Arts-based Social Prescribing for Mental Health in Adults With Psychiatric Diagnoses
Phase: NA
Conditions: Mental Health Issue, Anxiety Disorders, Affective Disorders, Affective Disorders, Psychotic, Psychotic Disorder, Adjustment Disorder, Autism Spectrum Disorder, Mild Cognitive Impairment, Depression Disorders, Schizophrenia Disorders
Sponsor: KAVADIA ELENI

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Arts-based Social Prescribing for Mental Health in Adults with Psychiatric 
Diagnoses. (AoP-II) 
 
 
NCT ID: NCT07137572 
Document date: August 23, 2025 
 
 
 
 
Study Protocol  
 

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Organization's Unique Protocol ID: AoP-II 
Brief Title: Arts-based Social Prescribing for Mental Health 
Acronym: AoP-II 
Study Type: Interventional 
Official Title: Arts-based Social Prescribing for Mental Health in Adults With Psychiatric 
Diagnoses 
 
Record Verification Date: August 2025 
Study Start Date: September 2025, Anticipated 
Primary Completion Date: January 2026, Anticipated 
Study Completion Date: January 2026, Anticipated 
 
Sponsors and Collaborators 
Responsible Party, by Official Title: Sponsor 
Name of the Sponsor: University Mental Health Research Institute, Athens, Greece 
 
Oversight 
U.S. FDA-regulated Drug: No 
U.S. FDA-regulated Device: No 
U.S. FDA IND/IDE: No 
 
Board Status: Submitted, approved 
Approval Number: UMHRI session 7/15-10-2024 
Board Name: Institutional Review Board; Epitropi Vioithikis kai Deontologias) of the 
UMHRI 
Board Affiliation: UMHRI 
 
Board Contact Information 
Phone: +302106170806 
Email: secretar@epipsi.gr 
Address: 2, Soranou Efesiou str., Papagou, Athens 11527 
 

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Study Description 
Brief Summary 
This is a parallel-group randomised-controlled trial aiming to assess the effect of 
exposure to the arts on mental health and wellbeing of community dwelling recipients of 
mental health care. The trial constitutes a comparison of two arms: An Art Intervention 
arm, hereby the Active Group (AG), versus a waitlist control arm (WL). 
 
Detailed description  
Design: 
This is a randomised controlled trial with two arms: art intervention (any of the arts 
interventions, see below), which is hereby called Active Group (AG) vs waitlist control 
(WL). This is a new RCT that is based on a previous RCT performed in 2024 
(NCT06361667). This trial has been approved by the Institutional Ethics Committee 
(Institutional Review Board; Epitropi Vioithikis kai Deontologias) of the UMHRI in Greece 
(UMHRI session 7/15-10-2024).   
This trial will be conducted as part of the novel Arts on Prescription initiative of the 
Hellenic Ministry of Culture in Greece and at several Ministry-of-Culture-approved 
Organisations from the field of arts and culture. The University Mental Health, 
Neurosciences and Precision Medicine Research Institute ‘COSTAS STEFANIS’ (UMHRI) 
was commissioned by the Ministry of Culture to organize and conduct the RCT. In the 
beginning, an open invitation to institutions of culture and mental health has been sent. 
Cultural organizations presented their action plans for interventional courses. After 
quality control by the UMHRI and the Ministry of Culture. the following cultural 
organizations provided approved action plans: National Gallery - Alexandros Soutsos 
Museum, National Museum of Contemporary Art Athens, Athens Concert Hall 
Organization, Greek National Opera, Athens Conservatoire, Michael Cacoyannis 
Foundation, Stavros Niarchos Foundation Cultural Center (SNFCC), Nikolaos and Dolly 
Goulandris Foundation - Museum of Cycladic Art, Galilee Palliative Care Centre of the 
Holy Metropolis of Mesogaia and Lavreotiki, Archaeological Museum of Thessaloniki, 
Thessaloniki Concert Hall Organization, Metropolitan Organisation of Museums of Visual 
Arts of Thessaloniki (MOMus)", Kazantzakis Museum, Paul and Alexandra Canellopoulos 
Museum, National School of Dance (KSOT),  Municipal Regional Theatre of Ioannina, 
National Theatre of Northern Greece, Drama International Short Film Festival (DISFF) 
Cultural Organization, and Heraklion Archaeological Museum. 
AG consists of art intervention sessions that have been a priori developed by each cultural 
organization, specific to the field of each cultural organization (i.e., theatre, dance, visual 
arts, music, cinema). The intervention sessions have been elaborated and enhanced 
based on the previous experience of the NCT06361667 trial; specifically, the differences 
versus the NCT06361667 trial are the following: i. all Cultural Organizations are offering 
weekly sessions and there is no variability in the total number of sessions provided, ii. a 
larger sample is included in this trial to improve the precision of estimates and be able to 
detect smaller effect sizes (given the potential scalability and public health relevance of 

