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Promoting mental health for university students in China through mindfulness

Promoting mental health for university students in China through mindfulness: a pilot randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12007110
Enrollment
112
Registered
2025-02-10
Start date
2025-02-17
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of severe mental disorders in students with mild to moderate mental health symptoms Mental and Behavioural Disorders

Interventions

Current interventions as of 09/04/2025: We will conduct a pilot study with 112 university students recruited online and offline from universities in China. Using the RCT method of impact evaluation,

Sponsors

Stanford University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 09/04/2025: 1. Undergraduate students enrolled in participating universities in China 2. 18+ years of age 3. Provide a written consent form 4. Can read, write, and speak Mandarin Chinese 5. Students reporting mild-severe levels of distress (PHQ-9 >= 5; GAD-7 >= 5) _____ Previous inclusion criteria: 1. Undergraduate students enrolled in participating universities in China 2. 18+ years of age 3. Provide a written consent form 4. Chinese citizen 5. Can read, write, and speak Mandarin Chinese 6. Students reporting mild-moderate levels of distress (PHQ-9 = 5-10; GAD-7 =5-10)

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 09/04/2025: The research team will screen for the following prior to enrollment in the study among potentially eligible participants: 1. Taking psychopharmaceutical medications 2. Receiving psychotherapy 3. Severe suicidality (severe suicidal ideation, intent and plan, recent suicidal attempts) and/or risk of causing harm to others 4. Presenting psychotic symptoms such as hallucinations and delusions* 5. Previously received structured mindfulness instruction 6. Has a structured meditation practice (practicing once per week or more) *Students detected to potentially have the above conditions will be further screened by a licensed counselor and then referred out for a counseling/medical evaluation through the established university referral mechanism. _____ Previous exclusion criteria: The research team will screen for the following prior to enrollment in the study among potentially eligible participants: 1. Taking psychopharmaceutical medications 2. Presenting psychotic symptoms such as hallucinations and delusions 3. High suicidality (severe suicidal ideation, intent and plan, recent suicidal attempts) 4. Cognitive impairment 5. Major depressive disorder 6. Severe anxiety 7. Other conditions that might compromise group attendance such as severe social anxiety and inadequately treated PTSD* *Students detected to potentially have the above conditions will be further screened by a licensed counselor and then referred out for a counseling/medical evaluation through the established university referral mechanism.

Design outcomes

Primary

MeasureTime frame
1. Anxiety symptoms will be measured using the General Anxiety Disorder Scale (GAD-7) at baseline, weekly during the intervention, and endline 2. Depression symptoms will be measured using the Patient Health Questionnaire Scale (PHQ-9) at baseline, weekly during the intervention, and endline 3. Stress (physiological) will be measured using cortisol levels. The cortisol levels will be measured starting one week prior to the intervention, for three days in a row, three times per day at consistent times. At the end of the intervention, the cortisol levels will be measured on days 5-7 after participation in the program ends, three times per day (at the same times each day as before the intervention). Stress (physiological) will also be measured using heart rate variability, measured continuously during the intervention via a wearable device 4. Perceived stress is measured using the Perceived Stress Scale (PSS), measured at baseline, weekly during the intervention, and endline

Secondary

MeasureTime frame
1. Emotion regulation will be measured using the Emotion Regulation Questionnaire (ERQ) at baseline and endline 2. Coping strategies will be measured using the Coping Strategies Scale and the Simplified Coping Styles Questionnaire at baseline and endline 3. Adverse Childhood Experiences will be measured using the Adverse Childhood Experiences International Questionnaire (ACES-IQ) at baseline 4. Mindfulness will be measured using the short-form of the Five Facet Mindfulness Questionnaire (FFMQ-SF) at baseline and endline, and measured weekly during the intervention 5. Loneliness will be measured using the short-form of the 6-item UCLA Loneliness Scale at baseline and endline 6. Parent attachment will be measured using the Inventory of Parent and Peer Attachment (IPPA) at baseline and endline 7. Smartphone addiction will be measured using the Smartphone Addiction Scale (SAS) at baseline and endline 8. Positive and negative affect will be measured using the Positive and Negative Affect Schedule -short form (PANAS-SF) at baseline and endline, and measured weekly during the intervention 9. State mindfulness will be measured using the Multidimensional State Mindfulness Questionnaire (MSMQ) at baseline and endline, and measured weekly during the intervention 10. Recent stress will be measured using the Adolescent Self-Rating Life Events Check list (ASLEC) at baseline and endline 11. Diet will be measured using the Perceived Healthy Diet Scale at baseline and endline 12. Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and endline 13. Flourishing will be measured using the Flourishing Scale (FS) at baseline and endline 14. Academic performance will be measured using the semester GPA and national English test results at baseline and endline 15. Lifestyle behaviors will be measured using items asking about the amount and frequency of behaviors such as screen time, exercise, and sleep, at baseline and endline 16. Neuroticism will be

Countries

China

Contacts

Public ContactCody;Huan Abbey;Wang

;

cjabbey@stanford.edu;huanw@stanford.edu+1 650-724-9254;+1 650-724-9254

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026