Dutch study: Need to change illness perception and beliefs

This looks worrying. Does anybody have access to the full article?

J Psychosom Res. 2012 May;72(5):399-404. Epub 2012 Feb 22.
Towards an evidence-based treatment model for cognitive behavioral interventions focusing on chronic fatigue syndrome.
Wiborg JF, Knoop H, Frank LE, Bleijenberg G.
Expert Centre for Chronic Fatigue, Radboud University Nijmegen Medical Centre, The Netherlands.

CONCLUSION:

Our findings suggest that cognitive behavioral interventions for CFS need to change the illness perception and beliefs of their patients in order to be effective.

http://www.ncbi.nlm.nih.gov/pubmed/22469284

Agreed, this is important. I did email the lead author to request a copy of the paper but never heard back. I've found that CFS psychologists/psychiatrists almost never reply, yet non-pyschologists and those outside CFS research are almost always happy to provide papers on request.

Is this translatable for ordinary people outside the psychos and their theoretic "modellings" - if it's designed to confuse it's doing a great job. As a twelve yearer I don't recall having any problems with my "perceptions" of this illness.

The "psychosomatics" not given up yet ? Ever heard of medical research/findings - obviously not.

The only illnes perception/belief we need to change is the one foisted on us by society that we don't have a real, physiological illness, and that the solution to this is to do more. That is the belief which damages so many people with ME.

Why bother reading it? The Nijmegen papers are all pretty much the same:

"ME/CFS patients report feeling less fatigue after CBT, where they are taught to stop saying they feel fatigued. ME/CFS patients do not perform any better according to objective measurements, so we didn't bother including those results. Only what the ME/CFS patient reports feeling is important anyhow, not objective ability to perform daily tasks, work, school, etc. Success is defined as convincing ME/CFS patients to stop saying they're sick. Ergo, CBT cures ME/CFS."

That's my paraphrasing, not completely identical to the conclusions of the actual papers

I have not yet seen the full text of this latest paper, but looking at the names of the authors, all but one (Frank) were involved in a previous meta-analysis of 3 CBT trials which concluded that although CBT leads to reductions in self-reported fatigue, there were no objective improvements in the reduced physical activity of patients (http://www.cfids-cab.org/rc/Wiborg.pdf). It would not surprise me if the data used in this latest paper came from one of the trials used in the previous meta-analysis, which would be an interesting twist.

Judging from the abstract alone, this new paper suggests that improvements in self-reported fatigue severity and disability are related to a decrease in perceived problems with activity and an increase in sense of control over fatigue but not related to changes in symptom focusing. The authors conclude here, "Our findings suggest that cognitive behavioral interventions for CFS need to change the illness perception and beliefs of their patients in order to be effective."

The problem is that CBT trials for CFS are never adequately blinded or placebo controlled. Issues with CFS criteria aside, their intervention techniques and subjective outcome measures are too heavily intertwined to rule out a range of biases in the reported improvements without additional objective measures like actigraphy or work employment, and can lead to circular conclusions. They use a similar assumption as that used for depression: patients complain of subjective depressive symptoms, CBT helps to change the cognitions which perpetuate depression, then patients self-report less depressive symptoms and is therefore helped.

I wouldn't rule out potential benefits of CBT, it is just that when there is multiple evidence CFS patients remain substantially impaired without improvements to objective measures of function we have to wonder why these patients are still self-reporting improvements in function after CBT and question whether the patients' previous perception of their disability was ever pathological in the first place rather than an accurate assessment of their illness related impairments.

CBT aims at increasing patients' perceived self-efficacy over fatigue and changing their perceptions about disability, so it is unsurprising that when they ask patients about fatigue and disability they report improvements even if there are no objective improvements in actual function (the abstract mentions improvements in "disability", but most trials use self-reported measures like the physical function subscale of the SF-36 health survey). Similarly, it would be unsurprising if patients who received 10 one-hour long sessions of war propaganda then reported increased disapproval of the targeted regime, a more extreme example but still.

According to the PACE Trial and systematic reviews on CBT, the overall effect size of the improvement in fatigue is small to moderate and it is only about 15-20% more participants than controls who report improvements in "fatigue" . So CBT is not particularly effective anyway even if the results are accurate without flaws. A reduction in fatigue is still useful even without improvement in function, but it needs to be genuine.

These people are 'making' more 'evidence' that their therapies work because in the Netherlands a guideline is being made how to diagnose and treat CFS. In the concept now CGT is named as the first treatment option while the effects are considered as low to poor quality of evidence.
Secondly GET is recommended.
Other treatment options are seen as 'not proven'.

