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"Culture and Well-being: Art as Prescription Therapy ("Art on Prescription"), Promoting Social Cohesion and Harnessing the "Silver Economy"
Stratified 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).
Design: Stratified 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). Stratifying 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.
Age
10 - 99 years
Sex
ALL
Healthy Volunteers
Yes
Eleni Kavadia
Athens, Greece
Start Date
March 20, 2024
Primary Completion Date
December 19, 2024
Completion Date
December 19, 2024
Last Updated
October 1, 2025
382
ACTUAL participants
Arts
OTHER
Lead Sponsor
KAVADIA ELENI
NCT07485673
NCT07115329
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06793397