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

[Sean]

Common to several of the research environments is that there is a hypothesis that there may be subgroups of ME patients. Eide Gotaas and her colleagues at NTNU are therefore in the process of investigating whether it is possible to identify the subgroups, which will have particularly use of cognitive behavioral therapy.

Reducing the claim is one phase in a back down. Part of the bargaining for face saving.

 

[Woolie]

The treatment was based on a biopsychosocial model (49) in which elements from interpersonal cognitive therapy (50) and personality-guided therapy (51) were integrated. It assumes that treatment must be individualized to match the prominent personality style of the patient. Four personality styles were identified: Cautious, achievement oriented, identity or role confused and disease oriented.

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.

 

[Woolie]

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).

 

[Kalliope]

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

 

[Kalliope]

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

 

[Midnattsol]

Today there is an article in Forskning.no about the paper

Flere burde få kognitiv atferdsterapi mot ME mener forsker
More people should be recieve cognitive behavior therapy for their ME says researcher

I'm not sure I agree with the statement that few people are offered CBT as is said in this article. It is also clarified how CBT can help people cope, but later on an example that is used is to challenge the patient to be more physically active.

 

[tomnext]

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

 

[ME/CFS Skeptic]

Today there is an article in Forskning.no about the paper

Flere burde få kognitiv atferdsterapi mot ME mener forsker
More people should be recieve cognitive behavior therapy for their ME says researcher

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

The patients the researchers received were referred from the GP because they had an unspecified fatigue.

581 of 626 patients completed an interdisciplinary study. 253 of these were not included in the study.

A large group of patients of those referred turned out to have completely different diagnoses than ME. Some of these also did not have fatigue.

This seems to Fors scary.

- Some of them had cancer. Some inflammatory bowel disease. Others had, for example, celiac disease, low metabolism or anemia. Patients with bipolar disorder and depression were also referred.

He experienced this as a very big responsibility, both for the doctors who had referred the patients and for the researchers.

- We do not know everything from A to Z in medicine. We therefore tried our best to refer these patients to specialists. But it is frightening how many were referred to the ME group who did not belong there, he believes.

 

[ME/CFS Skeptic]

Some highly problematic statements from Signe Agnes Flottrop:

Signe Agnes Flottorp is head of research at the Norwegian Institute of Public Health.

She has read the study from NTNU and writes to forskning.no that she believes it is a well-conducted study. It has a "low to moderate risk of systematic biases or errors", she writes.

She points out that the random sampling (randomization) is well done.

There is a low risk of bias between the three groups. There is a low risk that factors other than the intervention itself will affect the results. The dropout rate is not greater than what is usual in such studies. There is a low risk of reporting bias, and the authors explain in a straightforward way what they have done and deviations from the protocol.

It is difficult to get significantly better for this type of study, Flottorp believes.

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

 

[Midnattsol]

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.

I have been thinking about writing them an email to point out things like this. Just need to get my exams out of the way (last one tomorrow!) and get some rest so I'm able to argue coherently.

 

[Sean]

I have been thinking about writing them an email to point out things like this.

Half the battle is getting the criticisms on the formal public record, so nobody in power can say they didn't know, that they were not warned.

 

[ME/CFS Skeptic]

Saugstad's response is disappointing as well.

Saugstad sits on the ME association's scientific council. He tells Dagbladet that the study indicates that cognitive behavioral therapy can be helpful for ME patients who are not severely affected.

 

[ME/CFS Skeptic]

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.​

 

[Woolie]

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.

 

[Midnattsol]

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.​

Forskning.no no longer allow for comments on their articles, I think the article is published on facebook and can be commented on there.

 

[Hoopoe]

! 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!

 

[ME/CFS Skeptic]

Forskning.no no longer allow for comments on their articles, I think the article is published on facebook and can be commented on there.

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.

 

[benji]

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!

 

[Kalliope]

Saugstad's response is disappointing as well.

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/

 

[ME/CFS Skeptic]

I started by being polite to say something positive. Then I listed some weaknesses. I concluded that this is not an ME study.

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.