Study of Self-Help and Support Services for Student Mental Health in Tertiary Institutions

NCT ID: NCT06623682

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1684 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-09
• Study Completion Date: 2026-08-29

Brief 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

Mental Health; Mental Well-being; Psychological Intervention; Self-care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

JCTH+-integrated mental health services

In the intervention arm, the JCTH+ platform will be integrated into the existing services of tertiary education institutions and introduced to students through mass advertisement within the institution. After randomization, three tertiary education institutions are allocated in this arm, including Chinese University of Hong Kong (CUHK), University of Hong Kong (HKU), and Hong Kong University's School of Professional and Continuing Education (HKU SPACE). Students will be invited to join this study and give consent adhering to the declaration of Helsinki.

Group Type: EXPERIMENTAL

Transdiagnostic cognitive behavioural therapy

Intervention Type: BEHAVIORAL

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).

Service-as-usual (SAU)

In the no-intervention group, participants will continue with their usual practice, i.e. service-as-usual (SAU), for 4 months before implementing the project. After randomization, three tertiary education institutions are allocated in this arm, including The Hong Kong Polytechnic University (PolyU), Tung Wah College (TWC) and City University of Hong Kong (CityU). The same integration procedure will be implemented after this waiting period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Winnie W.S. MAK

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Diversity and Well-being Lab

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Winnie WS MAK

Role: CONTACT

wwsmak@cuhk.edu.hk

+852 3943 6577

Kai Lam Cheng

Role: CONTACT

klcheng@cuhk.edu.hk

+852 90609894

Facility Contacts

Winnie WK Mak

Role: primary

wwsmak@cuhk.edu.hk

+852 3943 6577

Other Identifiers

SBRE-23-0966A

Identifier Type: -

Identifier Source: org_study_id