Quess who is in the workinggroup that makes the guideline? Same Bleijenberg! It is also said that 'normal' GET won't do, but the protocol from Nijmegen must be practiced.

The Dutch patient organisations are hardly heard. Their suggestions about using the ICC are put aside. You cant recommend CBT and GET when you consider exercise intollerance as the main symptom

Here in Holland we still have a long way to go...

So is the idea that they must have a treatment at all costs, and "low to poor quality of evidence" is better than no evidence at all?

Yes, that's what it is. They can't say: You have an illness for which we dont have a treatment.

And then: Were very sorry, but we are going to investigate till we do.

That would cost them money!

They keep talking about RCT: Randomized Controlled Trials, and the only ones from the 4000-5000 cfs studies they find elegible are the ones about CGT.

It's even worse, as our doctors are advised against prescribing B12 or other supplements like vitamin C, Q10, magnesium or others because there is no evidence they work (but who is going to do a RCT on non-patentable supps?).
And we must be advised not to take more then daily recommended.
O, yeah, we are also advised against diets.

And our docter must motivate us to stick to the therapie...


Want to emigrate?

Wow it must be real science cause look everyone they've just reinvented the broken wheel. Doesn't matter if the facts don't fit reality. It doesn't matter if facts that detract or counter your theories and conclusions are left out or included. As long as the opening objective statement and closing conclusion reads/sounds good everything's good.

I've now read the full paper and will probably post some more detailed comments, but here are the most important points:

1. They found in the original CBT trial that CBT only made a small difference (or none at all, according to actometer measurements).

2. Analysing the trial, they concluded that this small difference was mediated by CBT increasing a sense of control over fatigue and decreasing perceived problems with activity. However, the authors admit to one major limitation and other limitations with their study, which means the model can't be relied on: "a replication of our finidngs in prospective intervention studies is thus needed to validate our treatment model". Which is more or less where they were before they started.

So they have a flaky explanation of a minor effect of CBT on CFS. Marvellous.

How the analysis in this study works

This study, like several others trying to explain how CBT 'works' in CFS, uses a fearsome-sounding technique called Structural Equation Modelling, which I try to explain below:

Structural Equation Modelling (SEM)

SEM can prove theories wrong, or plausible, but not 'right'
This statistical approach is from the same family of techniques as the multivariate regression models routinely used in data analysis. What makes SEM different is that rather than try to analyse data and draw conclusions it looks through the other end of the telescope and asks: can this model explain the data? i.e. it starts with a theoretical model and sees if it holds up in experimental studies. SEM is set up in such a way that the model is 'falseifiable', that is it can be proven wrong by the data. But the model can't be proven 'right', only that it fits the data well and is a credible explanation. There may be several other credible explanations that would also fit the data.

So SEM can be a good way to compare 2 competing theories: one or both might be shown not to fit the data. Neither can be definitively proven right.

SEM can give insights into how a treatment works
SEM is used in this paper to try to understand how CBT works - what mediates the effect of the treatment. Mediation is probably best explained with an example: Income correlates with education, but income also correlates, unsurprisingly, with occupation too. However, occupation correlates strongly with education, as shown by the diagram below:

(from presentation by Dr Peter Wang - slide 9)

So higher levels of education generally lead to higher incomes in later life, but the effect is mediated by the effect of education on occupation. Better education leads to better jobs which leads to higher incomes.

Or watch a short video that explains, with the aid of a tea towel, how SEM is used to probe mediation.

In this study the authors seek to show the effect of CBT was mediated by decreasing perceived problems with activity and a sense of control over fatigue. In other words, CBT works by changing perceived problems with activity and sense of control over fatigue - the mediators - which then produce the treatement effect of reduced fatigue.

However, to do this requires two things: first there must be a correlation between the mediators of activity problems perceived/sense of control and the outcome of reduced fatigue and second, that the mediators are changed first, then the outcome changes afterwards so there is a clear sequence of events. Without establishing this sequence of event no conclusions can be drawn over the direction of relationship. For instance, a reduction in fatigue may lead to a sense of control over fatigue, or both may be independently caused by CBT. Wheras in the example of education and income above, education takes place before the mediating factor of occupation giving much greater evidence of a causal relationship.

More on Structural Equation Modelling, including a longer video and slides.

Over the last few weeks I've drafted a critical 1500+ word assessment of this paper in context with their other work but it has grown too large for a single post so I need to trim it down first or break it up into parts. Maybe it isn't even worth the effort finishing it off, we all know this paper was a glamor piece on a small effect size in subjective measures with no effect on objective measures (which they fail to mention of course). Both the CBT group and control group remained classed as "severely fatigued" on average.

