Promoting Mental Health for University Students in China through Mindfulness: A Pilot Randomized Controlled Trial

Last registered on February 01, 2025

Pre-Trial

Trial Information

General Information

Title
Promoting Mental Health for University Students in China through Mindfulness: A Pilot Randomized Controlled Trial
RCT ID
AEARCTR-0015090
Initial registration date
December 27, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
December 29, 2024, 11:16 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
February 01, 2025, 3:50 PM EST

Last updated is the most recent time when changes to the trial's registration were published.

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Primary Investigator

Affiliation
Stanford

Other Primary Investigator(s)

PI Affiliation
Stanford University
PI Affiliation
Stanford University School of Medicine
PI Affiliation
Stanford University School of Medicine
PI Affiliation
Beijing Normal University Department of Psychology
PI Affiliation
Fudan University School of Public Health
PI Affiliation
Stanford University

Additional Trial Information

Status
In development
Start date
2025-03-10
End date
2026-06-01
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Mindfulness-Based Programs (MBPs), rooted in contemplative practices, have emerged as promising interventions for promoting mental well-being and resilience. Unfortunately, few if any large-scale studies have assessed the efficacy of MBPs for university students in China, a population with a high prevalence of mental health issues. The primary goal of this pilot study is to evaluate the impact of an eight-week mindfulness-based program specifically tailored for university students compared to a control group that will receive an educational intervention unrelated to mindfulness. We will investigate the effects on mental illness symptoms, stress, student inner resources such as mindfulness, emotion regulation skills, and other indicators of well-being such as sleep quality and and academic performance. The study design will be a two-arm randomized controlled trial with undergraduate students at two universities in China.
External Link(s)

Registration Citation

Citation
Abbey, Cody et al. 2025. "Promoting Mental Health for University Students in China through Mindfulness: A Pilot Randomized Controlled Trial." AEA RCT Registry. February 01. https://doi.org/10.1257/rct.15090-2.0
Experimental Details

Interventions

Intervention(s)
Students in the treatment group will receive 90-minute weekly mindfulness sessions tailored for university students in China for a total of eight weeks. They will be asked to conduct at least 30 minutes of formal mindfulness practice outside of class, six days per week, as well as engage in informal mindfulness practice.
Intervention Start Date
2025-03-24
Intervention End Date
2025-06-01

Primary Outcomes

Primary Outcomes (end points)
-Symptoms of anxiety
-Symptoms of depression
-Self-perceived stress
-Physiological indicators of stress
Primary Outcomes (explanation)
-Anxiety symptoms will be measured with the General Anxiety Disorder-7 (GAD-7)
-Depression symptoms will be measured with the Patient Health Questionnaire (PHQ-9)
-Self-perceived stress will be measured by the Perceived Stress Scale (PSS)
-Physiological indicators of stress will be measured with saliva measurements of cortisol and wearable measurements of heart-rate variability

Secondary Outcomes

Secondary Outcomes (end points)
emotion regulation, trait and state mindfulness, coping styles, self-compassion, purpose, loneliness, parent attachment, smartphone addiction, positive and negative affect, perceived healthy diet, sleep quality, flourishing, neuroticism, somatic symptoms, academic performance, procrastination, face saving, lifestyle behaviors, career plans and outcome
Secondary Outcomes (explanation)
Emotion regulation: Emotion Regulation Questionnaire
Trait and state mindfulness: Five Facet Mindfulness Questionnaire-Short Form, Multidimensional State Mindfulness Questionnaire
Coping styles: Simplified Coping Style Questionnaire, Coping Strategies Scale
Self-compassion: Self-Compassion Scale
Purpose: Claremont Purpose Scale
Loneliness: UCLA Loneliness Scale
Parent attachment: Inventory of Parent and Peer Attachment
Smartphone addiction: Smartphone Addiction Scale
Affect: Positive and Negative Affect Schedule short form
Perceived healthy diet: Perceived Healthy Diet Scale
Sleep quality: Pittsburgh Sleep Quality Inventory
Flourishing: Flourishing Scale
Neuroticism: Big Five Personality Inventory (neuroticism subscale)
Somatic symptoms: Somatic Symptom Scale
Academic performance: GPA
Procrastination: Short General Procrastination Scale
Face saving: Face Saving Scale
Lifestyle behaviors: items about daily habits
Career outcomes: items about future carer goals and outcome after graduation

Experimental Design

Experimental Design
We will conduct a pilot study with university students recruited online and offline from 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. By assuring the similarity of characteristics (such as baseline mental health, sex, etc.) between the treatment and control groups at baseline, we can confidently attribute any significant differences in outcomes between control and intervention groups to the program.

In this pilot study, 112 students will be randomly allocated into two experimental arms (in-person MBP and a pure control). Using STATA 16 software (https://www.stata.com/), with 80% power, and a significance level of 0.05, we determined that a sample size of 51 students per arm was required to detect a difference of 0.5 standard deviations in outcome measures. Our recruitment of 56 students per arm (112 in total) allows for 10% attrition.
Experimental Design Details
Not available
Randomization Method
The assignment of the subjects will be carried out after the evaluation by a member of the research group through a random sequence generated by computer.
Randomization Unit
Randomization will be conducted on the level of the individual student.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
2 universities
Sample size: planned number of observations
112 students
Sample size (or number of clusters) by treatment arms
In-person mindfulness group: 56 students
Control group: 56 students
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
0.5 SD (Cohen's d)
IRB

Institutional Review Boards (IRBs)

IRB Name
Stanford University Institutional Review Board
IRB Approval Date
2024-12-18
IRB Approval Number
75117