Depressive SymptomsMindfulCityUNCT07392632
MindfulCityU-- A Mindfulness Mobile Application for Promoting University Students' Mental Health
A study testing MindfulCityU in people with Depressive Symptoms, run by City University of Hong Kong at 1 site in Hong Kong.
Trial summary
The research aims to investigate the effectiveness a mobile phone application-based (app-based) mindfulness interventions for university students with mild depressive symptoms. This study adopts a multicentre randomized control trial two arms research design. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- MindfulCityU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2026to 30 Jun 2027
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- current undergraduate or postgraduate students; (ii) aged 18-30 years; (iii) possessing smartphone ownership and reliable internet access necessary for intervention engagement; (iv) having a score between 10-23 on the DASS-Y Depression subscale indicating a mild to moderate depressive symptom; and (v) provide informed consent
Who cannot join
- students currently engaged in formal mindfulness training exceeding one session per week will be excluded to prevent confounding effects from concurrent mindfulness practice; (ii) those scoring above 23 on the DASS-Y Depression subscale, indicating severe symptoms, will be excluded and referred to appropriate clinical services to ensure their safety and access to needed care; (iii) students reporting active suicidal ideation or self-harm behaviors will be immediately referred to crisis intervention services and excluded from study participation to prioritize their safety; (iv) current engagement in psychotherapy or recent medication changes within the previous four weeks; (v) students planning to leave the university during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MindfulCityU: Implementation and Evaluation of a Mindfulness Mobile Application for Promoting University Students' Mental Health
The research aims to investigate the effectiveness a mobile phone application-based (app-based) mindfulness interventions for university students with mild depressive symptoms.
This study adopts a multicentre randomized control trial two arms research design. A randomised controlled trial will compare a newly designed mobile phone application-based (app-based) mindfulness interventions, named MindfulCityU, with a waitlist control group to determine whether the MindfulCityU produces better intervention outcomes on promoting mental health for university students, including depressive symptoms, mindfulness, and wellbeing. The MindfulCityU provides 8 online modules on mindfulness for participants to access and learn at home through their smartphones and/or computer. Participants of waitlist control group participants receive no active intervention at the initial stage and receive the same MindfulCityU at a later stage.
Participants will complete online standardized assessment tools on their intervention outcomes before and after the intervention and 2-months follow-up. The ethical considerations of this study were reviewed and approved by the Human and Artefacts Ethics Sub-Committee of the City University of Hong Kong in 2025.
Read the detailed description
University students worldwide face an unprecedented mental health crisis that has intensified significantly in recent years. Meta-analytic evidence demonstrates pooled prevalence rates of 33.6% for depression and 39% for anxiety among this population globally.
In Hong Kong, the mental health crisis among university students is particularly pronounced. Specifically, a longitudinal research conducted between 2016 and 2021 revealed a significant escalation in psychological distress. The study found that 68.5% of students reported diverse depressive symptoms, with 49.4% considered at risk for mental health problems. By 2021, these numbers had escalated dramatically, with depressive symptoms affecting up to 80% of students and at risk cases reaching 60%.
Digital Mindfulness-based Interventions Systematic reviews and meta-analyses provide substantial evidence supporting mindfulness-based interventions (MBIs) for university students. Additionally, mobile phone application-based (app-based) or digital mindfulness interventions have demonstrated particularly promising outcomes among university student populations. It offers several distinct advantages that make them particularly suitable for university populations, including 24/7 accessibility that accommodates irregular student schedules, anonymity that reduces stigma-related barriers to help-seeking, cost-effectiveness that addresses financial constraints common among students, scalability that can reach large numbers of students simultaneously, and personalization capabilities that can adapt to individual needs and preferences.
However, there is a lack of university-specific adaptations in current digital mindfulness interventions. Most existing applications are designed for general adult populations rather than addressing the unique stressors and developmental challenges facing university students, such as academic pressure, social adjustment difficulties, identity development concerns, and career uncertainty.
Research Objective This study aims to addresses these identified gaps by developing and evaluating a culturally adapted, university-specific digital mindfulness intervention, named MindfulCityU. Additionally, this study will examine the mechanisms underlying therapeutic change.
Research Methods This research study adopts mixed methods research design, involving both quantitative and qualitative study. By adopting a randomized controlled trial, the quantitative study aims to investigate the effectiveness of the MindfulCityU on improving mental health for university students. The qualitative study aims to examine the benefits, advantages and limitations of the MindfulCityU from the users' perspective.
Quantitative Research Method
Research Questions and Hypotheses Primary Research Questions RQ1: Does the MindfulCityU intervention improve mental health outcomes (depression, anxiety, stress, well-being) among Hong Kong university students compared to waitlist controls? RQ2: Does app engagement moderate intervention effectiveness, with higher engagement levels predicting greater therapeutic improvements? Secondary Research Questions RQ3: Does baseline mental health symptom severity moderate intervention effectiveness? RQ4: How do participants experience integrating digital mindfulness practices into their daily university routines?
