The Lightning Process course contains elements from cognitive therapy, positive psychology and stress physiology. But does it work? A new Norwegian study will attempt to find answers, but is being met with criticism.
The Lightning Process course contains elements from cognitive therapy, positive psychology and stress physiology. But does it work? A new Norwegian study will attempt to find answers, but is being met with criticism.

Study on Lightning Process-course for CFS/ME patients raises controversy

“Our intent is simply to check whether the method works,” says NTNU project manager Leif Edward Ottesen Kennair. “A dangerous study,” says head physician Kristian Sommerfelt.

A new Norwegian research project has received a lot of attention. Researchers at NTNU want to determine if the Lightning Process (LP) training course has a positive effect for people with chronic fatigue syndrome (CFS), also known as myalgic myoencephalitis (ME).

A patient association is questioning the research method, the funding scheme and possible commercial interests in the study. Another patient association supports the study and is contributing through user participation. Others have also voiced their opinions for or against the study.

The ME association in Norway believes that many CFS patients could end up worse off from LP training. In a letter to the ethics approval committee, the association requests that the study be re-evaluated. Other critics call the LP method controversial and the study indefensible.

“It’s hard to understand the emotional uproar over psychosocial relationships being linked to CFS. We can study psychosocial conditions in everything, including cancer and femoral fractures in the elderly. Isn't CFS related to something?” asks Leif Edward Ottesen Kennair, who heads the research project.

"Completely normal study"

“This is a completely normal study, on par with other studies we conduct in the field of psychology,” says professor Kennair, who heads the research project.

According to Kennair, a whole range of different therapies and courses live a life outside the treatment apparatus. These are being used without research to back them up.

“In these cases, scientific methods should be applied to test those therapies so that we can find out whether they’re effective,” he says. The professor points out that this is a common process in medicine.

The study involves 100 adults with CFS taking a three-day LP course. The mental training programme takes place in a group, according to the project description. The course contains elements from cognitive therapy, positive psychology and stress physiology.

Participants receive training in self-coaching, relaxation techniques and regulating automatic thoughts and emotions. The method works quickly, and already after the first day of the course participants can engage in several activities, according to the project description.

“I don’t care if the method yields positive or negative results, I’m completely open in that regard," says Leif Edward Ottesen Kennair.
“I don’t care if the method yields positive or negative results, I’m completely open in that regard," says Leif Edward Ottesen Kennair.

Kennair has not worked with the LP programme himself.

"LP training can currently be purchased in the public sector, although no documentation is available on its effectiveness. I believe researching the LP programme is in everyone's interest,” Kennair says.

The debate around CFS has affected how the study is set up. Kennair says the study has taken many precautions.

A monitoring group that includes three expert researchers can stop further research if undesirable outcomes arise.

“The safety measures may be overkill, but we don’t know,” says Kennair.

Six-month follow up

Otherwise the study follows normal procedures. Researchers collaborate with a patient association, and they have an emergency group that includes a psychiatrist and psychologist. The selection of participants happens after a check from both a GP and a CFS specialist at Haukeland University Hospital in Bergen, to ensure that everyone involved in the study has a diagnosis of CFS according to the Canadian consensus criteria.

The study is set up so that half of the participants take the LP course first, and then the next group starts after ten weeks. According to project manager Kennair, this is how they usually set up studies in his field.

He believes that ten weeks is more than enough to measure whether the first participants experience any benefits from the course.

“LP is a three-day intervention. If it doesn’t work within ten weeks, what does that tell us about its effectiveness? And if it turns out that the participants see no benefit within ten weeks, then it won’t harm the patients, but it will damage LP's reputation,” Kennair says.

The participants receive a six-month follow up, and the researchers will then investigate whether the effect of the course has persisted or changed.

Kristian Sommerfelt, professor at the University of Bergen, works to help children diagnoes with ME/CFS.
Kristian Sommerfelt, professor at the University of Bergen, works to help children diagnoes with ME/CFS.

"No adequate control group"

Kristian Sommerfelt, a professor at the University of Bergen and a paediatrician, thinks the study is interesting, but poorly designed.

