A recent investigation published in The Lancet Psychiatry by experts from the Champalimaud Foundation and the University Medical Center Groningen (UMCG) has identified significant gaps in the description of psychotherapy treatments using psychedelics.
The researchers argue that these gaps could hinder the effective and safe application of this method, emphasizing the urgent need for more standardized descriptions in these psychotherapeutic interventions. They propose a checklist detailing everything that needs to be described in future projects.
Albino Maia, a researcher at the Champalimaud Foundation and one of the study's authors, explained to Lusa, “The issue lies in the definition of the protocol and the sufficient description necessary to adhere to it.”
Psychedelic psychotherapy is gaining traction as a promising approach to treat patients with psychiatric disorders when conventional treatments fall short. Substances like psilocybin (found in magic mushrooms), MDMA (known as ecstasy), LSD (referred to as acid), and ayahuasca (used as a tea) have shown potential in treating depressive disorders, post-traumatic stress disorder (PTSD), and some drug dependencies.
Despite the growing interest, no major regulatory agency has approved psychedelics for specific medical use to date. Therefore, access to these treatments remains limited to clinical trials, off-label prescriptions, or special access programs.
In the National Health Service, some hospitals are already providing treatments using psychedelic substances, for instance, for cases of treatment-resistant depression.
The researchers conducted a systematic review of 45 studies involving 1,464 participants to assess how well the psychological interventions were reported. Maia pointed out that when the description of the psychotherapeutic intervention is inadequate, it becomes unclear whether the tools for implementing a standard protocol exist, leaving those who wish to replicate the described methods without the necessary instruments.
He also emphasized the importance of efficiency and, above all, safety in these treatments: “We are talking about substances that induce alterations in consciousness, which have an extraordinarily significant impact on the fragility induced in individuals.”
Maia acknowledged that in some areas, “the description is a bit better,” citing the treatment of PTSD with MDMA as an example: “Behind those studies, there is a single promoter and a single manual.” In this case, since the same manual was used across various studies, “the procedures were more similar, and the quality of reporting was better.”
However, even in this case, he noted that the reporting quality was only average, with many elements still missing. This lack of clarity led the U.S. Food and Drug Administration (FDA) to reject the approval of MDMA-assisted therapy for PTSD last summer.
This decision is believed to be related to how the psychotherapy was administered in the studies presented to the FDA. According to the researcher, clear and consistent reporting of psychotherapy could advance these types of treatments.
Despite the challenges, Maia stated that reporting is improving but insisted on the necessity of moving faster, especially for the benefit of patients: “We are talking about studies aimed at addressing situations where there are very few alternatives. Patients and diseases do not wait.”