Mental Health IssueAoPNCT06361667
Culture and Well-being: Art as Prescription Therapy ("Art on Prescription")
A study testing Arts in people with Mental Health Issue and Anxiety Disorders, run by KAVADIA ELENI at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Anxiety Disorders, Depressive Disorder
- What is being tested?
- Arts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 382 participants
- Where
- 1 siteGreece
- Study dates
- 20 Mar 2024to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: "Culture and Well-being: Art as Prescription Therapy ("Art on Prescription"), Promoting Social Cohesion and Harnessing the "Silver Economy"
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).
Read the 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.
- Conditions
- Mental Health Issue, Anxiety Disorders, Depressive Disorder, Emotional Disorder, Schizophrenia, Autism
- Being tested
- Arts
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Schizophrenia, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtsOther
Also called Art as Prescription Therapy
Arts (music, cinema, dance).
| Study group | Role | What they receive |
|---|---|---|
| Active Group (AG) | Experimental | This arm will receive the arts intervention (any of the arts interventions). Receives: Other: Arts |
| Waitlist Control (WL) | Placebo comparator | This arm will be the waitlist control and after 3 months it will be active. Receives: Other: Arts |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). This tool was developed in order to measure mental wellbeing in the general population by Tennant et al. (2007). 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 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 showed acceptable internal consistency (Cronbach's alpha score 0.90).
Measured: 3 months
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 constructed by Kroenke et al. (2001) and validated in Greek by Hyphantis et al. (2011) is 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 symptom severity (0-4 no to minimal; 5-9 mild; 10-14 moderate; 15-19 moderately severe; 20-27 severe). The internal reliability of the PHQ-9 was excellent, with a Cronbach's α of 0.89 in the PHQ Primary Care Study (Kroenke et al., 2001) and 0.82 in Greek validation (Hyphantis et al., 2011).
Measured: 3 months
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 constructed by Spitzer et al (2006) and validated in Greek by Vogazianos et al (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 was excellent (Cronbach α = 0.92) (Spitzer et al., 2006).
Measured: 3 months
Secondary outcomes (2)
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 constructed by Russel et al. (1980) and validated in Greek by Anderson \& Malikiosi-Loizos (1992). The internal reliability of the UCLA-20 was excellent, with a Cronbach's α of 0.94 (Russel et al., 1980) and 0.89 in Greek validation (Anderson \& Malikiosi-Loizos, 1992). This long scale was shortened to 3 questions (UCLA 3-item Loneliness Scale) in order to be used in large surveys (Hughes et al., 2004). 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).
Measured: 3 months
The Strengths and Difficulties Questionnaire (SDQ)
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening tool for children and adolescents aged 2-17 years. PHQ-9 constructed by Goodman (2001) and validated in Greek by Gomez et al. (2021) is using a 3-point Likert-type scale ("not true," "somewhat true", "certainly true"). SDQ consists of 25 positive and negative items. These 25 items are divided between 5 scales: (i) emotional symptoms (5 items), (ii) conduct problems (5 items), (iii) hyperactivity/inattention (5 items), (iv) peer relationship problems (5 items), (v) prosocial behaviour (5 items). "Somewhat true" is always scored as 1 but the scoring of "not true" and "certainly true" varies and score 0 or 2. The total difficulties score is generated by summing the cores form all the scales except the prosocial scale. The final score can be ranged from 0 to 40. Higher scores mean most difficulties (worse outcome). Cronbach's alpha of the original study for all scales ranged from 0.35 to 0.64.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start20 Mar 2024
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- KAVADIA ELENI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, KAVADIA ELENI, University Mental Health Research Institute, Athens, Greece
- Investigators
- Nikos Stefanis, PhD, Principal investigator, University Mental Health Research Institute, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361667
- Sponsor's protocol ID
- 1/02.02.2024
- Acronym
- AoP
- Status last verified
- Sep 2025
- First submitted
- 26 Mar 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Culture and Well-being: Art as Prescription Therapy ("Art on Prescription"), Promoting Social Cohesion and Harnessing the "Silver Economy"
- ClinicalTrials.gov ID
- NCT06361667
- Acronym / sponsor ID
- AoP / 1/02.02.2024
- Conditions
- Mental Health Issue, Anxiety Disorders, Depressive Disorder, Emotional Disorder, Schizophrenia, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- KAVADIA ELENIUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Group (AG) | Experimental | Other: ArtsThis arm will receive the arts intervention (any of the arts interventions). |
| Waitlist Control (WL) | Placebo comparator | Other: ArtsThis arm will be the waitlist control and after 3 months it will be active. |
Who may qualify
- Ages
- 10 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArtsAlso: Art as Prescription TherapyArts (music, cinema, dance). | Other | Active Group (AG), Waitlist Control (WL) |
Primary outcome
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: 3 months
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). This tool was developed in order to measure mental wellbeing in the general population by Tennant et al. (2007). 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 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 showed acceptable internal consistency (Cronbach's alpha score 0.90).
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 months
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 constructed by Kroenke et al. (2001) and validated in Greek by Hyphantis et al. (2011) is 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 symptom severity (0-4 no to minimal; 5-9 mild; 10-14 moderate; 15-19 moderately severe; 20-27 severe). The internal reliability of the PHQ-9 was excellent, with a Cronbach's α of 0.89 in the PHQ Primary Care Study (Kroenke et al., 2001) and 0.82 in Greek validation (Hyphantis et al., 2011).
Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: 3 months
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 constructed by Spitzer et al (2006) and validated in Greek by Vogazianos et al (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 was excellent (Cronbach α = 0.92) (Spitzer et al., 2006).
2 secondary outcomes
UCLA 3-item Loneliness Scale
Time frame: 3 months
The Strengths and Difficulties Questionnaire (SDQ)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikos Stefanis, PhD principal investigator
University Mental Health Research Institute, Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arts in people with Mental Health Issue and Anxiety Disorders, run by KAVADIA ELENI at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.