Closed Mind Body Intervention for Long COVID-19 [Massachusetts, USA]

[Evergreen]

I think you're saying specifically the word "bothered" changes it from being about symptom levels, to about how symptoms are perceived, which is more susceptible to bias unrelated to improvement. And that it'd be better to choose a more direct scale that is more like "are the symptoms present >3 days a week".

I think it opens it up to misinterpreting improvement in distress as improvement in long covid.

Now, since Donnino thinks long covid is distress, he wouldn't see that as a problem.

But I do, because I found CBT good for coping, but it did nothing for my ME/CFS.

I was thinking you were moreso criticizing including the more severely affected in the trial, but I can see how this scale could be measuring something which can change even if symptoms don't change.

Oh no! Not at all.

 

[Jonathan Edwards]

A subjective outcome measure being used as an entry criterion seems to bring in a new level of bias I had not thought of. Everyone will want to juice up the scoring at the beginning to get the recruitment going. And as Graham said in that video... Human nature innit.

 

[forestglip]

From https://www.shapiroinstitute.org/faculty-staff/mike-donnino,-md

Professor in Emergency Medicine, not who you‘d expect to research mind-body approaches?

He's interested in it because of his personal experience with it. From the Wired article:

Michael Donnino, a professor of medicine at Harvard Medical School, also attributes his recovery to Sarno. Around a decade ago, he began suffering from horrific back pain. “I had stopped working in the hospital,” he told me. “I was on partial disability.” Round-the-clock Tylenol, ibuprofen, and gabapentin did nothing. Neither did steroid injections or oral steroids. His back specialist said he had piriformis syndrome, and scans showed a potential problem with his sciatic nerve.

But then Donnino saw accounts of miraculous Sarno book cures online. “I got two chapters into the book and I thought, this is a bunch of baloney,” he said. “This is ridiculous. It is nothing like what I learned in medical school.” After abandoning the book, something told him to give it one more chance. So he did. “Within 24 hours I was feeling tremendously better.” In less than a week he was back at work. In four months he was pain-free.

Donnino was inspired to design and run a pilot randomized controlled back pain trial that used Sarno’s approach (funded by the CEO of Quora, another Sarno convert). [...]

 

[Robert 1973]

You have to hand it to them. They may not have resolved the issue of the uninterpretabability of unblinded trials which rely on subjective outcomes measures but they’ve found a way to introduce even more bias!

Now I’m wondering if the mysterious active comparator arm may be teaching the patients students to be more bothered about their symptoms.

 

[Robert 1973]

From the Wired article (my bold):

But then Donnino saw accounts of miraculous Sarno book cures online. “I got two chapters into the book and I thought, this is a bunch of baloney,” he said. “This is ridiculous. It is nothing like what I learned in medical school.” After abandoning the book, something told him to give it one more chance. So he did. “Within 24 hours I was feeling tremendously better.” In less than a week he was back at work. In four months he was pain-free.

Donnino was inspired to design and run a pilot randomized controlled back pain trial that used Sarno’s approach

Funny that he chooses to mention that he was back at work in less than a week as evidence of the efficacy of the intervention, and yet he chose not to use returning to work as an outcome measure in his trial (or any other objective outcome measures). I don’t suppose he was taught to do that at medical school either – unless he was schooled in BPS methodology.

 

[rvallee]

You have to hand it to them. They may not have resolved the issue of the uninterpretabability of unblinded trials which rely on subjective outcomes measures but they’ve found a way to introduce even more bias!

Now I’m wondering if the mysterious active comparator arm may be teaching the patients students to be more bothered about their symptoms.

This is pretty much it, isn't it? The discipline solved the bias problem by making bias a good thing, necessary even. So now they may still have a highly suspicious 90% or so success rate, which is obviously impossible, but by increasing the bias and setting the baseline as 90% success rate being the floor, mainly by defining success as whatever, then more bias means better so of course you want more bias. And they'll still claim equipoise because bias in favor of good outcomes is equipoise. If you aren't biased, you're doing it wrong,

What an incredibly odd thing. Truly one of the most bizarre eras in human history.

 

[Hutan]

On the difference between mind-body brain retraining and CBT - I don't really think there is much difference. I suspect all of these sorts of courses are just a hodgepodge of various techniques aimed at telling the participants 'you are doing things all wrong, do what I say', along with a few relaxation techniques and a bit of psychotherapy, probably finding some trauma that has been repressed. So, sure, some nominal variation between individual offerings, but nothing particularly significant.

Possibly there used to be a distinction in that CBT is the offering from mainstream medicine and the brain retraining is offered by the private non-medically qualified charlatans who charge plenty. But, even that difference probably doesn't apply any more.

The trial website says recruiting, but the principal investigator posted on social media on June 5 that enrollment is closed, so I've edited the title.

I'm assuming that Alan Levinovitz has been told about the results from this participants who have finished the trial already. Presumably results are tracking along as expected, as otherwise AL would not be spruiking the trial. Even I am confident they will get a positive a result. If they don't, then they have really stuffed things up.


On the two mind-body treatment arms, I guess they can't be too clear which arm is the one that is supposed to work and which one is not in the online registry, as it would unblind the trial. It possibly creates some flexibility, as, if both of the treatment arms end up showing some benefits over the wait list control, they don't actually need to label one of them as a sham.

 

[forestglip]

On the two mind-body treatment arms, I guess they can't be too clear which arm is the one that is supposed to work and which one is not in the online registry, as it would unblind the trial.

Yes, I was thinking it might be to keep it ambiguous from participants. It's a logical design choice. There's a tension with making sure the registration includes all the important information, but I could see how this way makes sense. Maybe there could even be a secret pre-registration that is held onto by ClinicalTrials.gov and only revealed after the trial is done.

It possibly creates some flexibility, as, if both of the treatment arms end up showing some benefits over the wait list control, they don't actually need to label one of them as a sham.

I don't think that's a factor, since they've got at least three trials already on the mind-body intervention, one of which includes the mindfulness group as a control group. And the registration says one of the groups, apart from usual care, is a control group. If they did that, it'd be clearcut and obvious misconduct.

It's probably either for blinding or they just never got to it, but I think the former makes more sense.

 

[Sean]

Add me to the list of those who does not see a particularly meaningful difference between mind-body brain retraining and CBT/GET approaches. They are both based on the notion of cognitive-perceptual reframing. The distinction is largely marketing in my view. They failed to sell it as CBT/GET and that brand has become toxic, so now they have re-branded it as brain retraining to keep the gravy train rolling.

Same basic approach, just with a different hat on.

A decade or two from now, when this latest brand has lost its mojo, they will invent another one.

I’m hopelessly biased about evidence.

My hopeless bias is methodology. The means by which evidence is collected and interpreted.

This is pretty much it, isn't it? The discipline solved the bias problem by making bias a good thing, necessary even.

That is exactly what they have done. Deliberately selected known biases and confounders in trial methodology for psycho-behavioural studies, emphasised and amplified them, and re-branded them as a therapeutic success.

Reality and patients' lives be damned.