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Mental HealthAI-eCAMP_RCTNCT07704996

Effect of a Programme Including an AI-enhanced Mobile Application on the Mental Well- Being of Young Adolescents in Hong Kong

A study testing mobile app group in people with Mental Health and Depression and/or Anxiety in the Mild-to-moderate Range, run by Tung Wah College at 1 site in China.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Official record

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Trial summary

Study Aim and Methods (≈250 words) It aims to evaluate the effectiveness, user perceptions, and applicability of the e-CAMP intervention in improving mental well-being and reducing depressive symptoms among adolescents aged 11-15 years. Read more about this study

Who is it for?
Ages 11 to 15 years
What is being tested?
mobile app group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
3 Aug 2026to 31 Dec 2028
Phase
Interventional

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 11 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The inclusion criteria will be students at participating schools who can read Chinese and are aged 11-15 (P5 to F2), with parental consent.

Who cannot join

  • Students with known physical (musculoskeletal) or cognitive/mental problems that would compromise physical exercise or our intervention or outcomes will be excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Tung Wah College

    Hong Kong, Hong Kong, 00

    Eliza ML Wong, PhD, 852-34686803 ext. 6803, elizawong@twc.edu.hk

    Alan HL Tam, PhD, 852-3943 9306 ext. 9306, hltam@cuhk.edu.hk

Other trials in China

About this study

Official title: Effect of a Programme Including an AI-enhanced Mobile Application on the Mental Well-being of Young Adolescents in Hong Kong - A Cluster RCT Study

Study Aim and Methods (≈250 words) It aims to evaluate the effectiveness, user perceptions, and applicability of the e-CAMP intervention in improving mental well-being and reducing depressive symptoms among adolescents aged 11-15 years. The primary research question is whether e-CAMP can significantly reduce depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9).

Secondary objectives are to examine whether e-CAMP : improves mental health literacy using the Chinese-version Universal Mental Health Literacy Scale for Adolescents (UMHL), promotes healthier smart device use as measured by the Smartphone Addiction Scale (SAS), increases physical activity assessed through the Global Adolescent and Child Physical Activity Questionnaire (GAC-PAQ) , and to evaluate participants' perceptions of the intervention's applicability, acceptability through survey.

Read more

A prospective two-arm cluster randomized controlled trial (RCT) following CONSORT 2010 guidelines will be conducted in eight eligible Hong Kong schools, which will be randomly assigned to either the intervention or usual-care group. A process evaluation will also be undertaken.

320 students will be recruited with inclusion criteria : Chinese students aged 11-15 years (Primary 5 to Secondary 2) with parental consent. Students with physical, cognitive, or mental conditions that may affect participation will be excluded.

Students in the intervention group will receive usual school care and access to the e-CAMP mobile app, which they will be encouraged to use at least three times weekly for eight weeks (10-15 minutes per session). Students in the control group will receive usual school care, including a 45-minute nurse-led health talk and PowerPoint handouts.

Read the detailed description

Mental health during adolescence is a major public health concern with profound long term population health implications. A person's lifelong physical, psychological, and social well-being are established during this crucial developmental period. Estimating that approximately 15% of adolescents aged 10-19 years present with mental disorders, most commonly depression, the World Health Organization (WHO) has identified adolescent mental health promotion as a global public health priority [1]. Adolescent depression is associated with persistent mental health problems, impaired psychosocial functioning, and increased morbidity in adulthood [1-3,5].In Hong Kong, the mental health burden on children and adolescents recently has intensified markedly. During 2020-2024, more than 130 school aged children died by suicide, and the adolescent (age: 10-19) suicide rate reached 7.2 per 100,000 [2,3,8]. Diagnoses of depression, anxiety, and related mental health conditions increased substantially among primary and secondary school students during the 2024/25 school year (vs 2019/20) [2-3]. These alarming trends emphasise the need for effective and preventive population based mental health promotions.

Excessive smart device use is a key modifiable adolescent mental health behavioural risk factor. Empirical evidence links smartphone addiction with sedentary behaviour, unhealthy dietary patterns, and increased depressive symptoms [1,2,4-9,18,35]. Prolonged screen time contribute to established risk factors for physical and mental health problems during adolescence, including physical inactivity and unhealthy lifestyles. Local data indicate that 50.7% of Hong Kong adolescents do not meet the WHO recommendation of ≥60 minutes/day of moderate to vigorous physical activity [2,17,38]; thus, integrated health promotion approaches are needed to address behavioural determinants of mental well-being [1,3,7-9].

Aims: To evaluate the effectiveness, user perception, and applicability of the e CAMP intervention for improving mental well-being and reducing depressive symptoms among young adolescents.

Method: A prospective cluster RCT with two arms according to the cluster CONSORT 2010 checklist and guide [23] will be conducted. Eight eligible schools will be assigned randomly to the intervention or usual care group. The process evaluation will be guided by the RE-AIM framework [19-20].

Significance:

The cluster RCT design combined with implementation evaluation will generate locally relevant evidence to inform future digital mental health promotion strategies in school settings.

At the community and population levels, the project will offer a scalable, cost-effective model combining a mobile health intervention with a standardised school-based health talk, enabling broad school coverage. By evaluating user perception, applicability and sustainability, the study will move beyond efficacy to inform real-world applications.

