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Objective: Arts engagement has been proposed as a scalable adjunct to psychiatric care, but high-quality randomized evidence amongst psychiatric populations remains limited. This study evaluated the efficacy of arts on prescription (AoP) added to care as usual (CAU) on mental health outcomes amongst adults receiving community psychiatric care.Methods: We conducted two sequential 12-week parallel-group randomized controlled trials in Greece: a pilot (N=380) and a confirmatory trial (N=541). Adults receiving psychiatric care were referred by mental health professionals and randomized to AoP plus CAU or CAU alone. The intervention involved participation in structured arts activities (music, dance, cinema, storytelling, theatre, environmental and visual arts). Depression symptom score (Patient Health Questionnaire-9 [PHQ-9]) at 12 weeks was a primary outcome across both trials. Secondary outcomes included anxiety (GAD-7), wellbeing (WEMWBS), and loneliness. Analyses used intention-to-treat linear mixed-effects models.Results: Across both trials (N=921), AoP was associated with greater reductions in depression symptoms compared with CAU. In the pilot and the main trial, the between-group difference at 12 weeks were -1.91 PHQ-9 points (95% CI=-3.09 to -0.72; p= 0.001) and -0.97 (95% CI= -1.89 to -0.06; p= 0.001), respectively. Significant improvements were also observed for anxiety and wellbeing, but not loneliness. Attrition was modest (15.7% - 18.7%), and no serious adverse events attributable to the intervention were reported. Conclusions: AoP added to CAU produced consistent improvements in depression, anxiety, and wellbeing across two randomized trials. These findings support AoP as a scalable, person-centered adjunct within community mental health services.
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