Champalimaud Centre for the Unknown

Psychedelic substances like psilocybin (found in magic mushrooms), MDMA (commonly known as ecstasy), LSD (commonly known as acid), and ayahuasca have shown potential in treating conditions such as depression, post-traumatic stress disorder (PTSD), and addiction. These substances can induce profound psychological experiences that, when paired with psychotherapy — a form of talk therapy — have been proposed to lead to significant therapeutic benefits.

Why Now?

Despite the growing interest and media coverage, no major regulatory agency has yet approved psychedelics for specific medical use. Access to these treatments remains limited to clinical trials, off-label prescriptions, or special access programmes. As research continues, there’s a pressing need to establish consensus on best practices, particularly concerning the therapy sessions that accompany psychedelic use.

The urgency for standardised reporting has become more apparent in light of recent regulatory decisions. Specifically, the U.S. Food and Drug Administration (FDA) recently declined to approve MDMA-assisted therapy for PTSD, a decision thought to be due, at least in part, to concerns about how psychotherapy was delivered in the studies presented to the FDA. As more studies on psychedelic-assisted treatments emerge, ensuring that the psychotherapy aspect is clearly and consistently reported is essential for the advancement and acceptance of these treatments.

The Other "P"

While psychotherapy has often been considered the less significant "P" in psychedelic-assisted psychotherapy (PAP), it may be central to the treatment, with key questions still unanswered about its exact role in patient outcomes and the best ways to conduct it. The study published in The Lancet Psychiatry emphasises that inconsistent descriptions of the supportive therapy sessions—known as psychological interventions—make it difficult to replicate studies and may compromise patient well-being.

"We have a real opportunity to raise research standards across all treatments that combine psychotherapy and medication", said Albino Oliveira-Maia, Director of the CF’s Neuropsychiatry Unit and one of the study’s senior authors. "By paying greater attention to the psychotherapy component—both in developing treatment protocols and in publishing trial results—we can improve the replicability, safety, and potential effectiveness of these therapies, and train therapists adequately".

Reporting ShortfallsThe researchers conducted a systematic review of 45 studies involving 1,464 […]

Psychedelics Set New Therapy Standard