Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence (PsiPTSD)
This quadruple-blind, randomised controlled trial (n=76) will study the effects of psilocybin (25mg or 1mg) combined with Acceptance and Commitment Therapy (ACT) in adult survivors of intimate partner violence (IPV) with post-traumatic stress disorder (PTSD).
Details
Randomised, quadruple-blind, parallel-group Phase II trial comparing a single therapeutic psilocybin dose (25 mg) versus a low-dose active comparator (1 mg), each given 24 hours before the first ACT session, in IPV survivors with chronic PTSD (n=76).
All participants receive 5–6 weekly ACT sessions after dosing; outcomes include PCL-5 and CAPS-5 as primary efficacy measures, with secondary assessment of mood, anxiety, cognitive function, motor ability, quality of life and exploratory blood biomarkers.
Assessments occur at baseline, 1 week, 4 weeks, 3 months (PCL-5 only online) and 6 months post-dosing; allocation is 1:1 with blocked randomisation and central pharmacy blinding procedures.