Lightning Process study in Norway - Given Ethics Approval February 2022

[Adrian]

Leif Kennair
- They say that the research fellow is involved in so many parts of the study and that she is central, that they completely disregard the fact that we are five professors who act as supervisors and have no ties to either the course or the results.

Given the standard of reasoning and skill he demonstrates in this interview maybe they didn't ignore his role in the trial

Leif Kennair
- That's a terrible exaggeration. It's not about thinking positively. There are no objective criteria for ME, so there is no possibility of requiring objective outcomes.

SO if there are not objective criteria that means you can measure what ever you want and draw what ever conclusions you want. I would agree though its not about positive thinking its just coercion and brain washing.

- We have a control group. If one is afraid that it will be selection of the participants that is the problem, then the center for clinical research will make a randomization after an independent diagnostician from Haukeland has assessed the intake of the participants.

So I've not looked at the protocol but I very much doubt if they have a real control group. They may have another intervention or waitlist group but that is not a control setting the same expectations and balance to counteract bias.

The motivational interview is initially part of the intervention.

So it is ok to filter for those most susceptible to bias if you call it part of the treatment

If it has an effect, either positive or negative, you will be able to measure it even if it is the same type of group of people we have compared. That is good research.

Makes me wonder about the standard of his research as he doesn't seem to have a basic clue. If I were the ethics committee I would look very carefully at his trials.

 

[benji]

I wonder if this will be the last discussion of this in dax18. Henrik Vogt on his Facebook seems to have a lot of things he wants to say, and that this is not the last of it.
He was on the speaker list until an hour before the show, but then they canceled him. According to his Facebook, which is open for everyone to read.
Not sure if that is a good idea or not.

 

[Kalliope]

So I've not looked at the protocol but I very much doubt if they have a real control group. They may have another intervention or waitlist group but that is not a control setting the same expectations and balance to counteract bias.

Correct. The plan was to have a waiting list control group who would receive the same intervention ten weeks later than the first group.

 

[Midnattsol]

Correct. The plan was to have a waiting list control group who would receive the same intervention ten weeks later than the first group.

Sadly, this is seen as ok as it's "common practice" (what NEM wrote in their decision).

 

[Midnattsol]

Sadly, this is seen as ok as it's "common practice" (what NEM wrote in their decision).

This reminds me, last summer when Dagbladet ++ wrote about the project, it was said they used "gold standard" methods, that has not been mentioned this time around. Maybe because someone actually looked at their methodology instead of just assuming the five professors knew better than the patients?

 

[Adrian]

Correct. The plan was to have a waiting list control group who would receive the same intervention ten weeks later than the first group.

10 weeks also implies that the follow up is very short. We know from CBT and GET that they have short term effects on the questionnaires which dwindle after a while and long term follow up shows nothing. So it seems to be designed in to take advantage of such effects.

 

[Parsnip]

but then they canceled him

Not sure if that is a good idea or not.

Thanks for the warning.

Correct. The plan was to have a waiting list control group who would receive the same intervention ten weeks later than the first group.

Did u also pick up on him saying things that contradicts his previous statements in recentl articles and the protocol? Because i was baffled by his reponses, as he didn't come across as someone who would blatantly lie.

Btw, sorry if this is the wrong place to ask:

But is there anyone who remembers who / where it was said that Live held a talk for people who had broken out of conservative religious enviroments? And asked her to leave soon after she started talking, and went on to discuss how people who haid broken out of enviorments like that might be better at others to recognise certain signs? I belive it was a few years ago, on facebook

 

[Kalliope]

Btw, sorry if this is the wrong place to ask:

But is there anyone who remembers who / where it was said that Live held a talk for people who had broken out of conservative religious enviroments? And asked her to leave soon after she started talking, and went on to discuss how people who haid broken out of enviorments like that might be better at others to recognise certain signs? I belive it was a few years ago, on facebook

Yes, Nina E. Steinkopf mentioned this in a blog post in 2019:

Google translated quote:

In 2017, Lightning Process Instructor Live Landmark gave a lecture at a seminar for Hjelpekilden. Hjelpekilden is a voluntary organization that provides help and support to people in problematic religious break-out processes. The minutes state:

"It soon became apparent that her method, the Lightning Process, was very similar to the methods used in charismatic religious circles. This therefore led to major reactions from those of our participants who had a background in charismatic circles, and the speaker chose to cancel her speech due to the participants' skepticism.

Despite the fact that there was an unfortunate atmosphere between the speaker and the audience right there and then, the ensuing hour was very positive for the participants. We chose to talk about the different reactions we had, why some reacted, and how this can be a sign, among other things, that you have not finished processing your experiences, since several of the participants were surprised by their own reaction. In addition, we chose to look at various characteristics that characterize us as breakaways, including that our experiences can make us very skeptical of attempts at manipulation ……. "

 

[Parsnip]

Sadly, this is seen as ok as it's "common practice" (what NEM wrote in their decision).

I find it strange that this is common practice. Shouldnt they atleast have 'passive' controls to see how many 'recover' on their own? If i remember correctly, didnt the protocol say they would gather employment data after 1-2 years? Couldnt live simply pick the mildest cases of teenagers who recenlty had mono?

and the speaker chose to cancel her speech due to the participants' skepticism.

Ah thanks. I must have misread it the first time, as i got the impression that it was the others who asked her to leave.

I would say my coaches tactic where exactly like what one would find in a cult.

Edit: minor typo & removed an inappropriate remark

 

[Midnattsol]

I find it strange that this is common practice. Shouldnt they atleast have 'passive' controls to see how many 'recover' on their own? If i remember correctly, didnt the protocol say they would gather employment data after 1-2 years? Couldnt live simply pick the mildest cases of teenagers who recenlty had mono?

We could really need a study like that, but for some reason it has not been done.

This might be going off-topic, but I have been wondering if the Norwegian ME Association could ask The universities in Tromsø/Trondheim/Bergen and Oslo(?) to include ME in their population studies. The HUNT-studies that NTNU are responsible for have collected population data since the 1980s, they also have collected genetic, epigenetic, metabolomics and microbiome data for the two most recent rounds. Among questionnaires participants have to answer is one where they can say if they have developed any of a list of diseases. Fibro is one of them, it shouldn't be too hard to also include a new row in such a list with ME.

 

[Invisible Woman]

It may seem paradoxical to claim that such psychological treatment, provided with the best of intentions, should have negative effects.

Is he for real?

It doesn't matter what the therapist's intention is.

If a treatment is effective that means it has an effect. Hopefully, applied correctly to the right person, it will have a positive effect. Almost assuredly, incorrect applied or applied to the wrong person it will be detrimental.

There is no such thing as an effective treatment that is universally harmless. Not even aspirin is universally harmless.

I struggle to believe these people don't get this.

Edit - messed up the quote thingy.

 

[Parsnip]

We could really need a study like that, but for some reason it has not been done.

This might be going off-topic, but I have been wondering if the Norwegian ME Association could ask The universities in Tromsø/Trondheim/Bergen and Oslo(?) to include ME in their population studies. The HUNT-studies that NTNU are responsible for have collected population data since the 1980s, they also have collected genetic, epigenetic, metabolomics and microbiome data for the two most recent rounds. Among questionnaires participants have to answer is one where they can say if they have developed any of a list of diseases. Fibro is one of them, it shouldn't be too hard to also include a new row in such a list with ME.

That sounds like a good idea.

I struggle to believe these people don't get this.

I struggle to belive that these people are allowed to do research.


And would say that Adrian hit the mark.

Makes me wonder about the standard of his research as he doesn't seem to have a basic clue. If I were the ethics committee I would look very carefully at his trials.

 

[rainy]

Is he for real?

It doesn't matter what the therapist's intention is.

If a treatment is effective that means it has an effect. Hopefully, applied correctly to the right person, it will have a positive effect. Almost assuredly, incorrect applied or applied to the wrong person it will be detrimental.

There is no such thing as an effective treatment that is universally harmless. Not even aspirin is universally harmless.

I struggle to believe these people don't get this.

Edit - messed up the quote thingy.

That's his point in his book, that psychological therapies actually can cause harm, but that many people are reluctant to believe this.

I read his book once it was announced that he would be involved in the LP study, and he goes into detail about many ways of how therapy can harm patients, and that many therapists are very reluctant to record harm, or even believe harm is happening, and how researchers don't even have to include harm in their study results if they chose not to.

There were so many examples in the book of how therapies are harmful that perfectly describes ways the LP is harmful. It made me wonder why ME patients shouldn't also be protected from harm.

 

[Invisible Woman]

That's his point in his book, that psychological therapies actually can cause harm, but that many people are reluctant to believe this.

Wait. What?

Did this guy have a straight face when he was doing that interview?

Once again I'm struggling here to believe someone can genuinely have a blind spot the size of a large planet.

If Kennair genuinely can't see the problem then he really shouldn't be involved in patient research.

If he can see the problem....then, he still shouldn't be let loose.

The good thing is he can't deny he has expressed either viewpoint.

The third option is genuine discrimination against pwME.

 

[rainy]

Host
- We have more researchers and patients on. One last question. We talked together earlier. Then you said you go into this with an open mind. Just as concerned with finding out if it can be harmful as helpful. But if one has a suspicion that the treatment worsens the situation, as several previous patients have told. How is it ethically justifiable to expose them to such a project?

Leif Kennair
- That is why we had a monitoring committee with us in the first place. Unlike almost all other psychological intervention studies that have ever been conducted in Norway, we have a separate committee consisting of three experienced medics who will monitor whether there is a worsening and who will intervene if something goes wrong. This is essential for me. We are just as interested in the harmful effects as in the positive effects

I don't understand how in any way a committee can prevent a ME patient being harmed by this trial. The harm is done from the moment they are told that they "chose to have ME" - would the committee have stepped in already in the first minutes of the course?

What good is a committee when patients are traumatized and get permanent worsening from being told to do more because they must decide they don't have ME anymore?

 

[petrichor]

Leif Kennair
- That's a terrible exaggeration. It's not about thinking positively. There are no objective criteria for ME, so there is no possibility of requiring objective outcomes.

There are no objective criteria for getting the diagnosis in the first place. Everyone who has a diagnosis of ME today has it on subjective criteria. But we have specified in the application that we must have objective outcome measures and use NAV's data.

Is Kennair saying here that they did actually have objective outcomes? What outcomes is he talking about?

Also, this logic that because ME is defined subjectively that means that subjective questionnaire outcomes are sufficient is extraordinarily bad reasoning. It's like saying the news I see is defined by what I see on my computer screen, so if I use inspect element and change what the headlines say, that means that the news has changed. Or since left-handedness is defined subjectively, humiliating a student until they say they're no longer left handed means they're no longer left handed, as happened many years ago. It's just terrible reasoning, and it beggars belief that reasoning is taken seriously at all.

ME/CFS is defined subjectively, but if you use methods that make questionaires less reliable, objective outcomes can actually give you a better measure of the patients' subjective experience (because nothing actually directly measures the patient's subjective experience, unless medicine has advanced more than I thought). And ME/CFS is also defined behaviorally, not just subjectively.

 

[Midnattsol]

Is Kennair saying here that they did actually have objective outcomes? What outcomes is he talking about?

Also, this logic that because ME is defined subjectively that means that subjective questionnaire outcomes are sufficient is extraordinarily bad reasoning. It's like saying the news I see is defined by what I see on my computer screen, so if I use inspect element and change what the headlines say, that means that the news has changed. Or since left-handedness is defined subjectively, humiliating a student until they say they're no longer left handed means they're no longer left handed, as happened many years ago. It's just terrible reasoning, and it beggars belief that reasoning is taken seriously at all.

ME/CFS is defined subjectively, but if you use methods that make questionaires less reliable, objective outcomes can actually give you a better measure of the patients' subjective experience (because nothing actually directly measures the patient's subjective experience, unless medicine has advanced more than I thought). And ME/CFS is also defined behaviorally, not just subjectively.

NAV is the Norwegian disability institution, they were going to use NAV data to see if people improved their work capacity.

 

[petrichor]

NAV is the Norwegian disability institution, they were going to use NAV data to see if people improved their work capacity.

Do you know if they were going to do that as a long term follow up, or just check at the end of the ten weeks?

 

[Midnattsol]

Do you know if they were going to do that as a long term follow up, or just check at the end of the ten weeks?

In the project description this is what is said about the follow up data collection (rewritten by me):

NAV: 12 months before and 12-24 months after intervention.
Follow up conversation: Two, four and six weeks after intervention, and at six months. Additional follow up as needed.

 

[Snow Leopard]

Correct. The plan was to have a waiting list control group who would receive the same intervention ten weeks later than the first group.

Which conveniently eliminates the possibility to collect long term followup comparisons.