Psilocybin-Assisted Therapy for Physician Well-Being and Burnout: Feasibility, Safety, Clinical Effectiveness and Biomarkers of Response [PAT-B (Psilocybin-Assisted Therapy for Physician Well-Being and Burnout)]
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Stanford Professional Fulfillment Index (PFI)
Study Overview
Brief Summary
Through an open-label study involving a small group of UCSD physicians experiencing burnout, the investigators will evaluate the feasibility, safety, and preliminary effectiveness of PAT to reduce burnout symptoms.
Detailed Description
Physician burnout is a critical issue. Research shows that physician burnout is increasing, that physicians suffer higher rates of burnout than the general population, and that physician burnout is associated with poor mental health outcomes.
Psilocybin is a naturally occurring alkaloid within certain fungi that elicits acute perceptual, cognitive, and emotional changes when ingested, due to action on neurotransmitter and neurocirculatory systems. The combination of psilocybin with psychological support, termed Psilocybin-Assisted Therapy (PAT), is a promising new mental health intervention shown to produce rapid and sustained improvements in psychological domains affected in burnout. PAT demonstrates preliminary efficacy as a treatment for depression and substance use disorders, is associated with brain changes measured with electroencephalography (EEG) and is a strong candidate treatment for physician burnout.
The primary aim is to assess whether incorporating biofeedback of interpersonal synchrony and individual biosignal biofeedback measures can enhance PAT outcomes. This will be determined by the superiority in the reduction of pre- and post-treatment burnout subscale scores of the biofeedback arm compared to the standard PAT arm. The secondary aim is to confirm the safety, tolerability, and efficacy of PAT to reduce burnout symptoms in physicians. In addition to these aims, exploratory analyses will examine neurophysiological and behavioral measures (e.g., EEG and multimodal synchrony) to evaluate their associations with clinical outcomes and identify potential biomarkers of response to psilocybin-assisted therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Faculty physician, aged 21-
- •Volunteer faculty are not included
- •Meets criteria for physician burnout
- •Experiencing symptoms of burnout for >6 months
- •Able to complete all required study visits
- •Not previously diagnosed with a serious mental illness (including schizophrenia, bipolar disorder, and severe depression), or substance use disorder as confirmed in clinical interview
- •Not currently taking any psychotropic medications or nonpsychotropic medication that may be associated with serotonin syndrome, such as serotonin reuptake inhibitors (SSRI or SNRI), dextromethorphan, linezolid, tramadol, meperidine
Exclusion Criteria
- •Previous inpatient psychiatric hospitalization(s)
- •Previously diagnosed with a psychotic disorder (schizophrenia, schizoaffective disorder, or other psychotic spectrum disorder), bipolar spectrum disorder, personality disorder (borderline personality disorder, antisocial personality disorder, or other severe personality disorders), any severe psychiatric disorder.
- •Exhibiting elevated suicide risk
- •First degree family history of psychosis or bipolar disorder
- •Prior exposure to psilocybin or other psychedelic compounds in the previous 5 years
- •Currently pregnant, nursing, planning pregnancy, engaging in sexual intercourse without effective contraceptive method in last three months
- •Those who plan to donate sperm within three months following the study.
- •Known cardiovascular disease including history of stroke, myocardial infarction, uncontrolled hypertension, valvular heart disease, tachycardia, elongated QT interval, or clinically significant arrythmia.
- •History of seizure disorder
- •Use of recreational illicit drugs
- •Clinically concerning results from vital signs, ECG, physical examination, or laboratory tests during screening
- •Any other clinically significant illnesses deemed to pose risk for the participant
Arms & Interventions
Psilocybin-Assisted Therapy with Biofeedback
Subjects will receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy and real-time visual biofeedback available to the therapist during sessions.
Intervention: Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate (Drug)
Psilocybin-Assisted Therapy with Biofeedback
Subjects will receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy and real-time visual biofeedback available to the therapist during sessions.
Intervention: Real-time Biofeedback (Device)
Psilocybin-Assisted Therapy without Biofeedback
Subjects will receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy, without real-time visual biofeedback available to the therapist during sessions.
Intervention: Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate (Drug)
Outcomes
Primary Outcomes
Stanford Professional Fulfillment Index (PFI)
Time Frame: From enrollment until end of study at 12 week follow-up.
Assessment used to determine degree/severity of burnout.
Secondary Outcomes
No secondary outcomes reported
Investigators
Cory Weissman
Dr. Cory Weissman
University of California, San Diego