DepressionPhase 1PAPRNCT05557643
PAPR: PAP + MBSR for Front-line Healthcare Provider COVID-19 Related Burnout
A Phase 1 study testing Psilocybin and Mindfulness-Based Stress Reduction (MBSR) in people with Depression and Burnout, Professional, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Depression, Burnout, Professional
- What is being tested?
- Psilocybin and Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 20 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be physicians or nurses with at least 1 month of frontline clinical experience during the COVID pandemic.
- Yes/No Eligibility Questions (Response of "no" = subject ineligible)
- PHQ-9 score ≥ 10 and meet criteria for a DSM-5 depressive disorder (including adjustment disorder with depressed mood).
- Meet the study working definition of burnout which will involve a score on the emotional exhaustion subscale (≥ 27) and a 'high' score on one other subscale (either depersonalization ≥ 13 or personal accomplishment ≤ 21).
- Not taking regularly scheduled medications to treat depression and/or anxiety, including benzodiazepines, for at least 4 weeks prior to initiation of the study.
- Fluent in English.
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- Reading literacy and comprehension sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- ECOG Performance Status < or = 2.
- Have a support person that would be able to escort the subject home on the evening of the psilocybin dosing session. The use of ride services will not be permitted (e.g., Uber, Lift, taxi, etc.)
- Adequate liver function as defined as:
- Total Bilirubin < 1.5x institutional upper limit of normal (ULN) unless elevated bilirubin is related to Gilbert's Syndrome.
- AST(SGOT)/ALT(SGPT) <3 x institutional ULN
- For female subjects: Negative pregnancy test and agreement to use highly effective contraception or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.
- For male subjects: agree to condom use during intercourse for 24 hours post-psilocybin dose.
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages, ondansetron, cannabis, and non-routine PRN medications within 24 hours of the psilocybin administration. Exceptions include daily use of caffeine, nicotine, and opioid pain medication.
- Agree that for one week preceding the psilocybin session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
- Agree not to use nicotine for at least 2 hours before the psilocybin administration and for the duration of the psilocybin session.
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the psilocybin session. If the subject does not routinely consume caffeinated beverages, he or she must agree not to do so on the day of psilocybin administration.
- Subjects requiring opioid use for pain are on a stable pain management regimen. Long-acting opioid medications (e.g., oxycodone sustained-release, morphine sustained release) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration.
Who cannot join
- Yes/No Eligibility Questions (Response of "yes" = subject ineligible)
- Prior systemic antidepressants, antipsychotic, or anxiolytic medication within four weeks prior to study initiation.
- Personal history or first- or second-degree relatives with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness as determined by patient report and chart review.
- Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine). Current substance use disorders may be identified through the drug urine screening test as determined by patient report and chart review.
- Currently meeting DSM-V criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to psilocybin as determined by patient report and chart review.
- Currently meeting DSM-V criteria for Cluster B Personality Disorder as determined by patient report and chart review.
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- Severe depression requiring immediate standard-of-care treatment (e.g., hospitalization).
- Suicidal ideation over the past month as assessed as a yes to question 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale, Suicidal Ideation section
- Cancer with known CNS involvement, previously treated brain metastasis, or other major CNS disease.
- Employment as house staff/residents
- The subject has uncontrolled significant intercurrent or recent illness including, but not limited to, the following conditions:
- Cardiovascular disorders: Congestive heart failure, including all New York Heart Association Classes.
- Angina pectoris, cardiac hypertrophy, cardiac ischemia, myocardial infarction
- Uncontrolled hypertension at the time of enrollment (BP>140 systolic or 90 diastolic), coronary artery disease, artificial heart valve
- Prolonged or congenital long QT syndrome (>450 ms), serious cardiac arrhythmias, tachycardia, a clinically significant screening ECG abnormality
- Renal insufficiency as defined as creatinine clearance < 40 mL/min calculated by Cockcroft-Gault formula
- Hepatic disorders: Active infection including hepatitis B (known positive HBV surface antigen (HBsAg) result) or hepatitis C.
- Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [patients may not receive the drug through a feeding tube], social/ psychological issues, etc.)
- Known prior severe hypersensitivity to investigational product or any component in its formulations (NCI CTCAE v5.0 Grade > 3).
- Subjects taking prohibited medications. A washout period of prohibited medications for a period of at least five half-lives should occur prior to study registration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Mental Health Institute
Salt Lake City, Utah, 84108
About this study
Official title: PAPR: Psilocybin-assisted Psychotherapy + Mindfulness-Based Stress Reduction (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 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).
- Conditions
- Depression, Burnout, Professional
- Being tested
- Psilocybin, Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- burnout, psilocybin, psychedelic-assisted psychotherapy, healthcare, COVID-19
- Medical subject headings
- Depression, Burnout, Professional, Burnout, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Active comparator | 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. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
| Mindfulness-Based Stress Reduction (MBSR) + Psilocybin-Assisted Psychotherapy (PAP) | Experimental | 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. Receives: Drug: Psilocybin; Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of MBSR + PAP vs. MBSR alone in reducing symptoms of depression, as measured by the QIDS-SR-16
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.
Measured: 6 months
Secondary outcomes (7)
Effect of MBSR + PAP vs. MBSR alone on participant reported symptoms of burnout as measured by the Maslach Burnout Inventory, MBI-HSS(MP).
Mean change in MBI-HSS(MP) scores from baseline to 2 weeks and 6 months post intervention with between-group comparison.
Measured: Study enrollment to 2 weeks post completion of intervention as well as 6 months post intervention.
Effect of MBSR+PAP vs. MBSR alone on symptoms of demoralization
Change in scores on the Demoralization II Scale from baseline to 2-weeks post completion of intervention.
Measured: Study enrollment to 2 weeks post completion of intervention
Effect of MBSR + PAP vs. MBSR alone on symptoms of post-traumatic stress
Change in PCL-5 PTSD Checklist scores from baseline to 2 weeks post intervention
Measured: Study enrollment to 2 weeks post completion of intervention
Effect of MBSR + PAP vs. MBSR alone on participant reported quality of life.
The change in the McGill Quality of Life Questionnaire (MQOL) score from baseline to two weeks post-completion of intervention.
Measured: Study enrollment to 2 weeks post intervention
Effect of MBSR + PAP vs. MBSR alone on measures of connectedness to self, other, and world
The change in score on the Watts' Connectedness Scale (WCS) scale from baseline to two weeks post-¬completion of the intervention.
Measured: Study enrollment to 2 weeks post intervention
Storyline Health Integrative Assessment
Investigators will deploy the Storyline Integrative Assessment to narrow in on specific feature selection in small cohorts of patients with deep AI phenotyping to identify behavioral phenotype predictors of burnout, which is heterogeneously characterized. This will be administered to both study arms at baseline, at the primary outcome point (2 weeks post intervention on both study arms), and at 6 months post intervention.
Investigators will deploy Storyline technology to narrow in on specific feature selection using deep AI phenotyping to identify phenotypical predictors of treatment response to both MBSR as well as MBSR+PAP to better characterize factors that predict response to both interventions, which may inform future research. This will be administered to both study arms at baseline, at the primary outcome point (2 weeks post intervention on both study arms), and at 6 months post intervention.
Measured: Study enrollment to 2 weeks and 6 months post intervention
State and Trait Mindfulness
Assess the effect of MBSR + PAP vs. MBSR on measures of state and trait mindfulness using the Five Facet Mindfulness Questionnaire (FFMQ) and the Toronto Mindfulness Scale (TMS).
Measured: Study enrollment to 2 weeks post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start2 Jan 2023
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm, randomized, open-label trial for 24 participants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Heffter Research Institute, Usona Institute
- Responsible party
- Principal investigator, Benjamin Lewis, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557643
- Sponsor's protocol ID
- IRB_00152312
- Acronym
- PAPR
- Status last verified
- Nov 2024
- First submitted
- 23 Sep 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lewis BR, Hendrick J, Byrne K, Odette M, Wu C, Garland EL. Psilocybin-assisted group psychotherapy and mindfulness-based stress reduction for frontline healthcare provider COVID-19-related depression and burnout: A randomized controlled trial. PLoS Med. 2025 Sep 19;22(9):e1004519. doi: 10.1371/journal.pmed.1004519. eCollection 2025 Sep.
PubMed 40972137Lewis BR, Garland EL, Byrne K, Durns T, Hendrick J, Beck A, Thielking P. HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. J Pain Symptom Manage. 2023 Sep;66(3):258-269. doi: 10.1016/j.jpainsymman.2023.06.006. Epub 2023 Jun 10.
PubMed 37302533
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAPR: Psilocybin-assisted Psychotherapy + Mindfulness-Based Stress Reduction (MBSR) for Front-line Healthcare Provider COVID-19 Related Burnout
- ClinicalTrials.gov ID
- NCT05557643
- Acronym / sponsor ID
- PAPR / IRB_00152312
- Conditions
- Depression, Burnout, Professional
- Keywords
- burnout, psilocybin, psychedelic-assisted psychotherapy, healthcare, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Heffter Research Institute, Usona Institute
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm, randomized, open-label trial for 24 participants.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Active comparator | Behavioral: Mindfulness-Based Stress Reduction (MBSR)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. |
| Mindfulness-Based Stress Reduction (MBSR) + Psilocybin-Assisted Psychotherapy (PAP) | Experimental | Drug: Psilocybin, Behavioral: Mindfulness-Based Stress Reduction (MBSR)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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participants must be physicians or nurses with at least 1 month of frontline clinical experience during the COVID pandemic.
- Yes/No Eligibility Questions (Response of "no" = subject ineligible)
- PHQ-9 score ≥ 10 and meet criteria for a DSM-5 depressive disorder (including adjustment disorder with depressed mood).
- Meet the study working definition of burnout which will involve a score on the emotional exhaustion subscale (≥ 27) and a 'high' score on one other subscale (either depersonalization ≥ 13 or personal accomplishment ≤ 21).
- Not taking regularly scheduled medications to treat depression and/or anxiety, including benzodiazepines, for at least 4 weeks prior to initiation of the study.
Key exclusion criteria (20 listed)
- Yes/No Eligibility Questions (Response of "yes" = subject ineligible)
- Prior systemic antidepressants, antipsychotic, or anxiolytic medication within four weeks prior to study initiation.
- Personal history or first- or second-degree relatives with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness as determined by patient report and chart review.
- Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine). Current substance use disorders may be identified through the drug urine screening test as determined by patient report and chart review.
- Currently meeting DSM-V criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to psilocybin as determined by patient report and chart review.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinPsilocybin 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. | Drug | Mindfulness-Based Stress Reduction (MBSR) + Psilocybin-Assisted Psychotherapy (PAP) |
| Mindfulness-Based Stress Reduction (MBSR)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. | Behavioural | Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Stress Reduction (MBSR) + Psilocybin-Assisted Psychotherapy (PAP) |
Primary outcome
Efficacy of MBSR + PAP vs. MBSR alone in reducing symptoms of depression, as measured by the QIDS-SR-16
Time frame: 6 months
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.
7 secondary outcomes
Effect of MBSR + PAP vs. MBSR alone on participant reported symptoms of burnout as measured by the Maslach Burnout Inventory, MBI-HSS(MP).
Time frame: Study enrollment to 2 weeks post completion of intervention as well as 6 months post intervention.
Effect of MBSR+PAP vs. MBSR alone on symptoms of demoralization
Time frame: Study enrollment to 2 weeks post completion of intervention
Effect of MBSR + PAP vs. MBSR alone on symptoms of post-traumatic stress
Time frame: Study enrollment to 2 weeks post completion of intervention
Effect of MBSR + PAP vs. MBSR alone on participant reported quality of life.
Time frame: Study enrollment to 2 weeks post intervention
Effect of MBSR + PAP vs. MBSR alone on measures of connectedness to self, other, and world
Time frame: Study enrollment to 2 weeks post intervention
Storyline Health Integrative Assessment
Time frame: Study enrollment to 2 weeks and 6 months post intervention
State and Trait Mindfulness
Time frame: Study enrollment to 2 weeks post intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 40972137Lewis BR, Hendrick J, Byrne K, Odette M, Wu C, Garland EL. Psilocybin-assisted group psychotherapy and mindfulness-based stress reduction for frontline healthcare provider COVID-19-related depression and burnout: A randomized controlled trial. PLoS Med. 2025 Sep 19;22(9):e1004519. doi: 10.1371/journal.pmed.1004519. eCollection 2025 Sep.
- Derived from this study: PubMed 37302533Lewis BR, Garland EL, Byrne K, Durns T, Hendrick J, Beck A, Thielking P. HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. J Pain Symptom Manage. 2023 Sep;66(3):258-269. doi: 10.1016/j.jpainsymman.2023.06.006. Epub 2023 Jun 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin and Mindfulness-Based Stress Reduction (MBSR) in people with Depression and Burnout, Professional, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of MBSR + PAP vs. MBSR alone in reducing symptoms of depression, as measured by the QIDS-SR-16 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557643, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.