The efficacy of psilocybin assisted psychotherapy (PAP) for treatment resistant obsessive-compulsive disorder (OCD), body dysmorphic disorder (BDD), and anorexia nervosa (AN); a pilot, single-arm basket trial
This single-arm, Phase I/II pilot trial (n=30) will test psilocybin-assisted psychotherapy (25mg x 2 doses, 4 weeks apart) for treatment-resistant obsessive-compulsive disorder (OCD), body dysmorphic disorder (BDD), and anorexia nervosa (AN).
Details
Open-label, non-randomised single-arm pilot enrolling adults with treatment-resistant OCD, BDD or AN to receive two oral psilocybin doses (25 mg) four weeks apart paired with structured psychotherapy.
Therapy delivered by a therapist dyad includes preparation (1–2 sessions, ≈3 hours total), non-directive support during 8-hour dosing sessions, and two integration sessions after each dose (four total); sessions predominantly face-to-face with limited online option for the second integration.
Primary outcomes assess disorder-specific symptom severity (YBOCS, BDD-YBOCS, EDE) at baseline and 8 weeks post-baseline with safety monitoring per protocol.