A 4-day mindfulness-based cognitive behavioural intervention program for CFS/ME. An open study, with one-year follow-up, 2018, Stubhaug et al

JaimeS

JaimeS

Senior Member (Voting Rights)
Here's a weird one:
A 4-day mindfulness-based cognitive behavioural intervention program for CFS/ME. An open study, with one-year follow-up.
https://www.frontiersin.org/articles/10.3389/fpsyt.2018.00720/abstract

These people seem to be implying that four days of CBT will fix your "CFS/ME" permanently, showing continued improvement at one year follow-up.

Oxford of course. And all subjective surveys, of course. But man! Can you imagine telling someone they had a major psychiatric disorder but that four days of therapy would cure them permanently?
 
oh dear..
Bjarte Stubhaug is a psychiatrist with a doctorate on chronic fatigue syndrome or "neurasthenia", which is the same according to him. He runs a resort in Norway with a four-day treatment plan including mindfullness, walks and classes. He doesn't distinguish ME from stress, burnout etc. I've heard numerous accounts of ME patients deteriorate after treatment at his resort.

I think he was at a conference about CFS at Cook Islands quite a few years back where also some PACE-researchers participated.. But can't find the conference when googling..

He has published lots of articles about ME and done a lot of damage in general by spreading "facts" about ME as a stress disorder.

He's developed an expensive app about stress and mindfulness. I'm sure many here will be disappointed to learn its only available in Norwegian..
 
I guess this is about Stubbhaugs program/centre, but note the name Gerd Kvale also.

Gerd Kvale is a professor in psycology (at Haukeland university hospital, the home of Fluge/Mella), leading the OCD team. She is one of the two persons who developed the "Bergen 4 day treatment" (B4DT) - "get rid of your anxity in four days"

https://helse-bergen.no/klinikk-for-4-dagers-behandling-b4dt


Innovation of the year
The CTF was awarded “Innovation of the year” by The Norwegian Psychological Science Association in 2015. The CTF is highly requested by patients, families and therapists, both nationwide as well as internationally, not only for OCD but for other anxiety disorders as well as for depression

https://helse-bergen.no/klinikk-for-4-dagers-behandling-b4dt/the-bergen-4-day-treatment
 
inox said:
I guess this is about Stubbhaugs program/centre, but note the name Gerd Kvale also.

Gerd Kvale is a professor in psycology (at Haukeland university hospital, the home of Fluge/Mella), leading the OCD team. She is one of the two persons who developed the "Bergen 4 day treatment" (B4DT) - "get rid of your anxity in four days"

https://helse-bergen.no/klinikk-for-4-dagers-behandling-b4dt


Innovation of the year
The CTF was awarded “Innovation of the year” by The Norwegian Psychological Science Association in 2015. The CTF is highly requested by patients, families and therapists, both nationwide as well as internationally, not only for OCD but for other anxiety disorders as well as for depression

https://helse-bergen.no/klinikk-for-4-dagers-behandling-b4dt/the-bergen-4-day-treatment
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Sigh. This is the problem with assuming that a questionnaire is actual evidence of improvement after an unblinded intervention.

These interventions may be effective at changing cognitions with respect to how patients report symptoms, but this is not the same thing as objective improvements in their lives. Specifically achieving the human needs that were previously unfullfilled due to the illness. There is a fundamental lack of quality in how we assess the impact of interventions like this.
 
Ah. Of course. It's 4 A's, not 3. Better check with 5 just to be sure but 4 seems to be the right amount.

So it's pronounced Leviosaaaa after all, in Norwegian anyway. Now let's fund 40 more identical replications of the same trial that all conclude that more research is needed and that should secure a couple decades of employment doing the equivalent of shoveling rain during a huge storm.

This has always really just been an employment scheme for mediocre physicians, has it? Just stuff those trials with people randomly snatched from the street for all they care.
 
Snow Leopard said:
Sigh. This is the problem with assuming that a questionnaire is actual evidence of improvement after an unblinded intervention.

These interventions may be effective at changing cognitions with respect to how patients report symptoms, but this is not the same thing as objective improvements in their lives. Specifically achieving the human needs that were previously unfullfilled due to the illness. There is a fundamental lack of quality in how we assess the impact of interventions like this.
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I'm in no way defending this work on ME or disagree with you on the lack of quality.

More concerned that Gerd Kvale is connected to this research, as the B4DT is so well applauded over here, making it harder to criticice the "ME"-study :-/ Also the implication that ME is more or less the same as OCD and anxiety. Don't know how the quality of the B4DT study is, but the media coverage seems nothing but positive. Again, making it harder for ME-patients to criticise a similare approach for our illness - we are already heavily criticed for arguing against LP, CBT etc :-/

The Kavli trust, that also fund Fluge/Mella also funds the establishing of several B4DT centers for children/youth in Norway. The link also contains short description of each treatement day.

https://kavlifondet.no/2017/03/lar-angsten-slippe-taket/
 
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Ah hah! I bought into this in my early days and went ahead, had a 2 days silent mindfulnes workshop. I left the place slightly peaceful and content, remembering coming back home when I turn the corner to our street I saw my sister in law's car. I thought fuck! 2 days of peace and silence gonna be wasted in probably 10 minutes and I was right.