Primary Hypotheses H1 (Primary Effectiveness): Participants receiving the MindfulCityU intervention will demonstrate significantly greater improvements in DASS-Y scores (depression, anxiety, stress) and WHO-5 well-being scores compared to waitlist controls.
H2 (Engagement Moderation): App engagement levels will moderate intervention effectiveness, with higher engagement predicting larger therapeutic gains.
H3 (Baseline Moderation): Baseline symptom severity will moderate intervention effectiveness, with participants having moderate symptoms showing greater improvements than those with mild symptoms.
H4 (Secondary Outcomes): The intervention will produce significant improvements in mindfulness skills (FFMQ-SF), loneliness (UCL-8), and sleep quality (SCI) compared to controls.
Study Design This investigation employs a two-arm randomized controlled trial design to evaluate the efficacy of the MindfulCityU intervention while maintaining scientific rigor and minimizing potential confounding factors. The study design incorporates a 4-week intervention period followed by a 2-month follow-up assessment, allowing for evaluation of both immediate therapeutic effects and sustained benefits over time.
The MindfulCityU application adapted from Professor Daniel Young's established mindfulness curriculum into an interactive digital format specifically adapted for university students and Hong Kong's cultural context. Prior to the main trial implementation, a brief pilot testing phase involving approximately 15 students will be conducted to ensure optimal technical functionality, user experience, and cultural appropriateness.
Power Analysis and Sample Size Justification The sample size calculation is based on previous meta-analytic findings indicating moderate effect sizes for digital mindfulness interventions in university populations. With α = 0.05, power = 0.80, and accounting for an anticipated 20% attrition rate typical in digital intervention studies, the required sample size is 120 participants (60 per group).
Participants and Recruitment The study will recruit 120 CityU students through open promotion and recruitment. Participants will be equal assigned to intervention (n=60) and control (n=60) conditions.
Inclusion criteria (i) current CityU undergraduate or postgraduate students; (2) aged 18-30 years; (3) possess smartphone ownership and reliable internet access necessary for intervention engagement; (4) having mild to moderate depressive symptoms as assessed by the DASS-Y Depression subscale, and a DASS-Y Depression subscale score between 10-23 mild to moderate depressive symptoms; (5) able to listen and read simplified Chinese, Cantonese or English, reflecting Hong Kong's trilingual context.
(6) provide informed consent.
Exclusion criteria:
- a DASS-Y Depression subscale score above 23 on the DASS-Y Depression subscale, indicating severe symptoms;
- reporting active suicidal ideation or self-harm behaviors
- current engagement in psychotherapy or recent medication changes within the previous four weeks;
- planning to leave the university during the study period.
In particular, participants reporting suicidal ideation, self-harm behaviors or severe depressive symptoms will be immediately referred to crisis intervention services.
Randomization and Blinding Procedures Participants will be randomly allocated to intervention or control conditions using computer-generated randomization sequences with concealed allocation to prevent selection bias. Block randomization will be employed to ensure balanced group sizes throughout the recruitment period. While participants cannot be blinded to their intervention assignment due to the nature of the intervention, outcome assessors will remain blinded to group allocation during data collection and analysis phases to minimize assessment bias.
Intervention Description The MindfulCityU application represents a comprehensive digital mindfulness intervention specifically designed for university students in Hong Kong's cultural context.
The core curriculum consists of eight structured sessions delivered over four weeks, with two sessions released each week to maintain engagement while allowing adequate time for skill development. The first week introduces fundamental mindfulness concepts and practices through Session 1, which covers Introduction to Mindfulness and the Three-Minute Breathing Space technique, and Session 2, which focuses on Body Scan practices and developing physical awareness. These foundational sessions establish basic mindfulness skills and familiarity with core practices.
The second week builds upon foundational skills through Session 3, which introduces Mindful Movement and Stretching practices that integrate physical activity with mindfulness awareness, and Session 4, which teaches the Breathing Space for Difficult Emotions technique, providing practical tools for managing emotional distress. These sessions help participants apply mindfulness skills to common university stressors.
The third week addresses cognitive aspects of mindfulness through Session 5, which focuses on Working with Difficult Thoughts and Feelings, and Session 6, which teaches the concept that Thoughts Are Not Facts through cognitive defusion techniques. These sessions help participants develop a different relationship with negative thinking patterns common among university students.
The fourth week integrates advanced practices through Session 7, which covers Acceptance and Self-Compassion principles particularly relevant for perfectionistic university students, and Session 8, which introduces Loving-Kindness practices and strategies for Maintaining Practice beyond the intervention period.
Beyond the structured curriculum, the application provides daily practice options that include guided meditations ranging from 5-20 minutes in length, mindful breathing exercises that can be practiced between classes, body awareness practices suitable for dormitory settings, and informal mindfulness reminders integrated throughout the day.
Additional features enhance user engagement and safety through progress tracking and streak counters that provide motivational feedback, mood check-ins that enable pattern recognition over time, crisis resources and professional referral pathways for students experiencing severe distress, and integration with CityU counseling services to facilitate seamless transitions to professional care when needed.
