scale'. Anyway, the non-responders' perceived activity almost reflects their objective activity. The responders' perceived keeps going up whilst their actual follows a similar level to non-responders.

Strangely (having framed these results quite differently in their description) the results ends with a Q of asking patients what aspect they had found most helpful, and note that after 'changing sleep hours' (72%), the next most cited was 'increasing physical activity' (65%). But they made it v clear that despite including some reporting on it, for some reason actual activity was NOT a 'process variable'

There is the following classic: "Lower pre-treatment objective activity predicted lower fatigue at the first interim measurement. This finding is difficult to explain. Levels of objective activity during treatment were not related to subsequent levels of fatigue at other measurements. In the early phases of treatment, even patients who remain severely fatigued after treatment increase their level of physical activity (see Fig. 3). So an increase in physical activity per se does not seem sufficient to reduce fatigue. An increase in perceived activity, however, does seem important." Then all sorts of confusing pseudophilosophy...

Anyway there seems to be all sorts of strange things going on with post-hoc groupings by fatigue level and claims that those who refused to participate were worse at the end than those who did (rather than a control) despite there only being 291 people whittled down to 183 'results' they were working with by that point. They had the pre-activity level and indeed put the low-activity (non boom-bust) straight onto exercise without 'balancing sessions' first, so these were a pre-hoc variable. How can people call things 'research' or 'experiment' when it feels like if you throw enough 'process variables' at a wall then analyse with different framings and you might make something out of it.

Watching someone create groups of 40 to call them 'responders' based on perceived fatigue at measuring point 1,2, 3 [not any independent variable of the treatment itself or individuals within it] and do cross-comparisons to other similar (probably internally consistent if we went through all their papers) dependent variables, as if that is meaningful of the TREATMENT is just another level. It starts to make you feel that this group really think that 'the fatigue scale' is an objective measure. More so than an actimeter. Which is kind of what their pseudophil discussion suggests.

Despite the following being in the treatment protocol: "They are encouraged to perceive feelings of fatigue as a normal part of an active and healthy life and stop labelling themselves as a CFS patient."

The whole thing is weird and I've started to get the feel when responding o some of these papers recently that BPS weren't/aren't really fighting for anything other than the scam of getting a methodology where nothing you test can fail. The competitive advantage of being allowed to make up their own foolproof methodology sans regs vs any other science area (cheap fast research as no Blinded Controls, that counts anything towards level of significance whilst science has to begin with subtracting the placebo/control response, so 'double-win'). Grow the kingdom, then tail wags dog because that dept is the only place with space so more get sent there, rhetoric gets repeated to justify it and so on..

Given methodology/design/quality/validity is/should be somewhat universal and the end result is sucking funding for research and then resources slowly out of other parts of medicine (and scientific psychology) I'm shocked that instead of sitting on their own forums taking the mick out of patients they aren't waking up to this uneven playing field. And how it will affect them, and if they don't demand parity the right way - will it end up spilling into other parts (seems like it is with talk of 'less rigid' etc), death of science and quality etc being respected?

It's become silly/weird where a cheap B12 injection can give one person immediately visible differences - to anyone's eyes - and all sorts of objective measures for x time people see with their own eyes works for some and don't harm others but it needs a heterogenous trial. And yet for expensive treatments paper surveys done by beneficiaries themselves on subjective meaningless measures with high drop-outs not explained, hidden raw data and objective outcomes and all sort of 'whittling and post-hoc can overspeak people coming out of it in a wheelchair and requires no yellow card reporting. And we let those doing the latter claim 'placebo' on the first when patient also self-reports feeling better.

This post has been copied to a new thread on the mentioned study by Knoop et al., further discussion on this study should be in this thread: The process of CBT for CFS: Which changes in perpetuating cognitions and behaviour are related to a reduction in fatigue?, 2013, Knoop et al.

 

And that most important tactic of all - that if you make the monitored requirement hard enough then anyone who actually has ME drops out. I call it the Krypton Factor filter. The last thing you want is someone getting ill in your timeframe of measurement affecting your figures and having to count them so make sure the design doesn't allow them to be counted.

 

I can't believe how many people in this world act like this. It's dumb. It's apalling. And leads to quite dangerous things happening to ill people at laymen's hands. But they are allowed to get away with it and noone pulls them up or forces them to look at the consequences of their behaviour with their eyes open and not being constructivist. I've seen human beings in a new light the iller I got and it's quite astounding what is wrong with so many of them in their thinking.

Given most of said individuals do happily indulge themselves when they get a sniffle I just wonder whether the irony is that the slackers never get ill and assume those who are to be like them rather than realising it is the opposite etc.

 

A rather blatant source of bias it would seem - selection bias?

 

I have come to believe that these papers all work the same way.

They are written in a difficult to understand language where the numbers are made to seem impressive as they jump out at you. "200 people were in the patient group and 90% of those who completed the course were very much better" for instance, with the fact only 20 people filled in the follow up questionnaire obscured. (made up numbers)

The PACE trial did not say explicitly that a score of 65 meant you were sick enough to enter the trial but a score of 60 at the end meant you were now within normal limits. That figure was hidden in +/- margin of error added to plausible numbers.
I could go on.

Then the paper is usually full of references to back their case but when people have checked they are wrong. But how many people check references?

After scientific sounding methods and results where they manipulate the figures and do things like truncate the y-axis - something my statistics lecturer told us to watch out for and I had previously only seen in ads for beauty products - they present conclusions which rely heavily on simplified narratives.

The conclusion though, that is the whole point of the exercise and it is always that CBT and GET have great success in treating CFS. Now we have another paper to add to a whole body of work proving their theories and designed to impress politicians and medics who don't have the time to check the work of every researcher and who trust eminence anyway.

Add to that any criticism being trumpeted as harassment and you have a winning formula.