Data_Sheet_1_Development and Evaluation of a Therapist Training Program for Psilocybin Therapy for Treatment-Resistant Depression in Clinical Research.pdf

Introduction: Psychological support throughout psilocybin therapy is mandated by regulators as an essential part of ensuring participants' physical and psychological safety. There is an increased need for specially trained therapists who can provide high-quality care to participants in clinical studies. This paper describes the development and practical implementation of a therapist training program of psychological support within a current phase IIb international, multicenter, randomized controlled study of psilocybin therapy for people experiencing treatment-resistant depression.
Description of Training Program: This new and manualized approach, based on current evidence-based psychotherapeutic approaches, was developed in partnership with different mental health researchers, practitioners, and experts; and has been approved by the FDA. Training consists of four components: an online learning platform; in-person training; applied clinical training; and ongoing individual mentoring and participation in webinars.This paper provides a brief overview of the method of support, the rationale and methodology of the training program, and describes each stage of training. The design and implementation of fidelity procedures are also outlined.
Lessons Learned: As part of the phase IIb study of psilocybin therapy for treatment-resistant depression, 65 health care professionals have been fully trained as therapists and assisting therapists, across the US, Canada and Europe. Therapists provided informal feedback on the training program. Feedback indicates that the didactic and experiential interactive learning, delivered through a combination of online and in-person teaching, helped therapists build conceptual understanding and skill development in the therapeutic approach. Clinical training and engagement in participant care, under the guidance of experienced therapists, were considered the most beneficial and challenging aspects of the training.
Conclusions: Clinical training for therapists is essential for ensuring consistently high-quality psilocybin therapy. Development of a rigorous, effective and scalable training methodology has been possible through a process of early, active and ongoing collaborations between mental health experts. To maximize impact and meet phase III and post-approval need, enhanced online learning and establishing pathways for clinical training are identified as critical points for quality assurance. This will require close public, academic and industry collaboration.

一、引言：在裸盖菇素疗法（psilocybin therapy）全程中提供心理支持，是监管机构强制要求的核心环节，用以保障受试者的生理与心理安全。当前临床研究亟需经过专项培训的治疗师，为受试者提供高质量照护。本文针对一项正在开展的、针对难治性抑郁症（treatment-resistant depression）患者的裸盖菇素疗法国际多中心IIb期随机对照试验，阐述其中配套心理支持的治疗师培训项目的开发与实际落地流程。
二、培训项目概况：本培训方案基于现有循证心理治疗方法，采用标准化手册化框架，由多所精神卫生研究机构、从业者与专家联合开发，并已获得美国食品药品监督管理局（FDA）批准。培训包含四大模块：在线学习平台、线下实操培训、应用临床实训，以及持续性个体督导与网络研讨会参与。本文将简要概述该心理支持方法、培训项目的理论依据与实施方法，并逐一介绍各培训阶段，同时阐述治疗保真度（fidelity）流程的设计与落地方案。
三、经验总结：在针对难治性抑郁症的裸盖菇素疗法IIb期研究中，来自美国、加拿大与欧洲的65名医疗专业人员已完成治疗师与助理治疗师的全套培训。治疗师们针对培训项目提供了非正式反馈：反馈显示，结合线上与线下教学的讲授式与体验式互动学习，帮助治疗师建立了对该疗法的概念性认知，并提升了实操技能；而在资深治疗师指导下开展的临床实训与受试者照护参与，被认为是本次培训中收益最高但也最具挑战性的环节。
四、结论：治疗师的临床培训是保障裸盖菇素疗法服务质量稳定的核心要素。通过精神卫生领域专家早期、主动且持续的跨主体协作，我们得以开发出一套严谨、高效且可规模化推广的培训方法。为最大化项目影响力并满足III期临床试验及获批后市场的需求，优化在线学习体系与搭建临床实训通道被视为质量保障的关键环节，这需要公共部门、学术机构与产业界开展深度协作。