Control Condition Waitlist control participants receive access to standard university counselling services and general mental health information emails. Full access to the MindfulCityU application is provided following the 4-week waiting period.
Outcome Assessment Tools.
The primary intervention outcome is improvement in mental health, including depression, anxiety and stress, assessed with the 21-item DASS.
The secondary intervention outcome is improvement in mindfulness, psychological well-being and stress reduction, which are assessed by:
The 20-item Chinese Five Facets Mindfulness Questionnaire Short Form The 8-item UCLA Loneliness Scale (ULS-8) The 8-item Sleep Condition Indicator (SCI) The 5-item Chinese WHO 5-item Well-Being Index (WHO-5)
Data Analysis. An analysis will be performed in accordance with the intent-to-treat principle using multiple imputation method analysis for any missing data. Between group intervention effects will be investigated by using repeated measures of linear mixed model for repeated measures. In the linear mixed model, time, group, and time × group interactions were entered as fixed effects, with a random intercept for the subject. Effect sizes (Hedges' g) are calculated, with values of 0.2, 0.5, and 0.8 considered as small, medium, and large respectively. The predictive values of individual adherence of digital iMBI are analyzed using multiple linear regression analysis, with improved outcome assessment scores as dependent variables.
Qualitative Research Method
Objective. This qualitative study aims to explore the benefits, advantages and limitations of the MindfulCityU from the users' perspective.
Research Design. The qualitative study uses an interpretative interview method with purposive sampling. Semi-structured interviews with 15-20 participants in the current sample will provide rich qualitative data to complement quantitative findings and enhance understanding of intervention effects from participants' perspectives. Each interview will last for 0.5-1 hour. Interview topics will explore intervention experience, perceived benefits and limitations, barriers to engagement, suggested improvements, and integration of mindfulness practices into daily university life. Interviews will be conducted by trained research assistants using standardized interview guides while allowing flexibility to explore emerging themes.
Data collection. Each in-depth interview will be facilitated by a research staff with an interview protocol developed for this study. Participants will be asked questions such as the following: How relevant were the language, examples, and content of today's module of the mindful app to your daily life? How difficult or easy is it to use this app? How often do you use this app? In real life, under what circumstances do you first apply the method you learn from the app? Is there any particular time using the app when you feel "This app really help me"? Do you have any other feedback regarding content, examples, exercises, or app design? The content of the semi-structured in-depth interviews will be audio-recorded and transcribed into verbatim by the research team.
Reflective thematic analysis will be used to identify, analyse and report themes so that themes can be developed both inductively (i.e. data-driven) and deductively (i.e. theory-driven). The research team will systematically read and re-read the transcripts, following the six stages of analysis, including: (1) becoming familiar with the data, (2) generating codes, (3) constructing themes, (4) reviewing potential themes, (5) defining and naming themes, and (6) producing the report. Two research staff compare, review and refine the codes, categories and themes until they reach agreement.
- Conditions
- Depressive Symptoms
- Being tested
- MindfulCityU, Waitlist control
- Keywords
- Digital Mental Health Intervention, Mobile phone application-based, Mindfulness-based Intervention, Depression, Mindfulness
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulCityUBehavioural
The MindfulCityU provides 8 online modules on mindfulness for participants to access and learn at home through their smartphones and/or computer. Each participant is expected to complete 8 modules of mindfulness within four weeks, with two sessions released each week to maintain engagement while allowing adequate time for skill development. Beyond the structured curriculum, the application provides daily practice options that accommodate varying time constraints and preferences. These include guided meditations ranging from 5-20 minutes in length, mindful breathing exercises that can be practiced between classes, body awareness practices suitable for dormitory settings, and informal mindfulness reminders integrated throughout the day.
Waitlist controlOther
The non-active waitlist-controlled group participants receive standard services from the schools, universities or youth service units. Full access to the digital MBI application is provided following the 4-week waiting period
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The MindfulCityU provides 8 online modules on mindfulness for participants to access and learn at home through their smartphones and/or computer. Receives: Behavioral: MindfulCityU |
| Waitlist Control | Other | The waitlist-controlled group receive standard services from the schools, universities or youth service units. Receives: Other: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese Depression Anxiety Stress Scale Youth Version (DASS-Y)
The primary intervention outcome is improvement in mental health, including depression, anxiety and stress, assessed with the 21-item DASS-Y which has been demonstrated good validity and reliability (α = 0.80 for anxiety subscale, 0.83 for depression subscale, 0.82 for stress subscale, and 0.92 for whole scale; Cao et al., 2023). Each item (e.g. I felt down-hearted and blue) is scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The scores are summed over the items with higher scores indicating a higher severity of symptoms
Measured: This scale will be used at baseline, the 5th week, and the 13rd week.
Secondary outcomes (4)
Chinese Five Facets Mindfulness Questionnaire Short Form (FFMQ)
The Chinese Five Facets Mindfulness Questionnaire Short Form (FFMQ; Fong et al., 2021), which is a 20-item scale with good validity and internal consistency (Cronbach's α range from 0.77 to 0.85), was used to assess participants' level of mindfulness. Each item (e.g., "I pay attention to sensations, such as the wind in my hair or sun on my face") is rated on a 5-point Likert scale (1 = Never or very rarely true; 5 = Very often or always true). A higher score indicates a higher level of mindfulness
Measured: This scale will be used at baseline, the 5th week, and the 13rd week.
UCLA Loneliness Scale (ULS-8)
The UCLA Loneliness Scale (ULS-8), which is an 8-item scale with good validity and internal consistency (Cronbach's α = 0.80), is used to assess perceived loneliness (Xu et al., 2018). Each item (e.g., feel that a lack of companionship) is rated on a 4-point Likert-type scale ranging from 0 to 4. A higher score indicates a higher level of perceived loneliness
Measured: The scale will be used at baseline, the 5th week, and the 13rd week.
Sleep Condition Indicator (SCI)
The Sleep Condition Indicator (SCI), which is an 8-item scale with good validity and internal consistency (Cronbach's α = 0.82), is used to assess perceived loneliness (Meng et al., 2022). Each item (e.g., how would you rate your sleep quality?) is rated on a 5-point Likert-type scale ranging from 1 (never) to 4 (always). A higher score indicates a better sleep quality over the last month (Meng et al., 2022).
Measured: The scale will be used at baseline, the 5th week, and the 13rd week.
Chinese WHO 5-item Well-Being Index (WHO-5)
The Chinese WHO 5-item Well-Being Index (WHO-5) is a 5-item scale for assessing subjective well-being with satisfactory validity and internal consistency (Cronbach's α = 0.85; Fung et al., 2022). Each item (e.g., I have felt calm and relaxed) is rated on a 6-point Likert-type scale ranging from 0 (at no time) to 5 (all of the time). A higher score indicates a better well-being
Measured: The scale will be used at baseline, the 5th week, and the 13rd week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The MindfulCityU provides 8 online modules on mindfulness for participants to access and learn at home through their smartphones and/or computer. Participants of waitlist control group participants receive no active intervention at the initial stage and receive the same MindfulCityU at a later stage.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Young, City University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392632
- Sponsor's protocol ID
- HU-STA-00001949
- Acronym
- MindfulCityU
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oei TP, Sawang S, Goh YW, Mukhtar F. Using the Depression Anxiety Stress Scale 21 (DASS-21) across cultures. Int J Psychol. 2013;48(6):1018-29. doi: 10.1080/00207594.2012.755535. Epub 2013 Feb 21.
PubMed 23425257Xu S, Qiu D, Hahne J, Zhao M, Hu M. Psychometric properties of the short-form UCLA Loneliness Scale (ULS-8) among Chinese adolescents. Medicine (Baltimore). 2018 Sep;97(38):e12373. doi: 10.1097/MD.0000000000012373.
PubMed 30235699Philippe TJ, Sikder N, Jackson A, Koblanski ME, Liow E, Pilarinos A, Vasarhelyi K. Digital Health Interventions for Delivery of Mental Health Care: Systematic and Comprehensive Meta-Review. JMIR Ment Health. 2022 May 12;9(5):e35159. doi: 10.2196/35159.
PubMed 35551058Pan Y, Li F, Liang H, Shen X, Bing Z, Cheng L, Dong Y. Effectiveness of Mindfulness-Based Stress Reduction on Mental Health and Psychological Quality of Life among University Students: A GRADE-Assessed Systematic Review. Evid Based Complement Alternat Med. 2024 Feb 20;2024:8872685. doi: 10.1155/2024/8872685. eCollection 2024.
PubMed 38414520Linardon J, Torous J, Firth J, Cuijpers P, Messer M, Fuller-Tyszkiewicz M. Current evidence on the efficacy of mental health smartphone apps for symptoms of depression and anxiety. A meta-analysis of 176 randomized controlled trials. World Psychiatry. 2024 Feb;23(1):139-149. doi: 10.1002/wps.21183.
PubMed 38214614Li W, Zhao Z, Chen D, Peng Y, Lu Z. Prevalence and associated factors of depression and anxiety symptoms among college students: a systematic review and meta-analysis. J Child Psychol Psychiatry. 2022 Nov;63(11):1222-1230. doi: 10.1111/jcpp.13606. Epub 2022 Mar 16.
PubMed 35297041Fung SF, Kong CYW, Liu YM, Huang Q, Xiong Z, Jiang Z, Zhu F, Chen Z, Sun K, Zhao H, Yu P. Validity and Psychometric Evaluation of the Chinese Version of the 5-Item WHO Well-Being Index. Front Public Health. 2022 Mar 30;10:872436. doi: 10.3389/fpubh.2022.872436. eCollection 2022.
