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

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.