Compass Pathways has published a post hoc analysis of its open-label Phase 2 COMP360 study, reporting that monitoring and support provided during treatment sessions were minimal, non-directive and distinct from conventional psychotherapy.

The findings, published in the Journal of Psychopharmacology, analysed interactions between participants and support providers during treatment with investigational COMP360 synthetic psilocybin in patients with post-traumatic stress disorder (PTSD).

According to the analysis, 78% of treatment administration sessions were spent in silence, with support primarily focused on providing reassurance, validation and a consistent presence rather than directing patients’ experiences. Researchers reported that participants largely navigated the psychedelic experience independently, with support providers remaining available if required.

The company said the findings indicate that the monitoring and support used in its clinical trials differs from the structured therapeutic dialogue associated with conventional psychotherapy and trauma-focused psychological treatments.

Guy Goodwin, chief medical officer at Compass Pathways, said: “The monitoring and support we’ve incorporated across our COMP360 trials in both treatment-resistant depression and PTSD is designed to safeguard patients and protect data integrity during psychedelic treatment. Patients themselves have indicated they value a reassuring presence, but the key aspects of the experience are self-directed.

“These findings reinforce that the rapid and durable symptom improvement observed in the open-label Phase 2 PTSD trial was attributable to the psilocybin drug experience. It is incorrect to describe the treatment we are developing as psilocybin-assisted psychotherapy.”

The publication examined qualitative and quantitative data collected during treatment administration sessions. Researchers found that support providers used non-directive approaches designed to encourage participants to remain focused on their own experiences rather than guide or reinterpret them.

Participants described support providers as a reassuring presence who were available if needed but were otherwise largely outside their awareness during treatment. Physical proximity, brief verbal reassurance and validation were identified as the primary forms of support.

Compass said support providers across its COMP360 clinical programme receive standardised training through a structured programme based on clinical experience and regulatory guidance. The approach includes ongoing mentoring to promote consistency across trials investigating COMP360 in treatment-resistant depression and PTSD.

The publication adds to the growing body of research examining how psychedelic therapies are delivered in clinical settings. As investigational psychedelic medicines continue through clinical development, questions around the role of psychological support during treatment have become increasingly important for trial design, standardisation and future regulatory assessment.

COMP360 remains an investigational therapy and has not been approved for the treatment of PTSD or any other indication.