PubMed 35433612Fong TCT, Wan AHY, Wong VPY, Ho RTH. Psychometric properties of the Chinese version of Five Facet Mindfulness Questionnaire-short form in cancer patients: a Bayesian structural equation modeling approach. Health Qual Life Outcomes. 2021 Feb 10;19(1):51. doi: 10.1186/s12955-021-01692-1.
PubMed 33568146Cao CH, Liao XL, Gamble JH, Li LL, Jiang XY, Li XD, Griffiths MD, Chen IH, Lin CY. Evaluating the psychometric properties of the Chinese Depression Anxiety Stress Scale for Youth (DASS-Y) and DASS-21. Child Adolesc Psychiatry Ment Health. 2023 Sep 7;17(1):106. doi: 10.1186/s13034-023-00655-2.
PubMed 37679819
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MindfulCityU: Implementation and Evaluation of a Mindfulness Mobile Application for Promoting University Students' Mental Health
- ClinicalTrials.gov ID
- NCT07392632
- Acronym / sponsor ID
- MindfulCityU / HU-STA-00001949
- Conditions
- Depressive Symptoms
- Keywords
- Digital Mental Health Intervention, Mobile phone application-based, Mindfulness-based Intervention, Depression, Mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- City University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Feb 2026 (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.
The research aims to investigate the effectiveness a mobile phone application-based (app-based) mindfulness interventions for university students with mild depressive symptoms.
This study adopts a multicentre randomized control trial two arms research design. A randomised controlled trial will compare a newly designed mobile phone application-based (app-based) mindfulness interventions, named MindfulCityU, with a waitlist control group to determine whether the MindfulCityU produces better intervention outcomes on promoting mental health for university students, including depressive symptoms, mindfulness, and wellbeing. The MindfulCityU provides 8 online modules on mindfulness for participants to access and learn at home through their smartphones and/or computer. Participants of waitlist control group participants receive no active intervention at the initial stage and receive the same MindfulCityU at a later stage.
Participants will complete online standardized assessment tools on their intervention outcomes before and after the intervention and 2-months follow-up. The ethical considerations of this study were reviewed and approved by the Human and Artefacts Ethics Sub-Committee of the City University of Hong Kong in 2025.
Detailed description
University students worldwide face an unprecedented mental health crisis that has intensified significantly in recent years. Meta-analytic evidence demonstrates pooled prevalence rates of 33.6% for depression and 39% for anxiety among this population globally.
In Hong Kong, the mental health crisis among university students is particularly pronounced. Specifically, a longitudinal research conducted between 2016 and 2021 revealed a significant escalation in psychological distress. The study found that 68.5% of students reported diverse depressive symptoms, with 49.4% considered at risk for mental health problems. By 2021, these numbers had escalated dramatically, with depressive symptoms affecting up to 80% of students and at risk cases reaching 60%.
Digital Mindfulness-based Interventions Systematic reviews and meta-analyses provide substantial evidence supporting mindfulness-based interventions (MBIs) for university students. Additionally, mobile phone application-based (app-based) or digital mindfulness interventions have demonstrated particularly promising outcomes among university student populations. It offers several distinct advantages that make them particularly suitable for university populations, including 24/7 accessibility that accommodates irregular student schedules, anonymity that reduces stigma-related barriers to help-seeking, cost-effectiveness that addresses financial constraints common among students, scalability that can reach large numbers of students simultaneously, and personalization capabilities that can adapt to individual needs and preferences.
However, there is a lack of university-specific adaptations in current digital mindfulness interventions. Most existing applications are designed for general adult populations rather than addressing the unique stressors and developmental challenges facing university students, such as academic pressure, social adjustment difficulties, identity development concerns, and career uncertainty.
Research Objective This study aims to addresses these identified gaps by developing and evaluating a culturally adapted, university-specific digital mindfulness intervention, named MindfulCityU. Additionally, this study will examine the mechanisms underlying therapeutic change.
Research Methods This research study adopts mixed methods research design, involving both quantitative and qualitative study. By adopting a randomized controlled trial, the quantitative study aims to investigate the effectiveness of the MindfulCityU on improving mental health for university students. The qualitative study aims to examine the benefits, advantages and limitations of the MindfulCityU from the users' perspective.
Quantitative Research Method
Research Questions and Hypotheses Primary Research Questions RQ1: Does the MindfulCityU intervention improve mental health outcomes (depression, anxiety, stress, well-being) among Hong Kong university students compared to waitlist controls? RQ2: Does app engagement moderate intervention effectiveness, with higher engagement levels predicting greater therapeutic improvements? Secondary Research Questions RQ3: Does baseline mental health symptom severity moderate intervention effectiveness? RQ4: How do participants experience integrating digital mindfulness practices into their daily university routines?
Primary Hypotheses H1 (Primary Effectiveness): Participants receiving the MindfulCityU intervention will demonstrate significantly greater improvements in DASS-Y scores (depression, anxiety, stress) and WHO-5 well-being scores compared to waitlist controls.
H2 (Engagement Moderation): App engagement levels will moderate intervention effectiveness, with higher engagement predicting larger therapeutic gains.
