Basically all pwME and their allies say that trials without blinding or objective outcomes are worthless. Asking out of mere curiosity, there any trials of CBT in mental conditions that would meet this standard?
Good question. Also, how is this being discussed in the field of psychology and psychiatry? I realize there is some discussion about bias due to lack of blinding also in the field of psychology and some discussion on the placebo effect, but when I last looked, with the exception of authors in the field of ME/CFS I couldn't find a paper on CBT suggesting the idea that using objective outcomes could make open label trials still useful. So if people find such trials Redfox is looking for, please also post them there: https://www.s4me.info/threads/trial...bjective-outcomes-as-primary-endpoints.20862/
When I was an undergraduate over forty years ago now, there was lots of discussion on how to get around the problem of subjective measures in open label trials, but we seem to have regressed rather than moved forward in relation to this. Obviously objective outcome measures would be ideal, and in many instances where CBT is aimed at changing behaviour this ought to be eminently straight forward, such as measuring activity levels for people with ME, but where the aim is changing how we feel there may not be any possible objective measures. However, there are routes to try to compensate for potential bias, these include: Getting more meaningful controls Using different designs such as ABA or ABAB or ABC, where individuals act as their own control Obtaining differential effects from different but related approaches, for example achieving a larger effect in one group of patients than another or getting different effects by modifying components of the intervention Using a range of measurements, perhaps say asking carers/family to rate change, as well as the patient Etc None of these by themselves completely eliminates the potential for bias, but if you gather enough convergent evidence from different designs and approaches it strengthens any conclusion. However we seem to see in work on CBT, certainly at least in relation to ME, a wilful blindness about the problems of subjective outcomes in unblinded trials and a consequent failure to attempt any approaches to compensate for the inherent potential for bias.