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

Last updated: September 24, 2025
Sponsor: KAVADIA ELENI
Overall Status: Completed

Phase

N/A

Condition

Autism

Panic Disorders

Tourette's Syndrome

Treatment

Arts

Clinical Study ID

NCT06361667
1/02.02.2024
  • Ages 10-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age range: 10-99 years

  • be able to communicate effectively in order to provide answers to questionnairesthat 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

Exclusion Criteria:

  • active dependency,

  • patients that are not consistent in following pharmaceutical drugs,

  • patients from different Patient Association which is not "affiliated" with a MentalHealth Professional Therapist.

Study Design

Total Participants: 382
Treatment Group(s): 1
Primary Treatment: Arts
Phase:
Study Start date:
March 20, 2024
Estimated Completion Date:
December 19, 2024

Study 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.

Connect with a study center

  • Eleni Kavadia

    Athens,
    Greece

    Site Not Available

  • Eleni Kavadia

    Athens 264371,
    Greece

    Site Not Available

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