Efficacy of cognitive behavioral therapy targeting severe fatigue following COVID-19: results of a randomized controlled trial 2023, Kuut, Knoop et al

Efficacy of cognitive behavioral therapy targeting severe fatigue following COVID-19: results of a randomized controlled trial.

Tanja A Kuut, Fabiola Müller, Irene Csorba, Annemarie Braamse, Arnoud Aldenkamp, Brent Appelman, Eleonoor Assmann-Schuilwerve, Suzanne E Geerlings, Katherine B Gibney, Richard A A Kanaan,
Kirsten Mooij-Kalverda, Tim C Olde Hartman, Dominique Pauëlsen, Maria Prins, Kitty Slieker, Michele van Vugt, Stephan P Keijmel, Pythia Nieuwkerk, Chantal P Rovers, Hans Knoop.

Abstract
Background
Severe fatigue following COVID-19 is prevalent and debilitating. This study investigated the efficacy of cognitive behavioral therapy (CBT) for severe fatigue following COVID-19.

Methods
A multicenter, 2-arm randomized controlled trial was conducted in the Netherlands with patients being severely fatigued 3-12 months following COVID-19. Patients (n = 114) were randomly assigned (1:1) to CBT or care as usual (CAU). CBT, targeting perpetuating factors of fatigue, was provided for 17 weeks. The primary outcome was the overall mean difference between CBT and CAU on the fatigue severity subscale of the Checklist Individual Strength, directly post CBT or CAU (T1), and after six months (T2). Secondary outcomes were differences in proportions of patients meeting criteria for severe and/or chronic fatigue, differences in physical and social functioning, somatic symptoms and problems concentrating between CBT and CAU.

Results
Patients were mainly non-hospitalized and self-referred. Patients who received CBT were significantly less severely fatigued across follow-up assessments than patients receiving CAU (-8.8, (95% confidence interval (CI)) -11.9 to -5.8); P < 0.001), representing a medium Cohen’s d effect size (0.69). The between-group difference in fatigue severity was present at T1 -9.3 (95% CI -13.3 to -5.3) and T2 -8.4 (95% CI -13.1 to -3.7). All secondary outcomes favored CBT. Eight adverse events were recorded during CBT, and 20 during CAU. No serious adverse events were recorded.

Conclusions
Among patients, who were mainly non-hospitalized and self-referred, CBT was effective in reducing fatigue. The positive effect was sustained at six month follow-up.

https://academic.oup.com/cid/advanc...id/ciad257/7157021?searchresult=1&login=false

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

 

Yet another:

Subjective outcomes in an open label trial with no active control (‘care as usual’ is not a meaningful control to allow the conclusion that this intervention is any better than any other pseudo therapeutic interaction of the same interaction level).

(Not totally clear how ‘concentration’, was measured though I assume that was also measured by questionnaire. At least they attempted to record adverse events)

Also I found no mention of PEM or whether any subjects met the diagnostic criteria for ME/CFS, only focused on severity of fatigue or if the fatigue was chronic, so no serious consideration of the potential lack of homogeneity found in Long Covid.

(edit - corrected typos, also not clear if they understood the distinction between chronic fatigue and chronic fatigue syndrome. Not to even discuss this in a condition where potentially up to 50% of Long Covid sufferers meet the diagnostic criteria for ME/CFS is a concerning omission.)

 

My post on LinkedIn about the paper.

The new Dutch CBT trial for #longCOVID. From my initial scan.

All subjective outcome measures. The actometer that was used at the beginning of the trial to assess patients activity that could've provided objective evidence of improvements was not used? Neither right after the trial nor at 6 months.

Sounds very familiar where with studies in "CFS" and QFS the disappointing objective outcomes measure never seem to match the "positive" subjective outcome measures. So what do those physical function questionnaires really mean?

https://lnkd.in/gUEUc3j

Patients might simply report improvements because they received more attention than those with regular care that didn't. We all know the care that people with #LongCovid isn't that great in the Netherlands.

The majority of the patients were self referred and probably more motivated to participate increasing the bias when you solely rely on subjective outcome measures.

The effect size is really small. Considering these facts I'd say the effect is nothing more than participants reporting biases.

The study reports there was no harm, but that's not what I heard from patients involved.

Overal a similarly disappointing study as we've seen with "CFS" and QFS but admittingly a lot more nuanced about it's effect, but unfortunately still based on a rather harmful CBT model.

Why don't we invest in proper psychological support instead of this type of CBT? At least in ME it seems to be ineffective and patient report that it can be harmful to them when they're suffering from post-exertional malaise. It's not for nothing that we see centers like the CDC, NICE but also the Dutch and Belgian health council change their advice about this particular form of CBT.

https://lnkd.in/dYVJBaQT

.

#longCOVID

https://lnkd.in/d6uss77C

 

That's heavily suspicious. Perhaps they stopped using the actimeters because they realized it wouldn't show any actual improvement. Or maybe there's a more innocent explanation, but the purpose of sticking to your methodology is to stay above suspicion of such shenanigans.

 

It's deliberate. There are people in that list that have pointed out the errors in their research and they don't care as long as it brings the results they need.

 

https://twitter.com/user/status/1655678965732851712


Ugh!

 

Ben Ryan has been a hellacious supporter of the Gaffney and Shure perspective throughout the pandemic

 

Another potential issue in addition to the above - The study inclusion criterion for reduced function included either limits in physical function or limits in social function.

Limitations in physical functioning operationalized as a score of ≤ 65 on the physical functioning subscale of the SF-36[20] and/or social functioning operationalized as a score of ≥ 10 on the WSAS.[21]​

The question is whether some of those who have limits only in social function might be helped by targeting the cognitive-behavioral factors this study claims perpetuates them - e.g. sleep, low activity, unhelpful beliefs about fatigue, fears and worries, poor coping with pain, etc

If so, together with issues noted above, those non-specific criteria could add to possibility of seeing a positive signal in at least some patients and thus in the trial. Given what this claims to be targeting, it seems disingenuous to use such mixed criteria.

Maybe I missed it but didn't see them report these groups separately.

 

This plot is objectively worse than those I used to make in GCSE I.T. when I was just learning Excel. Absolutely no care at all. Looks like shit.

On a technical note, the error bars are somehow not lined up with the datapoints themselves. I'm not even sure how you'd manage that (maybe it's an artefact of the plotting software). I have absolutely no faith in any of this work.

 

I will discuss with this person is he/she wants to share their story.