Overview
Youth mental illness rates have risen steadily internationally, creating a need for new, disease-modifying treatments. Autistic youth are particularly vulnerable, with high rates of mental illness, especially social anxiety. Social anxiety compounds the core features of autism, leading to greater disability and psychological distress. First-line psychological and pharmacological treatments are ineffective for many young autistic people, highlighting the need for new intervention approaches. A preliminary trial indicated that a novel treatment approach using MDMA-assisted psychotherapy was well tolerated and reduced social anxiety in autistic adults, supporting evaluation during the critical transition to adulthood.
The PAPAYA study is a triple blind, multisite, superiority randomised controlled trial assessing whether MDMA-assisted psychotherapy reduces social anxiety and increases wellbeing, including self-compassion and openness to experience, compared to inert and active (dexamphetamine, lorazepam, and diphenhydramine) placebo conditions in autistic youth with social anxiety disorder (16-25 years old; n=156). Following screening and baseline assessment, participants receive three months of treatment comprising three preparation sessions, two medication sessions delivered four weeks apart and eight integration sessions, using a manualised cognitive behaviour therapy adapted for autistic youth. Assessments are conducted at weeks 6, 10 and 12, and at 6 and 12 months. The primary endpoint is change from baseline in interviewer-rated social anxiety at week 12 measured with the Leibowitz Social Anxiety Scale. Secondary endpoints include changes from baseline in neuroticism, open-mindedness, self-compassion, and social cognition and motivation.
Findings from this trial could establish a new treatment approach for social anxiety in autistic young people, a common and highly distressing condition for which effective treatment options remain limited.