Clinical trial NCT06361667: Culture and Well-being: Art as Prescription Therapy ("Art on Prescription")
Official title: "Culture and Well-being: Art as Prescription Therapy ("Art on Prescription"), Promoting Social Cohesion and Harnessing the "Silver Economy"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Anxiety Disorders
Depressive Disorder
Emotional Disorder
Schizophrenia
Autism
Lead sponsor: University Mental Health Research Institute, Athens, Greece
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 384
Sex: ALL
Minimum age (years): 10
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will follow standard practice for RCTs and apply an ANCOVA model to estimate the effects of treatment. The formalism is:

y \~ b0 + b1xtreatment_group + b2xtime + b3xtreatment_groupxtime + covariates (1)

Where, y is each outcome, b1-b3 are the regression coefficients and covariates denotes covariates at randomisation (DETERMINE)

The inference of interest for the model concerns b3, the interaction term, as we posit that there will be a difference in slopes between the treatment groups.

The inference is going to happen via an estimation of the t-statistic, defined as follows"

t = b3/SE (2)

Where SE is the standard error for coefficient b3

t \> 1.96 (3)

And 1.96 is the critical value for statistical significance at alpha = 0.05.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
timeFrame: 3 months
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 months
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: 3 months
Secondary outcomes:
measure: UCLA 3-item Loneliness Scale
timeFrame: 3 months
measure: The Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eleni Kavadia
Study officials:
affiliation: University Mental Health Research Institute, Athens, Greece
name: Nikos Stefanis, PhD
role: PRINCIPAL_INVESTIGATOR
References: