Clinical trial NCT06623682: Study of Self-Help and Support Services for Student Mental Health in Tertiary Institutions
Official title: Efficacy, Cost-effectiveness and Implementation of an Integrated Self-help and Support Services for Student Mental Health in Tertiary Institutions: JCTH+ Pragmatic Cluster RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Mental Well-being
Psychological Intervention
Self-care
Keywords: Online Psychological Intervention
Mental Health
Mental Well-being
Self-care
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 1684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Recovery Quality of Life-20
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Secondary outcomes:
measure: Generalized Anxiety Disorder Assessment
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: Patient Health Questionnaire
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: Self-Stigma Of Seeking Help
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: Youth Empowerment Scale-Mental Health
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: 5-level EQ-5D version
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: Nonattachment Scale-Short Form
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: General Mattering Scale
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: Anti-Mattering Scale
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: Perceived Competence
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: Treatment Self-regulation Questionnaire
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: Mindful Self-Care Scale
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: College Self-Efficacy Inventory
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
measure: Basic Psychological Need Satisfaction in General
timeFrame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Diversity and Well-being Lab
Study officials:
References: