Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial

The psychological morbidity experienced by physicians, advanced practice practitioners (APPs), and nurses from working during the COVID-19 pandemic includes burnout, depression, and posttraumatic stress disorder (PTSD). To investigate whether psilocybin therapy could improve symptoms of depression,...

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Veröffentlicht in:JAMA network open 2024-12, Vol.7 (12), p.e2449026
Hauptverfasser: Back, Anthony L, Freeman-Young, Timara K, Morgan, Ladybird, Sethi, Tanmeet, Baker, Kelsey K, Myers, Susanna, McGregor, Bonnie A, Harvey, Kalin, Tai, Marlene, Kollefrath, Austin, Thomas, Brandon J, Sorta, Dennis, Kaelen, Mendel, Kelmendi, Benjamin, Gooley, Ted A
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container_issue 12
container_start_page e2449026
container_title JAMA network open
container_volume 7
creator Back, Anthony L
Freeman-Young, Timara K
Morgan, Ladybird
Sethi, Tanmeet
Baker, Kelsey K
Myers, Susanna
McGregor, Bonnie A
Harvey, Kalin
Tai, Marlene
Kollefrath, Austin
Thomas, Brandon J
Sorta, Dennis
Kaelen, Mendel
Kelmendi, Benjamin
Gooley, Ted A
description The psychological morbidity experienced by physicians, advanced practice practitioners (APPs), and nurses from working during the COVID-19 pandemic includes burnout, depression, and posttraumatic stress disorder (PTSD). To investigate whether psilocybin therapy could improve symptoms of depression, burnout, and PTSD in US clinicians who developed these symptoms from frontline clinical work during the pandemic. This double-blind randomized clinical trial enrolled participants from February to December 2022. Participants included physicians, APPs, and nurses who provided frontline care for more than 1 month during the pandemic and had no prepandemic mental health diagnoses but had moderate or severe symptoms of depression at enrollment. Participants were randomly assigned to either the psilocybin or niacin arm. Data analysis was conducted between December 2023 and May 2024 and was based on the intention-to-treat principle. One intervention episode consisted of 2 preparation visits, 1 medication session, and 3 integration visits. At the medication session, participants received psilocybin, 25 mg, or niacin, 100 mg, orally. The primary outcome was a change from baseline (preparation 1 session) to day 28 (after medication administration) in symptoms of depression as measured by the clinician-administered Montgomery-Asberg Depression Rating Scale (MADRS) used by blinded raters. The secondary outcomes were a change in symptoms of burnout (measured with the Stanford Professional Fulfillment Index [SPFI]) and symptoms of PTSD (measured with the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [PCL-5]). A total of 30 clinicians (15 females [50%]; mean [range] age, 38 [29-60] years) participated, of whom 15 were randomly assigned to receive psilocybin and 15 to receive niacin. The mean change in symptoms of depression (MADRS scores) from preparation 1 session to day 28 was -21.33 (7.84) in the psilocybin arm compared with -9.33 (7.32) in the niacin arm, with a mean difference between arms of -12.00 (95% CI, -17.67 to -6.33; P 
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To investigate whether psilocybin therapy could improve symptoms of depression, burnout, and PTSD in US clinicians who developed these symptoms from frontline clinical work during the pandemic. This double-blind randomized clinical trial enrolled participants from February to December 2022. Participants included physicians, APPs, and nurses who provided frontline care for more than 1 month during the pandemic and had no prepandemic mental health diagnoses but had moderate or severe symptoms of depression at enrollment. Participants were randomly assigned to either the psilocybin or niacin arm. Data analysis was conducted between December 2023 and May 2024 and was based on the intention-to-treat principle. One intervention episode consisted of 2 preparation visits, 1 medication session, and 3 integration visits. At the medication session, participants received psilocybin, 25 mg, or niacin, 100 mg, orally. The primary outcome was a change from baseline (preparation 1 session) to day 28 (after medication administration) in symptoms of depression as measured by the clinician-administered Montgomery-Asberg Depression Rating Scale (MADRS) used by blinded raters. The secondary outcomes were a change in symptoms of burnout (measured with the Stanford Professional Fulfillment Index [SPFI]) and symptoms of PTSD (measured with the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [PCL-5]). A total of 30 clinicians (15 females [50%]; mean [range] age, 38 [29-60] years) participated, of