An expert panel of 12 builds a 165-item side-effects checklist for MDMA-assisted psychotherapy
- The MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) is described by its authors as the first structured tool for side effects specific to MDMA-assisted psychotherapy; the first author is at the Melbourne School of Psychological Sciences, University of Melbourne, Australia.
- The final version has 165 items in four questionnaires: screening (including potential contraindications), baseline, the day of the medication sessions, and longer-term follow-up.
- The items were selected in a modified two-round online Delphi process. Of 24 experts invited, 12 took part (six in MDMA-assisted psychotherapy research, six in the neuropsychopharmacology of MDMA); 58% were from the USA, 25% from Switzerland and 17% from the UK. Response rates were 83–92% in round 1 and 75% in round 2; the threshold was 80% of votes.
- Of 209 items before round 1, 129 reached consensus to keep, 9 to discard and 71 had no consensus. Round 2 started with 87 items; 29 were included and 58 discarded.
MDMA-assisted psychotherapy is studied in clinical trials, yet the authors note that no measure aimed specifically at its side effects existed. A group led from the University of Melbourne drafted one from a systematic review and existing questionnaires, then put it to an expert panel.
Twelve experts, two rounds
Twenty-four researchers and clinicians were invited and 12 agreed. In a modified Delphi process they voted to keep, discard or modify each item and could suggest new ones. An item was kept or dropped when 80% of the panel voted that way. Of the 209 draft items, 129 were kept at once, 9 were dropped and 71 had no consensus. Together with items split or added on the panel's advice, 87 went to round 2, where 29 were included and 58 discarded. The final tool has 165 items.
The same symptom list, asked at four points
The questionnaires follow the course of treatment. Screening covers relevant medical and psychiatric history, physical examination, clinical investigations such as blood tests and an ECG, current symptoms and vital signs; the authors add that specific contraindications will vary with the protocol. Baseline records physical and psychological symptoms before treatment. The session-day questionnaire repeats the symptoms and adds vital signs, a rating of the acute drug effect, a clinician tolerability rating and a discharge assessment. Follow-up returns to symptoms and vital signs in the weeks and months after the course.
Only the session-day module and the drug-effect rating belong to the protocol. The rest is a pattern a clinic can borrow for any new treatment: record history and physical status as well as diagnosis, put one symptom list to the client before treatment and again afterwards, and ask by checklist. The authors cite the reason for the last point: studies relying on general inquiry or spontaneous reporting risk missing side effects that checklists find.
The tool puts the same symptom questions to the client before treatment, on the day of the sessions and in follow-up – a pattern that does not depend on the drug.
The tool still has to be tested for reliability, validity and sensitivity. Of the 29 items included in round 2, 12 reached the 80% threshold and 17 were retained on the research team's judgement. The session-day questionnaire covers 49 symptoms at several time points, which the authors say may burden participants.