Lightning Process study in Norway - Given Ethics Approval February 2022

Sorry, got it mixed up there, my bad. No correlation should still raise some brows, if only.. Wyllers own music therapy study did show a decrease i step count though, no?
 
The research news site forskning.no has written an article about the LP study receiving new ethical approval

Omstridt ME-studie ble etisk godkjent. Så ble den stoppet. Nå er studien godkjent igjen
google translation: Controversial ME study was ethically approved. Then it was stopped. The study has now been approved again

quote:

The study will investigate whether a 3-day compressed, psychological course has an effect against chronic fatigue syndrome / myalgic encephalopathy (CFS / ME) in adults.

The course has components from the controversial Lightning Process method.

The national research ethics committee for medicine and health sciences - NEM - stopped the ethical approval last summer , and the study was put on hold.

On 31 January this year, the researchers again received ethical approval to carry out the study. But REK Midt sets clear conditions.

The researchers must inform the participants about who the course instructor is. And in all publications of the study, it must be stated that a research fellow in the project has conflicts of interest.

The ME association is considering complaining again
The ME association is now considering appealing the new decision.

- The ME association can not see that the applicant has taken into account the objections from NEM, in a way that makes any difference to the study, says Assistant Secretary General Trude Schei in the ME association to forskning.no.

The ME association also believes that there is a great chance that the study design will be able to give unreliable results, which will create further confusion about treatment for ME, and be detrimental to ME patients, Schei writes in an e-mail.
 
The initial decision was determined to be final. This modification is less than cosmetic, it changes nothing, so it would not be serious for the past decision to not apply as is, it is the same project. Which makes it a big test of institutional integrity, and I don't think they will pass. Probably by instructions from above, the independence of those kinds of processes is always overstated and subject to politics.

Normally this should be sent back down to the regional committee saying it's the same application and the decision was final, so quit wasting time with this nonsense. But none of this is normal, and apparently applications for a study can somehow include unhinged rants about imaginary things people are saying in Internet forums.
 
Kalliope said:
On 31 January this year, the researchers again received ethical approval to carry out the study. But REK Midt sets clear conditions.

The researchers must inform the participants about who the course instructor is. And in all publications of the study, it must be stated that a research fellow in the project has conflicts of interest.
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By this standard, it would be OK for tobacco companies to not just sponsor biased research but actually conduct them, be part of the process, and it's all OK as long as they have a mild disclaimer. Which probably happened a few times, before it was seen as controversial.

The standards in clinical psychology keep going down, at this point it's surpassed even historical examples of bad psychology like the Stanford and Milgram experiments, it's even worse than the horrible time when cancer patients were told they were dying because of their bad attitude. I frankly don't think I'll ever be able to take anything seriously out of psychology, fruit of rotten tree.
 
It's also weird that it's suddenly not any more a study on LP, but a psychological course with "components" of LP. I'm pretty sure nothing has changed substantially from the original version, so wonder what Phil Parker feels about his trademarked course being diluted to "components".
 
At least the NICE guidelines allow to shut this out, but only when patients are informed and armed with the information. So much of the LC story is about the chronic illness community trying to shield long haulers from misguided harm by medical professionals. Shameful.

 
Kalliope said:
The ME association is considering complaining again
The ME association is now considering appealing the new decision.

- The ME association can not see that the applicant has taken into account the objections from NEM, in a way that makes any difference to the study, says Assistant Secretary General Trude Schei in the ME association to forskning.no.

The ME association also believes that there is a great chance that the study design will be able to give unreliable results, which will create further confusion about treatment for ME, and be detrimental to ME patients, Schei writes in an e-mail.
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Was considering the idea that it might be worthwhile if at all feasible -- to have multiple groups of ME advocates sign up to complain. That is if a complaint can be agreed upon.

I think in general this should be what happens more often in as many situations as warrant it.
 
Kalliope said:
"It's important to be aware of the existence of the "ME-society", an internet based society, which among other has been described by Olaug Lian "United we stand" (2015). They followed 14 ME fora over three years and unraveled a virtual society with strong unity and feeling of togetherness.
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I also find this observation of theirs interesting. It's an observation so open to interpretation.
They are choosing to interpret the meaning to form a 'truth' that suits their needs.

Yet the BPS cabal also get together with the exception of covid in this moment their gatherings would be society gatherings of like minded followers of BPS. And they have had a certain unity of thinking. So what are we to make of that?

Nothing much I think. This problem of our being ill should be a problem that yields to science. Until they come to grips with that there opinions seem to me to be merely an attempt to vilify patients. It is an unworthy tactic from people who really hold most of the cards in terms of the power they wield (although they my sense that slipping).
 
Most major disease will have patient forums for mutual support where pretty much everyone agrees that the disease is "physical".

The people who think they're pointing out some unusual and abnormal behaviour don't seem to be bright.
 
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sneyz said:
Sorry, got it mixed up there, my bad. No correlation should still raise some brows, if only.. Wyllers own music therapy study did show a decrease i step count though, no?
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It did.


Snowdrop said:
Was considering the idea that it might be worthwhile if at all feasible -- to have multiple groups of ME advocates sign up to complain. That is if a complaint can be agreed upon.

I think in general this should be what happens more often in as many situations as warrant it.
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A problem is that the REKs have definitions of who are allowed to complain. So while patients can complain, we do not fit the criteria of those who should be listened to (I'm not making myself very clear in english today, sorry). The Norwegian ME Association is within the criteria, and while not taken into account in the same way as the ME Association complaint was, individual patient complaints were mentioned in the NEM withdrawal of the ethics approval last time if I remember correctly.
 
Midnattsol said:
It did.



A problem is that the REKs have definitions of who are allowed to complain. So while patients can complain, we do not fit the criteria of those who should be listened to (I'm not making myself very clear in english today, sorry). The Norwegian ME Association is within the criteria, and while not taken into account in the same way as the ME Association complaint was, individual patient complaints were mentioned in the NEM withdrawal of the ethics approval last time if I remember correctly.
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I wasn't really thinking of patient groups so much. There are the physio's for ME, Dr's for ME and other charities although as you point out there are specifics as to who can complain so they may not fit either.
 
I see no reason why the exact same documents objecting to the study initially can't just be sent again. It's the same proposal so it deserves the same response.

If they're going at it again it's probably because they got assurances that politics cleared the field behind the scenes and nothing matters, or it will be dismissed as nonsense for being exactly the same as a proposal whose rejection was final. Either way I don't think there's anything more to do than at first, this is the same proposal and these people aren't serious but if health authorities have decided they want the unicorn stuff than they will push it no matter what.

Can't fix a broken system. It's like when the king wants a giant firebreathing statue and everyone knows it's stupid and expensive but he's the king so comply and shut up or get the boot up the ass.
 
Copied post

Andy said:
Trial By Error: More on the Dutch CBT Long Covid Trial; Finnish Study of “Amygdala Retraining” Program

"I have written a couple of times about a Dutch trial of internet-delivered cognitive behavior therapy to prevent severe fatigue in long Covid patients. The goal is to address factors like “dysfunctional beliefs about fatigue,” “perceived low social support, “problems with processing the acute phase of COVID-19, and “fears and worries regarding COVID-19″ that are purportedly driving the prolonged symptoms. My posts—here and here–were not favorably disposed toward the research and suggested the design was biased toward producing positive results.

Last month, advocates from three Dutch patient organizations published their own report about the study. The researchers, from the Dutch Knowledge Center for Chronic Fatigue (NKCV), were awarded €308,000 by ZonMw, a major independent health care funding agency. The lead investigator, psychologist Hans Knoop, is a well-known proponent of the CBT/GET treatment paradigm for ME/CFS. In 2011, he and a Dutch colleague wrote a commentary for The Lancet that accompanied the PACE trial and declared that participants had met “a strict criterion of recovery”—a demonstrably untrue statement."

https://www.virology.ws/2022/02/04/...finnish-study-of-amygdala-retraining-program/
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Trial by Error by David Tuller My Exchange of Letters on Amygdala Retraining, That Undead Lightning Process Study

quote:
What I find perplexing—even more than the deficiencies of the study design–is that an ethics committee would approve a trial touting itself as investigating “amygdala and insula retraining.” For researchers to dangle the promise that participants’ amygdalae and insulae will undergo “retraining” is inappropriate. That’s marketing, not science.
 
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The project leader is interviewed in Khrono. Again stating that NEM was unreasonable, and backs it up by saying that the management at the university has been supportive which never happens if a study loses its ethical approval.

ME-studie som ble stoppet i fjor har nå fått etisk godkjenning
The ME study, which was stopped last year, has now received ethical approval

Article said:
- It was the rejection from NEM last year that was very surprising and extremely unreasonable, says professor of psychology at NTNU, Leif Edward Ottesen Kennair to Khrono. He is the research group leader for the study.

He believes that NEM last year first and foremost chose to relate to the ME association's complaint and not to the actual circumstances in the research group's application.

That said, it is of course as expected that the project was approved again in this round by REK. Anything else would be very surprising, says Kennair.

...

The research group has now taken into account several of the critical points of NEM.

- It is actually the case that we try to clarify even more that it is not correct that the research fellow influences everything. To the extent that there is unrest around it, we have tried to clarify it. There are more people involved in this study, says Kennair.

He says that a monitoring committee must monitor both negative and positive effects along the way.

- It is completely unusual in such a study. This committee will also be presented with the results, he says.

...

We have received clear support from both the department and the faculty here. It never happens that you are supported despite the rejection of an ethical application. In this case, however, the management has been clear in its support, says Kennair.
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I can't seem to find a link to the study itself. Is it here somewhere and I'm missing it?

It may well be that Kennair wishes to find out whether this is a viable treatment but if the selection criteria are not sound it won't even be a true study of people with ME so no insight can be gained.

And I'm a little confused also in that haven't studies of this type been done before? If so, how about a long-term follow up?
 
Snowdrop said:
I can't seem to find a link to the study itself. Is it here somewhere and I'm missing it?

It may well be that Kennair wishes to find out whether this is a viable treatment but if the selection criteria are not sound it won't even be a true study of people with ME so no insight can be gained.

And I'm a little confused also in that haven't studies of this type been done before? If so, how about a long-term follow up?
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The study itself? The application which includes the methods is the first pdf in post #746, but it's in Norwegian.
 
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