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

ABSTRACT: 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.

SUBMITTER: Tai SJ

PROVIDER: S-EPMC7908919 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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

Tai Sara J SJ Nielson Elizabeth M EM Lennard-Jones Molly M Johanna Ajantaival Riikka-Liisa RL Winzer Rachel R Richards William A WA Reinholdt Frederick F Richards Brian D BD Gasser Peter P Malievskaia Ekaterina E

Frontiers in psychiatry 20210203

<b>Introduction:</b> 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 ...[more]

PMID: 33643087

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Project description:BackgroundBlended cognitive behavioral therapy (bCBT)-the combination of digital elements and face-to-face psychotherapy-has been proposed to alleviate challenges that patients and therapists face in conventional cognitive behavioral therapy. There is growing evidence that adding digital elements to face-to-face psychotherapy can contribute to better treatment outcomes. However, bCBT programs still show considerable shortcomings, and knowledge on how to improve digital apps using a bCBT protocol is limited.ObjectiveThis study aimed to inductively identify functions and qualities that are expected from a bCBT treatment for depression in the eyes of patients and psychotherapists who were not currently receiving or practicing bCBT treatment.MethodsWe used a qualitative exploratory study design and conducted 3 focus group interviews (n=6 in each) and 5 semistructured in-depth interviews with therapists as well as 11 individual interviews with patients with a primary diagnosis of depression and currently undergoing cognitive behavioral therapy treatment in Germany. Themes and categories were established inductively from transcribed interview records based on a rigorous coding method.ResultsBoth therapists and patients expected a digital app to provide patients with the opportunity to track their mood, work on therapeutic homework activities, easily access an intervention set for harder moments, and efficiently facilitate administrative tasks. The desire to be able to customize bCBT protocols to individual patient circumstances was evident in both patient and therapist interviews. Patients differed with respect to what content and the amount of material the app should focus on as well as the method of recording experiences. Therapists viewed digital apps as potentially aiding in their documentation work outside of sessions. Different attitudes surfaced on the topic of data security, with patients not as concerned as therapists.ConclusionsBoth patients and therapists had substantially positive attitudes toward the option of an integrated bCBT treatment. Our study presents novel findings on the expectations and attitudes of patients and therapists.

Project description:BackgroundPatient-centered outcomes research (PCOR) emphasizes patient-generated research priorities and outcomes, and engages patients throughout every stage of the research process. In the cystic fibrosis (CF) community, patients frequently provide input into research studies, but rarely are integrated onto research teams. Therefore, we developed and evaluated a virtual pilot PCOR training program to build PCOR capacity in the CF community (patients, caregivers, researchers, nonprofit stakeholders and providers). We aimed to show changes among participants' perceived PCOR knowledge (a.k.a PCOR knowledge), confidence in engaging stakeholders, and post-training session satisfaction.MethodsGuided by a prior CF community educational needs assessment, our researcher and patient-partner team co-developed a four-part virtual online training program. We structured the program towards two learner groups: patients/caregivers and researchers/providers. We evaluated participants' PCOR knowledge, confidence in engaging stakeholders, and session satisfaction by administering 5-point Likert participant surveys. We tested for significant differences between median ratings pre- and post-training.ResultsA total of 28 patients/caregivers, and 31 researchers/providers participated. For both learner groups, we found the training resulted in significantly higher PCOR knowledge scores regarding "levels of engagement" (p = .008). For the patient/caregiver group, training significantly increased their PCOR knowledge about the barriers/enablers to doing PCOR (p = .017), effective PCOR team elements (p = .039), active participation (p = .012), and identifying solutions for successful PCOR teams (p = .021). For the researcher/healthcare provider group, training significantly increased participants' ability to describe PCOR core principles (p = .016), identify patient-partners (p = .039), formulate research from patient-driven priorities (p = .039), and describe engagement in research grants (p = .006). No learner group had significant changes in their confidence score. Most participants were either "satisfied" or "very satisfied" with the training program.ConclusionsOverall, our virtual pilot PCOR training program was well received by patients, caregivers, researchers and providers in the CF community. Participants significantly improved their perceived knowledge with core PCOR learning items. Trial registration Retrospectively registered at clinicaltrials.gov (NCT04999865).

Dataset Information

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

Publications

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

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