Evidence map›Paper›PMID 42114863›Full record

ArticleBMJ open2026

Development of the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET): a Delphi study.

Julia Colcott, Alexandre A Guerin, Olivia Carter, Matthew J Baggott, Anya Bershad, Alicia Danforth, Harriet de Wit, Allison A Feduccia, Matthew G Kirkpatrick, Matthias E Liechti and 3 more

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Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

Who cites it

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No citing paper in PubMed yet.

4 · The record

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5 · Who and what money

Authors and funding

13 authors.

Julia ColcottMelbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Alexandre A GuerinCentre for Youth Mental Health, University of Melbourne, Melbourne, Victoria, Australia.ORCID http://orcid.org/0000-0003-3833-3620
Olivia CarterMelbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Matthew J BaggottTactogen, Inc, Palo Alto, California, USA.
Anya BershadUCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California, USA.
Alicia DanforthThe Lundquist Institute for Biomedical Innovation, Harbor-UCLA Medical Center, Torrance, California, USA.
Harriet de WitDepartment of Psychiatry and Behavioral Neuroscience, The University of Chicago, Chicago, Illinois, USA.
Allison A FeducciaDepartment of Research Development, MAPS Public Benefit Corp, Santa Cruz, California, USA.
Matthew G KirkpatrickUniversity of Southern California Keck School of Medicine, Los Angeles, California, USA.
Matthias E LiechtiDepartment of Clinical Research, University Hospital Basel, Basel, Switzerland.
Peter OehenPrivate Practice of Psychiatry and Psychotherapy, Biberist, Switzerland.
Yasmin SchmidDepartment of Clinical Research, University Hospital Basel, Basel, Switzerland.
Gillinder BediCentre for Youth Mental Health, University of Melbourne, Melbourne, Victoria, Australia gill.bedi@unimelb.edu.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite 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.

objectiveOur aim was to develop an MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) to capture side effects over the course of MDMA-AP.

methodsInformed 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.

findingsTwelve experts consented to participate over two rounds of Delphi panel deliberations (response rate: Round 1 = 83-92%, 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.

conclusionsThe 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. CLINICAL IMPLICATIONS: 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.

Indexed as

HallucinogensN-Methyl-3,4-methylenedioxyamphetaminePsychotherapyDelphi TechniqueHumansSurveys and QuestionnairesHallucinogensN-Methyl-3,4-methylenedioxyamphetamineAdult psychiatryAdverse eventsPSYCHIATRY

Identifiers

PMID42114863
PMCPMC13182389

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.