H3 (Baseline Moderation): Baseline symptom severity will moderate intervention effectiveness, with participants having moderate symptoms showing greater improvements than those with mild symptoms.
H4 (Secondary Outcomes): The intervention will produce significant improvements in mindfulness skills (FFMQ-SF), loneliness (UCL-8), and sleep quality (SCI) compared to controls.
Study Design This investigation employs a two-arm randomized controlled trial design to evaluate the efficacy of the MindfulCityU intervention while maintaining scientific rigor and minimizing potential confounding factors. The study design incorporates a 4-week intervention period followed by a 2-month follow-up assessment, allowing for evaluation of both immediate therapeutic effects and sustained benefits over time.
The MindfulCityU application adapted from Professor Daniel Young's established mindfulness curriculum into an interactive digital format specifically adapted for university students and Hong Kong's cultural context. Prior to the main trial implementation, a brief pilot testing phase involving approximately 15 students will be conducted to ensure optimal technical functionality, user experience, and cultural appropriateness.
Power Analysis and Sample Size Justification The sample size calculation is based on previous meta-analytic findings indicating moderate effect sizes for digital mindfulness interventions in university populations. With α = 0.05, power = 0.80, and accounting for an anticipated 20% attrition rate typical in digital intervention studies, the required sample size is 120 participants (60 per group).
Participants and Recruitment The study will recruit 120 CityU students through open promotion and recruitment. Participants will be equal assigned to intervention (n=60) and control (n=60) conditions.
Inclusion criteria (i) current CityU undergraduate or postgraduate students; (2) aged 18-30 years; (3) possess smartphone ownership and reliable internet access necessary for intervention engagement; (4) having mild to moderate depressive symptoms as assessed by the DASS-Y Depression subscale, and a DASS-Y Depression subscale score between 10-23 mild to moderate depressive symptoms; (5) able to listen and read simplified Chinese, Cantonese or English, reflecting Hong Kong's trilingual context.
(6) provide informed consent.
Exclusion criteria:
- a DASS-Y Depression subscale score above 23 on the DASS-Y Depression subscale, indicating severe symptoms;
- reporting active suicidal ideation or self-harm behaviors
- current engagement in psychotherapy or recent medication changes within the previous four weeks;
- planning to leave the university during the study period.
In particular, participants reporting suicidal ideation, self-harm behaviors or severe depressive symptoms will be immediately referred to crisis intervention services.
Randomization and Blinding Procedures Participants will be randomly allocated to intervention or control conditions using computer-generated randomization sequences with concealed allocation to prevent selection bias. Block randomization will be employed to ensure balanced group sizes throughout the recruitment period. While participants cannot be blinded to their intervention assignment due to the nature of the intervention, outcome assessors will remain blinded to group allocation during data collection and analysis phases to minimize assessment bias.
Intervention Description The MindfulCityU application represents a comprehensive digital mindfulness intervention specifically designed for university students in Hong Kong's cultural context.
The core curriculum consists of eight structured sessions delivered over four weeks, with two sessions released each week to maintain engagement while allowing adequate time for skill development. The first week introduces fundamental mindfulness concepts and practices through Session 1, which covers Introduction to Mindfulness and the Three-Minute Breathing Space technique, and Session 2, which focuses on Body Scan practices and developing physical awareness. These foundational sessions establish basic mindfulness skills and familiarity with core practices.
The second week builds upon foundational skills through Session 3, which introduces Mindful Movement and Stretching practices that integrate physical activity with mindfulness awareness, and Session 4, which teaches the Breathing Space for Difficult Emotions technique, providing practical tools for managing emotional distress. These sessions help participants apply mindfulness skills to common university stressors.
The third week addresses cognitive aspects of mindfulness through Session 5, which focuses on Working with Difficult Thoughts and Feelings, and Session 6, which teaches the concept that Thoughts Are Not Facts through cognitive defusion techniques. These sessions help participants develop a different relationship with negative thinking patterns common among university students.
The fourth week integrates advanced practices through Session 7, which covers Acceptance and Self-Compassion principles particularly relevant for perfectionistic university students, and Session 8, which introduces Loving-Kindness practices and strategies for Maintaining Practice beyond the intervention period.
Beyond the structured curriculum, the application provides daily practice options that include guided meditations ranging from 5-20 minutes in length, mindful breathing exercises that can be practiced between classes, body awareness practices suitable for dormitory settings, and informal mindfulness reminders integrated throughout the day.
Additional features enhance user engagement and safety through progress tracking and streak counters that provide motivational feedback, mood check-ins that enable pattern recognition over time, crisis resources and professional referral pathways for students experiencing severe distress, and integration with CityU counseling services to facilitate seamless transitions to professional care when needed.
Control Condition Waitlist control participants receive access to standard university counselling services and general mental health information emails. Full access to the MindfulCityU application is provided following the 4-week waiting period.
Outcome Assessment Tools.
