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Development of the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET): a Delphi study
Julia Colcott1, Alexandre A Guerin2,3, Olivia Carter1
1Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia.
Background:
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.
Objective:
Our aim was to develop an MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) to capture side effects over the course of MDMA-AP.
Methods:
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.
Findings:
Twelve 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.
Conclusions:
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.
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.
Insights
Researchers developed the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) to systematically assess adverse events during MDMA-assisted psychotherapy. This new tool aids in improving patient safety and gathering robust evidence on MDMA-AP tolerability.
Area of Science:
- Psychopharmacology
- Clinical Psychology
- Therapeutic Innovation
Background:
- Growing interest in the therapeutic potential of 3,4-methylenedioxymethamphetamine (MDMA).
- Lack of a systematic tool to assess side effects of MDMA-assisted psychotherapy (MDMA-AP).
Purpose of the Study:
- To develop the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET).
- To capture and evaluate side effects throughout the course of MDMA-AP.
Main Methods:
- Systematic review and questionnaire review to draft potential side effects.
- Modified two-round online Delphi process with 12 experts in MDMA-AP and neuropsychopharmacology for validation.
- Expert consensus achieved through Delphi panel deliberations.
Main Results:
- The final M-SET includes 165 items across four distinct questionnaires.
- Information is collected at screening, baseline, medication sessions, and long-term follow-up.
- High expert participation rates in both rounds of the Delphi process (Round 1: 83-92%, Round 2: 75%).
Conclusions:
- The modified Delphi technique successfully generated content for the first structured tool for MDMA-AP side effects.
- The M-SET is recommended for research and clinical use to enhance MDMA-AP safety.
- Implementation of M-SET can support a robust evidence base for MDMA-AP safety and tolerability.
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