Trials / Recruiting
RecruitingNCT06623682
Study of Self-Help and Support Services for Student Mental Health in Tertiary Institutions
Efficacy, Cost-effectiveness and Implementation of an Integrated Self-help and Support Services for Student Mental Health in Tertiary Institutions: JCTH+ Pragmatic Cluster RCT
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,684 (estimated)
- Sponsor
- Chinese University of Hong Kong · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Transdiagnostic cognitive behavioural therapy | Transdiagnostic cognitive behavioural therapy for both depression and anxiety that including modules from (1) Mindfulness-based intervention, (2) Rumination-focused cognitive behavioural therapy, and also including modules for insomnia and from Mindwork (Internet-based cognitive behavioural therapy). |
Timeline
- Start date
- 2024-10-09
- Primary completion
- 2026-08-29
- Completion
- 2026-08-29
- First posted
- 2024-10-02
- Last updated
- 2026-03-24
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT06623682. Inclusion in this directory is not an endorsement.