Tai Sara J, Nielson Elizabeth M, Lennard-Jones Molly, Johanna Ajantaival Riikka-Liisa, Winzer Rachel, Richards William A, Reinholdt Frederick, Richards Brian D, Gasser Peter, Malievskaia Ekaterina
Division of Psychology and Mental Health, The University of Manchester, Manchester, United Kingdom.
Depression Evaluation Services, New York State Psychiatric Institute, New York, NY, United States.
Front Psychiatry. 2021 Feb 3;12:586682. doi: 10.3389/fpsyt.2021.586682. eCollection 2021.
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. 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. 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. 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.
监管机构规定，在裸盖菇素治疗过程中提供心理支持是确保参与者身心健康安全的重要组成部分。因此，对经过专门培训、能够为临床研究参与者提供高质量护理的治疗师的需求日益增加。本文介绍了在一项当前正在进行的国际多中心IIb期随机对照研究中，针对难治性抑郁症患者开展裸盖菇素治疗的心理支持治疗师培训计划的制定与实际实施情况。这种基于当前循证心理治疗方法的全新手册化方法，是与不同的心理健康研究人员、从业者和专家合作开发的，并已获得美国食品药品监督管理局（FDA）的批准。培训包括四个部分：在线学习平台、面对面培训、应用临床培训以及持续的个人指导和参加网络研讨会。本文简要概述了支持方法、培训计划的基本原理和方法，并描述了培训的各个阶段。还概述了保真程序的设计与实施。作为裸盖菇素治疗难治性抑郁症IIb期研究的一部分，美国、加拿大和欧洲的65名医护专业人员已接受全面培训，成为治疗师和助理治疗师。治疗师对培训计划提供了非正式反馈。反馈表明，通过在线和面对面教学相结合的方式进行的理论与体验式互动学习，有助于治疗师在治疗方法上建立概念理解并发展技能。在经验丰富的治疗师指导下进行临床培训并参与患者护理，被认为是培训中最有益且最具挑战性的方面。治疗师的临床培训对于确保裸盖菇素治疗始终保持高质量至关重要。通过心理健康专家之间早期、积极且持续的合作过程，有可能开发出严谨、有效且可扩展的培训方法。为了最大限度地发挥影响并满足III期研究及获批后的需求，加强在线学习和建立临床培训途径被确定为质量保证的关键点。这将需要公众、学术界和行业的密切合作。
