CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Psilocybin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05557643
NCT05557643Phase 1Completed

PAPR: Psilocybin-assisted Psychotherapy + Mindfulness-Based Stress Reduction (MBSR) for Front-line Healthcare Provider COVID-19 Related Burnout

University of Utah·interventional·Posted Sep 28, 2022·Updated Nov 12, 2024

In Brief

A Phase 1 clinical trial evaluating Psilocybin and Mindfulness-Based Stress Reduction (MBSR) for Depression and Burnout, Professional. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This project is an open-label randomized study looking at an 8-week Mindfulness-Based Stress Reduction (MBSR) curriculum vs. an 8-week MBSR curriculum + a group psilocybin-assisted psychotherapy intervention for frontline healthcare providers struggling with symptoms of depression and burnout associated with the SARS-CoV-2 pandemic. Following consenting and enrollment a total of 24 participants will be randomized to receive either an 8-week MBSR curriculum or the same 8-week MBSR curriculum + a group psilocybin-assisted psychotherapy intervention. The group psilocybin-assisted psychotherapy intervention will involve 3 group preparatory sessions (2 hours each), a single 8 hour group psilocybin administration session with a 1:1 therapist to participant ratio (25mg psilocybin dose), and 3 group integration sessions (2 hours each).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedSep 28, 2022
Enrollment StartJan 2, 2023
Primary CompletionSep 20, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.8 years ago

Interventions

Psilocybindrug

Psilocybin is a classic psychedelic of medium duration that is well-tolerated and has a documented safety and efficacy record that makes it uniquely well-suited to the issues that arise in this participant population. Psilocybin has been described as an 'existential medicine' given patient testimonials as to its acute and lasting effects on interpersonal connection, ability to more deeply engage with meaningful activities and relationships, dramatic reductions in fear of death, and a renewed sense of well-being.

Mindfulness-Based Stress Reduction (MBSR)behavioral

Mindfulness-Based Stress Reduction (MBSR) is a well-established evidence-based mindfulness training program initially developed by Jon Kabat-Zinn that has been shown to reduce symptoms of depression, anxiety, and burnout. The 8-week MBSR curriculum provides training in formal meditation practices including body scan techniques, mindfulness meditation, and yoga. Mindfulness can be understood as the non-judgmental acceptance and investigation of present experience, including body sensations, internal mental states, thoughts, emotions, impulses and memories, in order to reduce suffering or distress and to increase well-being.