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Psilocybin + MBSR for Burnout (PAPR Trial)

Phase < 1
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study enrollment to 2 weeks and 6 months post intervention
Awards & highlights

Summary

This trial will study the efficacy of MBSR + psilocybin psychotherapy for frontline healthcare workers battling depression & burnout from the pandemic.

Who is the study for?
This trial is for frontline healthcare providers (physicians or nurses) who have at least one month of experience during the COVID pandemic and are experiencing depression and burnout. They must not be on medication for depression/anxiety, should have a support person post-psilocybin session, agree to avoid psychoactive drugs before sessions, and meet specific health criteria including liver function tests.Check my eligibility
What is being tested?
The study compares an 8-week Mindfulness-Based Stress Reduction (MBSR) program with the same MBSR program plus a group psilocybin-assisted psychotherapy intervention. It includes preparatory sessions, one psilocybin administration session with individual therapist attention, and integration sessions afterwards.See study design
What are the potential side effects?
Possible side effects from psilocybin may include changes in sense perception, altered thinking processes, anxiety, headache or dizziness. Mindfulness practice typically has minimal risks but can sometimes cause discomfort when confronting difficult emotions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study enrollment to 2 weeks and 6 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and study enrollment to 2 weeks and 6 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mental Depression
Secondary outcome measures
Phosphorus
Phosphorus
Personality inventories
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Stress Reduction (MBSR) + Psilocybin-Assisted Psychotherapy (PAP)Experimental Treatment2 Interventions
Participants in the MBSR + PAP arm will complete an 8-week Mindfulness-Based Stress Reduction Curriculum involving a weekly 2 hour group meeting (either in person or virtual). They will additionally complete a psilocybin-assisted psychotherapy (PAP) intervention that involves three 2-hour group preparatory sessions, a single 8-hour group psilocybin administration session (done in place of the mindfulness retreat), and three 2-hour group integration sessions. All PAP intervention sessions will utilize a 1:1 therapist to participant ratio with an additional lead therapist present.
Group II: Mindfulness-Based Stress Reduction (MBSR)Active Control1 Intervention
Participants in the MBSR arm will complete an 8-week Mindfulness-Based Stress Reduction Curriculum involving a weekly 2 hour group meeting (either in person or virtual) as well as a 8 hour group mindfulness retreat in week 6-7 of the curriculum.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750
Mindfulness-Based Stress Reduction (MBSR)
2018
Completed Phase 2
~1430

Find a Location

Who is running the clinical trial?

Heffter Research InstituteOTHER
13 Previous Clinical Trials
475 Total Patients Enrolled
3 Trials studying Depression
104 Patients Enrolled for Depression
University of UtahLead Sponsor
1,110 Previous Clinical Trials
1,788,532 Total Patients Enrolled
23 Trials studying Depression
2,379 Patients Enrolled for Depression
Usona InstituteOTHER
14 Previous Clinical Trials
812 Total Patients Enrolled
7 Trials studying Depression
578 Patients Enrolled for Depression

Media Library

Mindfulness-Based Stress Reduction (MBSR) Clinical Trial Eligibility Overview. Trial Name: NCT05557643 — Phase < 1
Depression Research Study Groups: Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Stress Reduction (MBSR) + Psilocybin-Assisted Psychotherapy (PAP)
Depression Clinical Trial 2023: Mindfulness-Based Stress Reduction (MBSR) Highlights & Side Effects. Trial Name: NCT05557643 — Phase < 1
Mindfulness-Based Stress Reduction (MBSR) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557643 — Phase < 1
Depression Patient Testimony for trial: Trial Name: NCT05557643 — Phase < 1
~10 spots leftby Jul 2025