FIFO-PAT-20: A sequential multiple assignment randomised controlled trial comparing the efficacy and safety of treatment as usual against a Fly-In-Fly-Out (FIFO) model of Psilocybin-Assisted Therapy (PAT) for Major Depressive Disorder (MDD), alongside randomised adjunctive support (virtual-reality vs journalling)
This open-label, randomised controlled Phase II trial (n=30) will test a six-week Fly-In-Fly-Out Psilocybin-Assisted Therapy (FIFO-PAT) programme for major depressive disorder (MDD), using a single 25 mg oral dose of psilocybin alongside psychotherapy and either a virtual-reality (VR) integration tool or journaling.
Details
Randomised, parallel-group Phase II study comparing a Fly-In-Fly-Out psilocybin-assisted therapy programme (single 25 mg oral dose plus preparatory and integration psychotherapy) with a waitlist treatment-as-usual control; participants are randomised to PAT+journaling, PAT+VR, or waitlist, with waitlist participants offered PAT after 10 weeks.
Intervention includes three 90-minute preparatory sessions, one dosing session (25 mg psilocybin capsule) and three 90-minute integration sessions; home integration supported by a VR environment (15 minutes, 3–4× weekly suggested) or a reflective journal. Therapists are PAT-trained and receive ongoing supervision.