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the intervention, and iii. this trial includes Cultural Organizations and therefore patients 
beyond the metropolitan areas of Athens and Thessaloniki.  
Participants will be randomly allocated to AG or WL for 12 weeks; that marks the end of 
the trial period. After completion of the 12-week trial, people who were included in the 
WL will have the opportunity to receive art on prescription by the Cultural Organizations 
the participated in the trial, should they wish to take this up. 
Randomisation will be performed separately in each Cultural Organization and will be 
carried out using a computer-generated list provided centrally by SIBA Soft (Athens, 
Greece), an independent software and project management company.  
 
Frequency of Measurement: 
Data will be collected at baseline, including gender, age, educational level, marital status, 
socioeconomic characteristics, and mental health conditions. The primary and the 
secondary outcomes will be measured at time points: 
• 
T0: (before the randomisation; and after informed consent and patient's 
sociodemographic data)  
• 
T1: 6 weeks (after the start of the intervention for the AG group or the entry into the 
study for the WL group) 
• 
T2: 12 weeks (after the start of the intervention for the AG group or the entry into 
the study for the WL group)  
 
Interventional Model Description: 
The duration of the RCT will be 12 weeks. The AG group will engage in different art forms 
(theatre, dance, visual arts, music, and cinema), whereas the WL group will remain in the 
waiting list.  
The AG intervention will consist of sessions and/or performances in one of the five art 
forms: 
theatre, 
dance, 
visual 
arts, 
music 
and 
cinema. 
The 
number 
of 
sessions/performances will be 12 for all art forms over the duration of the trial, based on 
the specific features of each Cultural Organization. 
The intervention activities in the AG group have been organized by each site and approved 
by the UMHRI and the Hellenic Ministry of Culture creating a space for 8-16 participants 
per activity.  
The intervention consists of weekly visits over three months, featuring a guided tour 
followed by an art activity. All activities will include a discussion group, fostering reflection 
and connection, and each session will last approximately 1.5 to 2 hours. UMHRI and 
Ministry of Culture-approved, experienced professionals from the fields of mental health 
and arts, will lead the intervention sessions ensuring the safety and support of 
participants. 
 

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Statistical analysis model and sample size calculation 
The standard practice for RCTs will be followed and a linear mixed effects model will be 
applied, with random intercepts to estimate the effects of treatment, time, with 
interaction terms for treatment (AG treatment) and time (6 and 12 weeks). The inference 
of interest for the study concerns the interaction term at week 12.  
Assuming correlation coefficients equal to r_0_6_weeks = 0.71, r_0_12_weeks = 0.65 and r_6_12_weeks 
= 0.69 for the 0-6, 0-12 and 6-12 week intercorrelations, respectively, in the primary 
outcome values (PHQ-9), with a standard deviation of 5.60 at week 12 (numbers drawn 
from the results of the NCT06361667 trial) and a Cohen's d for the interaction term that is 
equal to 0.258 at week 12 for PHQ-9, at a type I error set at 5%, 205 participants per 
intervention arm would be needed for the achievement of 80% statistical power; 
importantly, assuming an anticipated 20% loss at follow-up rate, the total number 
required is 410/0.8, yielding 512 participants (256 participants by treatment arm). The 
power calculation was performed using the GLIMMPSE online statistical software 
(https://glimmpse.samplesizeshop.org/) 
Sensitivity analyses will be carried out, including site as a fixed/random effects factor in 
the models. In case of missing longitudinal data, sensitivity analyses will be performed 
using maximum likelihood / Last Observation Carried Forward (LOCF) approaches.   
 
