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Pilot investigation of psychedelic-assisted psychotherapy for treatment of post-traumatic stress disorder (PTSD) in people diagnosed with co-occurring borderline personality disorder – a controlled before-and-after study

Not yet recruitingRegisteredANZCTR

This interventional controlled study (n=20) will evaluate GPM-Complex psychotherapy with or without 2–5 MDMA-assisted sessions (initial 80 mg with optional 40 mg supplemental dose) for treating PTSD in individuals with co-occurring BPD.

Details

Participants undergo a six-week pre-treatment module of one-hour weekly individual GPM-Complex sessions for psychoeducation, treatment planning and, for the MDMA arm, preparatory sessions. MDMA sessions are oral, delivered in a dedicated space with two therapists (one psychiatrist prescriber and one DBT-experienced co-therapist) and last up to eight hours.

Between two and five MDMA sessions are offered over a six-month course; dosing is individualised with a standard starting dose of 80 mg plus an optional 40 mg supplemental dose. Post-MDMA integration sessions continue weekly as part of GPM-Complex and outcomes are assessed during treatment and at 3 and 6 months post-discharge.

Comparator participants receive the same GPM-Complex psychotherapy schedule without MDMA. The study focuses on clinical effectiveness and safety within a public mental health service setting.

Topics:PTSD

Registry

Registry linkACTRN12624000871549