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临床试验/NCT06623682
NCT06623682
招募中
不适用

Efficacy, Cost-effectiveness and Implementation of an Integrated Self-help and Support Services for Student Mental Health in Tertiary Institutions: JCTH+ Pragmatic Cluster RCT

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,684 人2024年10月9日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Mental Health
发起方
Chinese University of Hong Kong
入组人数
1684
试验地点
1
主要终点
Recovery Quality of Life-20
状态
招募中
最后更新
上个月

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.

注册库
clinicaltrials.gov
开始日期
2024年10月9日
结束日期
2026年8月29日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Winnie W.S. MAK

Professor

Chinese University of Hong Kong

入排标准

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)

研究点 (1)

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