Browsing by Subject "psilocybin"

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  • 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 (2021)
    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.
  • Ajantaival, Teo (Helsingin yliopisto, 2018)
    Objectives. Renewed clinical research finds treatment effects from psychedelic (psilocybin or LSD)-assisted therapy sustained at 12 month follow-up. Population studies find the association between lifetime psychedelic use (even once, Yes/No) and current mental health absent or protective after adjusting for sociodemographics, risk-taking tendency, and non-medical use of other drugs. This study aimed to investigate whether the recency of psychedelic use (>12, 1–12, or <1 months ago) is associated with past month psychological distress, past year suicidality, or everyday impairment. This study also addressed a previously expressed concern that the previous results stem from overadjustment for non-medical use of other drugs, explored how such adjustments should be done, and compared use of psilocybin, LSD, and psilocybin and/or LSD. All code was published. Methods. The analysis was based on combined data of adult respondents of the National Survey on Drug Use and Health (NSDUH) years 2008–2014 randomly selected to be representative of the population of the United States. Comparison groups by the psychedelic used and its recency of use were inferred from the data. Weighted odds ratios were calculated adjusting for sociodemographics, risk-taking tendency, and non-medical use of other drugs. Adjustments for other drug use were compared between a minimally adjusted model, a lifetime use-adjusting model, and a recency of use-adjusting model. Mirroring adjustments were made in order to see whether crack cocaine and heroin use recency would associate to psychological distress in an unexpectedly protective way, indicating overadjustment in the psychedelic recency associations. Results. No independent association between any recency of any psychedelic use and increased likelihood of past month psychological distress, past year suicidality, or everyday impairment was found. A decreased likelihood for past year suicidal thinking was found among all groups that had last used psychedelics >12 months ago or psilocybin <1 month ago, as well as for past year suicide plans and past month serious psychological distress among those whose last psychedelic use was psilocybin >12 months ago. More recent crack cocaine or heroin use was still associated with a higher risk for past month serious psychological distress after adjusting for lifetime non-medical use of other drugs. LSD and psilocybin could not be properly intercompared due to surprisingly small LSD-only recency groups. Adjusting for non-medical use of other drugs made a big difference, but adjustments for their lifetime use or recency of use did not mutually differ. Conclusions. This study strongly supports the results of previous population studies, as no independent risk from psychedelic use was found even when considering their recency of use. The results are also consistent with research indicating that psychedelics may have long-lasting beneficial effects for anxiety, depression, neuroticism, substance dependence, cognitive flexibility, and meaningfulness, and do not lead to dependence.