CBT combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study, 2020, Wyller et al

I remember when this study got funded. It was presented as a trial on ME. But it's not possible to call the result an ME-study, is it?

Here's a presentation I found in English:
Norwegian Academy of Music: Music Therapy and Cognitive Therapy for Chronic Fatigue Syndrome (CFS/ME) following Epstein Barr infection in adolescents
https://nmh.no/en/research/projects...llowing-epstein-barr-infection-in-adolescents

Here's the presentation for REK - Regional Committes For Medical And Health Research Ethics where the title is: Mental training for chronic fatigue syndrome (CFS/ME) following EBV infection in adolescents: a randomised controlled trial
https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?_ikbLanguageCode=n

google translation:
project description:
In the project 'Fatigue after Epstein Barr virus infection' (EBV infection), we follow 200 adolescents for six months to identify the risk of developing chronic fatigue syndrome (CFS / ME). In this study, we want to study whether a mental exercise program can be a useful treatment for the young people who actually develop CFS / ME. Half of the patients will be randomly assigned to this treatment, the other half will receive routine follow-up by the GP. The training program consists of 10 sessions of 90 min. duration and consists partly of cognitive therapy, which is previously known to be useful in patients with CFS / ME, and partly of music therapy, which has not previously been tried in this disease. We examine effects on both symptoms (fatigue), function (number of steps) and underlying disease markers (immune function, nerve function, etc.) immediately after treatment termination and 1 year later.
(Project manager's project description)

 

WTAF?

 

@dave30th came up with this idea years ago

https://www.virology.ws/2016/12/02/...ch-studies-again-and-an-esther-crawley-bonus/

 

Does anyone know what they did to the control group? It says "usual care", but the figure shows the controls got worse during the intervention period. If they received care as usual, why fewer steps, more PEM and more fatigue?

 

Only two follow-up visits: "care as usual’ implies that the relevant individuals would not receive any healthcare for their CF condition in the follow-up period apart from the follow-up visits in the present study."

Its hilarious, or rather, close to to fraudulent, to not raise the question in their discussion of why the control group showed almost the exact same patterns on questionnaires and steps as the intervention group.

This study clearly shows the intervention has no effect whatsoever, just as with PACE, FITNET, and all the others.

 

Well,

Be careful @dave30th, with giving them sarcastic research ideas. Apparently they will get approved and funded by the government..

 

*Ahem* clears throat what's next, free beer as treatment for CFS? Haha. That would be silly and should never happen.

Actually, pretty sure it would be just as good as any of the dumb things tried so far. Anyway they write whatever conclusions they want so it's not as if the substance of the experiments mattered at all when being on a waiting list is considered an active control or whatever. So much silly stuff in this field I have no idea what they're thinking.

 

A few more notes (I'll ignore all the claims about CBT and GET being known to be effective):

https://clinicaltrials.gov/ct2/show/NCT02499302

So for their primary outcome, patients receiving this intervention "tended to decrease", yet the abstract's conclusion spoke just of a tendency "towards positive effects on patients’ symptoms and recovery"?

Maybe they should have mentioned results for their primary outcome there?

Their 'recovery' claims seem to just be based on the Chalder Fatigue scores ("Recovery was defined as being classified as non- CF (ie, dichotomised response <4 on the CFQ).")- any sign this recovery criteria was pre-specified? I could see no mention of it on the trial registration and saw no information on whether this was a prespecified outcome or not in the paper. Seeing as the inclusion criteria was a score of four, this would allow the smallest of possible improvements in CFQ score to be classed as a 'recovery'.

No mention of their primary outcome in this pull out box:

Whatever the context, they thought that the intervention wasn't worth the bother.

 

We need charities to knock this kind of thing on the head.

There is so much wrong with this.

The deliberate conflation of CF has so much potential for harm .

 

My father was transferred to a convalescent home after a heart attack in 1970. They were given a glass of Guinness every day. Stout was seen as a way to build up patients and was given on the wards for years

Now it would be CBT ...

 

Yes, there seem to be quite a lot of problems with the way the results are reported here.

The authors write "that the study indicates that the mental training programme may improve symptoms and lead to higher recovery rate over time". Yet as Esther pointed out the pre-specified primary outcome was mean steps per day during 7 consecutive days measured by accelerometer and measured 12 weeks post-randomization. For this outcome, the intervention group did worse than the control group!

