Culture and Well-being: Art as Prescription Therapy ("Art on Prescription") — AoP  

Schizophrenia Clinical Trial

Official title: "Culture and Well-being: Art as Prescription Therapy ("Art on Prescription"), Promoting Social Cohesion and Harnessing the "Silver Economy"

Status Recruiting

Clinical Trial Summary

Cluster randomised controlled trial with two arms: arts intervention (any of the arts interventions, see list), which we call here Active Group (AG) vs waitlist control (WL).

Clinical Trial Description

Design Cluster randomised controlled trial with two arms: arts intervention (any of the arts interventions, see list), which we call here Active Group (AG) vs waitlist control (WL). Clustering will happen at each site.

Invastigators want to measure AG and WL, then WL becomes AG after 3 months and both the initial AG and the WL. AG will be measured in exactly the same way for another 3 months.

AG for 3 months. Then goes into 3 month follow up. WL for 3 months. Then this group receives intervention and becomes AG and has measurements for 3 months as the AG did.

There will be a 2-month break between T3 and T4 due to summer vacation.

In the beginning, an open invitation to institutions of culture and mental health had been sent. Culture institutions i.e. Opera House, Contemporary Art Museum, National Theater etc. presented their action plans for interventional courses. Investigators did the connection between mental health and culture institutions.

Potential participants declared their preference for the interventional course such as dance, cinema etc. and they listed while an external investigator did the blind randomization into AG or WL group.

Frequency of Measurement:

The primary outcome will be measured at time points (for adults):

• T0: (before the randomisation; patient's personal data and demographics)

• T1: (before the start of the intervention for the active group or the entry into the study for the WL group)

• T2: 6 weeks (after the start of the intervention for the active group or the entry into the study for the WL group)

• T3: 12 weeks (after the start of the intervention for the active group or the entry into the study for the WL group) The secondary outcomes will be measured at time points 0 (T4) and 12 weeks (T5) for both AG and WL.

The primary outcome will be measured at time points (for children/adolescents):

• T0: (before the randomisation; patient's personal data and demographics)

• T1: (before the start of the intervention for the active group or the entry into the study for the WL group)

• T3: 12 weeks (after the start of the intervention for the active group or the entry into the study for the WL group) The secondary outcomes will be measured at time points 0 (T4) and 12 weeks (T5) for both AG and WL. ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Autism
• Depressive Disorder
• Emotional Disorder
• Mental Health Issue
• Schizophrenia

• NCT number: NCT06361667
• Study type: Interventional
• Source: University Mental Health Research Institute, Athens, Greece
• Contact: Nikos Stefanis, PhD
• Phone: +30210 6170805
• Email: nistefan@med.uoa.gr
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Completion date: January 15, 2025