The findings will provide actionable evidence for schools, healthcare professionals, and policymakers to support early preventive mental health promotion strategies responsive to the needs of Hong Kong adolescents

Being tested
Control Group :health talk and usual care by school, mobile app group
Keywords
mental health, depression, adolescents, programme, AI, mobile application
Medical subject headings
Psychological Well-Being, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control Group :health talk and usual care by schoolBehavioural

    control group-usual care . Eligible students will receive usual school care, a 45-minute health talk delivered by a nurse . The health talk, titled 'Enhance mental well-being and prevent depression', has been generated from e-CAMP app content. A PowerPoint handout will be provided to all participants after the health talk.

  • mobile app groupDevice

    In addition to receiving the usual school care, participants in intervention schools will be provided a QR code and installation guide and instructed to install the e-CAMP mobile app. WhatsApp groups will be established among students (approx. 15 students/class), volunteer schoolteachers, and research assistants (RAs) to facilitate communication and address inquiries. Participants will be encouraged to use the e-CAMP app at least thrice weekly during the first 8 weeks of the intervention. Each usage session is expected to last approximately 10-15 minutes. Participants can share and discuss the e-CAMP app with their parents.

Study groups in NCT07704996
Study groupRoleWhat they receive
experimental : app groupExperimentalapp group :The e-CAMP mobile app is an AI-enhanced behavioural health promotion intervention in which AI functionalities support engagement and timely prompting. The app's front page directs users to two sections: an educational module and an individual member area. The educational module includes animations and five learning units covering: 1. Facts and risk factors for depression in adolescents. 2. Depressive signs, symptoms, and care. 3. Strategies/tips for promoting well being (healthy diet, exercise, balanced use of smart devices and social media). 4. Stress management and substance abuse avoidance. 5. Help seeking resources. The individual member area displays personalised data on daily physical activities (goal, type and duration). Students can access AI enhanced self learning features, the Three Kingdoms game, and self reflection functions.
Receives: Device: mobile app group
control group : face to face health talkActive comparatorParticipants in control schools will be selected based on the above-stated inclusion and exclusion criteria. Eligible students will receive usual school care, a 45-minute health talk delivered by a nurse, and a mental health assessment survey . The health talk, titled 'Enhance mental well-being and prevent depression', has been generated from e-CAMP app content. A PowerPoint handout will be provided to all participants after the health talk. Upon study completion, all participants will receive access to the e-CAMP mobile app and an installation guide.
Receives: Behavioral: Control Group :health talk and usual care by school

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of depression scoreby Patient Health questionnaire (PHQ9 )

    Depressive symptoms will be assessed using the PHQ9 [13], a widely used depression screening tool comprising nine items (scores: 0-3) and a total score range of 0-27. Scores of 0-4, 5-9, 10-14, 15-19, and ≥20 indicate minimal, mild, moderate, moderate-severe, and severe depression, respectively. The PHQ9 has good psychometric properties for use in adolescent populations

    Measured: 4 months

Secondary outcomes (3)
  1. Change in mental health literarcy by The Chinese-version UMHL for adolescents

    The Chinese-version UMHL for adolescents is a 17-item questionnaire evaluating the mental health literacy of adolescents aged 10-14; it encompasses five elements: recognition, knowledge of risks, treatment/ care, help seeking attitudes/stigma, and help seeking skill . It has good psychometric properties, with Cronbach's alpha coefficients of 0.80 and 0.78, respectively, for subscales.

    Measured: 4 months

  2. Change in amart phone addiction (SAS)

    The SAS-Short Version (Chinese version) will be used to measure smartphone addiction or use. This 10-item scale is rated using a 6-point Likert scale (1-6), with summed scores of 10-60, and measures daily life disturbance, withdrawal, cyberspace-oriented relationships, and overuse. Scores of 10-30, 31-40, and 41-60 indicate normal use, moderate and severe addiction respectively. Total smartphone usage will also be recorded. The scale has good psychometric properties, with a Cronbach's alpha of 0.91 and sensitivity and specificity ranges of 0.87-0.88 and 0.89-0.89, respectively

    Measured: 4 months

  3. Change in exercise behaviour by Global Physical Activity Questionnaire (GPAQ)

    Responses to the Global Physical Activity Questionnaire (GPAQ) will be converted to time spent on vigorous-intensity and moderate-intensity activity and Metabolic Equivalent Task minutes per week (MET-min/week) according to the GPAQ scoring guide. Total minutes of vigorous-intensity, moderate-intensity, and travelling activity in a typical week will be multiplied by 8.0, 4.0, and 4.0, respectively. Participants will be classified as having adequate moderate-to-vigorous physical activity (MVPA) if they accumulate at least 60 minutes of MVPA per day The total exercise time per week (METs) will also be obtained

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start3 Aug 2026 (estimated)
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Model description
Experimental group : In addition to receiving the usual school care, participants in intervention schools will be provided with a QR code and installation guide and instructed to install the e-CAMP mobile app. Participants will be encouraged to use the e-CAMP app at least thrice weekly during the first 8 weeks of the intervention. Each usage session is expected to last approximately 10-15 minutes. Participants can share and discuss the e-CAMP app with their parents. Control group : Participants in control schools will be selected based on the above-stated inclusion and exclusion criteria. Eligible students will receive usual school care, a 45-minute health talk delivered by a nurse, and a mental health assessment survey. The health talk, titled 'Enhance mental well-being and prevent depression', has been generated from e-CAMP app content. A PowerPoint handout will be provided to all participants after the health talk.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07704996
Sponsor's protocol ID
HMRF2026_TMP17526
Acronym
AI-eCAMP_RCT
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: the plan can be in due course after completion of the study

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