By David Tuller, DrPH
Since the emergence of the phenomenon now called long Covid (or Long COVID, depending on news organization), skeptics have been out in full force. Even as huge numbers of people experience a range of sequelae after a bout of Covid-19, some experts maintain that common non-specific symptoms, like cognitive impairment and relapses of profound exhaustion, arise from anxiety, depression, post-traumatic stress disorder, hypochondriasis (renamed “health anxiety”) and other mental health issues. At times, their arguments have involved citing the PACE trial as supportive evidence of something or other.
It’s clear that anxiety, depression, post-traumatic stress disorder, hypochondriasis and other mental health issues can trigger and/or exacerbate any number of somatic sensations and associated fears. That possibility is not sufficient reason for the default assumption on the part of some that all of those whose prolonged symptoms currently resist satisfactory pathophysiological explanations are experiencing psychogenic or psychosomatic illness.
That has been the standard assumption about people with ME, CFS or ME/CFS for decades. Certainly the PACE trial and others have shown that cognitive behavior therapy (CBT) and graded exercise therapy (GET) are not effective treatments, despite continuing claims to the contrary. In issuing new ME/CFS guidelines in October, the UK’s National Institute for Health and Care Excellence (NICE) assessed the quality of evidence in support of these interventions as “very low” or merely “low.”
Not surprisingly, this decision drew protests from the CBT/GET advocates, who are eager to promote this same treatment approach for long Covid patients. In 2020, one of those fierce advocates, Professor Hans Knoop of the University of Amsterdam, received funding for a study of CBT for post-Covid-19 fatigue 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. The study follows the PACE model, which posits that some stressful event, often an infectious illness, serves as a trigger for fatigue and other symptoms, which are then perpetuated by “psychosocial” factors. I wrote about the proposed study here.
(I have previously criticized the work of Professor Knoop. In a commentary published alongside the 2011 PACE trial report in The Lancet, Professor Knoop and a co-author wrongly claimed that 30 percent of those who received CBT or graded exercise therapy met a “strict criterion” for recovery. I documented the commentary’s misrepresentations and misstatements here. It remains an embarrassment to the medical literature, as does PACE.)
Last month, Professor Knoop and his colleagues published the protocol for the study, titled “A randomised controlled trial testing the efficacy of Fit after COVID, a cognitive behavioural therapy targeting severe post-infectious fatigue following COVID-19 (ReCOVer): study protocol.” Here’s how the protocol explains the rationale for their approach:
“According to the cognitive behavioural model of post-infectious fatigue, the infection triggers fatigue and cognitive behavioural factors contribute to its perpetuation… These cognitive behavioural perpetuating factors can be addressed in cognitive behavioural therapy (CBT).”
And here’s how the protocol describes the Fit after COVID intervention:
“The main part of the intervention is based on an existing CBT manual for Chronic Fatigue Syndrome (CFS) by our research group and was adapted by experienced cognitive behavioural therapists… As the original CBT manual for CFS, Fit after COVID is based on a cognitive behavioural model of fatigue. According to this model, a disease or stressor (here: COVID-19) initially triggers fatigue while cognitive behavioural variables perpetuate fatigue. The seven perpetuating factors addressed in Fit after COVID are (1) disrupted sleep-wake pattern, (2) dysfunctional beliefs about fatigue, (3) low or unevenly distributed level of activity, (4) perceived low social support, (5) problems with processing the acute phase of COVID-19, (6) fears and worries regarding COVID-19, and (7) poor coping with pain.”
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.
In the study, which is ongoing, more than 100 patients still suffering from fatigue months after Covid-19 are to be randomized to Fit after COVID or to “care as usual.” In other words, no effort has been made to structure the “care as usual” group in order to match–or control for–the experience of receiving an active intervention, which is likely to exert its own impact on recipients regardless of program content. It is therefore questionable whether this research should be granted the distinction of being called a “controlled” trial.
Fit after COVID is a 17-week CBT program designed to be delivered mainly online, although users also have access to multiple conversations and consultations with an actual therapist. The primary outcome, measured at the end of treatment and six months later, is reported fatigue severity. Secondary outcomes include work and social adjustment, problems concentrating, and reported physical functioning.
This is an unblinded trial relying on self-reported, subjective outcomes–a study design that is a recipe for an unknown amount of bias. It is not surprising, for any number of psychological and emotional reasons, that participants who receive an intervention they are told could or should help them while engaging with a sympathetic therapist are more likely to report improvement than patients who receive neither the intervention nor the therapeutic contact. And yet objective measures might show no or minimal difference between the two groups, as happened in the PACE trial. Adherence to this study design is a deficiency in many ME/CFS trials, and the trend continues with this long covid one. The findings of such research are essentially uninterpretable.
