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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. 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 waitlist control group. 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.
Trial Start Date March 10, 2025 March 17, 2025
Last Published February 01, 2025 03:50 PM March 19, 2025 04:08 PM
Experimental Design (Public) 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. We will conduct a pilot study with university students recruited online and offline from two universities in China. Using the RCT method of impact evaluation, we will be able to ensure that the intervention group and waitlist control group 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.
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 emotion regulation, trait and state mindfulness, coping styles, self-compassion, gratitude, purpose, loneliness, parent attachment, smartphone addiction, positive and negative affect, perceived healthy diet, sleep quality, flourishing, neuroticism, somatic symptoms, academic performance, procrastination, face saving, stress mindset, stress management approaches, lifestyle behaviors
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 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 Self-compassion: Self-Compassion Scale Gratitude: 5-item Gratitude Questionnaire Purpose: Claremont Purpose Scale, open-ended questions 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 Stress mindset: Stress Mindset Scale Stress management: open-ended question Lifestyle behaviors: items about daily habits like phone use and exercise
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