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临床试验/NCT06361667
NCT06361667已完成不适用

"Culture and Well-being: Art as Prescription Therapy ("Art on Prescription"), Promoting Social Cohesion and Harnessing the "Silver Economy"

KAVADIA ELENI1 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2024年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
382
试验地点
1
主要终点
The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

时间窗: 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)

时间窗: 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)

时间窗: 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).

次要结局

  • UCLA 3-item Loneliness Scale(3 months)
  • The Strengths and Difficulties Questionnaire (SDQ)(3 months)

研究者

发起方
KAVADIA ELENI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

KAVADIA ELENI

Executive Secretariat

University Mental Health Research Institute, Athens, Greece

研究点 (1)

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