NCT07392632

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 24, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

January 20, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Digital Mental Health InterventionMobile phone application-basedMindfulness-based InterventionDepressionMindfulness

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    This scale will be used at baseline, the 5th week, and the 13rd week.

  • UCLA Loneliness Scale (ULS-8)

    The scale will be used at baseline, the 5th week, and the 13rd week.

  • Sleep Condition Indicator (SCI)

    The scale will be used at baseline, the 5th week, and the 13rd week.

  • Chinese WHO 5-item Well-Being Index (WHO-5)

    The scale will be used at baseline, the 5th week, and the 13rd week.

Study Arms (2)

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.

Behavioral: MindfulCityU

Waitlist Control

OTHER

The waitlist-controlled group receive standard services from the schools, universities or youth service units.

Other: Waitlist control

Interventions

MindfulCityUBEHAVIORAL

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.

Intervention group

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

Waitlist Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (i) 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

You may not qualify if:

  • (i) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City University of Hong Kong

Kowloon Tong, Hong Kong, Hong Kong

Location

Related Publications (9)

  • 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.

    PMID: 23425257BACKGROUND
  • Xu 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.

    PMID: 30235699BACKGROUND
  • Philippe 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.

    PMID: 35551058BACKGROUND
  • Pan, Y., Li, F., Liang, H., Shen, X., Bing, Z., Cheng, L., & Dong, Y. (2024). Effectiveness of Mindfulness-Based Stress Reduction on Mental Health and Psychological Quality of Life among University Students: A GRADE-Assessed Systematic Review. Evidence-Based Complementary and Alternative Medicine : eCAM, 2024, 8872685. https://doi.org/10.1155/2024/8872685

    BACKGROUND
  • Linardon 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.

    PMID: 38214614BACKGROUND
  • Li, W., Zhao, Z., Chen, D., Peng, Y., & Lu, Z. (2022). Prevalence and associated factors of depression and anxiety symptoms among college students: A systematic review and meta-analysis. Journal of Child Psychology and Psychiatry, and Allied Disciplines, 63(11), 1222-1230. https://doi.org/10.1111/jcpp.13606

    BACKGROUND
  • Fung, S., Kong, C. Y. W., Liu, Y., Huang, Q., Xiong, Z., Jiang, Z., Zhu, F., Chen, Z., Sun, K., Zhao, H., & Yu, P. (2022). Validity and Psychometric Evaluation of the Chinese Version of the 5-Item WHO Well-Being Index. Frontiers in Public Health, 10. https://doi.org/10.3389/fpubh.2022.872436

    BACKGROUND
  • Fong 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.

    PMID: 33568146BACKGROUND
  • Cao, C., Liao, X., Gamble, J. H., Li, L., Jiang, X.-Y., Li, X.-D., Griffiths, M. D., Chen, I.-H., & Lin, C.-Y. (2023). Evaluating the psychometric properties of the Chinese Depression Anxiety Stress Scale for Youth (DASS-Y) and DASS-21. Child and Adolescent Psychiatry and Mental Health, 17(1), 106. https://doi.org/10.1186/s13034-023-00655-2

    BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Kim-wan Daniel YOUNG, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
A researcher, who is blinded to the randomized allocation of participants and does not involve in the intervention delivery, will do the data collection at before and after the intervention and 2-month follow up. Actually, participants will complete online standardized assessment tools on their intervention outcomes before and after the intervention and 2-month follow-up.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 6, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

April 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations