Canada’s McMaster University Launches Trial of Lightning Process for Long Covid

By David Tuller, DrPH

McMaster University in Hamilton, Ontario, has launched a clinical trial of the Lightning Process (LP), a well-known “mind-body” intervention, as a treatment for Long Covid. The study, called Fatigue in Long COVID, or FALCON, was registered last month on ClinicalTrials.gov. The Lightning Process is a commercially branded product that has made expansive claims of effectiveness. (I wrote about it at length here.)

Many patients have expressed concerns and raised questions about the decision to launch the trial. One critic has posted a petition on change.org seeking a delay. “We are calling on McMaster University to pause recruitment for the FALCON trial until an independent scientific, ethical, and patient-led review has addressed serious concerns regarding the study’s design, transparency, participant protections, conflicts of interest, commercial relationships, and use of objective outcome measures,” states the petition, which currently has more than 1200 signers.

It is not surprising that this brouhaha over the LP involves McMaster, which seems to be Canada’s Ground Zero for psychosomatic theorizing. In March, 2021, a psychiatrist-in-training, Jeremy Devine, published an opinion in The Wall Street Journal titled “The Dubious Origins of Long Covid.” (I wrote about it here.) The animating trope of Devine’s screed amounted to this: People with persistent, non-specific medical complaints after a bout of COVID-19 were experiencing psychogenic symptoms and/or had a mental illness. “Long Covid is largely an invention of vocal patient activist groups,” he declared.

Devine’s piece presaged further questionable initiatives. In the fall of 2024, for example, The BMJ published a problematic paper, spearheaded by McMaster investigators, called “Interventions for the management of long covid (post-covid condition): living systematic review.” (I wrote about this piece of nonsense here and here.) Paul Garner, the British physician who has boasted that he cured himself of Long Covid with his manly cognitions, joined the group as a co-author.

Now we have the announcement of this Lightning Process trial—another development in the ongoing debate over whether mind-body interventions lead to significant improvement and full recovery in people suffering from ME/CFS, Long Covid, and related disorders. These mind-body programs all invoke the concept of “neuroplasticity” to make their scientific case. They generally include a range of modalities, including meditation, relaxation techniques, positive affirmations, and so on. They postulate that symptoms are caused by an overactive and/or dysregulated nervous system; the interventions are designed to calm it down.

The LP specifically trains people to reject and push away any negative thoughts and replace them with uplifting ones. The program was created by Phil Parker, a British osteopath, psychologist and former spiritual healer who once claimed to be able to “step into other people’s bodies… to assist them in their healing with amazing results.” A major English trial of the LP for pediatric cases of what was then being called CFS, published in a BMJ journal in 2017, was an ethical and methodological train wreck with unreliable findings. It now carries a 3,000-word correction–half as long as the article itself.

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The lead investigator of the new trial is Jason Busse, a pain specialist and a professor in McMaster’s anestiosology department; he is also the senior author of the “living systematic review” of Long Covid interventions published by The BMJ. It is not clear who is funding the LP trial, which will recruit 100 people with Long Covid and will be conducted online. Participants will be randomized to receive the LP or an intervention called “activity pacing.” (Is “activity pacing” the same as, well, “pacing”? It sounds like the concept is the same. But pacing, as practiced by patients, is a self-help strategy designed to prevent post-exertional malaise, not a treatment designed to make them better. Operationalizing it as a therapeutic intervention with—in this case—15 training sessions turns it into something else.)

The primary outcome is the mean difference between the groups on a fatigue questionnaire at 12 months after randomization. Eight subjective secondary measures include physical function, pain, post-exertional malaise, and health-related quality of life, among others. No objective outcomes assessing physical or cognitive function—how far people can walk, if they returned to work or school, if they got off benefits, and so on—are included. In general, such objective measures have failed to support subjective results in trials of psychosocial interventions for ME/CFS, Long Covid and related disorders.

The LP trial features an interesting quirk. In the registration, the investigators write that the trial “will enroll people living with long COVID who are motivated and show willingness to change their condition through intervention.” This is an odd statement. Presumably many if not most patients are “motivated” to get better and would “show willingness” to try different interventions. That doesn’t mean they would be willing to try any intervention at all, no matter how questionable the evidence for it.

According to the inclusion criteria listed in the registration, the trial is open only to people “scoring higher in contemplation, action or maintenance scores than the precontemplation phase on the readiness to change questionnaire.” (The reference might be to this readiness to change instrument from the American Psychological Association, but it is not clear.) Will the investigators use this questionnaire to assess whether potential subjects “show willingness” to undergo an intervention?

This sounds very much like what LP participants have reported as a required step before they started the three-day program. They were expected to affirm their belief that the LP worked. If they couldn’t do so, they were deemed ineligible or not ready for engaging with the LP. One implication of such an affirmation would be that failure to improve or recover could easily be construed as the fault of the individual for not believing enough in the process, not of the LP itself.

So will the participants in the McMaster trial have to profess their belief specifically in the LP, as LP practitioners have asked of people seeking to sign up? Or will the participants just have to demonstrate more generally that they are open to some intervention or other? Either way, this requirement for entering the trial creates enormous questions for how any results would be interpreted. In any event, given that unblinded trials with subjective outcomes generate an unknown amount of bias, the study is likely to report marginally or modestly positive findings even in the absence of actual treatment effects.

(View the original post at virology.ws)