Mental HealthNCT06623682
Study of Self-Help and Support Services for Student Mental Health in Tertiary Institutions
A study testing Transdiagnostic cognitive behavioural therapy in people with Mental Health and Mental Well-being, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Mental Well-being, Psychological Intervention
- What is being tested?
- Transdiagnostic cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,684 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Oct 2024to 29 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Diversity and Well-being Lab
Hong Kong
Winnie WK Mak, +852 3943 6577, wwsmak@cuhk.edu.hk
About this study
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
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).
Read the 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.
- Being tested
- Transdiagnostic cognitive behavioural therapy
- Keywords
- Online Psychological Intervention, Mental Health, Mental Well-being, Self-care
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic cognitive behavioural therapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| JCTH+-integrated mental health services | Experimental | 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. Receives: Behavioral: Transdiagnostic cognitive behavioural therapy |
| Service-as-usual (SAU) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Secondary outcomes (13)
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
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.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
5-level EQ-5D version
The EQ-5D-5L comprises five dimensions, MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY/ DEPRESSION, each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. The digits for the five dimensions can be combined in a 5-digit code that describes the respondent\'s health state; for instance, 21111 means slight problems in the mobility dimension and no problems in any of the other dimensions.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Nonattachment Scale-Short Form
Nonattachment Scale-Short Form (NAS-SF) includes 8 items to measure nonattachment using a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). Total scores ranged from 8 to 48, where higher scores indicated higher levels of nonattachment. It yielded satisfactory internal consistency and validity.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
General Mattering Scale
The 5-item General Mattering Scale measures perceptions and feelings of being important to other people (e.g., "How much would you be missed if you went away?"). Items are rated on a scale ranging from 1 (Not at all) to 4 (A lot) with good reliability and validity. Total scores ranged from 5 to 20, where higher scores indicated higher level of mattering.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Anti-Mattering Scale
The Anti-Mattering Scale is a five-item scale ranging from 1 (Not at all) to 4 (A lot) assessing the degree to which people feel like they do not matter to others. Sample item include "To what extent have you been made to feel like you are invisible?". Total scores ranged from 5 to 20, where higher scores indicated lower levels of mattering.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Perceived Competence
It contains 4 items on a 7-point Likert scale from 1 (none at all) to 7 (very true) to assess the self-perceived competence in maintaining regular self-care. Total scores ranged from 4 to 28, where higher scores indicated higher levels of self-perceived competence in maintaining regular self-care.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Treatment Self-regulation Questionnaire
It contains 15 items on a 7-point Likert scale from 1 (not true at all) to 5 (completely true) to understand the reason for beginning or keeping regular mental self-care. Higher scores in each item indicate higher importance of the reason for keeping mental self-care.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Mindful Self-Care Scale
The scale utilizes a 6-point Likert scale, ranging from 0 = never to 4 = regularly, to measure self-care in six factors: physical care, supportive relationships, mindful awareness, self-compassion and purpose, mindful relaxation, and supportive structure. A higher score indicates a higher frequency of engaging in mindful self-care within the past week. The scale demonstrates adequate reliability with Cronbach's coefficient alphas equal to 0.89 for the total 33-item.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
College Self-Efficacy Inventory
It evaluates the self-efficacy of college students in academic settings. It consisted of 20 items that load into three subscales: Course Efficacy, Social Efficacy, and Roommate Efficacy. In this study, only 16 items on Course Efficacy, Social Efficacy will be included since dormitory is not usually available for students at post-secondary institutions. The confidence level is measured by using a scale ranging from 1 (Not confident at all) to 10 (Extremely confident). Higher scores in each subscale demonstrate a higher level of self-efficacy in that dimension.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Basic Psychological Need Satisfaction in General
It contains 21 items to measure basic psychological need satisfaction in 3 subscales: Autonomy, Competence, and Relatedness. The scale used a 7-point Likert scale from 1 (not at all true ) to 7 (very true). Higher scores in each subscale indicated a higher degree to which the person experiences satisfaction with each of the three needs.
Measured: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start9 Oct 2024
- Primary completion29 Aug 2026 (estimated)
- Study completion29 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,684 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winnie W.S. MAK, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623682
- Sponsor's protocol ID
- SBRE-23-0966A
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06623682
- Acronym / sponsor ID
- SBRE-23-0966A
- Keywords
- Online Psychological Intervention, Mental Health, Mental Well-being, Self-care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,684 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 29 Aug 2026 (estimated)
- Study completion
- 29 Aug 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JCTH+-integrated mental health services | Experimental | Behavioral: Transdiagnostic cognitive behavioural therapyIn 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. |
| Service-as-usual (SAU) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdiagnostic cognitive behavioural therapyTransdiagnostic 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). | Behavioural | JCTH+-integrated mental health services |
Primary outcome
Recovery Quality of Life-20
Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
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.
13 secondary outcomes
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
Basic Psychological Need Satisfaction in General
Time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Mental Health
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic cognitive behavioural therapy in people with Mental Health and Mental Well-being, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Winnie WS MAK (+852 3943 6577, wwsmak@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery Quality of Life-20 (time frame: Baseline, 4 months, 8 months, 12 months, 16 months, 20 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.