whom 15 were randomly assigned to receive psilocybin and 15 to receive niacin. The mean change in symptoms of depression (MADRS scores) from preparation 1 session to day 28 was -21.33 (7.84) in the psilocybin arm compared with -9.33 (7.32) in the niacin arm, with a mean difference between arms of -12.00 (95% CI, -17.67 to -6.33; P &lt; .001), a decrease in MADRS scores indicating improvement. The mean change in SPFI scores from preparation 1 session to day 28 showed a numerically larger improvement in symptoms of burnout in the psilocybin compared with the niacin arm (-6.40 [5.00] vs -2.33 [5.97]; P = .05) but was not statistically significant. Since the SPFI score change did not reach statistical significance, the PCL-5 score change was evaluated descriptively. The mean change in PCL-5 scores showed a numerically larger decrease in symptoms of PTSD from preparation 1 session to day 28 in the psilocybin vs the niacin arm (-16.67 [15.04] vs -6.73 [10.69]), but this difference was not statistically tested. This randomized clinical trial found that psilocybin therapy resulted in a significant, sustained reduction in symptoms of depression experienced by clinicians after frontline work during the COVID-19 pandemic. The findings establish psilocybin therapy as a new paradigm of treatment for this postpandemic condition. ClinicalTrials.gov Identifier: NCT05163496.</description><identifier>ISSN: 2574-3805</identifier><identifier>EISSN: 2574-3805</identifier><identifier>DOI: 10.1001/jamanetworkopen.2024.49026</identifier><identifier>PMID: 39636638</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Adult ; Burnout, Professional - drug therapy ; COVID-19 - psychology ; Depression - drug therapy ; Double-Blind Method ; Female ; Hallucinogens - therapeutic use ; Humans ; Male ; Middle Aged ; Online Only ; Original Investigation ; Pandemics ; Psilocybin - therapeutic use ; Psychiatry ; SARS-CoV-2 ; Stress Disorders, Post-Traumatic - drug therapy ; Treatment Outcome</subject><ispartof>JAMA network open, 2024-12, Vol.7 (12), p.e2449026</ispartof><rights>Copyright 2024 Back AL et al. .</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,864,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39636638$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Back, Anthony L</creatorcontrib><creatorcontrib>Freeman-Young, Timara K</creatorcontrib><creatorcontrib>Morgan, Ladybird</creatorcontrib><creatorcontrib>Sethi, Tanmeet</creatorcontrib><creatorcontrib>Baker, Kelsey K</creatorcontrib><creatorcontrib>Myers, Susanna</creatorcontrib><creatorcontrib>McGregor, Bonnie A</creatorcontrib><creatorcontrib>Harvey, Kalin</creatorcontrib><creatorcontrib>Tai, Marlene</creatorcontrib><creatorcontrib>Kollefrath, Austin</creatorcontrib><creatorcontrib>Thomas, Brandon J</creatorcontrib><creatorcontrib>Sorta, Dennis</creatorcontrib><creatorcontrib>Kaelen, Mendel</creatorcontrib><creatorcontrib>Kelmendi, Benjamin</creatorcontrib><creatorcontrib>Gooley, Ted A</creatorcontrib><title>Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial</title><title>JAMA network open</title><addtitle>JAMA Netw Open</addtitle><description>The psychological morbidity experienced by physicians, advanced practice practitioners (APPs), and nurses from working during the COVID-19 pandemic includes burnout, depression, and posttraumatic stress disorder (PTSD). To investigate whether psilocybin therapy could improve symptoms of depression, burnout, and PTSD in US clinicians who developed these symptoms from frontline clinical work during the pandemic. This double-blind randomized clinical trial enrolled participants from February to December 2022. Participants included physicians, APPs, and nurses who provided frontline care for more than 1 month during the pandemic and had no prepandemic mental health diagnoses but had moderate or severe symptoms of depression at enrollment. Participants were randomly assigned to either the psilocybin or niacin arm. Data analysis was conducted between December 2023 and May 2024 and was based on the intention-to-treat principle. One intervention episode consisted of 2 preparation visits, 1 medication session, and 3 integration visits. At the medication session, participants received psilocybin, 25 mg, or niacin, 100 mg, orally. The primary outcome was a change from baseline (preparation 1 session) to day 28 (after medication administration) in symptoms of depression as measured by the clinician-administered Montgomery-Asberg Depression Rating Scale (MADRS) used by blinded raters. The secondary outcomes were a change in symptoms of burnout (measured with the Stanford Professional Fulfillment Index [SPFI]) and symptoms of PTSD (measured with the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [PCL-5]). A total of 30 clinicians (15 females [50%]; mean [range] age, 38 [29-60] years) participated, of whom 15 were randomly assigned to receive psilocybin and 15 to receive niacin. The mean change in symptoms of depression (MADRS scores) from preparation 1 session to day 28 was -21.33 (7.84) in the psilocybin arm compared with -9.33 (7.32) in the niacin arm, with a mean difference between arms of -12.00 (95% CI, -17.67 to -6.33; P &lt; .001), a decrease in MADRS scores indicating improvement. The mean change in SPFI scores from preparation 1 session to day 28 showed a numerically larger improvement in symptoms of burnout in the psilocybin compared with the niacin arm (-6.40 [5.00] vs -2.33 [5.97]; P = .05) but was not statistically significant. Since the SPFI score change did not reach statistical significance, the PCL-5 score change was evaluated descriptively. The mean change in PCL-5 scores showed a numerically larger decrease in symptoms of PTSD from preparation 1 session to day 28 in the psilocybin vs the niacin arm (-16.67 [15.04] vs -6.73 [10.69]), but this difference was not statistically tested. This randomized clinical trial found that psilocybin therapy resulted in a significant, sustained reduction in symptoms of depression experienced by clinicians after frontline work during the COVID-19 pandemic. The findings establish psilocybin therapy as a new paradigm of treatment for this postpandemic condition. ClinicalTrials.gov Identifier: NCT05163496.</description><subject>Adult</subject><subject>Burnout, Professional - drug therapy</subject><subject>COVID-19 - psychology</subject><subject>Depression - drug therapy</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Hallucinogens - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Online Only</subject><subject>Original Investigation</subject><subject>Pandemics</subject><subject>Psilocybin - therapeutic use</subject><subject>Psychiatry</subject><subject>SARS-CoV-2</subject><subject>Stress Disorders, Post-Traumatic - drug therapy</subject><subject>Treatment Outcome</subject><issn>2574-3805</issn><issn>2574-3805</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUU1LxDAUDKKoqH9BgicvXd9L2uzWi8iuXyAouuqxpG3iRpukJl1l_Qv-aSuuopc3M7xh5jCE7CEMEAAPnqSVTnVvPjz7VrkBA5YO0hyYWCGbLBumCR9BtvqHb5CdGJ8AgAHyXGTrZKMHLgQfbZKP62gaXy1K4-h0poJsF1T7QMeNcaYy0kX6YLoZvV3YtvM2Uq_pRLVBxWi8o6fB26_jut6v6FgGRSfzYNwj7Wa9vrq_mCSY02vpamVNdUiP6U3PvTXvql62yIZOg5HNNlnTsolqZ4lb5O70ZDo-Ty6vzi7Gx5eJZCi6BHmmoExLrXMccpZVwGsYatSyFKnmrK45yyFlUCPmPBuOkDGBFao8BV1pwbfI0XduOy-tqivluiCbog3GyrAovDTF_48zs-LRvxaIgmE-4n3C_jIh-Je5il1hTaxU0_TT-HksOKYi4yDwy7r7t-y35WcC_gnTOo8Y</recordid><startdate>20241202</startdate><enddate>20241202</enddate><creator>Back, Anthony L</creator><creator>Freeman-Young, Timara K</creator><creator>Morgan, Ladybird</creator><creator>Sethi, Tanmeet</creator><creator>Baker, Kelsey K</creator><creator>Myers, Susanna</creator><creator>McGregor, Bonnie A</creator><creator>Harvey, Kalin</creator><creator>Tai, Marlene</creator><creator>Kollefrath, Austin</creator><creator>Thomas, Brandon J</creator><creator>Sorta, Dennis</creator><creator>Kaelen, Mendel</creator><creator>Kelmendi, Benjamin</creator><creator>Gooley, Ted A</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20241202</creationdate><title>Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial</title><author>Back, Anthony L ; Freeman-Young, Timara K ; Morgan, Ladybird ; Sethi, Tanmeet ; Baker, Kelsey K ; Myers, Susanna ; McGregor, Bonnie A ; Harvey, Kalin ; Tai, Marlene ; Kollefrath, Austin ; Thomas, Brandon J ; Sorta, Dennis ; Kaelen, Mendel ; Kelmendi, Benjamin ; Gooley, Ted A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a216t-135e0b4bff917325c03d07f1fab64f32dd3290420d119357812261c1e940fcf63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Burnout, Professional - drug therapy</topic><topic>COVID-19 - psychology</topic><topic>Depression - drug therapy</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Hallucinogens - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Online Only</topic><topic>Original Investigation</topic><topic>Pandemics</topic><topic>Psilocybin - therapeutic use</topic><topic>Psychiatry</topic><topic>SARS-CoV-2</topic><topic>Stress Disorders, Post-Traumatic - drug therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Back, Anthony L</creatorcontrib><creatorcontrib>Freeman-Young, Timara K</creatorcontrib><creatorcontrib>Morgan, Ladybird</creatorcontrib><creatorcontrib>Sethi, Tanmeet</creatorcontrib><creatorcontrib>Baker, Kelsey K</creatorcontrib><creatorcontrib>Myers, Susanna</creatorcontrib><creatorcontrib>McGregor, Bonnie A</creatorcontrib><creatorcontrib>Harvey, Kalin</creatorcontrib><creatorcontrib>Tai, Marlene</creatorcontrib><creatorcontrib>Kollefrath, Austin</creatorcontrib><creatorcontrib>Thomas, Brandon