Conditions  
Mental Health Issue; Anxiety Disorders; Affective Disorders; Affective Disorders, 
Psychotic; Psychotic disorder; Adjustment Disorder; Autism Spectrum Disorder; Mild 
Cognitive Impairment; Depression Disorders; Schizophrenia Disorders 
 
Keywords 
Mental Health Issue; Anxiety Disorders; Affective Disorders; Affective Psychotic 
Disorders; Psychotic disorders; Adjustment Disorders; Autism Spectrum Disorders; Mild 
Cognitive Impairment; Depression; Schizophrenia; Non-affective psychotic disorders; 
Psychological and behavioural factors associated with disorders or diseases classified 
elsewhere (ICD-10 diagnosis code F54  
 
Primary Purpose: Other 
Study Phase: N/A 
Interventional Study Model: Parallel 
Number of Arms: 2 
Masking: None (Open Label) 
Allocation: Randomized 
Enrollment – Number of Participants: 512 

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Type: Anticipated 
 
Arms and Interventions 
Arms  
Intervention 
Arm Title: Active Group (AG) 
Arm Type: Experimental 
Arm Description: This arm will 
receive the arts intervention (any 
of the arts interventions). 
Intervention Type: Other 
Intervention Name: Art Prescription 
Other Intervention Names: Arts (theatre, 
dance, visual arts, music or cinema). 
 
Intervention Description: Any of the art 
interventions (theatre, dance, visual arts, 
music or cinema) 
Arm Title: Waiting list Control (WL) 
Arm Type: No intervention   
Arm Description: This arm will 
remain in the waiting list during the 
12-week period 
No intervention 
 
 
Primary Outcome Measure 
Outcome 
Measure 
Measure Description 
Time 
Frame 
The Patient Health 
Questionnaire-9 
(PHQ-9) 
The Patient Health Questionnaire-9 (PHQ-9) is a 
questionnaire which measures depression and grade 
severity of symptoms in general medical and mental 
health settings using nine DSM-5 criteria for major 
depression within the last two weeks. PHQ-9 was 
constructed in 2001 and has been validated in Greek in 
2011, using a four-point Likert-type scale. After summing 
all responses (0=not at all, 3=nearly every day), scores 
range from 0 to 27, with higher levels indicating increased 
From 
enrollment 
to the end 
of 
intervention 
at 12 weeks 

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Outcome 
Measure 
Measure Description 
Time 
Frame 
symptom severity (0-4 no to minimal; 5-9 mild; 10-14 
moderate; 15-19 moderately severe; 20-27 severe). The 
reliability of the PHQ-9 was excellent, with a Cronbach's 
alpha of 0.89 in the PHQ Primary Care Study and 0.82 in 
the Greek validation study. 
 
Secondary Outcome Measures  
Outcome 
Measure 
Measure Description 
Time 
Frame 
Generalised 
Anxiety 
Disorder 
Assessment (GAD-
7) 
The Generalised Anxiety Disorder Assessment (GAD-7) is 
provided to screen symptom severity for the four most 
common anxiety disorders (generalized anxiety disorder, 
panic disorder, social phobia and posttraumatic stress 
disorder). GAD-7 was constructed in 2006 and was 
validated in Greek in 2022. It consists of 7 items. The 
GAD-7 score is computed by assigning scores of 0, 1, 2, 
and 3, to the response categories of 'not at all', 'several 
days', 'more than half the days', and 'nearly every day', 
respectively, and summing together the scores for the 
seven questions (scores range from 0 to 21). Higher levels 
indicate increased anxiety. There are cut-offs for severity 
of anxiety as: (i) score 0-4: Minimal Anxiety; (ii) score 5-9: 
Mild Anxiety; (iii) score 10-14: Moderate Anxiety; (iv) score 
greater than 15: Severe Anxiety. The internal consistency 
of the GAD-7 has been excellent. 
From 
enrollment 
to the end 
of 
intervention 
at 12 weeks 
The 
Warwick-
Edinburgh Mental 
Wellbeing 
Scale 
(WEMWBS) 
The 
Warwick-Edinburgh 
Mental 
Wellbeing 
Scale 
(WEMWBS). This tool was developed in 2007, in order to 
measure mental wellbeing in the general population. It 
consists of 14 items responding using a 5-point Likert 
scale from 1 (never) to 5 (all the time). The overall score is 
calculated by summing the responses for every item 
without reversing none. The minimum overall score 
ranges from 14 to 70. Higher scores indicate increased 
mental wellbeing. The scale has been widely used 
From 
enrollment 
to the end 
of 
intervention 
at 12 weeks 

