Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT06361667
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 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.
Study:
NCT06361667
Study Brief:
Protocol Section:
NCT06361667