“A basic problem is that CFS patients' hopes of benefitting from measures like LP last significantly longer than ten weeks. Any lack of improvement or worsening in the patients’ condition is very difficult to detect in follow-up studies. We don’t have good enough objective measures of improvement for CFS, and so we’re left with using subjective measures like questionnaires,” Sommerfelt says.

“The way Kennair's study is designed, I believe that the positive effect of LP is almost a guaranteed result, without having any real way to shed light on whether or not this is due to the placebo effect,” he says.

Kennair thinks this criticism is strange and that it doesn’t make sense.

“If it isn’t possible to measure the effect of LP, and yet the study is also designed to yield a positive effect from LP, then one of the statements has to be incorrect,” he says.

Sommerfelt believes that having half of the participants take the LP training at the beginning of the study, while the rest take the same course after ten weeks, is problematic.

“There’s no adequate control group that isn’t taking the LP training to compare with, because the follow-up time needs to be significantly longer. I mean at least one year,” says Sommerfelt. He believes that only then would it be possible to see whether the training had benefitted patients.

“It’s always nice to have a longer follow-up period. If we receive financial support, this is of course something we can consider in the future. But in this round we’ll gauge effectiveness after six months,” says Kennair.

Has never experienced anything like this as a researcher

Sommerfelt thinks it may be difficult to capture any side effects of the LP training.

“CFS patients have a strong desire to get well and may be too positive that they’re condition is improving. This can lead to them being too active, for too long, with a long-term worsening of the disease as a result. This often happens with CFS patients,” says Sommerfelt.

Kennair, on the other hand, does not understand the objections that have arisen in various quarters.

“The study can clarify whether the LP treatment works or not and whether it has negative side effects. All parties should want to know that. As a researcher, I’ve never experienced anything like this before and I find it strange that people want to stop research that provides more knowledge.

Commercial interests

The PhD candidate for the project, Live Landmark, was diagnosed with CFS in 2004. After three years, she went through an LP training course herself and recovered. She is one of nine Lightning Process instructors in Norway.

Landmark has been criticized precisely because she herself is an instructor and makes money from the courses.

Project manager Kennair believes it is both common and unproblematic for the PhD candidate to be involved with LP courses.

“It’s common for people who work with a certain treatment method to be the ones most interested in researching it. You also have to know the method in order to conduct the study. It’s difficult to require others to adequately familiarize themselves with a method and then research it,” says Kennair.

He does not find it problematic that Landmark has commercial interests. The study is designed so that the PhD candidate cannot access or influence the data as it is collected.

“In this study, we state very clearly that commercial interests exist. In other studies, that’s often not stated openly. But it's not unusual. Anyone who develops methods or sells books can make money from good study results,” says Kennair.

He emphasizes that this study will only be profitable for people who run LP training courses if the results are positive. Negative results can have the opposite effect. Kennair believes this is a chance to test such methods scientifically.

Lørenskog municipality near Oslo, the backer of the study, states that it has no agreements to buy LP courses if the study shows positive results. On the contrary, the municipality wants develop its own courses which would be offered for free to residents with CFS.

Landmark thinks the criticism of the study is strange.

“Very little treatment exists for this patient group, so it’s important to leave no stone unturned. In any case, we’ll only be able to contribute one piece in the bigger puzzle – if the study shows the method to be effective,” says Landmark.

Nor does Kennair think they will find the final answer from this study. “Research is how we address unresolved health problems. We’ve weeded out a lot of strange things in the treatment system precisely by researching the methods being used,” he says.

Completely open for both negative or positive results

Sommerfelt believes that Kennair's study could be dangerous.

“The study won’t move the research forward on the usefulness of LP. And since the study is designed so that the results show the benefits of LP, it could lead to more patients taking LP courses for the wrong reasons. The disease might get worse for some of them. I’ve met patients who’ve experienced this,” says Sommerfelt.

Kennair’s response is that this is a strange, scientifically unfounded and gross claim.

He disputes the claim that the study design will ensure positive results for LP.

“I don’t care if the method yields positive or negative results, I’m completely open in that regard.”

He also does not want to pay attention to the protests outside the research community, saying, “We need knowledge. It’s not okay for someone who is very upset to decide what knowledge can emerge and what we can research. That I do get frustrated about,” says Kennair.

Translated by: Ingrid P. Nuse

Read the Norwegian version of this article at forskning.no

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