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

NCT06361667 | Completed

• 1 other identifier: 1/02.02.2024
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  3 months

Secondary Outcomes (2)

• UCLA 3-item Loneliness Scale

  3 months

• The Strengths and Difficulties Questionnaire (SDQ)

  3 months

Study Arms (2)

Active Group (AG)

EXPERIMENTAL

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

Other: Arts

Waitlist Control (WL)

PLACEBO COMPARATOR

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

Other: Arts

Interventions

Arts OTHER

Arts (music, cinema, dance).

Also known as: Art as Prescription Therapy

Active Group (AG); Waitlist Control (WL)

Eligibility Criteria

• Age: 10 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KAVADIA ELENI: lead

Study Sites (1)

Eleni Kavadia

Athens, Greece

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Schizophrenia; Autistic Disorder

Interventions

Reproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Nikos Stefanis, PhD

  University Mental Health Research Institute, Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Secretariat

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 12, 2024
• Study Start: March 20, 2024
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)