Gaps in reporting psychotherapy may hinder effectiveness of psychedelic treatments

Psychedelic-assisted psychotherapy is gaining attention as a promising approach to treat patients with mental disorders for whom conventional treatments have been insufficient. A new collaborative study by researchers at the Champalimaud Foundation (CF) and University Medical Center Gröningen (UMCG) reveals important gaps in how the psychotherapeutic aspect of these treatments is reported, potentially hindering their effectiveness and safety.

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 programs. 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 standardized 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. 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”.

Albino Oliveira-Maia, Director of the CF’s Neuropsychiatry Unit and one of the study’s senior authors

Reporting shortfalls

The researchers conducted a systematic review of 45 studies involving 1,464 participants to assess how well the psychological interventions were reported. They used an adapted version of the Template for Intervention Description and Replication (TIDieR) checklist -; a tool designed to ensure studies provide enough detail for others to replicate their interventions accurately.

The review revealed that psychological interventions varied widely across studies and were often poorly described. Many lacked detailed information about the therapy model setting, therapists’ qualifications, and specific techniques used. Key details, such as the number of therapy sessions -; critical for determining how much therapy is needed for effective treatment -; were frequently omitted.

While the quality of the patient-therapist relationship is well known to impact psychotherapy’s effectiveness, many other less-studied factors may also play an important role in patient outcomes. As noted by first author Carolina Seybert, “For example, measuring therapist adherence -; how closely therapists follow treatment protocols -; is essential for ensuring safety and effectiveness. However, tracking adherence is costly and time-consuming, so it’s often overlooked. As a result, we can’t be certain the therapy was delivered as intended, which makes it hard to interpret the results”.

“We noticed that MDMA studies, unlike those on psilocybin or ayahuasca, had higher quality reporting because they often used the same standardised treatment manual”, said Seybert, who has been using research tools to standardise psychotherapy descriptions since her PhD. “Our findings suggest that having clear guidelines can improve how interventions are reported. This approach could not only help us understand which psychological interventions work best for specific mental disorders but also enable us to deliver PAP in a way that maximises its replicability in real-world settings”.

Closing reporting gaps

“Realising the potential of psychedelic-assisted treatments requires a concerted effort to improve reporting standards and to establish clear, evidence-based protocols”, Seybert explained. “These standards can guide clinicians and professional boards on the training, competencies, and experience needed to deliver these treatments safely and effectively. This will enhance future studies and, at the same time, support regulatory agencies in making their assessments”.

Oliveira-Maia added, “The good news is that reporting is already improving-;we found that the most recent studies showed improved reporting. If this trend continues and is reinforced, regulatory authorities are more likely to have the data they need to make informed decisions. This will not only benefit research but also ensure that patients receive the highest quality care and that delivery of treatments is equitable”.