Lancet Psychiatry: Regulatory requirements for psychological interventions (Purgato, 2021)

Sid

Senior Member (Voting Rights)
Pretty ironic seeing one of Lancet’s subjournals publishing an editorial calling out the unregulated nature of psychological interventions.

However, for new psychological interventions, the pathway from development to assessment and dissemination for use in practice does not follow any commonly accepted criteria. There are no specific standards about the type and quantity of evidence required before a new psychological intervention is made available for everyday use.

For pharmacological interventions, market release of new medications is regulated by formal rules and methodological requirements developed by national and international regulatory agencies.

4 Not only are there well defined criteria for establishing efficacy and assessing tolerability and side-effects of new medications, but also marketing authorisation is granted for restricted use, outlining that a positive benefit–harm balance has been established for a specific clinical condition only.

5 An absence of regulatory requirements for new psychological interventions might have several negative consequences. First, newly developed psychological interventions might be disseminated in the absence of evidence about their efficacy and tolerability. Harmful consequences might include: worsening of symptomatology; negative changes in family, occupation, or general adjustment in life; or adverse effects.
6

https://doi.org/10.1016/S2215-0366(20)30414-4
 
Quite simply, a lot of the current problems in medicine could be avoided if psychological treatments had to meet the same standards as physical ones. In cases where it is not possible to have objective outcomes it must be acknowledged that this means the evidence is of lower quality so use of those treatments requires a formal system where harms can be noted.
 
Quite simply, a lot of the current problems in medicine could be avoided if psychological treatments had to meet the same standards as physical ones. In cases where it is not possible to have objective outcomes it must be acknowledged that this means the evidence is of lower quality so use of those treatments requires a formal system where harms can be noted.

Completely agree. Also, psychotherapy trials should be at least single-blind. There is no excuse not to at least blind the rater who scores outcome measures such as observer-rated depression scales.

Also, better control groups are possible. Instead of waitlist control or treatment as usual (aka 7 minute appointment with the GP), CBT trials should have a control group matched for duration and intensity of clinical contact (say, control group gets the same number of sessions with a counsellor who just listens supportively but doesn’t administer the cognitive behavioural mumbo jumbo secret sauce of CBT).

I bet you the effect of CBT would be shown to be zero with just these modest improvements in methodology.
 
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