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Outcome 
Measure 
Measure Description 
Time 
Frame 
nationally and internationally for monitoring, evaluating 
projects 
and 
programmes 
and 
investigating 
the 
determinants of mental wellbeing. An efficient internal 
consistency was proven using Cronbach's alpha score 
which was 0.89 for the student sample and 0.91 for the 
general population sample. Also, test-retest reliability at 
one week was high (0.83). The Greek validation study 
showed acceptable internal consistency (Cronbach's 
alpha score 0.90). 
UCLA 
3-item 
Loneliness Scale 
The Revised UCLA Loneliness Scale-20 (UCLA-20) is a 
questionnaire which measures level of psychological 
loneliness experienced by a person. UCLA-20 was 
constructed in 1980 and was validated in Greek in 1992. 
The internal reliability of the UCLA-20 was excellent, with 
a Cronbach's alpha of 0.94 in the original study and and 
0.89 in the Greek validation study. In 2004, this long scale 
was shortened to 3 questions (UCLA 3-item Loneliness 
Scale) in order to be used in large surveys. It is using a 3-
point Likert-type scale (hard ever, some of the time, 
often). The scores can be added together to give a range 
of scores from 3 to 9. Higher scores mean most lonely 
(worse outcome). 
From 
enrollment 
to the end 
of 
intervention 
at 12 weeks 
 
 
 
Eligibility 
Accepts Healthy Volunteers: No 
Sex/Gender: All 
Gender Based: No 
 
Age Limits 
Minimum Age: 18 years 
Maximum Age: No Limit 

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Eligibility Criteria 
Description 
The study will be advertised to public and private mental health professionals across 
Greece, including those in public hospitals, day care centres, and non-governmental and 
non-profit organisations. Clinicians will then refer potential participants to the study. 
Inclusion Criteria: 
• 
Recipients of mental health care in the community, or private practice with an F-
category ICD-10 diagnosis referred to the trial by their mental healthcare provider  
• 
Age range: >=18 years 
• 
Being able to communicate effectively in order to provide answers to 
questionnaires that he/she/they will be asked to complete 
• 
Being able to participate in the activity alone (unaccompanied, without a carer) 
• 
Being able to answer the questionnaires 
• 
Having legal capacity to consent  
Exclusion Criteria: 
• 
Current substance abuse dependence, 
• 
Current condition posing clinical risks (e.g. acute psychosis) 
• 
Patients that are not compliant in following their medication plans, 
• 
Patients that are not able attend due to severe physical, cognitive or other 
impairments 
• 
Patients not "affiliated" with a mental health professional therapist. 
 
Contacts and Locations 
Central Contact Person 
Name: Nikos Stefanis, MD, PhD, FRANZCP 
Phone Number: +30210 6170805,6 
Email: nistefan@med.uoa.gr 
 
Location  
The University Mental Health, Neurosciences and Precision Medicine Research Institute 
‘COSTAS STEFANIS’ (UMHRI) 
Athens 11527, Greece 

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Facility Contact: Eleni Kavvadia 
Phone Number: +302106170806 
E-mail: ekavadia@epipsi.gr 
 
IPD Sharing: No 
  
Funding: Recovery and Resilience Fund European Union, Greece 2.0  
 
Investigators  
• 
Principal Investigator: Prof. Nikos Stefanis, MD, PhD, FRANZCP, The University 
Mental Health, Neurosciences and Precision Medicine Research Institute 
‘COSTAS STEFANIS’ (UMHRI)  
 
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