The primary intervention outcome is improvement in mental health, including depression, anxiety and stress, assessed with the 21-item DASS.
The secondary intervention outcome is improvement in mindfulness, psychological well-being and stress reduction, which are assessed by:
The 20-item Chinese Five Facets Mindfulness Questionnaire Short Form The 8-item UCLA Loneliness Scale (ULS-8) The 8-item Sleep Condition Indicator (SCI) The 5-item Chinese WHO 5-item Well-Being Index (WHO-5)
Data Analysis. An analysis will be performed in accordance with the intent-to-treat principle using multiple imputation method analysis for any missing data. Between group intervention effects will be investigated by using repeated measures of linear mixed model for repeated measures. In the linear mixed model, time, group, and time × group interactions were entered as fixed effects, with a random intercept for the subject. Effect sizes (Hedges' g) are calculated, with values of 0.2, 0.5, and 0.8 considered as small, medium, and large respectively. The predictive values of individual adherence of digital iMBI are analyzed using multiple linear regression analysis, with improved outcome assessment scores as dependent variables.
Qualitative Research Method
Objective. This qualitative study aims to explore the benefits, advantages and limitations of the MindfulCityU from the users' perspective.
Research Design. The qualitative study uses an interpretative interview method with purposive sampling. Semi-structured interviews with 15-20 participants in the current sample will provide rich qualitative data to complement quantitative findings and enhance understanding of intervention effects from participants' perspectives. Each interview will last for 0.5-1 hour. Interview topics will explore intervention experience, perceived benefits and limitations, barriers to engagement, suggested improvements, and integration of mindfulness practices into daily university life. Interviews will be conducted by trained research assistants using standardized interview guides while allowing flexibility to explore emerging themes.
Data collection. Each in-depth interview will be facilitated by a research staff with an interview protocol developed for this study. Participants will be asked questions such as the following: How relevant were the language, examples, and content of today's module of the mindful app to your daily life? How difficult or easy is it to use this app? How often do you use this app? In real life, under what circumstances do you first apply the method you learn from the app? Is there any particular time using the app when you feel "This app really help me"? Do you have any other feedback regarding content, examples, exercises, or app design? The content of the semi-structured in-depth interviews will be audio-recorded and transcribed into verbatim by the research team.
Reflective thematic analysis will be used to identify, analyse and report themes so that themes can be developed both inductively (i.e. data-driven) and deductively (i.e. theory-driven). The research team will systematically read and re-read the transcripts, following the six stages of analysis, including: (1) becoming familiar with the data, (2) generating codes, (3) constructing themes, (4) reviewing potential themes, (5) defining and naming themes, and (6) producing the report. Two research staff compare, review and refine the codes, categories and themes until they reach agreement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The MindfulCityU provides 8 online modules on mindfulness for participants to access and learn at home through their smartphones and/or computer. Participants of waitlist control group participants receive no active intervention at the initial stage and receive the same MindfulCityU at a later stage.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: MindfulCityUThe MindfulCityU provides 8 online modules on mindfulness for participants to access and learn at home through their smartphones and/or computer. |
| Waitlist Control | Other | Other: Waitlist controlThe waitlist-controlled group receive standard services from the schools, universities or youth service units. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- current undergraduate or postgraduate students; (ii) aged 18-30 years; (iii) possessing smartphone ownership and reliable internet access necessary for intervention engagement; (iv) having a score between 10-23 on the DASS-Y Depression subscale indicating a mild to moderate depressive symptom; and (v) provide informed consent
Key exclusion criteria (1 listed)
- students currently engaged in formal mindfulness training exceeding one session per week will be excluded to prevent confounding effects from concurrent mindfulness practice; (ii) those scoring above 23 on the DASS-Y Depression subscale, indicating severe symptoms, will be excluded and referred to appropriate clinical services to ensure their safety and access to needed care; (iii) students reporting active suicidal ideation or self-harm behaviors will be immediately referred to crisis intervention services and excluded from study participation to prioritize their safety; (iv) current engagement in psychotherapy or recent medication changes within the previous four weeks; (v) students planning to leave the university during the study period.
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 |
|---|---|---|
| MindfulCityUThe MindfulCityU provides 8 online modules on mindfulness for participants to access and learn at home through their smartphones and/or computer. Each participant is expected to complete 8 modules of mindfulness within four weeks, with two sessions released each week to maintain engagement while allowing adequate time for skill development. Beyond the structured curriculum, the application provides daily practice options that accommodate varying time constraints and preferences. These include guided meditations ranging from 5-20 minutes in length, mindful breathing exercises that can be practiced between classes, body awareness practices suitable for dormitory settings, and informal mindfulness reminders integrated throughout the day. | Behavioural | Intervention group |
| Waitlist controlThe non-active waitlist-controlled group participants receive standard services from the schools, universities or youth service units. Full access to the digital MBI application is provided following the 4-week waiting period | Other | Waitlist Control |
Primary outcome
Chinese Depression Anxiety Stress Scale Youth Version (DASS-Y)
Time frame: This scale will be used at baseline, the 5th week, and the 13rd week.
