Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS... 2023 Wortman et al

If patients were included who did not expect a psychosomatic approach then it seems to me that the principles of Free Prior Informed Consent were not followed. This is because the treatment is fundamentally a psychosomatic therapy (the authors acknowledge that in the title), with all the potential harms that come with that.

In the case of @Peter Trewhitt's experience, which sounds awful by the way, the treatment was biomedical. Therefore, for sure, in that case patients may have been included 'who did not always expect a psychosomatic approach' but who had still been adequately informed about the trial before they consented. In that case it sounds as though the prejudice was incidental rather than baked into the trial design. (Although it could probably be argued that the fact that blood sample donation required being naked from the waist up while lying down was something that it was necessary to tell prospective participants in advance.)

(Sorry for a couple of edits for clarity after posting.)

 

It's a bit like having a trial of gay conversion therapy and saying 'Due to our selection procedure we may have included patients who did not always expect a conversion therapy approach'. Quite apart from whether such a trial would be ethical, it is clearly wrong for mentally competent people to be recruited into a trial unaware of something so fundamental.

It's therefore amazing to me that these investigators had no problem admitting that not all their participants understood what they were signing up for. But, as others have said, these particular investigators seem to be willing to say out loud what other BPS people tend to only say when they are among friends.

I wonder if legal action on the principle of free prior informed consent might be one way to tackle BPS trials? In a lot of countries there will be legal requirements that people may only be recruited into trials of health treatments with free prior informed consent (unless they are unable to give it, in which case, guardians may be able to give consent for them). I think if investigators had to clearly say what they are really aiming to do (so, not just 'CBT' for example, but 'CBT to change your belief that you have a biomedical problem that is stopping you from living a normal life'), then they would find it much harder to recruit.

I'd really like to know more about this study - what information prospective participants were given, what they were told.

 

And would somehow spin that into anti-psych prejudice.