Efficacy of an Online Mindfulness-based Cognitive Skills Program on Depressive Symptoms and Quality of Life in University Students
Phase: NA
Conditions: Depression in Adolescence
Sponsor: Chung Shan Medical University

Study Protocol 
Efficacy of an online mindfulness-based cognitive skills 
program on depressive symptoms and quality of life in university 
student 
 
 
 
Principal Investigator ​​
        Yun-Ling Chen, Doctor 
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Study Director 
Chung Shan Medical University 
Taichung, Taiwan, 402 
 
Protocol identification number ​
Online MBCT Program for University Students  
(dated 2023-04-07) 
 
ClinicalTrials.gov Identifier: ​​
NCT05804877 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1.​
Introduction 
The goal of this interventional study was to examine the efficacy of the online 
mindfulness-based cognitive therapy program(MBCT) in youth (18-25 years old) 
with depressive symptoms. The main questions it aimed to answer were: 
Whether the program could reduce depressive symptoms in university students. 
Whether the program could increase the quality of life in university students. 
The effectiveness, acceptance, and practicability of the program for university 
students. Participants in the experimental group would be arranged to attend online 
mindfulness-based cognitive programs for eight weeks. The control group would be 
educated with the knowledge of mental health to manage their negative emotions. 
 
 
2.​
Statistical Analysis Plan (SAP) 
A randomized controlled trial (RCT) was conducted to examine the efficacy of the 
online mindfulness-based cognitive therapy program(MBCT) in youth (18-25 years 
old) with depressive symptoms. The investigators expected the online MBCT 
program could assist university students in reducing their depressive mood and 
facilitating quality of life. The investigators also discussed the effectiveness, 
acceptance, and practicability of the online MBCT program to the subjects. 
 
2.1 Study design 
Participants in the experimental group would be arranged to attend online 
mindfulness-based cognitive programs for eight weeks. Each week was divided into 3 
parts: detailed skill training with pictures or short videos, techniques application in 
different scenarios, and concepts consolidation through a web-based assignment. 
Participants were requested to complete the 3 parts above, which would take 
approximately 15 minutes in total per week. The content of the online intervention 
includes 8 chapters reflecting multiple topics (e.g. explaining MBCT, automatic pilot, 
awareness of mood, accentedness, staying with the present experience, linking 
habitual reactions to the unpleasant event, using breathing and body as an anchor, and 
planning to continue mindfulness practice) which were delivered to subjects each 
week by the research team. 
Participants in the control group would acquire knowledge of mental health to 
manage their negative emotions. There would be 2 times of mental health education 
and one web-based assignment including writing feedback to ensure learning 
effectiveness each week. The content for 8 weeks would include knowledge about 
depression, recognition of depression and depressive mood, symptom management, 
adaptation skills and coping skills, myths of depression, depression prevention, and 
referral information for mental health. The investigators would evaluate the 
effectiveness of the two groups using the outcome assessment of BDI-II, 
WHOQOL-BREF, BAI, OSA, and COPM 1 week before intervention (pre-test) and 1 
week after intervention (post-test). 
 
2.2 Populations and subgroups to be analysed  
This study would use a Survey Cake form, announced through the university website 
or online platforms, to recruit participants, primarily targeting undergraduate students 
at a certain medical university in Taichung, Taiwan. Participants would be screened 
through the BDI-II and the basic information questionnaire. The inclusion criteria 
were as follows: (1) aged between 18 and 25 years; (2) scoring at least mild on the 
Beck Depression Inventory-II (BDI-II); (3) having the LINE messaging application; 
and (4) being literate and willing to participate in the study. Exclusion criteria were: 
(1) self-reported other mental illnesses such as schizophrenia or bipolar disorder; (2) 
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self-reported major physical illnesses such as cancer or stroke; and (3) unwillingness 
to accept random assignment. The sample size was estimated that a correlational 
study requires at least 30 participants. Considering potential dropouts or inability to 
complete the online study, a 35% attrition rate was applied, resulting in a minimum of 
46 valid questionnaires being collected. Participants would then be randomly 
assigned, with 23 in the experimental group and 23 in the control group. 
 
