[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06814522":3,"trial-entities:NCT06814522":100,"trial-summary:NCT06814522":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":38,"interventions":41,"primary_outcomes":56,"secondary_outcomes":61,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":92,"overall_officials":97,"references":98,"see_also_links":99},"NCT06814522","176596","Psilocybin-Assisted Therapy for Physician Well-Being and Burnout","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)]","RECRUITING","2028-08","2025-11","2026-09-02","2025-01-13","University of California, San Diego","OTHER",true,"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.","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.\n\nPsilocybin 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.\n\nThe 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.",[19,20],"Burnout","Burnout, Healthcare Workers",[22,23,24,25,26,27,28,29,30,31,32],"burnout","physician","doctor","psilocybin","biofeedback","electroencephalography","psychotherapy","synchrony","professional fulfillment","dyadic","neurofeedback","INTERVENTIONAL","TREATMENT",[36,37],"PHASE1","PHASE2",{"count":39,"type":40},30,"ESTIMATED",[42,51],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":49},"DRUG","Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate","25 mg, single dose of psilocybin",[47,48],"Psilocybin-Assisted Therapy with Biofeedback","Psilocybin-Assisted Therapy without Biofeedback",[50],"Psilocybin",{"type":52,"name":53,"description":54,"armGroupLabels":55},"DEVICE","Real-time Biofeedback","Real-time visual biofeedback signal derived from multimodal dyadic synchrony measures (e.g., EEG, autonomic physiology, facial expression, speech) presented to the therapist during therapy sessions to inform delivery of psychotherapy.",[47],[57],{"measure":58,"description":59,"timeFrame":60},"Stanford Professional Fulfillment Index (PFI)","Assessment used to determine degree\u002Fseverity of burnout.","From enrollment until end of study at 12 week follow-up.",[],"ALL","21 Years","70 Years",false,{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Inclusion Criteria:\n\n1. Faculty physician, aged 21-70. Volunteer faculty are not included\n2. Meets criteria for physician burnout\n3. Experiencing symptoms of burnout for \\>6 months\n4. Able to complete all required study visits\n5. Not previously diagnosed with a serious mental illness (including schizophrenia, bipolar disorder, and severe depression), or substance use disorder as confirmed in clinical interview\n6. 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\n\nExclusion Criteria:\n\n1. Previous inpatient psychiatric hospitalization(s)\n2. 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.\n3. Exhibiting elevated suicide risk\n4. First degree family history of psychosis or bipolar disorder\n5. Prior exposure to psilocybin or other psychedelic compounds in the previous 5 years\n6. Currently pregnant, nursing, planning pregnancy, engaging in sexual intercourse without effective contraceptive method in last three months\n7. Those who plan to donate sperm within three months following the study.\n8. Known cardiovascular disease including history of stroke, myocardial infarction, uncontrolled hypertension, valvular heart disease, tachycardia, elongated QT interval, or clinically significant arrythmia.\n9. History of seizure disorder\n10. Use of recreational illicit drugs\n11. Clinically concerning results from vital signs, ECG, physical examination, or laboratory tests during screening\n12. Any other clinically significant illnesses deemed to pose risk for the participant",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"UC San Diego","San Diego","California","92037","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Vy Nguyen","CONTACT","619-363-2465","vyn014@health.ucsd.edu",{"name":87,"role":88},"Cory R Weissman, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},32.71571,-117.16472,[93,94],{"name":82,"role":83,"phone":84,"email":85},{"name":95,"role":83,"email":96},"Cory Weissman","cweissman@health.ucsd.edu",[],[],[],{"nct_id":4,"conditions":101,"biomarkers":103},[102],"Physical AND emotional exhaustion state",[],{"nct_id":4,"found":15,"summary":105,"prompt_version":115},{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an open-label study, meaning both you and the researchers will know what treatment you are receiving. It involves a small group of 10 participants.","completed","Psilocybin-Assisted Therapy for Physician Burnout","This study is looking at Psilocybin-Assisted Therapy (PAT) to help UCSD physicians who are experiencing burnout. PAT combines a single 25 mg dose of psilocybin, a naturally occurring compound, with psychological support. Researchers want to see if this therapy is safe, practical, and can help reduce burnout symptoms. To join, you must be a UCSD faculty physician between 21 and 70 years old, have experienced burnout symptoms for over six months, and not have a history of serious mental illness or substance use disorder. The main goal is to measure changes in your well-being using the Stanford Professional Fulfillment Index (PFI) from when you start until 12 weeks after the study ends. This study is currently unclear on its recruitment status.","Your well-being will be measured from enrollment until 12 weeks after the study ends.",121,"You would participate in preparatory therapy sessions, receive a single dose of psilocybin, and then have post-treatment integration sessions.","Not stated in the trial record.",[],"v2"]