How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity, 2010, Wiborg, Knoop +

Hutan

Hutan

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2010 study
https://www.researchgate.net/public...atigue_syndrome_The_role_of_physical_activity

J. F. Wiborg*, H. Knoop, M. Stulemeijer, J. B. Prins and G. Bleijenberg
Expert Centre Chronic Fatigue and Department of Medical Psychology, Radboud University Nijmegen Medical Centre, The Netherlands


Abstract
Background
Cognitive behaviour therapy (CBT) is known to reduce fatigue severity in chronic fatigue syndrome (CFS). How this change in symptomatology is accomplished is not yet understood. The purpose of the present study was to determine whether the effect of CBT on fatigue is mediated by an increase in physical activity.

Method
Three randomized controlled trials were reanalysed, previously conducted to evaluate the efficacy of CBT for CFS. In all samples, actigraphy was used to assess the level of physical activity prior and subsequent to treatment or a control group period. The mediation hypothesis was analysed according to guidelines of Baron & Kenny [Journal of Personality and Social Psychology (1986)51, 1173–1182]. A non-parametric bootstrap approach was used to test statistical significance of the mediation effect.

Results
Although CBT effectively reduced fatigue, it did not change the level of physical activity. Furthermore, changes in physical activity were not related to changes in fatigue. Across the samples, the mean mediation effect of physical activity averaged about 1% of the total treatment effect. This effect did not yield significance in any of the samples.

Conclusions
The effect of CBT on fatigue in CFS is not mediated by a persistent increase in physical activity.
 
Pretty remarkable admission coming from some key BPS researchers.

If CBT isn't changing physical activity, the it's really just changing how people interpret their symptoms and/or changing how they fill out a survey about them.

Also, as @Sean noted elsewhere, it's interesting to see that the three trials analysed in this review all used actigraphy. That was in the first decade of this century, and yet we have rehabilitationist researchers now claiming that wearables are not suitable for use in assessing changes in functionality in ME/CFS.

How- ever, considerably less attention has been paid to whether the effect of these interventions actually de- pends on a change in physical parameters. Such a finding would be vital to the validation of all treat- ment models which rely on a physical activity pro- gramme in some way to improve fatigue. In the only study of such nature that we are aware of, Moss- Morris et al. (2005) demonstrated that an increase in physical fitness does not contribute to the treatment effect of GET on fatigue in CFS.
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This seems relevant to the Cochrane Larun et al review.
 
Jonathan Edwards said:
I forget but wasn't this the basis for the PACE trial steering committee abandoning altimetry as an endpoint in PACE be because it had been shown to be 'unhelpful' (i.e. not to give the predicted result).
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Just a side note on this point, while it is often described this way - as something they planned to do and then "dropped" - the trial management group meeting minutes tell a different story. They planned for actigraphy as a predictor, and then considered making actigraphy not just a predictor but also an outcome, but decided not to add it as an outcome.

The protocol paper, published in 2007, long after they started planning and indeed doing the trial, does not list actigraphy as an outcome measure, only as a predictor.

In the Trial Management Group minutes in 2004-5, you can see they they did consider whether or not they should make actigraphy not just a predictor, but also an outcome measure, and opted not to for well-dodgy reasons.

It was noted that the Dutch study by Bleijenberg and colleagues reported that actigraphy was not a good outcome measure since the majority of patients are reasonably active and there is no change in this in spite of improvement in fatigue. However, pervasively passive people at baseline may do worse on CBT and perhaps better on GET.
A final decision on using this as an outcome has been postponed until we see how much of a measurement load actigraphy is, and it was agreed that this may be changed later if desired.
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In the minutes the primary outcome measures were always questionnaires - Chalder Fatigue and SF36 physical function - right from 2003 (see the Trial Management Group minutes Meeting No. 2). In TMG meeting #7 they did discuss whether they should have an objective primary outcome measure, but clearly they ultimately decided not to. They seemed most interested in the potential of the 6 minute walking test:

Objective Measures of outcome. We had much discussion about various potential objective measures of outcome, including a six-minute walking test where the patient is timed using a stopwatch and the distance walked is recorded. The possibilities of using actigraphy and the step test for fitness were also discussed. We agreed that we would pilot the use of actigraphy, the step test and the six minute walking test in the first three centres. We had some discussion about whether an objective measure was to be a primary outcome. We had some discussion about the power of the trial to detect clinically significant differences between groups using the six-minute walking test.
ACTION: to send raw data of Oxford Trial in which used the six minute walking test.
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I did not find further mention of objective outcome measures after this.

[For more on outcome vs predictor, see https://s4me.info/threads/paul-garn...es-and-other-media.15629/page-105#post-530333]
 
Yann04 said:
How is that defendable. It seems ridiculous?
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I could be confabulating given my memory, but my recollection is that this was justified by any such data being limited and not uniform enough to pool the various small studies. Though I agree not to mention it at all when much of it contradicts Larun et al’s theme of the wonderfulness of GET is inexcusable.
 
Hutan said:
That was in the first decade of this century, and yet we have rehabilitationist researchers now claiming that wearables are not suitable for use in assessing changes in functionality in ME/CFS.
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Because it doesn't give them the results they want. There are many instances of this. Even PACE noped out to avoid having to report failure.

Although ironically there is now a new cohort of rehabilitation researchers who aren't aware of this and are using wearables. That we haven't seen any research showing positive benefits says just as much as this.
 
In the only study of such nature that we are aware of, Moss- Morris et al. (2005) demonstrated that an increase in physical fitness does not contribute to the treatment effect of GET on fatigue in CFS.
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But. That's literally the premise they have been asserting for decades. And still do.

It's things like this that make it clear that however harsh we are with these researchers, it's not nearly as much as they deserve. They know their stuff is wrong just as much as the tobacco companies knew about the harms of their products. It's completely indefensible to stick to feigned ignorance.
 
Peter Trewhitt said:
However if I remember correctly the protocol for this then new version of Cochrane’s exercise review explicitly excluded studies/data using such ‘objective outcomes’.
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it didn't exclude the studies (PACE had "objective outcomes"). It excluded the objective outcomes from the studies--a change with the new protocol developed for the revised exercise guidelines.
 
Jonathan Edwards said:
I forget but wasn't this the basis for the PACE trial steering committee abandoning altimetry as an endpoint in PACE be because it had been shown to be 'unhelpful' (i.e. not to give the predicted result).
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Yes, they learned that a Dutch trial or trials had null results for it, so they decided it didn't accurately reflect "fatigue"--just as Knoop argued recently about why their CBT and Long Covid study didn't report their null actigraphy findings. But in correspondence regarding the protocol, the PACE authors responded to criticism for having dropped actigraphy (from Tom Kindlon, and one other person, I think) by giving another version. They claimed they dropped it because they decided it was too much of a burden for patients to do at the end of the trial--even though they had managed to do it at the beginning. This answer seems like it can be called a lie--they didn't mention that they had learned from their colleagues that the actigraphy didn't produce desireable results.
 
Hutan said:
Also, as @Sean noted elsewhere, it's interesting to see that the three trials analysed in this review all used actigraphy. That was in the first decade of this century, and yet we have rehabilitationist researchers now claiming that wearables are not suitable for use in assessing changes in functionality in ME/CFS.
.
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It was interesting that they withheld the actigraphy data from all of the primary publications and only published them in this study,
 
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