So, never mind sorting you for life 10 minutes it took me to get dizzied with verbal diahorrea and back to the usual tiredness.
 
I have looked through it and am not impressed.

305 patients diagnosed with Oxford criteria. 219 completed all the assessments including 1 year follow up.

Assessments were done by self-reports prior to the first consultation, 1 week before and 1 week after the intervention program, and at 3 months and 1 year after the intervention.
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A subgroup fulfilling the inclusion criteria from the PACE study (Chalder Fatigue Scale >6/11, SF-36 Physical functioning <65/100)
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148 patients fulfilled PACE entry criteria
All patients were also examined according to the CDC (1994) case definition of chronic fatigue syndrome (32). In accordance with CFS-CDC case definition, comorbid conditions of mild to moderate depression or anxiety were allowed. A subgroup of patients with CFS (CDC) was defined.
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'Clinically significant' improvement was defined as at least half a standard deviation, which meant improvement on CFQ of 2 and on SF-36 of 7 points.

54 patients Oxford only,
46 of these gave 1 year follow up data
39 of these improved on CFQ from baseline,
Mean CFQ drop of 8.1 in 1 year
36 improved on SF36 PF from baseline.
Mean SF36 PF increase of 20.4

94 CDC criteria as well as Oxford,
68 of these gave 1 year follow up data
62 improved on CFQ from baseline,
Mean CFQ drop of 10.8 in 1 year
Mean SF36 PF increase of 29.2
59 improved on SF36 PF from baseline.

Graphs for the whole group suggest that a third of the improvement happened between initial interview (which included lifestyle advice and an 'explanation' of their symptoms) and starting the 4 day treatment program, and the rest of the improvement happened during the 4 days, with scores slipping back a bit in the year following the treatment.

Given the huge loss to follow up, the brainwashing effect of the treatment on how to perceive the illness and symptoms that will greatly influence the outcomes, the lack of a control group and the subjective outcome measures, I don't think anything can be concluded from this trial.

The claim that 80 to 90 percent of participants showed clinically significant improvement is nonsense for several reasons:

1. Less than 72% gave 1 year follow up data. The figure should have been calculated for all those treated, which would reduce the proportion showing 'improvement' to about 55 to 65% of the patients.

2. 'Clinically significant' improvement was defined as at least half a standard deviation, which meant improvement on CFQ of 2 and on SF-36 of 7 points.
This is clearly nonsense - a little persuasion can make a much bigger change than this without any objective change.

3. Given that practically all the 'improvement' shown on the questionnaires happened over the treatment days, any suggestion that it is unhelpful beliefs leading to deconditioning that is perpetuating symptoms is nonsense. A daily walk for 4 days isn't going to reverse years of alleged deconditioning, and if patients continued these daily walks for the year after treatment, how come their SF36PF got a bit worse over the rest of the year.

4. Similarly if it is 'central sensitisation' that is perpetuating ME, and this is a physical phenomenon in the brain, how can 4 exhausting days of listening to talks doing CBT, meditating and being made to go on long walks magically reverse this. And if it did, how come the patients haven't fully recovered?

Surely what this trial 'proves' if anything, is that ME is not caused or perpetuated by deconditioning (or by central sensitisation).
 
From the discussion:
The therapeutic rationale behind the program was to increase the medical knowledge and interpretation of bodily distress, challenge and modify dysfunctional illness perceptions as well as illness behavior, and through acceptance and commitment strategies contribute to behavioral change and clinical improvement.
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So they admit it's about changing perceptions, not about objective improvement in health.

At 1 year follow-up, half of the patients completing assessments (56%) still report levels of fatigue representing substantial fatigue (> 4/11 Fatigue Scale).
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And they admit that despite the brainwashing patients were still fatigued.

In this study, patients were offered additional medical treatment for comorbid conditions, especially for sleep disturbance and depression. When controlling for the possible effects of melatonin and antidepressants, the clinical changes from pre- to post intervention and through 1-year follow-up were not influenced by melatonin medication, while use of antidepressants from baseline to 1 week pre-treatment had a weak influence on changes within this period.
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Confounding factors to any analysis of outcomes weakening the conclusions further.

Whether the reported improvement and symptom reduction represent the effect of the program or merely represent the time effect, return to homeostasis or regression to the mean, is not possible to determine due to the study design and available data. Possibly, a selection bias from a majority of patients having a positive attitude to the clinic and the treatment approach might also influence the outcome. The outcome measures based on self-report represent a methodological challenge, as self-reported improvement and objective functional improvement may differ (60). Nevertheless, this is the general method of outcome measures in clinical studies on CFS/ME.
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So they admit the conclusions have no solid scientific validity beyond 'everyone else gets away with shoddy methods so we will too'.
 
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