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. In some earlier ME/CFS studies, actigraphs have been worn at baseline and during a follow-up period but not during the end-of-treatment period. At the follow-up assessment points, actigraph findings have not generally matched the self-reported improvements in fatigue and other measures. Some authors have delayed publication of these unattractive data while touting subjective findings as evidence of success.
For unexplained reasons, in this case Professor Knoop and his colleagues are not asking participants to wear actigraphs at the six-month follow-up period. Limiting this outcome measure to the assessment period at the end of treatment would appear to maximize the chances of positive results. Patients often report that they can increase their levels of activity through willpower for a short period–17 weeks, for example–before suffering a serious relapse. So actigraph readings right at the end of treatment are likely to be misleading.
Beyond all this, the study seems to treat the range of non-specific symptoms of long covid patients as if everything comes down to “fatigue.” It also seems to ignore the possible impacts or even the existence of the symptom of post-exertional malaise among this post-Covid-19 group. Although I have little hope that this study will yield useful findings, I assume it is likely to be presented and published as if it does. .
Also during active intervention, subjects may restructure their lives to participate more freely in both the sessions and any therapy goals. They can cut out other activities and pace themselves more to avoid post exertional malaise or crashes.
This may mean average activity levels might seem to be improved over the intervention, both subjectively and objectively, but after the end of intervention you increasingly become faced with unavoidable demands of everyday life, a parent falls ill, you start a new job, your household members or work colleagues no longer feel they need to pick up the slack because you have been ‘treated’ now, etc. It becomes impossible to avoid increased exertion, and crashes become a regular part of your life again. A day in bed here, a week in bed there, a fortnight off sick, and so on.
Any objective measure of activity levels needs to be also undertaken as part of long term follow up if you are to distinguish between just short term changes in coping behaviour from any actual sustained change in the underlying condition.
I haven’t participated in this study myself because I don’t agree with the CBT approach.
However, about self reported improvement without evidence of higher levels of activity: I’ve been measuring my activity levels with a Garmin watch since march last year and while my activity levels don’t seem to have improved over all, I have made some major steps, mainly because I’ve somewhat learned to manage symptoms and stay within my energy envelope. The correct (supportive and adaptive) CBT could help Long Covid patients achieve that.
It took me a year to figure out where my boundaries are and since I’m not getting (much) worse, I’m hoping some level of recovery is now possible.
I’m still at around 850 steps a day (that’s just 50 over what I’ve started with), but I can walk 200 metres at once if I need to in stead of just 30 before I need to rest. I also know in case of emergency I can walk up to 500 metres but that will land me in bed for a week. So, have I improved? I would say I have, because life got better (even though I didn’t).
The sad thing is, while maybe some participants may have benefited somewhat, this study wasn’t aimed at helping patients. It was aimed at finding ‘evidence’ for the researchers distorted beliefs about Long Covid (and ME/CFS).
Even if the outcome for patients was slightly positive (which is debatable), there is no proof whatsoever that Long Covid has anything to do with their proposed perpetuating factors… But it’s presented as if it is anyway.
Ironically, the only damaging false beliefs are the beliefs of these researchers and of physicians that choose to blindly follow them…
Thanks for this David, but I’d take issue with your opening sentence of paragraph 2, specifically “any number of somatic sensations and associated fears”. I’d agree that a limited number of somatic symptoms could be triggered by the mental health conditions you mention, and symptoms of pre-existing physical conditions could potentially be exacerbated by the effect of mental stress on the biochemistry and physiology of the body, but I worry that “any number of somatic symptoms ” could be interpreted as “any somatic symptoms” or “a very large number of somatic symptoms” and so lend weight to the wholesale dismissal of patients’ harder-to-diagnose complaints as ‘MUS’ or equivalent. Sorry to be pedantic, but the level of suffering from the psychosomatic dogma is off the scale now.
“The seven perpetuating factors addressed in Fit after COVID are . . . (2) dysfunctional beliefs about fatigue.”
This is a classic example of circular reasoning (also called “begging the question” in formal logic). The study assumes that “dysfunctional beliefs” cause fatigue, when in fact that is the conclusion to be tested.
