Effectiveness of a digital mindfulness-based program on the mental health of college students: A randomized controlled trial in China
| ISRCTN | ISRCTN34437131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34437131 |
| Sponsor | Stanford University |
| Funder | Cyrus Tang Foundation |
- Submission date
- 08/09/2026
- Registration date
- 24/09/2026
- Last edited
- 22/09/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Mindfulness-based programs (MBPs), rooted in contemplative practices, have emerged as promising interventions for promoting mental well-being and resilience. Unfortunately, no large-scale study has assessed the efficacy of a digitally delivered MBP for university students in China, a population with a high prevalence of mental health issues. Building off of a study of an in-person mindfulness-based program implemented in fall 2025, the primary goal of this study is to evaluate the impact of an app-based mindfulness-based program specifically tailored for university students. We will investigate the effects on the primary outcome of anxiety and depression symptoms.
Who can participate?
Undergraduate students at the participating university with mild to severe symptoms of anxiety and/or depression (see inclusion and exclusion criteria above).
What does the study involve?
Students in the intervention group will participate in an eight-week mindfulness program (asynchronously delivered via an app).
What are the possible benefits and risk of participating?
Potential benefits are improved mental and physical health. Students will also receive small financial rewards for participating in the study.
Potential risks are unlikely, but may include increased awareness of mental or physical discomfort, as well as time stress due to extra time dedicated to participation.
Where is the study run from?
Overall, students from three universities will participate in the study. The China-based PI (Prof. Lian Tong) will oversee the study implementation, facilitating participant recruitment and data collection. Researchers at Stanford University will work with these partners to implement the project.
When is the study starting and how long is it expected to run for?
The study will begin recruitment for the September 2026. The intervention is planned to begin in October and last for eight weeks.
Who is funding the study?
Study funders include the Cyrus Tang Foundation, the Enlight Foundation, and Vincent Woo Foundation.
Who is the main contact?
Researchers may contact Dr. Huan Wang (huanw@stanford.edu), Dr. Hui-Qi Tong (htong@stanford.edu), Dr. Lian Tong (ltong@fudan.edu.cn), or Cody Abbey (cjabbey@stanford.edu) for more information about this study.
Contact information
Scientific, Public
616 Jane Stanford Way
Stanford
94305
United States of America
| Phone | +1 650-724-9254 |
|---|---|
| cjabbey@stanford.edu |
Principal investigator, Scientific, Public
616 Jane Stanford Way
Stanford
94305
United States of America
| Phone | +1 650-724-9254 |
|---|---|
| huanw@stanford.edu |
Principal investigator, Scientific, Public
616 Jane Stanford Way
Stanford
94305
United States of America
| Phone | +1 650-724-9254 |
|---|---|
| htong@stanford.edu |
Scientific, Public
616 Jane Stanford Way
Stanford
94305
United States of America
| Phone | +1 650-724-9254 |
|---|---|
| xinshe@stanford.edu |
Scientific, Public, Principal investigator
No. 220 Handan Road, Yangpu District
Shanghai
200433
China
| Phone | +86-21-65642250 |
|---|---|
| ltong@fudan.edu.cn |
Principal investigator
616 Jane Stanford Way E501
Stanford
CA 94305
United States of America
| rozelle@stanford.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Placebo |
| Assignment | Single |
| Purpose | Prevention |
| Scientific title | Effectiveness of a digital mindfulness-based intervention on the mental health of college students: A randomized controlled trial in China |
| Study objectives | Evaluate the effect of a digitally delivered mindfulness-based program on anxiety and depression symptoms in college students |
| Ethics approval(s) |
Approved 18/12/2024, Stanford University Institutional Review Board (1705 El Camino Real Palo Alto, Stanford, 94305, United States of America; +1 8282803225; irbnonmed@stanford.edu), ref: IRB-75117 |
| Health condition(s) or problem(s) studied | Prevention of chronic mental conditions in students presenting depression and/or anxiety symptoms |
| Intervention | Intervention: We will deliver an eight-week, mindfulness-based program via a phone-based digital platform. The platform will provide students access to mindfulness recordings and videos as well as check-in features to self-report practices and track their progress. Participants will learn foundational principles related to the role of mindfulness in specific domains such as responding to stress, mindful communication in relationships, and gratitude. They will also learn formal mindfulness practices (e.g., sitting meditation, body scan, qigong) and informal mindfulness practices (e.g., mindful eating, mindful walking, and mindful daily routine activities ) via the platform. Treatment group students will be asked to commit to completing assigned mindfulness practice independently throughout the intervention period. Participants assigned to the control group will receive no other intervention during the program period (pure control). Study design: The experimental design will be a randomized study with undergraduate students recruited from three universities in China. Using the RCT method of impact evaluation, we will be able to ensure that the intervention and control groups have similar characteristics at baseline, which is vital for drawing a causal connection between the intervention and any changes in student outcomes. By assuring the similarity of characteristics (such as sex, baseline mental health, etc.) between the treatment and control groups at baseline, we can confidently attribute any significant differences in outcomes between the control and intervention group to the program. We will use an online random number generator to assign students to either digital mindfulness treatment or control group. All study participants will receive adequate financial compensation for participating in the study. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 15/01/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | All |
| Target sample size at registration | 250 |
| Key inclusion criteria | 1. Undergraduate student enrolled at participating universities in China 2. Reporting mild, moderate, or severe symptoms of depression and/or anxiety (PHQ-9>=5; GAD-7 >=5) 3. Willing to engage in consistent use with the digital program and engage in mindfulness practice at home 4. 18 years or older |
| Key exclusion criteria | 1. Has moderate/severe risk of self-harm or harm to others (thoughts of self-harm and/or harm to others occurring several or more days per week) 2. Has received formal, teacher-led mindfulness meditation training before and/or has a regular meditation practice (once or more per week over the past two months) 3. Is currently receiving psychotherapy and/or taking psychiatric medication 4. Presenting symptoms of psychoticism 5. Active substance (alcohol) abuse 6. Presenting symptoms of unresolved complex trauma |
| Date of first enrolment | 20/09/2026 |
| Date of final enrolment | 01/10/2026 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 26/09/2008 | 08/09/2026 | No | No |
Additional files
- 50245 Analysis Plan for Digital Mindfulness Project_2026.09.08_clean.pdf
- Statistical Analysis Plan
Editorial Notes
21/09/2026: Trial's existence confirmed by Stanford University.
