Lightning Process study in Norway - Given Ethics Approval February 2022

Trial by Error by David Tuller
Deja Vu All Over Again with Proposed Lightning Process Study in Norway

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The proposed LP trial led by LP investigator and Recovery Norway co-founder Landmark cannot be supported on scientific and ethical grounds, for multiple reasons. It is troubling that key players in Norway’s medical establishment believe otherwise. Hopefully, the NEM will once again draw the appropriate conclusions.
 
Andy said:
For info, I'm guessing that this is the studys entry on the Clinical Trials website, https://clinicaltrials.gov/ct2/show/NCT05236465
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Looks correct. I don't know if it's a quirk of clinical trials, but I find it weird to say that the research council is a collaborator at the top, they are the funding body, not a collaborator. OK to have them in the sponsors and collaborator list, but not the pure collaborator one I think. Yest maybe nitpicking, but I've seen the argument "the research council has approved of the study!" one too many times. The council makes no judgement on the quality of the project, they are a first-come first-served funding body for the type of project this is.
 
Brief Summary:
Chronic fatigue syndrome/Myalgic encephalomyelitis (CFS/ME) can be a serious and disabling condition with a heavy symptom burden and low function. Work disability is common, and social life dramatically affected. CFS/ME is a challenging health problem as well as a societal problem.

In recent years, a doubling of the number of patients with a CFS/ME diagnoses has been reported in Norway. The patient group represents a challenge for the health care system, the municipality, and the Norwegian Labour and Welfare Organization (NAV). According to new figures, the NAV pays 100 million Norwegian Kroner (NOK) each month in permanently incapacitated expenses for people with CFS/ME. Municipalities have expenses in form of care, rehabilitation and other measures.

There is a lack of effective treatment for CFS/ME. Evidence-based knowledge is highly needed.

If the 3-day course shows promising effects, this could have positive consequences for patients, relatives and health personnel, but also financially for the society and the municipality.
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my bolding

Do others find it as offensive as I do that the brief summary focuses more on what a burden we are to society rather than on the effect on individuals of having a life changing serious disease, along with being told we are a burden on society? I think this is especially awful in the context of a treatment that lays the blame squarely on the patient if the don't 'recover'.
 
Trish said:
my bolding

Do others find it as offensive as I do that the brief summary focuses more on what a burden we are to society rather than on the effect on individuals of having a life changing serious disease, along with being told we are a burden on society? I think this is especially awful in the context of a treatment that lays the blame squarely on the patient if the don't 'recover'.
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It's terrible, and the longer project description in Norwegian adds even more of this.
Trish said:
Does this mean the trail has been given the go ahead?
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No, the verdict from NEM on the study ethics have not been published yet.
 
Merged thread

A 3-day Course for Adults With Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME): a Randomized Controlled Trial : 2022 Norway

Not a recommendation!

the description of this trial as it appears on this website(medifind)

Chronic fatigue syndrome/Myalgic encephalomyelitis (CFS/ME) can be a serious and disabling condition with a heavy symptom burden and low function. Work disability is common, and social life dramatically affected. CFS/ME is a challenging health problem as well as a societal problem. In recent years, a doubling of the number of patients with a CFS/ME diagnoses has been reported in Norway.

The patient group represents a challenge for the health care system, the municipality, and the Norwegian Labour and Welfare Organization (NAV). According to new figures, the NAV pays 100 million Norwegian Kroner (NOK) each month in permanently incapacitated expenses for people with CFS/ME. Municipalities have expenses in form of care, rehabilitation and other measures. There is a lack of effective treatment for CFS/ME. Evidence-based knowledge is highly needed. If the 3-day course shows promising effects, this could have positive consequences for patients, relatives and health personnel, but also financially for the society and the municipality.
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Experimental: A 3-day course
The course consists of teaching in basic psychology, stress physiology and practice of a specific technique with self-instructions and visualization in a group setting by non-health personnel
Active Comparator: Waiting list
Treatment as usual (TAU)
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Department of Psychology, NTNU
Recruiting
Trondheim

Author: Leif Edward Ottesen Kennair
Backup: Live Landmark

https://www.medifind.com/articles/clinical-trial/334206297

sourced from clinicaltrials.gov where we find what it is actually.......... ie the Lightning Process

Sponsor:
Norwegian University of Science and Technology
Collaborators:
University of Oslo
Haukeland University Hospital
University of Bristol
Lørenskog municipality
The Research Council of Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology
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Detailed Description:
This is a randomized controlled trial (RCT) to investigate potential effects (positive and negative) of a 3-day course with follow-up for 100 adults with CFS/ME.

The 3-day course used in this trial is named the Lightning Process (LP). The course is built on the LP manual (Parker, 2013) and includes stress theory, Positive Psychology and knowledge about regulating thoughts, feelings and behavior, and through that positively influencing physiology.

Positive and negative effects of the course on symptoms, disability and quality of life will be investigated, and a long-term follow-up of work participation conducted.

Any adverse events experienced during or after the 3-day course will be handled according to protocol.
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https://clinicaltrials.gov/ct2/show/NCT05236465
 
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There is a lack of effective treatment for CFS/ME
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Also: CBT & GET work, according to the people who think LP is great. Or "psychological-led rehabilitation", if they feel very generic. That's even how they know it's psychological, even though it's well-known that inferring cause from pragmatic trials is invalid.

It's the quantum treatments that both work and don't work depending on how convenient it is to say either. There's both lots of evidence, hundreds of trials along with a "definitive" trial that is "the definitive one" but also just one among many, but so much more research is needed, so much that they just keep doing the exact same studies hundreds of times over, identical to one another, a completely generic formula.

We've literally always been at war with East Asia and anyone who says otherwise is suffering from psychosis, or whatever. Also, and obviously it must be said, but there has never, ever, been a war in Ba-Sing-Se, only special, uh, conflict mobilization, or something.

In addition to that, though, I don't understand how there aren't issues with pretending this is some generic "intervention", rather than a commercial product. They don't name it on purpose where it counts, it should be in the title and summary, explicitly named, since this is what's being tested, knowing it's unethical to do something like that, just not caring about it because by using different words, they genuinely seem to think it makes it all OK.

So tobacco companies funding trials showing their product is safe and healthy and will make your skin glow? Just say they have "motivated sponsors" with the actual names in footnotes, I guess. Conflicts of interest are so easy to deal with, you simply have to avoid using any reference to the commercial interests and it's all good.
 
The verdict from the national ethic's board came today.

Short version: The National ethic's board has given the study approval, and it will go ahead.
Decision said:
The complaints are not upheld. The research project has an ethical prior approval in line with REK in the middle of its decision of 31.01.2022, as well as the following conditions:

- The conflict of interest must appear in the information letter to NAV, the GP and the specialist health service.
- In the information letter to the participants, it must be clear all the possibilities for deterioration in participation that there is a professional basis for informing about.
- Information and consent letters must be revised in accordance with the conditions set in the decision, and sent to REK for approval before the project can start.
- Research data and code used in the project shall be made public and permanently available as far as practicable, provided that it takes place within the framework of the law and in line with agreements already entered into. Facilitation and sharing of data should follow FAIR principles (www.go-fair.org). The data must be made available regardless of whether the project leads to scientific publications.

The terms set by the majority are in addition to the terms set by REK in the middle of its decision dated 31.01.2022.

The decision is final and cannot be appealed, cf. the Research Ethics Act § 10, 3rd paragraph.
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The whole verdict can be read HERE (google translated)

A minority on the board did not agree with the soundness of the project
Minority view said:
The minority, members Kari Milch Agledahl, Anne Kjersti Befring and Steven Blackman, believe that the change that has been made is not sufficient to make the research ethically sound. The minority believes that the research fellow's strong self-interest and prominent role in the project must be offset by a solid research method if the results are to have credibility. The primary endpoint of the study is based on a questionnaire with self-evaluation of symptoms and function. This is less suitable as an objective evaluation if there is real doubt about the researchers' independence, and the validity of the answers also becomes uncertain when a central part of the course consists of learning verbal reformulations of one's own experiences.

The minority further believes that the potential for physical side effects has not been sufficiently taken into account, as the participants may have unknown underlying diseases. One of the characteristics of CFS / ME, based on the criteria by which the project itself operates, is precisely effort-induced fatigue, and the risk for vulnerable participants therefore appears to be real.
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I am gutted this still went through.
 
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Nina E. Steinkopf: Kontroversiell ME-studie får etisk godkjenning
google translation: Controversial ME study receives ethical approval

quote:
A long-planned study where 100 ME patients will be treated with the alternative method Lightning Process received ethical approval in 2020. Following complaints, the approval was withdrawn in 2021. After a minor adjustment in the study design, the project received new ethical approval. New complaints have not been taken into account.
 
The verdict:

Et 3-dagers kurs for kronisk utmattelsessyndrom/Myalgisk encefalopati (CFS/ME) hos voksne: en randomisert, kontrollert studie

google translation:
A 3-day course for chronic fatigue syndrome/Myalgic encephalopathy (CFS/ME) in adults: a randomised, controlled trial

quote:
Appeal against a decision from REK In the middle of 8 April 2022, where a previously rejected project received prior approval after certain adjustments. The decision was appealed by, among others, two interest groups that REK found to have the right to appeal.

NEM does not accept the complaints, but supports the terms from REK Midt. NEM also sets additional conditions for pre-approval.
 
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