Efficacy, Cost-effectiveness and Implementation of an Integrated Self-help and Support Services for Student Mental Health in Tertiary Institutions: JCTH+ Pragmatic Cluster RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,684
- 试验地点
- 1
- 主要终点
- Recovery Quality of Life-20
研究概览
简要总结
This proposed study aims to evaluate the implementation of integrating the existing services in tertiary education institutions with the JCTH+ platform. The study aims to evaluate the efficacy of JCTH+ on students' mental health outcomes as compared to service as usual, and to assess the cost-utility of the platform to determine whether the benefits of implementing the platform justify the costs associated. It is hypothesized that participants who receive integrated self-help and support services will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants in the control condition, i.e. service-as-usual (SAU).
详细描述
This study is a parallel pragmatic cluster-randomized control trial evaluating the efficacy and cost-utility of a JCTH+-integrated services, as compared to service-as-usual among tertiary education institutions in Hong Kong. Randomisation will be carried out at institution level based on a computer-generated sequence. The estimated sample size will be 1,684, with 842 participants per condition. A factorial design will be adopted with all eligible participants completing assessments at 7 timepoints: baseline, 4 months post-test, 8-, 12-, 16-, 20- and 24-months follow-up. The primary endpoint is 4 months at post-test after baseline assessment. Concurrently, all staff involved in the project will be interviewed qualitatively at 12 months and 24 months from enrolment to understand their experience in the integration process and effectiveness of implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18 years old or above
- •Able to read Chinese or English
- •With internet connection and able to access the internet
- •With moderate-severe GAD-7 a/o moderate-severe PHQ-9
- •studying full-time at a tertiary education institution in Hong Kong
排除标准
- •not able to read and understand Chinese;
- •under 18 years old;
- •not able to access the Internet or use digital devices
- •without depressive symptoms or anxiety symptoms
结局指标
主要结局
Recovery Quality of Life-20
时间窗: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
It measures the quality of life in individuals with mental health conditions using a 5-point scale from 0 (none of the time) to 4 (most or all of the time). It focuses on aspects crucial to those recovering from mental illness, such as well-being, self-perception, relationships, and activity. Total scores ranged from 0 to 80, where higher scores indicated higher overall quality of life. The scale is validated for its reliability and sensitivity in the Chinese-Hong Kong population, making it an effective tool for both clinical settings and research to track recovery progress and treatment outcomes in mental health in the local context.
次要结局
- Generalized Anxiety Disorder Assessment(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- Patient Health Questionnaire(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- Self-Stigma Of Seeking Help(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- Youth Empowerment Scale-Mental Health(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- 5-level EQ-5D version(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- Nonattachment Scale-Short Form(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- General Mattering Scale(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- Anti-Mattering Scale(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- Perceived Competence(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- Treatment Self-regulation Questionnaire(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- Mindful Self-Care Scale(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- College Self-Efficacy Inventory(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
- Basic Psychological Need Satisfaction in General(Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months)
研究者
Winnie W.S. MAK
Professor
Chinese University of Hong Kong