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Recruiting NCT06623682

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

No phase Interventional Mental Health Mental Well-being Psychological Intervention Self-care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transdiagnostic cognitive behavioural therapy.
Who it may be relevant to
Registry conditions: Mental Health, Mental Well-being, Psychological Intervention, Self-care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Recovery Quality of Life-20 [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
Secondary outcome measures (12)
  • Generalized Anxiety Disorder Assessment [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • Patient Health Questionnaire [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • Self-Stigma Of Seeking Help [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • Youth Empowerment Scale-Mental Health [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • 5-level EQ-5D version [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • Nonattachment Scale-Short Form [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • General Mattering Scale [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • Anti-Mattering Scale [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • Perceived Competence [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • Treatment Self-regulation Questionnaire [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • Mindful Self-Care Scale [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]
  • College Self-Efficacy Inventory [Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Hong Kong · 1 center
  • Diversity and Well-being Lab — Hong Kong

Identifiers

NCT: NCT06623682 · SBRE-23-0966A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