Protocol: Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE), 2015 onwards, Chalder, Moss-Morris, et al

@Jonathan Edwards can you use this story for the NICE hearing? I think the psychological abuse / brainwashing aspect hasn't been considered much.

Telling this story would really illustrate the point that patients can be ruined by CBT/GET while still giving the impression to therapists that everything was going well.

 

Aren't there legal obligations not to lie this way to patients?

It's perfectly reasonable to say they don't know what's wrong but to assert that there is nothing wrong, and therefore there is definitely no disease, is seriously unethical. Aren't there discrimination provisions about denying disease? If not that sounds like a huge mistake as clearly it is being abused.

 

Protocol says it ended in December 2018 so they are likely in the analysis phase. They always take a long time, it's not that easy to massage poor data into a predetermined outcome in a way that isn't obviously fraudulent. Technically it should be trivial for them to remove a single participant and if not that's their problem. Sometimes they don't even publish when the results are especially bad so there should be plenty of time. Which one was it that never got published? GETSET?

The protocol is about a GP-delivered CBT integrated care. How much involved was the GP?

 

Not involved at all. They sent a letter to GP saying I was taking part in the trial. Then later on, when I dropped out of the trial, my GP only knew because I sent a letter to them documenting that I had become ill as a result of the trial, and the nurse who came to visit me documented that I had become bedbound as a result of the prince trial. GP has never commented on it, it’s like I never did the trial at all!

 

Somewhere in the booklet it says “your symptoms are real” But..

Elsewhere it says, “you have nothing to lose”

And: “ Firstly, let’s begin by better understanding how the human body works. Our body consists of physical body parts (skeleton, skin, muscles, internal organs etc.) and body systems (the immune system, the digestive system, the cardiovascular system etc.). When persistent physical symptoms occur it is believed that itis because of a problem with how the body systems are functioning and not due to damage or disease of the actual physical body.

For those familiar with computers, it can be helpful to think of the body systems like a ‘software programme or operating system’ that runs on a computer (e.g. Microsoft Windows, Word, Excel). The physical body parts (e.g. bones, muscles, internal organs etc.), are like the computer itself. So, when there is a problem with the ‘software’ (i.e. the body systems) there is not much point in looking at the hardware (i.e. the physical body) to try to fix it.”

“This can make people think that they are making their condition worse. Let us reassure you that while it is common for symptoms to get worse to start with, as you repeat the activity, or even gradually increase it, before long any worsening of symptoms will fade” - another lie

They have actually, in black and white, said it is not due to damage or disease of the actual physical body. Not that they don’t know. But that there isn’t a disease.

So they’ve definitely lied.

Edit: also I don’t actually understand their reasoning. And it’s not scientific in the least and is actually dangerous. I don’t think they should be allowed to get away with writing this. The body systems (immune, cardiovascular and gastrointestinal systems) are actual physical parts of the body.

Like if there’s a damage to the immune system would you say there’s no disease to the physical body or internal organs? With lupus the immune system literally attacks internal organs. If someone had a heart condition would they say there’s no disease? No one would say that. It’s not like the immune system and cardiovascular system are just made up fluff or something. Can they get away with writing made up science?

And they’ve worded it in such a way so that people don’t look into it too much and worry. “Oh it’s ok I don’t actually have something wrong in “my actual physical body””.

Please, can these lies about science be brought up in the NICE committee somehow? @Keela Too , and anyone else.

 

Yes I think you are right.

 

It is difficult to definitely prove that the treatment caused this deterioration but this adverse event must be recorded. I think they will try to hide it.

 

So going back to the protocol

meant to compare standard GP care (which is nothing) vs. standard GP care + CBT. If it's described as a controlled trial (unlike PACE), then I guess the SMC (nothing) is supposed to be the control. But the control is usually a placebo and the whole point of CBT for CFS is a placebo effect so it tests one placebo against a different placebo without acknowledging either is a placebo but referencing it as controlled (but not specifically placebo-controlled so then I don't know what the "control" is supposed to be).

Since the standard of GP care is nothing I guess they did actually test what it does correctly but obviously this was not the point by any reasonable understanding of what medical research is about. And this is basically the 10th or so almost identical trial that doesn't actually test anything meaningful. As it's described it's half a PACE but even more useless.

All the funding that was wasted on those trials should be paid back in full. This is simply not serious work.

 

@lunarainbows, very sorry to hear about what you have been subjected to. Thank you for sharing your experience here.

I was looking into this a while ago. It looks awful. I did plan to start a thread about it, as I think we need to pay attention to what the US organization that promotes it, the Psychophysiologic Disorders Association
are up to. I have mentioned them elsewhere here; https://www.s4me.info/posts/155814/, and here;
https://www.s4me.info/threads/this-...on-pain-treated-with-mind-body-medicine.8087/

They promote the idea that chronic pain/MUS is caused by emotional trauma.

Can I ask how you came across this Curable app? Was it recommended to you as part of the trial, or by the NHS, or did you hear about it some other way?