The primary intervention outcome is improvement in mental health, including depression, anxiety and stress, assessed with the 21-item DASS-Y which has been demonstrated good validity and reliability (α = 0.80 for anxiety subscale, 0.83 for depression subscale, 0.82 for stress subscale, and 0.92 for whole scale; Cao et al., 2023). Each item (e.g. I felt down-hearted and blue) is scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The scores are summed over the items with higher scores indicating a higher severity of symptoms
4 secondary outcomes
Chinese Five Facets Mindfulness Questionnaire Short Form (FFMQ)
Time frame: This scale will be used at baseline, the 5th week, and the 13rd week.
UCLA Loneliness Scale (ULS-8)
Time frame: The scale will be used at baseline, the 5th week, and the 13rd week.
Sleep Condition Indicator (SCI)
Time frame: The scale will be used at baseline, the 5th week, and the 13rd week.
Chinese WHO 5-item Well-Being Index (WHO-5)
Time frame: The scale will be used at baseline, the 5th week, and the 13rd week.
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 Apr 2026.
- Background: PubMed 23425257Oei TP, Sawang S, Goh YW, Mukhtar F. Using the Depression Anxiety Stress Scale 21 (DASS-21) across cultures. Int J Psychol. 2013;48(6):1018-29. doi: 10.1080/00207594.2012.755535. Epub 2013 Feb 21.
- Background: PubMed 30235699Xu S, Qiu D, Hahne J, Zhao M, Hu M. Psychometric properties of the short-form UCLA Loneliness Scale (ULS-8) among Chinese adolescents. Medicine (Baltimore). 2018 Sep;97(38):e12373. doi: 10.1097/MD.0000000000012373.
- Background: PubMed 35551058Philippe TJ, Sikder N, Jackson A, Koblanski ME, Liow E, Pilarinos A, Vasarhelyi K. Digital Health Interventions for Delivery of Mental Health Care: Systematic and Comprehensive Meta-Review. JMIR Ment Health. 2022 May 12;9(5):e35159. doi: 10.2196/35159.
- Background: PubMed 38414520Pan Y, Li F, Liang H, Shen X, Bing Z, Cheng L, Dong Y. Effectiveness of Mindfulness-Based Stress Reduction on Mental Health and Psychological Quality of Life among University Students: A GRADE-Assessed Systematic Review. Evid Based Complement Alternat Med. 2024 Feb 20;2024:8872685. doi: 10.1155/2024/8872685. eCollection 2024.
- Background: PubMed 38214614Linardon J, Torous J, Firth J, Cuijpers P, Messer M, Fuller-Tyszkiewicz M. Current evidence on the efficacy of mental health smartphone apps for symptoms of depression and anxiety. A meta-analysis of 176 randomized controlled trials. World Psychiatry. 2024 Feb;23(1):139-149. doi: 10.1002/wps.21183.
- Background: PubMed 35297041Li W, Zhao Z, Chen D, Peng Y, Lu Z. Prevalence and associated factors of depression and anxiety symptoms among college students: a systematic review and meta-analysis. J Child Psychol Psychiatry. 2022 Nov;63(11):1222-1230. doi: 10.1111/jcpp.13606. Epub 2022 Mar 16.
- Background: PubMed 35433612Fung SF, Kong CYW, Liu YM, Huang Q, Xiong Z, Jiang Z, Zhu F, Chen Z, Sun K, Zhao H, Yu P. Validity and Psychometric Evaluation of the Chinese Version of the 5-Item WHO Well-Being Index. Front Public Health. 2022 Mar 30;10:872436. doi: 10.3389/fpubh.2022.872436. eCollection 2022.
- Background: PubMed 33568146Fong TCT, Wan AHY, Wong VPY, Ho RTH. Psychometric properties of the Chinese version of Five Facet Mindfulness Questionnaire-short form in cancer patients: a Bayesian structural equation modeling approach. Health Qual Life Outcomes. 2021 Feb 10;19(1):51. doi: 10.1186/s12955-021-01692-1.
- Background: PubMed 37679819Cao CH, Liao XL, Gamble JH, Li LL, Jiang XY, Li XD, Griffiths MD, Chen IH, Lin CY. Evaluating the psychometric properties of the Chinese Depression Anxiety Stress Scale for Youth (DASS-Y) and DASS-21. Child Adolesc Psychiatry Ment Health. 2023 Sep 7;17(1):106. doi: 10.1186/s13034-023-00655-2.
- Individual participant dataSharing planned: No
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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 MindfulCityU in people with Depressive Symptoms, run by City 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Apr 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 Kim-wan Daniel YOUNG, PhD (+85234428954 ext. 8954, dkwyoung@cityu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese Depression Anxiety Stress Scale Youth Version (DASS-Y) (time frame: This scale will be used at baseline, the 5th week, and the 13rd week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07392632, which also lists 9 linked publications.
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 Apr 2026.