A critical evaluation of psilocybin-assisted therapy protocol components from clinical trial patients, facilitators, and caregivers.
Roman Palitsky, Jessica L Maples-Keller, Caroline Peacock, Boadie W Dunlop, Tanja Mletzko, George H. Grant, Charles L. Raison, Sam Chao, Isabelle Shub, Michal Mendelbaum-Kweller, Liam Smolyar, Deanna M Kaplan, Barbara O Rothbaum, Ali J Zarrabi
Psychotherapy January 13, 2025 DOI: 10.1037/pst0000551 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Qualitative study Open-label Peer reviewed |
|---|---|
| Sample size | 24 |
| Population | Patients with cancer-related demoralization and chronic pain, facilitators (licensed mental health and certified spiritual health clinicians), and caregivers in an open-label trial of psilocybin-assisted therapy |
| Intervention | Psilocybin-assisted therapy |
| Topics | Psychedelic-assisted therapy Psilocybin |
| Keywords | Psilocybin treatment Mental health care Therapeutic protocols Patient experience |
| Citations | 13 |
| Key findings | Protocol components for psilocybin-assisted therapy should be tailored to patient medical history, support common therapeutic factors, and ensure collaborative care. |
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).
Comparable studies
Other qualitative studies on psilocybin and psychedelic-assisted therapy, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Patients’ Accounts of Increased “Connectedness” and “Acceptance” After Psilocybin for Treatment-Resistant Depression Patients with treatment-resistant depression enrolled in an open-label trial of psilocybin | 2017 | Qualitative study | n = 20 |
| Patient Experiences of Psilocybin-Assisted Psychotherapy: An Interpretative Phenomenological Analysis Adults aged 22 to 69 with clinically elevated anxiety associated with a cancer diagnosis | 2017 | Qualitative study | n = 13 |
| Psychedelic therapy for smoking cessation: Qualitative analysis of participant accounts Participants who completed a psilocybin-facilitated smoking cessation pilot study | 2018 | Qualitative follow-up study using semi-structured interviews and thematic analysis | n = 12 |
| Cancer at the Dinner Table: Experiences of Psilocybin-Assisted Psychotherapy for the Treatment of Cancer-Related Distress Adult participants with clinically elevated anxiety associated with a cancer diagnosis | 2017 | Qualitative study using interpretative phenomenological analysis | n = 13 |
| Reports of self-compassion and affect regulation in psilocybin-assisted therapy for alcohol use disorder: An interpretive phenomenological analysis. non-Hispanic White cisgender men and women with alcohol use disorder | 2023 | Qualitative study | n = 13 |
Citations in the library
Cited by 4
- Psilocybin treatment extends cellular lifespan and improves survival of aged mice npj Aging July 8, 2025
- The Emergence of Psilocybin in Psychiatry and Neuroscience Pharmaceuticals April 9, 2025
- Psilocybin-assisted psychotherapy as a rapid-acting treatment for cancer-related depression and anxiety: Evidence from a network meta-analysis The International Journal of Psychiatry in Medicine April 25, 2025
- What motivates spiritual health practitioners in psychedelic-assisted therapy? A qualitative study and implications for facilitator training practices Psychedelics April 29, 2025