In this paper and other recent Nijmegen papers: 1) they cleverly skip around the fact that their own data shows no objective improvements, despite this discrepancy they continue to promote CBT as reducing disability, they even speculate about unrecorded improvements in activity and claim that patients don't need to increase their activity to be cured; 2) they admit the subjective measures used are prone to the same cognitive biases they believe are central to CFS, but then ignore any potential biases introduced by CBT; 3) they automatically blame any discrepancies on patients without any effort to determine the accuracy of patients' cognitions before or after CBT, it is just assumed CBT must be doing good.

Nijmegen also seems to be salvaging the remains after blows to their hypothesis, as anyone would do. Only a few years ago they were claiming that the majority of CFS patients are characterized by a low level of physical activity (confirmed in two recent systematic reviews) and a dysfunctional boom and bust cycle (debunked in a recent systematic review). Now in Wiborg et al 2012 they are claiming that the vast majority of us are "relatively active" and this is supposed to explain why CBT doesn't necessarily lead to increased activity as originally presumed, but we still need CBT to "correct" our perceptions about disability anyway of course.

I have noticed in recent years that the cognitive behavioural model of CFS has been chipped away with unfavourable data and all that really remains now are subjective factors; focusing on symptoms, sense of control, and perceived disability. As others have already touched upon, the effect sizes are relatively small anyway, and the effects and mediators of CBT are all too heavily intertwined with the subjective questionnaires which measure them, and with the placebo response. They focus too much on fatigue and their interpretation seems a tad circular.

The "success" in the cited CBT/GET studies is of course a reduction of subjective fatigue and perceived disability, rather than actual impairment or consideration for pathophysiology. Obviously subjective improvements are desirable for a medical diagnosis primarily determined by subjective measures, but CBT trials may be even more unreliable than open label (unblinded) trials because the therapy is directly aimed at reducing the perception or score on the same self-reported measures that are prone to bias, not to mention the experimenters' bias and the reactivity biases of participants under study which has never been properly controlled for either (the difficulty or impossibility of doing this doesn't suddenly mean it doesn't matter).

I don't rule out possible benefits of CBT for a minority of patients meeting broad CFS criteria, some reported improvements may be genuine but mostly generic (eg self-efficacy) rather than specific to CBT rationale for CFS as a cognitive-behavioural illness per se, but I would be inclined to take the results and underlying hypothesis more seriously if the patient criteria was stricter and the effect sizes were larger (more like CBT for major depression) and the limited objective data available didn't contradict the much promoted "evidence base" of CBT.

Actigraphy isn't perfect and some activities aren't necessarily detected using it, but it would be sad if all this time they were mainly just detecting their ability to change their patients' "questionnaire taking behaviour" rather than the symptoms and disability of CFS. I'm also weary of frequent spin from CBT/GET proponents, keeping in mind these Nijmegen researchers are responsible for the dodgy editorial which accompanied the Lancet paper on the PACE Trial, flagrantly and erroneously promoting "normal" as "recovered" despite being familiar with all the figures, that was the last straw for me.

Why is CBT the magic treatment for ME/CFS and everything else?..............Its CHEAP!

Thats one reason why you get these silly papers that masquerade as real science, making such ridiculous claims. When they get ill with something, or get old, I hope all they get is the treatment they promote - CB bloody T. They wont really have cancer, or heart disease, or ME, or old age, they'll just have got their perceptions in a twist and a little bit of CBT will get them back to normal...lovely!

That's like saying it's cheaper to put a plastic tarp over one's roof after hail damage instead of re-roofing the house.

I think it is really irronic that CBT actually gives us false illness beliefs (makes people falsely believe they have improved), when one looks at the response to activity by going by the actometres. One could say that CBT causes false illness beliefs.

If CBT convinced a cancer patient their illness wasnt that bad to the point where the person said it wasnt, does it make the cancer better? "They said it was better so it must be" lol.. this is how ridiculous the psychs are being.

All those psychologists who do such bad studies will one day in the eyes of the rest of the medical field, be laughing stock.

I wonder if we could produce a paper, joking or serious, marvelling at how wonderful CBT was at improving patient capacity to fill in questionaires? We could make it a review paper, cite all the evidence, and so on. Pity its past April 1st though. We could then discredit alternative explanations using data from their own studies. I don't know how seriously it would be received, but it would be interesting even if we were the only audience. Bye, Alex