Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361667
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-26
Brief Title:
Culture and Well-being Art as Prescription Therapy Art on Prescription
Sponsor:
KAVADIA ELENI
Organization:
University Mental Health Research Institute Athens Greece
Study Overview
Official Title:
Culture and Well-being Art as Prescription Therapy Art on Prescription Promoting Social Cohesion and Harnessing the Silver Economy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AoP
Brief 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 ie 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 patients 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 childrenadolescents
T0 before the randomisation patients 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
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 ie 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 patients 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 childrenadolescents
T0 before the randomisation patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None