Trials of new treatments for mental disorders should be comparative (indeed more regulatory trials should thelancet.com/journals/lance…
Patients in the comparison group should receive a 1st line/recommended by guidelines/effective treatment even if *NOT* biological or pharmacological.
The fact that new treatments are touted as breakthroughs after not being compared to the standard of care is a mockery of the patients' time and distress and a negation of ethics and equipoise.
E.g. benchmarking MDMA-assisted psychotherapy for #PTSD nature.com/articles/s4159…
Stop labeling patients as treatment-resistant because they failed a variable number of courses of EXCLUSIVELY pharmacological or biological treatment alternatives when there is effective psychotherapy for their primary disorder #depression thelancet.com/journals/lanps…
From our comment: "Trials that include psychotherapies as active comparators would enhance our knowledge of differential therapeutics. Excluding psychotherapies
when evaluating new treatments excludes testing relative to a key section of the mental health armamentarium."
"Reclaiming a more central role for psychotherapies in regulatory decisions re-opens the question of their own regulation, particularly for new interventions."
Is regulation possible? A 1st step (regulatory standards) already been proposed (@psych_verona: thelancet.com/journals/lanps…
Our illustrative appendix (which took a ton of work and does not use expressions like "evidence exists") looks at the evidence comparing for pharmacotherapy and psychotherapy for #depression & #PTSD
Finally, let's take a 1st step in this direction. @TheLancet@JAMA_current@bmj_latest any major medical journal commission a high-profile review of novel, effective, promising, scalable psychosocial #psychotherapy treatment alternative along the many of drugs/devices/biologics
I used to be on the fence about this. Trials have protocols and these are customarily published or made public w/ publication. But I changed my mind (with some caveats)
Even when protocols r published, linking them to final publications & checking whether significant changes occurred & if they are justified is difficult. Trial registries often don't bring this information together. Key details are often missing. Often protocols r not published.
In 2 examples I examined of very high-profile trials in the highest impact journals in medicine, either there was no published protocol (thelancet.com/journals/lance…) or the protocol versions were published w/ final article, documenting major changes (osf.io/ne26f)
Bashing #metaanalysis is as fashionable as ever, as always with hands up in the air. In response to a thread moaning the lack of added value of meta-analyses over individual studies, I realized I know of *many* meta-analyses that literally overturned whole fields.
So I want to start my alternative thread, in which instead the of the same old lamets, we list consequential meta-analyses in #Mentalhealth, which definitely provided more information than each and any single individual study.
These don't have to be methodologically flawless, because no study is. They do have to have a decent quality (which is much less of an elusive construct than oft presented). I will start with a few and update when I have time. Feel free to add to the collection. Order random.
In this viewpoint we make two main arguments. 1. There is equipoise for non-pharmacological interventions (NPI) for #SARSCoV2#COVID19 containment because there is uncertainty re: the magnitude of both effectiveness & harms. Uncertainty is vast for some measures.
2. An agenda of randomized controlled trials of NPIs is both possible & feasible. We delineate measures that could be the focus on RCTs, along w/ issues related to designs, comparators (not advocating doing nothing!), outcomes (type, timing), obstacles & counterarguments to RCTs.
People who follow this field know I have been one of its first and unrelenting critics, starting with my meta-analysis in 2015 @TheBJPsych (again w/ @pimcuijpers) cambridge.org/core/journals/…, followed by others, including many viewpoints, comments & replies that I will spare you.
I was one of the first researchers to have explicitly state that maybe #CBM just does not work and there are no moderators or boundary conditions that can save it. But time passed, studies went on, the field continued to grow & adapt, and so maybe it was time for a reassessment.