This Phase II, single-group trial (n=30) will assess group psilocybin-assisted cognitive behavioural therapy for adults with major depressive disorder, with a focus on acceptability and feasibility, while also exploring effects on depressive symptoms and psychosocial functioning. Participants aged 21 to 60 years with current or past major depressive episodes and active depressive symptoms will receive manualised group cognitive behavioural therapy alongside oral psilocybin. The intervention consists of 12 group PA-CBT sessions and two oral psilocybin administrations, given as a 10mg dose followed by a 25mg dose one month later, with all treatments delivered together in a group format. Primary outcomes include treatment acceptability from baseline to post-treatment, feasibility measured by participant retention, and change on the Hamilton Depression Rating Scale from baseline to the end of the study.
This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.
12 sessions of PA-CBT (as manualized by our research team; Weintraub et al., 2023) and two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later), all of which will be delivered in a group format whereby participants receive the treatments together and simultaneously
Two administrations of psilocybin, administered orally (a 10mg dose followed by a 25mg dose one month later)