{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T15:54:10Z","timestamp":1782489250508,"version":"3.54.5"},"reference-count":27,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T00:00:00Z","timestamp":1778457600000},"content-version":"unspecified","delay-in-days":10,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015539","name":"Australian Government","doi-asserted-by":"publisher","award":["MRF2010957"],"award-info":[{"award-number":["MRF2010957"]}],"id":[{"id":"10.13039\/100015539","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,2,25]]},"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Despite growing interest in the therapeutic potential of 3,4-methylenedioxymethamphetamine (MDMA), no targeted measure to systematically assess side effects of MDMA-assisted psychotherapy (MDMA-AP) exists.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Our aim was to develop an MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) to capture side effects over the course of MDMA-AP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Informed by a systematic review and a review of other relevant questionnaires, we drafted a list of potential side effects. Face and content validation were obtained via a modified two-round online Delphi process involving experts in MDMA-AP and the neuropsychopharmacology of MDMA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Findings<\/jats:title>\n                    <jats:p>Twelve experts consented to participate over two rounds of Delphi panel deliberations (response rate: Round 1 = 83\u201392%, Round 2 = 75%). The Delphi panellists were asked to keep, discard, modify or suggest additional items. The final version of the M-SET consists of 165 items across four questionnaires that collect information at screening, baseline, the day of medication sessions and longer term follow-up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The use of a modified Delphi technique proved a successful method to generate content for the first structured tool designed to evaluate side effects specifically associated with MDMA-AP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical implications<\/jats:title>\n                    <jats:p>The M-SET is recommended for use in both research and clinical settings. Its implementation has the potential to improve the safety of delivering MDMA-AP as well as support the development of a more systematic and robust evidence base on its safety and tolerability.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-105630","type":"journal-article","created":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T12:35:10Z","timestamp":1778502910000},"page":"e105630","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Development of the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET): a Delphi study"],"prefix":"10.1136","volume":"16","author":[{"given":"Julia","family":"Colcott","sequence":"first","affiliation":[{"name":"Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3833-3620","authenticated-orcid":false,"given":"Alexandre A","family":"Guerin","sequence":"additional","affiliation":[{"name":"Centre for Youth Mental Health, University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Orygen, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Carter","sequence":"additional","affiliation":[{"name":"Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J","family":"Baggott","sequence":"additional","affiliation":[{"name":"Tactogen, Inc, Palo Alto, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anya","family":"Bershad","sequence":"additional","affiliation":[{"name":"UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia","family":"Danforth","sequence":"additional","affiliation":[{"name":"The Lundquist Institute for Biomedical Innovation, Harbor-UCLA Medical Center, Torrance, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harriet","family":"de Wit","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Neuroscience, The University of Chicago, Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison A","family":"Feduccia","sequence":"additional","affiliation":[{"name":"Department of Research Development, MAPS Public Benefit Corp, Santa Cruz, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew G","family":"Kirkpatrick","sequence":"additional","affiliation":[{"name":"University of Southern California Keck School of Medicine, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias E","family":"Liechti","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, University Hospital Basel, Basel, Switzerland"},{"name":"Division of Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland"},{"name":"Department of Biomedicine, University of Basel, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Oehen","sequence":"additional","affiliation":[{"name":"Private Practice of Psychiatry and Psychotherapy, Biberist, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasmin","family":"Schmid","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, University Hospital Basel, Basel, Switzerland"},{"name":"Division of Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland"},{"name":"Department of Biomedicine, University of Basel, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gillinder","family":"Bedi","sequence":"additional","affiliation":[{"name":"Centre for Youth Mental Health, University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Orygen, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,5,11]]},"reference":[{"key":"2026062608321555000_16.5.e105630.1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-023-02565-4"},{"key":"2026062608321555000_16.5.e105630.2","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-021-01336-3"},{"key":"2026062608321555000_16.5.e105630.3","unstructured":"Therapeutic Goods Administration . 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