2.3 Outcomes 
Baseline Characteristics 
The contents included the subject's gender, age, grade, living situation, employment 
status, economic status, whether there was a diagnosis of mental or physical illness (if 
so, the subject was asked to provide the name of the diagnosing hospital and 
physician), whether there was any psychological treatment involving medication (if 
so, the subject was asked to provide the frequency and location of treatment), contact 
phone number, and LINE ID. 
Self-Assessment Questionnaire  
This study used well-validated instruments with good reliability, including the Beck 
Depression Inventory-II (BDI-II), the Beck Anxiety Inventory (BAI), the Chinese 
version of the Occupational Self-Assessment (OSA), the Chinese version of the 
Canadian Occupational Performance Measure (COPM), and the Taiwan version of the 
World Health Organization Quality of Life-BREF (WHOQOL-BREF-TW) in both 
pre- and post-tests (with BDI-II used for case screening only). These tools assessed 
the level of depression, anxiety, self-efficacy, environmental support, occupational 
performance issues and changes, and quality of life. 
Qualitative Feedback Information 
One week after the intervention ends, the researcher would design a questionnaire for 
participants to evaluate the effectiveness and practicality of the online "Mindfulness 
Cognitive Skills" program. This would include qualitative interview questions and 
quantitative items for participants to rate. The purpose was to understand whether the 
eight-week online study meets the needs of the participants, assisted in learning and 
managing self-emotions, and to gather feedback on usage after the study and 
suggestions for the research. 
 
2.4 Analyses  
The study would use descriptive statistics to record and analyze the basic information 
and follow-up measurement data of the participants, described in terms of 
percentages, means, and standard deviations. Changed in depression levels and 
quality of life between the experimental and control groups would be analyzed using 
a mixed-effects model to verify the effectiveness of the "Online Mindfulness 
Cognitive Skills" program on depression and quality of life among students with 
depressive tendencies. The analysis would be conducted using SAS 9.4 statistical 
software, with a significance level set at α = 0.05. 
 
2.5 Aims and objectives 
The purpose of this study was to explore the impact of the "Online Mindfulness 
Cognitive Skills" program on the depressive emotions and quality of life of university 
students. It was hoped that through the learning of mindfulness cognitive skills, 
participants would be guided to recognize their irrational thoughts, distinguish 
automatic thinking, and achieve significant counseling effects. Additionally, 
participants would be able to apply mindfulness techniques in daily life when 
experiencing negative emotions, improving self-acceptance, reducing depressive 
emotions, and enhancing quality of life. The researchers hoped that this study would 
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provide a deeper understanding of the challenges and living conditions of students 
with depressive tendencies, and identified which mindfulness techniques are more 
effective in reducing emotional distress among university students. The goal was to 
confirm the most suitable mindfulness techniques and behavioral programs for 
students with depressive tendencies and to explore the advantages of delivering 
counseling information online to this population. It was anticipated that, following the 
completion of the study, the promotion of mindfulness cognitive skills through the 
LINE platform would continue, allowing students at the university to access 
mindfulness information. The findings were also expected to be valuable for 
educators, healthcare professionals, and social welfare organizations. 
 
3.​
Informed Consent Form (ICF) 
This study design had been approved by the First Institutional Review Board (IRB) of 
Chung Shan Medical University Hospital (CSMUH No: CS1-22150). Additionally, a 
Waiver of Documentation of Informed Consent or Written ICF was applied for and 
granted by the Research Proposal Committee at Chung Shan Medical University 
Hospital. Approval details can be found in Figure 1. The following points outline the 
justification for this waiver: 
Minimal Risk Design 
The study is designed to pose minimal risk to participants, involving participatory 
mindfulness exercises and questionnaire surveys without any invasive procedures or 
treatments. The research activities are expected to cause no discomfort or adverse 
effects during the execution phase. 
Approved Research Design 
The research design has been reviewed and approved by the National Science Council 
(NSC). The study’s feasibility and structure are appropriate for the research 
objectives. This study utilizes a "randomized controlled trial" design, where the 
experimental group will receive an eight-week "Online Mindfulness Cognitive Skills" 
program, delivered once a week via the LINE social platform, while the control group 
will be provided with information on depression and self-emotion management. To 
ensure the well-being of participants, the co-investigator will monitor and engage 
with participants weekly through messages on the online platform. The informed 
consent form clearly states that researchers will send information to participants via a 
social platform on mobile devices each week and invite them to complete 
questionnaires. Participants can freely choose the time and place to review the 
information and complete the questionnaires. The procedures and methods of this 
study are integrated into daily life activities. 
Informed Consent Procedure 
The informed consent process will be conducted by the co-investigator through an 
online document, explaining the study details to the participants or their legal 
representatives and obtaining their consent. This process is estimated to take about 
5-10 minutes to ensure participants fully understand the study. Participants will be 
asked to complete an online informed consent feedback form to confirm their 
comprehension of the study. Detailed information about the informed consent process 
is provided in the attached "005-1 Informed Consent Form for Participants" (see 
Figure 2). This informed consent form will also be emailed to participants for their 
reference and records. 
 
 
 
 
 
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Figure 1 Permission of Research Proposal Committee at Chung Shan Medical 
University Hospital 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Figure 2 "005-1 Informed Consent Form for Participants” 
 
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