A critical evaluation of psilocybin-assisted therapy protocol components from clinical trial patients, facilitators, and caregivers.

In an open-label trial of psilocybin-assisted therapy for cancer-related demoralization and chronic pain, patients, facilitators, and caregivers identified key components and improvements for the treatment protocol. Using the Enhanced Critical Incident Technique, interviews revealed critical incidents, wish list items, and contributing factors related to therapy aspects like intention-setting and overall protocol transitions. The findings emphasize tailoring treatment to individual medical history, supporting common therapeutic factors, and ensuring collaborative care. Nine topic areas for protocol improvement emerged from the data.

Study at a glance

Abstract

Psilocybin-assisted therapy (PAT) is an experimental treatment with transformative promise. Developing standards for PAT psychotherapy protocols is a priority, but psychotherapeutic protocol components of PAT have been subjected to little rigorous research. This study was designed to assess protocol components in a trial of PAT. The Enhanced Critical Incident Technique (E-CIT) was used to identify critical incidents in the treatment, wish list items comprising components or modifications that would have improved the treatment experience, and contributing factors that influenced the treatment. Participants included patients (n = 10), facilitators (n = 7 licensed mental health clinicians and certified spiritual health clinicians), and caregivers (n = 7) in an open-label trial investigating PAT for cancer-related demoralization and chronic pain. Patients and caregivers were interviewed after their last treatment session in the trial; facilitators were interviewed at the end of the entire trial. Rapid qualitative analysis identified specific domains for improvement in the treatment protocol based on the E-CIT. Critical incidents, wish list items, and contributing factors pertained to aspects of the therapy (e.g., importance of intention-setting) and the overall protocol (e.g., navigating transitions in the treatment). Findings indicate the importance of tailoring PAT to accommodate the medical history and needs of this population, support common factors, and ensure collaborative care. Recommendations across nine topic areas were derived from the data and presented in the Discussion. The E-CIT shows promise for advancing early stage research on PAT components. (PsycInfo Database Record (c) 2025 APA, all rights reserved).