There is an issue about ethics that I have been intending to raise in another context.
The CBT used in PACE was, as I understand it, based on concepts such as 'educating patients' and using 'cognitive strategies' to persuade them that their views about their physical capacities were erroneous. However, there was never reliable evidence that their views were erroneous and still isn't.
This implies that when consent was obtained it was not based on honest information, which is unethical. The detail in the material in the information sheets and the newsletter may be relevant here. There is of course a catch22 in that the trial was only ethical if the authors did not know whether or not this education was valid (equipoise). But the original account of the method by Wessely and Chalder emphasises that persuading the patient of its validity is essential to the technique.
My feeling is that this problem is too complicated for the HRA to be expected to understand, but it is a serious ethical issue now, since we still have no reliable evidence and no doubt CBT patients are being 'educated' that they will get better if they believe what the therapist says.
Do we know what information participants were given before they gave their consent? Were they given details about all the treatments, and the theoretical models they were based on, before giving their consent? If so, presumably it would have been clear that the theories behind CBT and APT were mutually exclusive and that there could therefore be no certainty about the validity of either. Or was consent given after they were assigned to a treatment arm?
Could it ever be ethical to test a medical intervention which required the therapist to mislead participants about the evidence upon which the intervention is based? Notwithstanding the fact that it would invalidate the experiment by priming participants to doubt the validity of what they are being told, could such a trail be deemed ethical if its participants were informed (prior to giving consent) that they may be presented with information about their illness and the treatments which is not supported by reliable evidence and may therefore be untrue?
I presume there is no ethical problem with psychology experiments which involve participants being lied to as part of the experiment, but in those cases I assume that it would be necessary to inform the participants of the deceit in the debriefing at the end of the experiment, which would not be possible in a trial of CBT, as the deceit has to be maintained. And of course, there is a big difference between a psychology experiment involving healthy volunteers and a medical trial.
I’m trying to better understand the point that Jo is making. Is it analogous to a trial in which some participants are: 1) falsely informed that the drug is known to be safe, despite a lack of reliable evidence to support this view; 2) presented with an unsubstantiated theories (falsely presented as scientific knowledge) about the mechanisms of the disease and how the drug will interact with those mechanisms in order to effect recovery; 3) told that in order for the drug to be effective the patient must understand and believe what they have been told? Could such a trial ever get ethical approval?
I’m guessing that lying to patients in this way would be considered unethical, regardless of what apparent consent has been given, and I’m struggling to see how this scenario is any different to what happened in PACE.
It seems to me that, if persuading the patient that the treatment is valid is considered to be a requirement for it to work, then it may be impossible to design an ethical trial to test it (because of the Catch 22). But then, to me, any treatment which requires the patient to believe in its efficacy in order for it to work isn’t a serious medical intervention, so it’s not really problem in need of a solution.
Sorry this is a bit of a ramble. I’m just thinking aloud really.