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NCT05557643 · ClinicalTrials.gov registry record · Phase 1
PAPR: PAP + MBSR for Front-line Healthcare Provider COVID-19 Related Burnout
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT05557643: Completed Phase 1 study, sponsored by University of Utah.
NCT05557643 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05557643, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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).
Primary Outcome
Efficacy will be assessed through mean reduction in QIDS-SR-16 scores at 2-weeks post intervention with between-group comparison. To understand longitudinal effects, the investigators will gather data to 6 months post intervention for both arms. Participants will be screened for eligibility with the PHQ-9 with a cut-off score of ≥ 8 required for enrollment.
Interventions
- DRUG Psilocybin
- BEHAVIORAL Mindfulness-Based Stress Reduction (MBSR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-01-02 |
| Est. Completion | 2024-09-20 |
| Phase | Phase 1 |
What the finished NCT05557643 record still lists
NCT05557643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Psilocybin is the first listed.
NCT05557643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05557643 about?
NCT05557643 is a clinical study titled "PAPR: PAP + MBSR for Front-line Healthcare Provider COVID-19 Related Burnout". 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 associ...
What is the current status of trial NCT05557643?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-01-02. Estimated completion is 2024-09-20.
What interventions are being tested in trial NCT05557643?
The interventions under investigation include: Psilocybin (DRUG), Mindfulness-Based Stress Reduction (MBSR) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05557643?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05557643's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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