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Trial Title
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Before
Promoting Mental Health for University Students in China through Mindfulness
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Promoting Mental Health for University Students in China through Mindfulness: A Pilot Randomized Controlled Trial
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Abstract
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Before
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 study is to evaluate the impact of an eight-week mindfulness-based program specifically tailored for university students. We will investigate the effects on mental illness symptoms, stress, student inner resources such as mindfulness, emotion regulation skills, other indicators of well-being such as sleep quality and and academic performance. Additionally, we intend to assess how the impact of the MBP varies when delivered in person or online. The study design will be a three-arm randomized controlled trial with undergraduate students enrolled at different tiers of universities in China.
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After
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.
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Trial Start Date
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September 01, 2025
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March 10, 2025
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Trial End Date
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Before
December 31, 2028
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June 01, 2026
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Last Published
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December 29, 2024 11:16 PM
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February 01, 2025 03:50 PM
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Intervention (Public)
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Before
Students in the treatment groups will receive weekly 90-minute 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.
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After
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.
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Intervention Start Date
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September 15, 2025
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March 24, 2025
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Intervention End Date
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November 30, 2025
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June 01, 2025
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Primary Outcomes (End Points)
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Before
-Symptoms of anxiety
-Symptoms depression
-Self-perceived stress
-Physiological indicators of stress
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After
-Symptoms of anxiety
-Symptoms of depression
-Self-perceived stress
-Physiological indicators of stress
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Primary Outcomes (Explanation)
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Before
-Anxiety symptoms will be measured with the 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
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After
-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
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Experimental Design (Public)
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Before
We will conduct a pilot study and a randomized controlled trial (RCT) 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 family income, age, 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.
For the pilot study, which we will implement prior to the full-scale RCT, a smaller sample (n=112) 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.
For the full-scale RCT, participants (n=290) will be randomly assigned to one of three groups: online 8-week MBP training, in-person 8-week MBP training, and a control group. The 290-student sample size is based on the statistical power calculations for the randomized controlled trial. Using STATA 16 software (https://www.stata.com/), for 80% power and a significance level of 0.05, we calculated a sample size of 78 students per arm was required to to detect a difference of 0.4 standard deviations in outcome measures. Our recruitment of 94 students per treatment arm allows for 20% attrition.
With two treatment arms (in-person and online), we will have 188 students for the treatment group. Due to the multi-arm experimental design, we will increase the size of the control group by 30% to ensure an efficient sample for the comparison across different groups. This means we will have 102 students in the control group. With a total of 290 students, we will have efficient power to detect the effect size of 0.4 standard deviations. The effect size that the trial is designed to detect is based on other mindfulness trials: Breedvelt et al. (2019) reviewed 24 studies with experimental designs and found an overall effect size of 0.6 SD. Thus, as a conservative estimate, we use 0.4 SD to ensure sufficient statistical power.
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After
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.
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Was the treatment clustered?
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No
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Yes
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Planned Number of Clusters
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N/A
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2 universities
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Planned Number of Observations
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290 students
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112 students
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Sample size (or number of clusters) by treatment arms
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Before
In-person mindfulness group: 94 students
Online mindfulness group: 94 students
Control group: 102 students
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In-person mindfulness group: 56 students
Control group: 56 students
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Power calculation: Minimum Detectable Effect Size for Main Outcomes
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0.4 SD (Cohen's d)
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0.5 SD (Cohen's d)
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Secondary Outcomes (End Points)
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Before
emotion regulation, trait and state mindfulness, copying 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
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After
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
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Secondary Outcomes (Explanation)
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Before
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 career goals and outcome after graduation
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After
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
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