Correction: Re my comment above – if I’m going to be pedantic I should at least get the quotation correct! I see that David wrote “any number of somatic sensations” not “any number of somatic symptoms”, which is different, so apologies for that. But I still think care is needed so’s not to leave people with the impression that somatization is accepted as commonplace. Immense suffering is caused by doctors believing that that is the case.
Moving on, it looks like ‘Functional Cognitive Disorder’ (FCD) is another one to watch out for now along with this trial of Acceptance and Commitment Therapy (ACT) for FCD -https://twitter.com/ProfRobHoward/status/1479418721777115137 . It seems that if you’ve lost some of your cognitive abilities then you just have to accept it and work with it, if you’re able to get a handle on what any of it means, that is. Sorry, what does ACT stand for again?
I would like to propose a study to investigate how Professor Knoop copes with pain with my foot up his ass.
The only dysfunctional beliefs about fatigue are generated within the imaginations of members of the BPS brigades. Despite post-publication review of their shoddy work, with explicit critiques coming in from scientists and other observers around the world, their beliefs about “fatigue” prevent them from being able to see and accept reason about myalgic encephalomyelitis and the people suffering from it.
This is a study that should not have been funded. It is an insult to patients and a waste of taxpayers’ money.
Agree with what Peter Trewitt has said, and I think any scientist involved in the area knows full well that this is the case. ie that all energy will be required to be prioritised onto the ‘committment’ in order for people to not drop out. They might as well be testing whether if someone has intense peer pressure to use their one slice of energy for the day to complete having a shower warps their perception to think that ‘having a shower is the easy bit’ of the day ‘and the rest is hard’ rather than say focusing on eating and doing other essential to life things first and noticing whether it is a bad or good day based on whether they can shower.
When did what they do and measure as an experiment become mediated by blurb in the middle to hide the scientific facts – why are this area’s experiments not required to in a table just right down what is being measured (and when), what is being ‘done differently’ (yes, all things the 2 groups will do differently – the days should be required to be ‘blueprinted’), and therefore what a significant difference would actually mean/be due to BASED ONLY ON THESE.
They can riff all they like on pseudomechanisms and blurb but if you make trainee golfers sign up to a scheme requiring them to turn up to weekly training sessions without fail otherwise they are logged as ‘drop-outs’ where they say mantras and compare that filtered group to others left to train themselves as usual and work their training around their full-time job or whatever is normally on then even this bunch would surely have to admit ‘saying the mantras’ was not the only thing different between the two groups. Indeed the progress could have been ‘despite the mantras’, or as likely, ‘because they weeded out those who couldn’t rearrange their life to train weekly vs the other group’. And that there being a difference in outcome did not somehow ‘prove’ that the biggest hurdle to trainee golfers was some false belief harboured by them all.
What I don’t get is how any of these research of this type got to be allowed. You are supposed to begin with a Research Question then design how that can be tested. I can only think they are pretending these are trials in order that they can just turn these into ‘here’s my treatment I’m going to measure it’. Should proper scientific robust exploratory research not be required before the ‘inferential’ otherwise (or are they all still using a debunked trial to get away with this precedent? They simply and utterly fail to ever draw a line between their ‘treatment’ (which is often never actually explained in anything other than ‘claims’ of what it does rather than details of what it asks and involves) and anything substantive. If they hadn’t nicked the name ‘CBT’ (and goodness knows how they were allowed to do this without it having required standards to be met) it would be looked at by most normal people with as much snake-oil-cynicism as certain other unaccredited parapsychology/pseudostuff.
They are ‘treatments looking for patients’, with made-up tosh to try and fill gaps about their reason-for-being. If you look at CBT for catastrophic thinking the level of detail and confirmation that this existed is a world away from what they individuals bother with. And someone has to have catastrophic thinking to do it. There is no deduction. No observation that could be diagramed so someone could check their facts. It requires ‘leaps of faith’ to ‘fuzz’ of undefined false beliefs they don’t define and can’t demonstrate the mechanism for them creating any sort of effect.
What is more shocking is that given the issue for all the ‘7 issues’ they’ve claimed/named is that they’ve basically ‘reversed the arrow’ in causation – people feel unwell because they do less rather than the other way around, people perceive they are ill not because they are ill (therefore that is the body working) but the other way around ARE all scientifically confirmed and demonstrated and logical. Psychology is supposed to check and look at the situational first and address the cause, except in this weird niche where they basically took out the arrows.
Something is very wrong indeed. It’s giving a bad name to whole areas of science who don’t engage in this sort of thing and I don’t understand why this time (it’s happened enough times before over the decades and centuries) we aren’t hearing the voices of criticism and disownership.