Cognitive Behavioral Therapy Improves Physical Function & Fatigue in Mild & Moderate CFS: A Consecutive RCT, 2021, Gotaas et al

Just noticed this, @Three Chord Monty.

Who knew that "disease oriented" was a personality style?

Hell, end of life care units must be full of people with this personality style. Those folks just can't seem to ignore their disease.

 

Also wanted to say, I don't think this study has much import. It was probably dumped in a Frontiers journal after being rejected from other journals, largely due to the absence of an adequate control condition (waitlisting is well below minimum standard).

 

Nina E. Steinkopf has written a comment where she raises several problematic issues about the study, among others this:

- The I-CBT 8-week intervention took place at the Coperio health centre. Coperio has an agreement with the Central Norway Regional Health Authority, a state-owned regional health authority, to deliver rehabilitation services for CFS/ME-patients. For several years, Coperio also had an agreement with the Norwegian Labour and Welfare Administration (NAV) for referral of patients to a project with the aim to get patients rapidly back to work. Coperio is a commercial company, solely owned by T. C. Stiles. There seems to be a financial conflict of interest in the results of this study which is not reported.

The whole comment is at the end of the page:
https://www.frontiersin.org/articles/10.3389/fpsyt.2021.580924/full

 

Nina E. Steinkopf has looked further into the financial conflicts of interests in this study, and also about the network to these researchers:

- Professor (MD/PhD) and specialist in general practice and psychiatry Egil Fors was project manager for CBT-study. At that time, he was employed at St Olav’s Hospital. He now works at the Coperio Centre. He is also part of the project team in the planned LP-study.

...

- Since the Coperio Center was established in 2002, T. C. Stiles has co-authored at least 79 published research articles, of which 21 are clinical studies. Most articles are with topics and treatment related to Coperio’s healthcare services. Frontiers has published 10 of these. None of them disclose a conflict of interest.

Undisclosed financial conflict of interest in Norwegian ME research

 

So sad to read this new article at sciencenorway, where it works as indirect marketing for the method and for the clinic that is run by one of the authors.

Writing comments on their FB post about the study to vent my frustration

 

Thought this was interesting (from the google translation of the article):

 

Some highly problematic statements from Signe Agnes Flottrop:

The study she discusses had a waiting list control group, was not blinded, and used subjective outcomes.

 

Saugstad's response is disappointing as well.

 

Plan to post the following comment under the article. Feedback is appreciated.

The results of this randomized trial are presented rather misleadingly.​

The authors (Gotaas et al.) have designed a new form of treatment for patients with ME/CFS which they call “interpersonal oriented cognitive behavioral therapy (I-CBT)”. After 8 weeks of treatment the difference between the group that received I-CBT and the control group that was on a waiting list to receive I-CBT, was clinically insignificant.

For the primary outcome of this trial, self-reported physical function on the SF-36, the difference between both groups was 6.8 points, lower than the 10 points the authors had chosen as the minimal important difference. For the secondary outcome of fatigue measured with the Chalder Fatigue Questionnaire, the difference between the I-CBT and waiting list control group was not statistically significant, despite an adequate sample size.

These results indicate that I-CBT is likely an ineffective treatment for patients suffering from ME/CFS. The abstract, however, gives the exact opposite impression stating, for example, that the “I-CBT program improves physical function.” It also concludes that this effect “persist 1 year after baseline”. At that time point (52 weeks post-randomization) there were no longer any outcome measurements for patients in the control group. It is rather misleading to speak of a treatment effect if results are not compared to a control condition.

Lastly, the protocol provided in the supplementary material, lists physical condition VO2 max as a secondary outcome and indicates that it was the intention to publish these data in the main paper (paper 1). It is unclear why the VO2 max data haven’t been published in this paper.​

 

! I think all of us can hazard a pretty good guess as to why the VO2 max data haven’t been published in this paper.

 

Because it would look silly to claim an improvement in physical function without a change in VO2 max!

 

I was thinking about a comment under the actual paper on Frontiers in Psychiatry.

Would this be worth contacting the editors for? People who only read the abstract get quite a misleading message.

 

As i see this study is very much used by the BPS crowd at least in Norway, it would be very good to have a comment like this in the journal to point to. The best place!

 

He says why in a comment under a blog post by Nina E. Steinkopf about the study.

google translated:

Hi Nina You are absolutely right in your criticism of this study. When I commented on it to Dagbladet, I started by being polite to say something positive. Then I listed some weaknesses. I concluded that this is not an ME study. Dagbladet included only the first sentences. I complained to the journalist. She said it was an editorial edit and I understood it so that it was not she who had done it. I should know now that Dagbladet has its own ME agenda. Best regards Ola D

https://melivet.com/2021/05/25/norsk-me-studie-ikke-sa-viktige-funn-likevel/

 

In my view, he focuses too much on diagnostic criteria, rather than methodological weaknesses of the trial. That might have given journalists the impression that it works for some.