 

"It is believed that ..."
Why the passive verb - who is doing the believing? And why? Evidence? Causal mechanism? And why do these believers get to put people in wheelchairs and then believe it's nothing to do with them? And get away with calling it science? Can't they just go away and start a cult of something? Oh, sorry, they have. Apart from the going away part.

 

It actually kept coming up as adverts on social media. It came up on insta a few times and I kept ignoring it because i only use Instagram to keep up to date with book releases and Harry Potter news and wanted nothing to do with it. Then it came up on Facebook.

Then it came up on Instagram again and again, and this time I decided to click on it. It said it was based on the latest pain science, and their website seemed quite impressive in the sense there were board-certified physicians who were involved and who had endorsed it. And I’m in a heck of a lot of pain day in day out. I had an inkling it may be similar to PACE but also it seemed different - and based from America, so I tried it out.

And there was a story by a girl called Fiona from the UK I think who had used the app and had been cured of M.E. She gave a 45 minute interview in the app which I listened to and it was on their fb pages too.

She said she had been ill for (I think) 12ish years with M.E, and she was very sceptical of the claims this would work for fatigue or M.E. That’s what got me - because Im very sceptical too. Yet it worked for her, so why not for me? She said she sat down to do these exercises through the app, and realised that her fatigue was definitely linked to trauma, and then within a few weeks she tried walking a certain distance she hadn’t been able to do for years.

Then she stood in one place and meditated for 5 minutes, and then walked back home and couldn’t believe she had done it. She did it again the next day and the next and then soon she was climbing, and now she’s just gone on a holiday to Israel. And she said she’s recommended this app to her friends with M.E some who were even worse than her, and they’re all seeing big improvements too.

She also said, I think interestingly, that she listened to one certain interview over and over again, one in which someone with another pain problem had mentioned their fatigue had lifted as well, so by listening to this, she became certain the same thing could happen for her.

So I tried those exercises. Yes as you say it’s all about trauma, they are obsessed with that in the app. I have trauma myself but it got to the point I ended up removing the “trauma” part from their checklist in settings so that would stop coming up on my app. I’m sorry but I do not need to go over and over my trauma, journal it, write to myself, write it out and “reframe it” and whatever else they were going on about.

I thought about it afterwards..Life is a series of traumas, some big some small and it’s ridiculous that they are using that in the way they are. Because everyone will find some trauma to talk about and that’s why they’re able to keep going with marketing this app- because literally everyone, whether healthy or not, will think “oh yes I have trauma too!” Or “I have issues with my boyfriend/partner/mum too that I need to work through!”, or “this happened in my life that I never really worked through”, Etc.

Yes psychologically it can help people if that’s what they want to talk about, but no, this has no place in treating M.E or fibromyalgia. I can barely speak or wash myself - I don’t need to be journaling about “trauma”. In any case, at the time I wanted to try and the journaling and having to do exercises for a few days made me crash quite badly and later on I deleted the app.

The curable app all sounds so convincing. The lady who talks on there has a very soothing and kindly voice. They seem to back up everything they say with science and research. And have “expert clips”. And they make you feel like it really can work for you.

my mum said to me, “haven’t we talked about not trying things like this, like a hundred times before”. But I’m desperate, so desperate to get better and that’s why I try these things.

 

I wish they would do the going away part. And yes it is like a cult, one that the NHS and many other healthcare systems have bought into completely.

 

I suspect that many of these testimonials about patients making a miraculous recovery with some commercial program are made up.

It is trivial to make them up, and no less of a lie than outcome switching or other misleading research practices which the same kind of people seem to have no problem with. In fact they seem to rationalize this as benign lies that create high expectation of recovery which they believe helps patients. Of course that it helps is only ever measured according to self-report which is biased by expectations, but they can't seem to see the problem.

 

Agreed and it is surely also difficult for them to prove it didn't cause deterioration, especially when patient surveys show such high levels of harm from these treatments ?

 

If it worked, there would be clinical trials with significant objective improvement published already. This is the distinction between science and pseudoscience, no matter the belief system underneath. This is the only response: prove it, it's literally how science works. With CBT/GET there is still not a single bit of objective evidence after 3 decades. That should settle the debate entirely. That it doesn't only reinforces the fact that it is a belief system.

After all, the standard has been set that those trials are taken seriously when they are wrapped in the language of science, even if devoid of substance. This is the entire point of EBM, you don't need to know why it works, only that it does. And the funding is nearly unlimited for this type of "research", plus if it worked they would have no problem getting private funding anyway.

Prove. It. You can't, so STFU with your dumb questionnaires.

 

I am limited in my presentation to the material I submitted in April in written form.


However, that submission included expression of concern about the ethics of psychological manipulation. Individual stories are not going to be what counts in terms of the NICE committee but it is useful to have specific examples of general issues. One of the issues I raised in my submission was that the prima facie evidence of harm from patients' reports of deterioration has to be taken as being at least as valid as the claimed evidence for efficacy.