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.
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.
Psilocybin-assisted therapy with journaling-supported integration; single 25 mg oral psilocybin dose plus preparatory and integration psychotherapy sessions and home journaling.
25 mg oral psilocybin capsule; paired with three 90-minute prep and three 90-minute integration sessions and home journaling.
Psilocybin-assisted therapy with VR-supported integration; single 25 mg oral psilocybin dose plus preparatory and integration psychotherapy sessions and VR headset for home use.
25 mg oral psilocybin capsule; paired with three 90-minute prep and three 90-minute integration sessions and VR headset for home integration.
Treatment as usual (participants continue with their regular psychotherapist at the partner clinic) and commence experimental PAT after 10 weeks.