J</creatorcontrib><creatorcontrib>Sorta, Dennis</creatorcontrib><creatorcontrib>Kaelen, Mendel</creatorcontrib><creatorcontrib>Kelmendi, Benjamin</creatorcontrib><creatorcontrib>Gooley, Ted A</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>JAMA network open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Back, Anthony L</au><au>Freeman-Young, Timara K</au><au>Morgan, Ladybird</au><au>Sethi, Tanmeet</au><au>Baker, Kelsey K</au><au>Myers, Susanna</au><au>McGregor, Bonnie A</au><au>Harvey, Kalin</au><au>Tai, Marlene</au><au>Kollefrath, Austin</au><au>Thomas, Brandon J</au><au>Sorta, Dennis</au><au>Kaelen, Mendel</au><au>Kelmendi, Benjamin</au><au>Gooley, Ted A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial</atitle><jtitle>JAMA network open</jtitle><addtitle>JAMA Netw Open</addtitle><date>2024-12-02</date><risdate>2024</risdate><volume>7</volume><issue>12</issue><spage>e2449026</spage><pages>e2449026-</pages><issn>2574-3805</issn><eissn>2574-3805</eissn><abstract>The psychological morbidity experienced by physicians, advanced practice practitioners (APPs), and nurses from working during the COVID-19 pandemic includes burnout, depression, and posttraumatic stress disorder (PTSD). To investigate whether psilocybin therapy could improve symptoms of depression, burnout, and PTSD in US clinicians who developed these symptoms from frontline clinical work during the pandemic. This double-blind randomized clinical trial enrolled participants from February to December 2022. Participants included physicians, APPs, and nurses who provided frontline care for more than 1 month during the pandemic and had no prepandemic mental health diagnoses but had moderate or severe symptoms of depression at enrollment. Participants were randomly assigned to either the psilocybin or niacin arm. Data analysis was conducted between December 2023 and May 2024 and was based on the intention-to-treat principle. One intervention episode consisted of 2 preparation visits, 1 medication session, and 3 integration visits. At the medication session, participants received psilocybin, 25 mg, or niacin, 100 mg, orally. The primary outcome was a change from baseline (preparation 1 session) to day 28 (after medication administration) in symptoms of depression as measured by the clinician-administered Montgomery-Asberg Depression Rating Scale (MADRS) used by blinded raters. The secondary outcomes were a change in symptoms of burnout (measured with the Stanford Professional Fulfillment Index [SPFI]) and symptoms of PTSD (measured with the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [PCL-5]). A total of 30 clinicians (15 females [50%]; mean [range] age, 38 [29-60] years) participated, of whom 15 were randomly assigned to receive psilocybin and 15 to receive niacin. The mean change in symptoms of depression (MADRS scores) from preparation 1 session to day 28 was -21.33 (7.84) in the psilocybin arm compared with -9.33 (7.32) in the niacin arm, with a mean difference between arms of -12.00 (95% CI, -17.67 to -6.33; P &lt; .001), a decrease in MADRS scores indicating improvement. The mean change in SPFI scores from preparation 1 session to day 28 showed a numerically larger improvement in symptoms of burnout in the psilocybin compared with the niacin arm (-6.40 [5.00] vs -2.33 [5.97]; P = .05) but was not statistically significant. Since the SPFI score change did not reach statistical significance, the PCL-5 score change was evaluated descriptively. The mean change in PCL-5 scores showed a numerically larger decrease in symptoms of PTSD from preparation 1 session to day 28 in the psilocybin vs the niacin arm (-16.67 [15.04] vs -6.73 [10.69]), but this difference was not statistically tested. This randomized clinical trial found that psilocybin therapy resulted in a significant, sustained reduction in symptoms of depression experienced by clinicians after frontline work during the COVID-19 pandemic. The findings establish psilocybin therapy as a new paradigm of treatment for this postpandemic condition. ClinicalTrials.gov Identifier: NCT05163496.</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>39636638</pmid><doi>10.1001/jamanetworkopen.2024.49026</doi><oa>free_for_read</oa></addata></record>
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subjects Adult
Burnout, Professional - drug therapy
COVID-19 - psychology
Depression - drug therapy
Double-Blind Method
Female
Hallucinogens - therapeutic use
Humans
Male
Middle Aged
Online Only
Original Investigation
Pandemics
Psilocybin - therapeutic use
Psychiatry
SARS-CoV-2
Stress Disorders, Post-Traumatic - drug therapy
Treatment Outcome
title Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial
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