Arts-based Social Prescribing for Mental Health

NCT07137572 | Completed

• 1 other identifier: AoP-II
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 1

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).

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)

Outcome Measures

Primary Outcomes (1)

• 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 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.

  From enrollment to the end of intervention at 12 weeks

Secondary Outcomes (3)

• Generalised Anxiety Disorder Assessment (GAD-7)

  From enrollment to the end of intervention at 12 weeks

• The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

  From enrollment to the end of intervention at 12 weeks

• UCLA 3-item Loneliness Scale

  From enrollment to the end of intervention at 12 weeks

Study Arms (2)

Active Group (AG)

EXPERIMENTAL

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

Other: Art Prescription

Waiting list Control (WL)

NO INTERVENTION

This arm will remain in the waiting list during the 12-week period

Interventions

Art Prescription OTHER

Any of the art interventions (theatre, dance, visual arts, music or cinema)

Active Group (AG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KAVADIA ELENI: lead

Study Sites (1)

The University Mental Health, Neurosciences and Precision Medicine Research Institute 'COSTAS STEFANIS' (UMHRI)

Athens, 11527, Greece

Location

Related Publications (8)

• Vogazianos P, Motrico E, Dominguez-Salas S, Christoforou A, Hadjigeorgiou E. Validation of the generalized anxiety disorder screener (GAD-7) in Cypriot pregnant and postpartum women. BMC Pregnancy Childbirth. 2022 Nov 15;22(1):841. doi: 10.1186/s12884-022-05127-7.

  PMID: 36380278 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.

  PMID: 7431205 BACKGROUND

• Hyphantis T, Kotsis K, Voulgari PV, Tsifetaki N, Creed F, Drosos AA. Diagnostic accuracy, internal consistency, and convergent validity of the Greek version of the patient health questionnaire 9 in diagnosing depression in rheumatologic disorders. Arthritis Care Res (Hoboken). 2011 Sep;63(9):1313-21. doi: 10.1002/acr.20505.

  PMID: 21618450 BACKGROUND

• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

  PMID: 18504506 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Carey EG, Ridler I, Ford TJ, Stringaris A. Editorial Perspective: When is a 'small effect' actually large and impactful? J Child Psychol Psychiatry. 2023 Nov;64(11):1643-1647. doi: 10.1111/jcpp.13817. Epub 2023 May 25.

  PMID: 37226639 BACKGROUND

• Anderson LR, Malikiosi-Loizos M. Reliability data for a Greek translation of the Revised UCLA Loneliness Scale: comparisons with data from the USA. Psychol Rep. 1992 Oct;71(2):665-6. doi: 10.2466/pr0.1992.71.2.665.

  PMID: 1410126 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders; Affective Disorders, Psychotic; Psychotic Disorders; Adjustment Disorders; Autism Spectrum Disorder; Cognitive Dysfunction; Schizophrenia; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Trauma and Stressor Related Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Cognition Disorders; Neurocognitive Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Administrative Services

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: September 4, 2025
• Primary Completion: February 25, 2026
• Study Completion: February 25, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)