Clinical Trials Directory

Trials / Completed

CompletedNCT06361667

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
382 (actual)
Sponsor
KAVADIA ELENI · Academic / Other
Sex
All
Age
10 Years – 99 Years
Healthy volunteers
Accepted

Summary

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).

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERArtsArts (music, cinema, dance).

Timeline

Start date
2024-03-20
Primary completion
2024-12-19
Completion
2024-12-19
First posted
2024-04-12
Last updated
2025-10-01

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT06361667. Inclusion in this directory is not an endorsement.