Arts-based Social Prescribing for Mental Health in Adults With Psychiatric Diagnoses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 541
- 试验地点
- 2
- 主要终点
- The Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
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).
详细描述
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 the intervention, and iii. this trial includes Cultural Organizations and therefore patients beyond the metropolitan areas of Athens and Thessaloniki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Active Group (AG)
This arm will receive the arts intervention (any of the arts interventions)
干预措施: Art Prescription (Other)
Waiting list Control (WL)
This arm will remain in the waiting list during the 12-week period
结局指标
主要结局
The Patient Health Questionnaire-9 (PHQ-9)
时间窗: From enrollment to the end of intervention at 12 weeks
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.
次要结局
- 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)
- Generalised Anxiety Disorder Assessment (GAD-7)(From enrollment to the end of intervention at 12 weeks)
研究者
KAVADIA ELENI
Head of Administrative Services
University Mental Health Research Institute, Athens, Greece