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

KAVADIA ELENI

Status: Enrolling

Conditions: Emotional Disorder; Schizophrenia; Mental Health Issue; Anxiety Disorders; Autism; Depressive Disorder

Treatments: Other: Arts

Study type: Interventional

Funder types: Other

Identifiers

NCT06361667

1/02.02.2024

Details and patient eligibility

About

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).

Full 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.

Enrollment: 384 estimated patients

Sex: All

Ages: 10 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age range: 10-99 years
• be able to communicate effectively in order to provide answers to questionnaires that he/she will be asked to complete
• be able to commit to monitoring the action
• be able to participate in the activity alone (unaccompanied, without a carer),
• be able to answer the questionnaires
• to have legal capacity

Exclusion criteria

• active dependency,
• patients that are not consistent in following pharmaceutical drugs,
• patients from different Patient Association which is not "affiliated" with a Mental Health Professional Therapist.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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384 participants in 2 patient groups, including a placebo group

Active Group (AG)

Experimental group

Description:

This arm will receive the arts intervention (any of the arts interventions).

Treatment:

Other: Arts

Waitlist Control (WL)

Placebo Comparator group

Description:

This arm will be the waitlist control and after 3 months it will be active.

Treatment:

Other: Arts