The control group was called 'treatment as usual' but with the caveat that patients usually don't receive anything. The paper admits: "‘care as usual’ implies that the relevant individuals would not receive any healthcare for their CF condition in the follow-up period apart from the follow-up visits in the present study." So it seems that the intervention tested did worse than nothing. A possible explanation is that all that psychoeducation, bodily stress reduction and getting in contact with positive emotions were hindering patients to resume their ordinary life.

The differences for all outcomes were rather small and in total 41 secondary outcomes were listed, so it doesn't seem that hard to pick one out (like PEM) that shows a trend towards improvement. The paper speaks of recovery rates although this was not listed among those 41 secondary outcomes. It's also not really a definition of recovery, it simply indicates the percentage of patients who no longer meet the inclusion criterium of scoring 4 points or higher on the Chalder Fatigue Scale. A lot of healthy people score 4 or higher on this scale, a lot of healthy people score lower, so it's unclear what significance this threshold is supposed to represent. In any case, it's inappropriate to use it as recovery threshold participants could simply have improved from 4 to 3 points on the scale to be classified as recovered. Also if you look at the data there was no notable difference in fatigue scores post-treatment, the small difference only appeared between the end of treatment and the one-year follow-up assessment, so it might just be a meaningless fluctuation. In contrast to the other outcome measures, this 'recovery rate' also doesn't account for the large drop-out rate in the intervention group.

That brings me to another point. The paper emphasizes that "combined CBT and music therapy is feasible and acceptable in adolescent postinfectious CF." it isn't clear what measure represented acceptability - this also wasn't mentioned as an outcome. Compliance was good and there were few reports of harm, but there were also more drop-outs in the intervention (29%) compared to the control group (5%) and more than half of the eligible participants declined to participate. That seem to suggest some issues with acceptability.

The authors write that the results "might justify a full-scale clinical trial". I fail to see why. Using their selection criteria, most participants (only a minority had CFS) will probably recover anyway (or already did). For the primary outcome doing nothing seemed to do better than the intervention. Most patients didn't want to participate and more than a quarter of the participants in the intervention dropped out.

 

It might justify a full trial because Wyller is well connected, and spending money on CFS junk science shows a brave willingness to stand up for science... with Esther Crawley an associate editor at BMJ Paediatrics Open, they know that they'll be able to publish whatever spin they want to put on things too!

I wonder if there's anything Norwegian patient groups can do to stop more money being wasted on Wyller?

 

There has been attempts, but as you say he's well connected.

Here's just one example. A letter to the editor from the director of the department Wyller works at when Wyller didn't get funds for a Lightning Process study he wanted to conduct: Patient groups harass ME researchers and exert pressure to influence who gets research funding

 

Wow - that piece was weak. Did anyone manage to get any debate going after it? The quality of thinking even from the people who aren't even directly connected to ME/CFS work is so worrying.

 

I may have just the song for the music therapy portion of this treatment.

https://www.youtube.com/watch?v=6Q16o87sPoM

 

No sadly not.

Even when over 7 000 people signed a petition asking for the removal of the national competence service for CFS/ME and their biopsychosocial approach, nothing happened.
The leader of the competence service used to work in Wyller's team.

 

How about playing music for all the folks getting cover? Force em in rehab and impose group CBT to learn about unhelpful beliefs and definitely not listening to your body because the message you get from your brain are not always correct and yes folks, this has been heard this last week on a webinar by a so called specialist.

 

The supplementary material includes a treatment manual. It explains that the treatment is based on the "sustained arousal–model of CFS/ME." The document writes:

"An important premise in this model is that CFS/ME can arise as a result of classical and operant conditioning (25); for example can natural fatigue during long lasting infection gradually be automatically associated with other stimuli, like physical activity. By this the fatigue is sustained even though the infection gradually gets healed."​

So if I understand correctly- a bit like Pavlov's dogs started drooling when they heard a bell, ME/CFS patients learned to associate certain stimuli with the fatigue they experienced after a bad infection. And that automatic association creates sustained arousal and fatigue.

The manual explains:

"Troublesome symptoms (like fatigue) may be triggered, not only by physical activities, but also by imagining such activities (36), which in next moment may strengthen the already established “mislearning” that all activity leads to afflictions"​

The treatment tries to break those automatic associations and bad thoughts with fun and spontaneous activities like listening to and composing music.

"The intention is to create new automatic associations: Instead of the association “activity leads to fatigue” one shall facilitate associations like “activity gives energy” and “activity is fun”.
​

This seems like a soft version of the Lightning Process. In his response to my comment, Wyller emphasized that: "Ample evidence from other fields suggests that bodily complaints may arise in the absence of any bodily disorder."