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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
PAPR Trial 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.
PAPR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study enrollment to 2 weeks and 6 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study enrollment to 2 weeks and 6 months post intervention
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 morePAPR 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
~730
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
474 Total Patients Enrolled
3 Trials studying Depression
104 Patients Enrolled for Depression
University of UtahLead Sponsor
1,102 Previous Clinical Trials
1,779,237 Total Patients Enrolled
23 Trials studying Depression
2,393 Patients Enrolled for Depression
Usona InstituteOTHER
12 Previous Clinical Trials
734 Total Patients Enrolled
7 Trials studying Depression
578 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzymes should be less than three times the normal limit at the medical center where you are being treated.You currently have a specific type of personality disorder according to a doctor's evaluation.You have had thoughts about hurting yourself in the past month, as determined by certain questions on a specific rating scale.You have a medical condition that is not well controlled, like heart problems, kidney issues, or liver disorders. Your doctor thinks it's not safe for you to join the study or follow study rules because of other health concerns.You or your close family members have a history of certain mental health conditions like schizophrenia or bipolar disorder.You have a mental health condition that might make it unsafe for you to take psilocybin, as determined by your own report and medical records.You have severe depression that needs to be treated right away with standard care, like being in the hospital.You have a PHQ-9 score of 10 or higher and are diagnosed with a depressive disorder according to the DSM-5.Your liver is working well, as shown by blood tests for bilirubin and liver enzymes.You are able to perform everyday activities without help or needing to stay in bed most of the time.You have had a problem with drugs or alcohol within the last two years, as determined by a urine test and medical records.You have high scores on the emotional exhaustion and depersonalization or personal accomplishment tests, indicating burnout.You have not been taking prescribed medications for depression and anxiety for at least 4 weeks before the study starts.You have cancer that has spread to your brain, or you have had previous treatment for cancer that has spread to your brain, or you have a major disease affecting your central nervous system.If you need to use opioid pain medications, you must have taken your last dose at least 6 hours before receiving the psilocybin treatment, and you cannot take another dose until at least 6 hours after the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness-Based Stress Reduction (MBSR)
- Group 2: Mindfulness-Based Stress Reduction (MBSR) + Psilocybin-Assisted Psychotherapy (PAP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05557643 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals currently apply to participate in this research?
"As per clinicaltrials.gov, this investigation is still enrolling patients and remains open to applications since its debut on February 1st 2023 and recent amendment on April 26th 2023."
Answered by AI
How many individuals are currently involved in this research endeavor?
"Affirmative. Clinicaltrials.gov confirms that, since its inception on 2nd January 2023 and most recent update on 26th April 2023, this medical trial is actively seeking 24 volunteers from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
Missouri
Utah
What site did they apply to?
Huntsman Mental Health Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I can’t seem to stay awake . I’m not sad but my friends say I’m depressed I need help.
PatientReceived no prior treatments
I'm interested in the use of microdosing to elemiate the need for daily prescriptions. I would like something more natural.
PatientReceived 1 prior treatment
I have struggled with Major Depressive Disorder and PTSD from ongoing traumatic life events for several years. I have not worked in over a year now. I was employed by my county’s EMS department. One of the critical care paramedics suggested other forms of therapy such as MDMA and/or psylocibin.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Are you able to fly me back and forth from my home to SLC on a regular basis?
PatientReceived no prior treatments
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