Lightning Process study in Norway - Given Ethics Approval February 2022

Forum member @trudeschei has written a blog post about the design of the trial.

The big problem is that this is NOT a good study . To me, it looks like a study designed to show an effect, not to see if there is an effect. It seems to be designed to confirm the hypothesis, not see if it is correct.

Thus, this study, if it gets approval from the Ethics Committee ( something it does not currently have ), can at best be completely worthless, and at worst do harm. Strictly speaking, I'm a little shocked that this is a doctoral project - I thought it required more?

Hvordan designe en dårlig studie
google translation: How to design a bad study

She has also uploaded the project description by Live Landmark from the Research Council of Norway (May 2019).

Prosjektbeskrivelse
google translation: project description

Here are some of its contents:

1.2 The project
There are few treatment options available to the patient group and the best documented treatment
is cognitive behavioral therapy and graded exercise, but the effect is low to moderate. And 3 days
intervention has indicated rapid and significant improvement. There has been little documentation on
effect, but a randomized controlled trial of 100 adolescents (12-
18 years) with CFS / ME (Crawley, 2018). The group that received specialist treatment plus 3 days
the intervention showed significant improvement compared to those receiving only
specialist treatment. Since the 3-day intervention has an effect on youth, it is reasonable
to assume that it also affects adults. Thus, an adult study may have great positives
implications if efficacy can be documented because it can be implemented in clinical work.

.....

3.1 Candidates
The candidate has been involved in the CFS / ME field since 2004 and has published dozens
debate articles in the media for the past ten years. The candidate has also published a book on the subject (Kagge forlag i
2009, published in a new edition at Arneberg publishing company, now part of the publisher Cappelen Damm, in 2016).
The candidate has met more than fifteen hundred people with long-term fatigue since 2008-
and pain problems through their daily work. The candidate has received a conditional admission
at NTNU, this means that the candidate has been approved to be scientifically qualified
admission to the PhD program and that the project is approved by the Department of Psychology at
Faculty of Social and Educational Sciences. Cooperation agreement can be completed in it
The moment the funding is confirmed.
3.2 Actors
The Public Health Institute by Professor Per M. Magnus provides professional advice.
The University of Bristol by Professor Esther Crawley provides professional advice.
Recovery Norway by leader, physician and social medicine Henrik Vogt, contributes
user representatives for the project.
3.3 Supporters
The Directorate of Health at the time Director Geir Stene-Larsen (now Head of Expedition in Health and
the Ministry of Care) and Department Director Morten Græsli have given their support to the project.
National competence service for CFS / ME at Rikshospitalet, chaired by Ingrid B. Helland
given their support for the project.

...

4.2 The professional environment of any other partners
Head of Recovery Norway, physician Henrik Vogt, PhD, is a community medicine specialist
interest in diffuse states. He was the initiator of the organization Recovery Norway as
consists of members who have been diagnosed with chronic fatigue syndrome (CFS / ME) or
similar conditions. Today the organization consists of several hundred members, who have
common that they have experienced a great deal of symptom pressure and a dramatic loss of function, but who know
using an understanding that deals with thoughts, feelings and behaviors has become completely healthy. In addition to
To be the leader of the organization, he is an active social debater in the field.
Professor Esther Crawley at the University of Bristol conducted the first randomized
controlled the study of 100 adolescents with chronic fatigue CFS / ME who underwent a 3-
day intervention. She is the head of the CFS / ME Pediatric Center at the Royal United Hospital i
Bath in England. Crawley joined the group that developed NICE guidelines (2007) and «the Medical
Research Council and CFS / ME »expert group (2009/2010). She has been vice-chairman in the UK
CFS / ME Research Collaborative (CMRC) until 2018, and is the second most funded researcher
in England.
The Public Health Institute by Department Director Per Magnus is Professor at the Department of
social medicine and global health at the Faculty of Medicine at the University of Oslo and
will cooperate with the municipality in connection with the project. He will thus make sure that
The professional community in the municipality has the necessary expertise and support for its R&D activities.
Professor Per Magnus has participated in a population study on CFS / ME, and is central to it
development of new projects at the Institute of Public Health.

....

The business sector also represents a conflict of interest. It could be a potential
financial gain in relation to further work on the intervention if it proves to have
effect. There is also a corresponding risk if the intervention does not prove effective. This
can be considered to be ethically problematic, and at the same time a possible positive outcome could be
the patient group is served by receiving an offer that can produce an effect. Considering that there are few
offers to the patient group are offset by this consideration. The elements of the intervention
is otherwise detailed in book form and thus widely available

(Edited a spelling mistake and introduction of blog post author)
 
Last edited:
Kalliope said:
Forum member @trudeschei has written a blog post about the design of the trial.

The big problem is that this is NOT a good study . To me, it looks like a study designed to show an effect, not to see if there is an effect. It seems to be designed to confirm the hypothesis, not see if it is correct.

Thus, this study, if it gets approval from the Ethics Committee ( something it does not currently have ), can at best be completely worthless, and at worst do harm. Strictly speaking, I'm a little shocked that this is a doctoral project - I thought it required more?

Hvordan designe en dårlig studie
google translation: How to design a bad study

She has also uploaded the project description by Live Landmark from the Research Council of Norway (May 2019).

Prosjektbeskrivelse
google translation: project description

Her are some of its contents:

1.2 The project
There are few treatment options available to the patient group and the best documented treatment
is cognitive behavioral therapy and graded exercise, but the effect is low to moderate. And 3 days
intervention has indicated rapid and significant improvement. There has been little documentation on
effect, but a randomized controlled trial of 100 adolescents (12-
18 years) with CFS / ME (Crawley, 2018). The group that received specialist treatment plus 3 days
the intervention showed significant improvement compared to those receiving only
specialist treatment. Since the 3-day intervention has an effect on youth, it is reasonable
to assume that it also affects adults. Thus, an adult study may have great positives
implications if efficacy can be documented because it can be implemented in clinical work.

.....

3.1 Candidates
The candidate has been involved in the CFS / ME field since 2004 and has published dozens
debate articles in the media for the past ten years. The candidate has also published a book on the subject (Kagge forlag i
2009, published in a new edition at Arneberg publishing company, now part of the publisher Cappelen Damm, in 2016).
The candidate has met more than fifteen hundred people with long-term fatigue since 2008-
and pain problems through their daily work. The candidate has received a conditional admission
at NTNU, this means that the candidate has been approved to be scientifically qualified
admission to the PhD program and that the project is approved by the Department of Psychology at
Faculty of Social and Educational Sciences. Cooperation agreement can be completed in it
The moment the funding is confirmed.
3.2 Actors
The Public Health Institute by Professor Per M. Magnus provides professional advice.
The University of Bristol by Professor Esther Crawley provides professional advice.
Recovery Norway by leader, physician and social medicine Henrik Vogt, contributes
user representatives for the project.
3.3 Supporters
The Directorate of Health at the time Director Geir Stene-Larsen (now Head of Expedition in Health and
the Ministry of Care) and Department Director Morten Græsli have given their support to the project.
National competence service for CFS / ME at Rikshospitalet, chaired by Ingrid B. Helland
given their support for the project.

...

4.2 The professional environment of any other partners
Head of Recovery Norway, physician Henrik Vogt, PhD, is a community medicine specialist
interest in diffuse states. He was the initiator of the organization Recovery Norway as
consists of members who have been diagnosed with chronic fatigue syndrome (CFS / ME) or
similar conditions. Today the organization consists of several hundred members, who have
common that they have experienced a great deal of symptom pressure and a dramatic loss of function, but who know
using an understanding that deals with thoughts, feelings and behaviors has become completely healthy. In addition to
To be the leader of the organization, he is an active social debater in the field.
Professor Esther Crawley at the University of Bristol conducted the first randomized
controlled the study of 100 adolescents with chronic fatigue CFS / ME who underwent a 3-
day intervention. She is the head of the CFS / ME Pediatric Center at the Royal United Hospital i
Bath in England. Crawley joined the group that developed NICE guidelines (2007) and «the Medical
Research Council and CFS / ME »expert group (2009/2010). She has been vice-chairman in the UK
CFS / ME Research Collaborative (CMRC) until 2018, and is the second most funded researcher
in England.
The Public Health Institute by Department Director Per Magnus is Professor at the Department of
social medicine and global health at the Faculty of Medicine at the University of Oslo and
will cooperate with the municipality in connection with the project. He will thus make sure that
The professional community in the municipality has the necessary expertise and support for its R&D activities.
Professor Per Magnus has participated in a population study on CFS / ME, and is central to it
development of new projects at the Institute of Public Health.

....

The business sector also represents a conflict of interest. It could be a potential
financial gain in relation to further work on the intervention if it proves to have
effect. There is also a corresponding risk if the intervention does not prove effective. This
can be considered to be ethically problematic, and at the same time a possible positive outcome could be
the patient group is served by receiving an offer that can produce an effect. Considering that there are few
offers to the patient group are offset by this consideration. The elements of the intervention
is otherwise detailed in book form and thus widely available
Click to expand...
Well, SMILE didn't actually show more attendance in schools now, did it? And that would be the equivalent of the goal here of getting adults back to work? Not to mention the whole thing about the study being fit for retraction. If this gets any further it is beyond frustrating. That Forskningsrådet (research council of norway) has given support saddens me.

Also I would like to edit @trudeschei statement a bit: "at best a worthless study that cost millions".

Edit:
In 2018 Live Landmark wrote (my translation) "Recovery is not the same as being able to work. Returning to work can take time. Getting a job, which can be hard after years of illness that shows on the CV, might require retraining for another profession or different priorities in life."
From an article about the current research on CFS/ME (another curious point is her stance that objective outcomes are hard to use as there is no clear proof cfs/me patients do less than others): https://forskning.no/debattinnlegg-...orskningen-om-lightning-process-og-me/1242807

Now, if the objective of this new study is to help people return to work I hope all involved agree on what the term "recovery" means.
 
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Kalliope said:
Forum member @trudeschei has written a blog post about the design of the trial.

The big problem is that this is NOT a good study . To me, it looks like a study designed to show an effect, not to see if there is an effect. It seems to be designed to confirm the hypothesis, not see if it is correct.

Thus, this study, if it gets approval from the Ethics Committee ( something it does not currently have ), can at best be completely worthless, and at worst do harm. Strictly speaking, I'm a little shocked that this is a doctoral project - I thought it required more?

Hvordan designe en dårlig studie
google translation: How to design a bad study

She has also uploaded the project description by Live Landmark from the Research Council of Norway (May 2019).

Prosjektbeskrivelse
google translation: project description

Here are some of its contents:

1.2 The project
There are few treatment options available to the patient group and the best documented treatment
is cognitive behavioral therapy and graded exercise, but the effect is low to moderate. And 3 days
intervention has indicated rapid and significant improvement. There has been little documentation on
effect, but a randomized controlled trial of 100 adolescents (12-
18 years) with CFS / ME (Crawley, 2018). The group that received specialist treatment plus 3 days
the intervention showed significant improvement compared to those receiving only
specialist treatment. Since the 3-day intervention has an effect on youth, it is reasonable
to assume that it also affects adults. Thus, an adult study may have great positives
implications if efficacy can be documented because it can be implemented in clinical work.

.....

3.1 Candidates
The candidate has been involved in the CFS / ME field since 2004 and has published dozens
debate articles in the media for the past ten years. The candidate has also published a book on the subject (Kagge forlag i
2009, published in a new edition at Arneberg publishing company, now part of the publisher Cappelen Damm, in 2016).
The candidate has met more than fifteen hundred people with long-term fatigue since 2008-
and pain problems through their daily work. The candidate has received a conditional admission
at NTNU, this means that the candidate has been approved to be scientifically qualified
admission to the PhD program and that the project is approved by the Department of Psychology at
Faculty of Social and Educational Sciences. Cooperation agreement can be completed in it
The moment the funding is confirmed.
3.2 Actors
The Public Health Institute by Professor Per M. Magnus provides professional advice.
The University of Bristol by Professor Esther Crawley provides professional advice.
Recovery Norway by leader, physician and social medicine Henrik Vogt, contributes
user representatives for the project.
3.3 Supporters
The Directorate of Health at the time Director Geir Stene-Larsen (now Head of Expedition in Health and
the Ministry of Care) and Department Director Morten Græsli have given their support to the project.
National competence service for CFS / ME at Rikshospitalet, chaired by Ingrid B. Helland
given their support for the project.

...

4.2 The professional environment of any other partners
Head of Recovery Norway, physician Henrik Vogt, PhD, is a community medicine specialist
interest in diffuse states. He was the initiator of the organization Recovery Norway as
consists of members who have been diagnosed with chronic fatigue syndrome (CFS / ME) or
similar conditions. Today the organization consists of several hundred members, who have
common that they have experienced a great deal of symptom pressure and a dramatic loss of function, but who know
using an understanding that deals with thoughts, feelings and behaviors has become completely healthy. In addition to
To be the leader of the organization, he is an active social debater in the field.
Professor Esther Crawley at the University of Bristol conducted the first randomized
controlled the study of 100 adolescents with chronic fatigue CFS / ME who underwent a 3-
day intervention. She is the head of the CFS / ME Pediatric Center at the Royal United Hospital i
Bath in England. Crawley joined the group that developed NICE guidelines (2007) and «the Medical
Research Council and CFS / ME »expert group (2009/2010). She has been vice-chairman in the UK
CFS / ME Research Collaborative (CMRC) until 2018, and is the second most funded researcher
in England.
The Public Health Institute by Department Director Per Magnus is Professor at the Department of
social medicine and global health at the Faculty of Medicine at the University of Oslo and
will cooperate with the municipality in connection with the project. He will thus make sure that
The professional community in the municipality has the necessary expertise and support for its R&D activities.
Professor Per Magnus has participated in a population study on CFS / ME, and is central to it
development of new projects at the Institute of Public Health.

....

The business sector also represents a conflict of interest. It could be a potential
financial gain in relation to further work on the intervention if it proves to have
effect. There is also a corresponding risk if the intervention does not prove effective. This
can be considered to be ethically problematic, and at the same time a possible positive outcome could be
the patient group is served by receiving an offer that can produce an effect. Considering that there are few
offers to the patient group are offset by this consideration. The elements of the intervention
is otherwise detailed in book form and thus widely available

(Edited a spelling mistake and introduction of blog post author)
Click to expand...
So everyone involved is hugely biased, even financially conflicted in the case of Landmark, the design is a clear outcome-seeking exercise of no clinical value (and even less scientific value, as it has none), no one involved has any actual expertise on the topic of ME (why not "trial" this for mood disorders or whatever?!). This can't even be called a trial, it's a psychological experiment, and despite this it's par for the course for this school of thought. The lessons from SMILE is clearly that accountability is nonexistent and there is basically no point even putting effort into pretending it's nothing but an outcome-seeking exercise with the conclusions written up long in advance.

Who is the bigger clown? The one giving a clown show on a serious topic, or the authorities who give the clown show credibility? Easy answer. Quacks are a dime a dozen. Professional institutions are supposed to be safeguards against quacks, not be involved in funding and promoting laughable quackery.

To the people involved in this, you are a bunch of clowns and should have your medical license revoked. Everyone, especially in positions of authority in official institutions. Complete dereliction of duty.
 
Midnattsol said:
In 2018 Live Landmark wrote (my translation) "Recovery is not the same as being able to work. Returning to work can take time. Getting a job, which can be hard after years of illness that shows on the CV, might require retraining for another profession or different priorities in life."
From an article about the current research on CFS/ME (another curious point is her stance that objective outcomes are hard to use as there is no clear proof cfs/me patients do less than others): https://forskning.no/debattinnlegg-...orskningen-om-lightning-process-og-me/1242807
Click to expand...
Oh, get bent, Landmark. I could get work tomorrow if I were able to. Even in this damn pandemic. Stop. Effing. Lying.
 
benji said:
I thought so too. But it seems it is not in the usual programme, there’s is a special thing for public Ph.D’s https://translate.google.no/translate?hl=no&sl=auto&tl=en&u=https://www.forskningsradet.no/sok-om-finansiering/midler-fra-forskningsradet/offentlig-sektor-phd/
Click to expand...
Yes, but to get this funding the project has to (among other things):
"The doctoral project is to help to generate knowledge that is relevant and applicable to public actors and their users. It is important that the doctoral project leads to new insights in areas where there is a great need for knowledge and innovation and supports the public entity’s R&D and innovation strategy."
https://www.forskningsradet.no/en/c...oject--doctoral-project-in-the-public-sector/

Is this project relevant and applicable to most ME sufferers? I would say no (except if we're lucky there are null-results and LP disappears, but until I see what type of data they are going to collect from patients I doubt this will be the case).

Will it give new insight and knowledge? Doubtful, research into cbt and similar is not exactly lacking on CFS/ME patients, and it has not made any difference. They use SMILE to argue that LP could provide "rapid improvement" but as we know this is cherry picking from the results of SMILE and not looking at the outcome that would be relevant for this new study, namely school attendance. Not to mention all the other problems with SMILE.

And for this they got 1.8 million NOK. That they got the money implies that the project fulfills the research council's criteria for this type of application, which to me is giving support of the study. And that the project is in collaboration with FHI (Norwegian institute of public health) is not making it any better.
 
Marky said:
Its kind of bizarre, many of the so called "cured" in the recovery groups that get advertised left and right, are not actually recovered but are still on benefits for.. Years. I mean thats even illegal lol
Click to expand...
Lessons learned from PACE, which showed no reliable subjective improvements, actually shown significant objectively negative impact, yet still was promoted with the boasts that happy thoughts and exercise are a complete cure for ME, if you want it. The lesson learned is that they can say whatever they want, even where the evidence literally contradicts them, and there are no consequences, even as people continue wasting away and dying as a direct consequence.

pace-conclusions-not-curative.jpg

It absolutely is fraud. Blatant, not even subtle, yet has the full support of medical authorities. I'm not even sure if it's despite the outcomes it has, or because of those outcomes. What a mess.
 
Nonetheless, according to recent news reports, Norwegian researchers are plowing ahead with a Lightning Process study of their own. A request for funding for a similar study was turned down by federal last year. Now Live Landmark, a long-time LP practitioner and proponent, has revived the proposal as a research project affiliated with her current enrollment in a graduate program in psychology. Although this iteration appears to have received financial support, it has not obtained ethical approval, according to Nina Steinkopf, a blogger and activist who has been tracking the situation.

Here’s a link to what Steinkopf wrote on Thursday. The post below is from Google Translate. I will take a look at the study design in a subsequent post.
Click to expand...
https://www.virology.ws/2020/05/02/trial-by-error-norways-proposed-lightning-process-trial/
 
Kalliope said:
It's great that news about this planned trial gets shared more widely and I'm very grateful that Tuller writes he will take a further look at the study design in a subsequent post. Looking forward to read it!
Click to expand...
Honestly I think that too much publicity here would have the same effect as with the shopping bag study and just cut it in shame. It's one of those things where the more people look and the more closely they look the worst it gets.

Especially where the details are made explicitly clear. There is zero scientific or clinical basis to this and defending the underlying principles, especially NLP, will look very silly. Echoes of the Superman radio show destroys the KKK by exposing its idiocy.

Woo never withstands the spotlight. It breeds only under gaslights.
 
rvallee said:
Honestly I think that too much publicity here would have the same effect as with the shopping bag study and just cut it in shame. It's one of those things where the more people look and the more closely they look the worst it gets.

Especially where the details are made explicitly clear. There is zero scientific or clinical basis to this and defending the underlying principles, especially NLP, will look very silly. Echoes of the Superman radio show destroys the KKK by exposing its idiocy.

Woo never withstands the spotlight. It breeds only under gaslights.
Click to expand...
It's kind of telling how LP is not mentioned explicitly, it's just a "three day Intervention".
 
ME patient Sissel Sunde has written a blog post about the planned study

We can stop laughing at President Trump's proposal to inject disinfectant as a potential treatment for Covid-19. For now, the Norwegian health authorities, NTNU, the Research Council and some municipalities will investigate whether a stop button and the power of thought can cure ME.

ME, Covid-19 og Live LIVE
google translation: ME, Covid-19 and Live LIVE
 
As of today there is a petition by "Victor" against the study. The petition is directed towards the Regional Committees for Medical and Health Research Ethics (REK).

We who sign request that REK look carefully at the following methodological objections related to "project fatigue" that Lighting Process instructor Live Landmark, will seek approval of from you in collaboration with NTNU.

Metodologiske innvendinger til "Prosjekt Utmattelse"
google translation: Methodological objections to "Project Fatigue"
 
Don't know if outside of Norway is OK but I can't see why not.

If anyone else signs it, the form doesn't seem to work on the translated page but works fine if you just go to the original URL: https://www.underskrift.no/signer.asp?Kampanje=7935.

I would have wanted to leave a comment if possible. Oh well. This is pseudoscience, there is no reason beyond that not to go ahead with something this ridiculous. The fact that the "protocol" is blatant outcome-seeking and everyone involves is incredibly biased adds to the sheer moral and intellectual bankruptcy behind supporting something this idiotic.

I wonder if they will go after the COVID patients. Probably. Should go very well, I'm sure.
 
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