Study of Self-Help and Support Services for Student Mental Health in Tertiary Institutions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transdiagnostic cognitive behavioural therapy
BehavioralTransdiagnostic 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).
Treatment groups
1,684 Participants
are divided into 2 treatment groupsGroup A: JCTH+-integrated mental health servicesExperimental treatment 1 intervention
Group B: Service-as-usual (SAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recovery Quality of Life-20
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.
Time frame
Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 monthsSecondary outcomes
1
Generalized Anxiety Disorder Assessment
It is a 7-item scale to assess the extent to which respondents are bothered by anxiety-related symptoms using a 4-point scale from 0 (not at all) to 3 (nearly every day). Scores of 5, 10, and 15 denote the mild, moderate, and severe levels of anxiety respectively (range: 0-21). At a cut-off of 10, GAD-7 has sensitivity of 0.89 and specificity of 0.82 in detecting generalized anxiety disorder (GAD). The internal consistency of the Chinese version was 0.93.
Time frame
Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months2
Patient Health Questionnaire
It includes 9 items to assess the extent to which respondents are bothered by depression-related symptoms using a 4-point scale from 0 (not at all) to 3 (nearly every day). PHQ-9 has been validated and used widely in the general population for screening and measuring depression severity. Scores of 5, 10, 15, and 20 denote mild, moderate, moderately severe, and severe levels of depression respectively (range: 0-27). PHQ-9 has sensitivity of 0.88 and specificity of 0.88 in detecting major depressive disorder (MDD) at a cut-off of 10. The internal consistency reliability of the Chinese version of the scale was 0.86.
Time frame
Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months3
Self-Stigma Of Seeking Help
It assesses the person's perception and reaction to seeking professional help using a 5-point scale from 1 (Strongly Disagree) to 5 (Strongly Agree). The SSOH consists of 10 items. Total scores ranged from 10 to 50, where higher scores indicate higher levels of self-stigma of seeking help. The measurement demonstrated good reliability and validity in previous studies.
Time frame
Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months4
Youth Empowerment Scale-Mental Health
The individual level subscale was adopted, which contains 6 items to assess the level of self-empowerment in mental health using a 5-point scale from 0 (Never or almost never) to 5 (Always or almost always). Total scores ranged from 6 to 30, where higher scores indicated higher level of ability in managing emotion and mental health. The scale has demonstrated good internal consistency and construct validity.
Time frame
Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov