DepressionPhase 2NCT07565909
Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression
A Phase 2 study testing Psilocybin in people with Depression and Anxiety, run by University of Washington.
Trial summary
In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) currently in clinical practice
- Age 25-70 years
- Loss of meaning single question "I used to find deep meaning in my work as a healthcare clinician, but during the past 5 years that sense of meaning has faded".
- PHQ-9 score ≥10 (moderate symptoms of depression)
- Ability to commit to all preparation sessions and retreat attendance
- English fluency sufficient for group participation
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- Screening laboratory tests within acceptable limits, including liver function tests
- Negative urine drug screen for non-prescribed psychoactive medications.
- ECG with QTc <450 ms
- Willing to taper and discontinue any supplements with serotonin-like properties, including but not limited to 5-HTP, St. John's Wort, and 'brain food' supplements.
- For participants of childbearing potential, agree to use to use highly effective contraception. Highly effective contraceptive methods are defined as those that, alone or in combination, result in a low failure rate (less than 1 percent per year), including but not limited to implants, IUDs, contraceptive injections, or contraceptive pills.
Who cannot join
- Personal or first-degree family history of psychotic disorder or bipolar I disorder
- Personal major depressive episode prior to entering healthcare as a professional
- Active suicidal ideation with intent or plan
- Unstable medical conditions
- Pregnancy or breastfeeding
- Hypertension with BP systolic >150 or diastolic > 90
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2 Sequential Dose-Finding Study of Preparation for Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression
In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression and loss of meaning during the past 5 years. Each participant will be in a group cohort of 8, and 3 cohorts will be tested at each dose level. The objectives are safety, feasibility, mechanism testing, and outcomes.
Read the detailed description
This is a single-arm study that examines the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation.
Population: Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression (PHQ-9 ≥10) and loss of meaning during the past 5 years.
Study Design: Phase 2, non-randomized, sequential cohort dose-escalation study examining the optimal number of preparation sessions for group retreat psilocybin therapy. Three cohorts will receive different "doses" of preparation: Cohort 1 receives 7 total preparation sessions (6 virtual + 1 in-person), Cohort 2 receives 4 total preparation sessions (3 virtual + 1 in-person), and Cohort 3 receives 2 total preparation sessions (1 virtual + 1 in-person). Each cohort includes 3 retreats with 8 participants per retreat.
Sample Size: 72 participants total (24 per cohort, distributed across 3 retreats of 8 participants each) Study Duration: 18-24 months from enrollment of first participant to completion of final data analysis. Individual participant involvement spans approximately 8-10 months including 6-month post-retreat follow-up.
Primary Objectives: (1) Safety: Assess incidence and severity of challenging experiences and adverse events across preparation dose levels using the Challenging Experience Questionnaire (CEQ), adverse event monitoring, and psychiatric symptom scales (PHQ-9, GAD-7, C-SSRS). (2) Feasibility: Determine completion rates for preparation sessions at each dose level.
Secondary Objectives: (1) Mechanism Testing: Examine relationship between preparation dose, group cohesion, and challenging experiences. (2) Clinical Outcomes: Explore effects on depression and burnout for future power calculations. (3) Participant Preference: Assess participant-reported optimal preparation length.
Summary: Psilocybin therapy has demonstrated promising efficacy for symptoms of depression related to frontline work during the COVID pandemic for clinicians. The group retreat format offers potential advantages over individual treatment, including enhanced accessibility, reduced cost per participant, and potential therapeutic benefits from group cohesion and shared experience. However, a critical unanswered question concerns the optimal number of preparation sessions. A sequential dose-finding design is appropriate because: (1) the dose-response curve for preparation sessions in group format is unknown; (2) attrition/completion rate is a critical feasibility outcome, particularly for time-constrained healthcare clinicians; (3) the design allows protocol refinement between cohorts based on emerging data; (4) this approach is more scientifically honest about genuine uncertainty regarding optimal preparation dose than premature randomization; and (5) it seeks to establish a minimum effective dose of preparation for practical feasibility and future scalability.
- Conditions
- Depression, Anxiety
- Being tested
- Psilocybin
- Keywords
- psilocybin, group, retreat, preparation, healthcare workers
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called Group Retreat Psilocybin Therapy
Includes preparation sessions, a single psilocybin session, and integration sessions
| Study group | Role | What they receive |
|---|---|---|
| Group Retreat Psilocybin Therapy | Experimental | In this non-randomized trial, the dose of psilocybin will be as follows: for participants not taking an antidepressant, the dose will be psilocybin 25 mg + optional booster 10 mg; for participants who are taking an antidepressant the dose will be psilocybin 35 mg + optional booster 10 mg, Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Feasibility measures
Adverse events
Measured: 1 week, 1 month, and 3 months after the retreat.
Secondary outcomes (3)
Mechanism testing measures
MEQ30
Measured: 3rd day of retreat
Exploratory symptom measures
Stanford Fulfillment Index
Measured: 1 week, 1 month, and 3 months after the retreat.
Symptom measures
PHQ9
Measured: 1 week, 1 month, and 3 months after the retreat.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3 different dose levels of preparation will be tested, with 3 cohorts in each dose level.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Back MD, University of Washington
- Investigators
- Anthony Back, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565909
- Sponsor's protocol ID
- STUDY00025289
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Sequential Dose-Finding Study of Preparation for Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression
- ClinicalTrials.gov ID
- NCT07565909
- Acronym / sponsor ID
- STUDY00025289
- Conditions
- Depression, Anxiety
- Keywords
- psilocybin, group, retreat, preparation, healthcare workers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 4 May 2026 (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.
In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression and loss of meaning during the past 5 years. Each participant will be in a group cohort of 8, and 3 cohorts will be tested at each dose level. The objectives are safety, feasibility, mechanism testing, and outcomes.
Detailed description
This is a single-arm study that examines the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation.
Population: Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression (PHQ-9 ≥10) and loss of meaning during the past 5 years.
Study Design: Phase 2, non-randomized, sequential cohort dose-escalation study examining the optimal number of preparation sessions for group retreat psilocybin therapy. Three cohorts will receive different "doses" of preparation: Cohort 1 receives 7 total preparation sessions (6 virtual + 1 in-person), Cohort 2 receives 4 total preparation sessions (3 virtual + 1 in-person), and Cohort 3 receives 2 total preparation sessions (1 virtual + 1 in-person). Each cohort includes 3 retreats with 8 participants per retreat.
Sample Size: 72 participants total (24 per cohort, distributed across 3 retreats of 8 participants each) Study Duration: 18-24 months from enrollment of first participant to completion of final data analysis. Individual participant involvement spans approximately 8-10 months including 6-month post-retreat follow-up.
Primary Objectives: (1) Safety: Assess incidence and severity of challenging experiences and adverse events across preparation dose levels using the Challenging Experience Questionnaire (CEQ), adverse event monitoring, and psychiatric symptom scales (PHQ-9, GAD-7, C-SSRS). (2) Feasibility: Determine completion rates for preparation sessions at each dose level.
Secondary Objectives: (1) Mechanism Testing: Examine relationship between preparation dose, group cohesion, and challenging experiences. (2) Clinical Outcomes: Explore effects on depression and burnout for future power calculations. (3) Participant Preference: Assess participant-reported optimal preparation length.
Summary: Psilocybin therapy has demonstrated promising efficacy for symptoms of depression related to frontline work during the COVID pandemic for clinicians. The group retreat format offers potential advantages over individual treatment, including enhanced accessibility, reduced cost per participant, and potential therapeutic benefits from group cohesion and shared experience. However, a critical unanswered question concerns the optimal number of preparation sessions. A sequential dose-finding design is appropriate because: (1) the dose-response curve for preparation sessions in group format is unknown; (2) attrition/completion rate is a critical feasibility outcome, particularly for time-constrained healthcare clinicians; (3) the design allows protocol refinement between cohorts based on emerging data; (4) this approach is more scientifically honest about genuine uncertainty regarding optimal preparation dose than premature randomization; and (5) it seeks to establish a minimum effective dose of preparation for practical feasibility and future scalability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 different dose levels of preparation will be tested, with 3 cohorts in each dose level.
| Arm | Type | Receives |
|---|---|---|
| Group Retreat Psilocybin Therapy | Experimental | Drug: PsilocybinIn this non-randomized trial, the dose of psilocybin will be as follows: for participants not taking an antidepressant, the dose will be psilocybin 25 mg + optional booster 10 mg; for participants who are taking an antidepressant the dose will be psilocybin 35 mg + optional booster 10 mg, |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) currently in clinical practice
- Age 25-70 years
- Loss of meaning single question "I used to find deep meaning in my work as a healthcare clinician, but during the past 5 years that sense of meaning has faded".
- PHQ-9 score ≥10 (moderate symptoms of depression)
- Ability to commit to all preparation sessions and retreat attendance
Key exclusion criteria (6 listed)
- Personal or first-degree family history of psychotic disorder or bipolar I disorder
- Personal major depressive episode prior to entering healthcare as a professional
- Active suicidal ideation with intent or plan
- Unstable medical conditions
- Pregnancy or breastfeeding
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 |
|---|---|---|
| PsilocybinAlso: Group Retreat Psilocybin TherapyIncludes preparation sessions, a single psilocybin session, and integration sessions | Drug | Group Retreat Psilocybin Therapy |
Primary outcome
Safety and Feasibility measures
Time frame: 1 week, 1 month, and 3 months after the retreat.
Adverse events
3 secondary outcomes
Mechanism testing measures
Time frame: 3rd day of retreat
Exploratory symptom measures
Time frame: 1 week, 1 month, and 3 months after the retreat.
Symptom measures
Time frame: 1 week, 1 month, and 3 months after the retreat.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
Anthony Back, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Depression and Anxiety, run by University of Washington.
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 11 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie Thorn ((206) 295-4425, lazthorn@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Feasibility measures (time frame: 1 week, 1 month, and 3 months after the retreat.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.