Online MBCT Program for University Students

Study Overview
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Brief Summary
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The goal of this interventional study is 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 aims to answer are: Whether the program could reduce depressive symptoms in university students. Whether the program could increase 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 the knowledge of mental health to manage their negative emotions.

Detailed Description
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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 expect 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. 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).

Official Title
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Efficacy of an Online Mindfulness-based Cognitive Skills Program on Depressive Symptoms and Quality of Life in University Students

Conditions
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Depression in Adolescence

Intervention / Treatment
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* Behavioral: mindfulness-based cognitive therapy
* Other: Mental health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 and 25 Has Beck Depression Inventory-2 (BDI-II) score of at least mild severity, with no upper limit Able to communicate through LINE app Able to read Chinese and willing to participate in research Exclusion Criteria: Meets the Diagnostic and Statistical Manual of Mental Disorders-V, such as schizophrenia, substance abuse, and Bipolar disorder Has ever been diagnosed as any significant physical illness, such as cancer, organ damage, and stroke Refuse to be assigned to different groups randomly

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: online mindfulness-based cognitive therapy program<br>The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks | Behavioral: mindfulness-based cognitive therapy<br>* 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, which were detailed mindfulness-based skills training with pictures or short videos, techniques application in different scenarios, and concepts consolidation through a web-based assignment.<br>|
| Placebo Comparator: mental health education<br>The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks | Other: Mental health education<br>* The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI-II -pretest | The Beck Depression Inventory II (BDI-II) is a 21-item self-report questionnaire designed to measure the level of severity of disorders of depression. Items are scored from 0 to 3; higher scores indicate greater symptom severity. In the BDI-II values below 13 points are regarded as no or minimal depressive symptoms. Values between 14 and 19 points indicate a mild expression of depressive symptoms, values between 20 and 28 points a moderate severity. Scores between 29 and 63 are regarded as evidence of severe depressive disorder. | BDI-II score at pre-test (1week before intervention) | 
| BDI-II -posttest | The Beck Depression Inventory II (BDI-II) is a 21-item self-report questionnaire designed to measure the level of severity of disorders of depression. Items are scored from 0 to 3; higher scores indicate greater symptom severity. In the BDI-II values below 13 points are regarded as no or minimal depressive symptoms. Values between 14 and 19 points indicate a mild expression of depressive symptoms, values between 20 and 28 points a moderate severity. Scores between 29 and 63 are regarded as evidence of severe depressive disorder. | BDI-II score at post-test (1week after intervention) | 
| WHOQOL-BREF-TW -pretest | The World Health Organization Quality of Life-BREF-Taiwan version (WHOQOL-BREF-TW) is a 28-item self-report questionnaire designed to measure the quality of life. Items are scored from 1 to 5; higher scores indicate greater quality of life. | WHOQOL-BREF-TW score at pre-test (1week before intervention) | 
| WHOQOL-BREF-TW -posttest | The World Health Organization Quality of Life-BREF-Taiwan version (WHOQOL-BREF-TW) is a 28-item self-report questionnaire designed to measure the quality of life. Items are scored from 1 to 5; higher scores indicate greater quality of life. | WHOQOL-BREF-TW score at post-test (1week after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BAI -pretest | The Beck Anxiety Inventory (BAI) is a 21-item self-report measure designed to reflect the severity of somatic and cognitive symptoms of anxiety over the previous week. Items are scored from 0 to 3; higher scores indicate greater symptom severity. The BAI scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63). | BAI score at pre-test (1week before intervention) | 
| BAI -posttest | The Beck Anxiety Inventory (BAI) is a 21-item self-report measure designed to reflect the severity of somatic and cognitive symptoms of anxiety over the previous week. Items are scored from 0 to 3; higher scores indicate greater symptom severity. The BAI scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63). | BAI score at post-test (1week after intervention) | 
| OSA -pretest | The Occupational Self Assessment (OSA) is designed to capture clients' perceptions of their own occupational competence and of the occupations they consider important. These interval level scores range from 21 - 84 on both the Competence Key Form and the Value Key Form. Higher interval scores represent higher levels of client perception of occupational competence and higher degrees of value or importance. | OSA score at pre-test (1week before intervention) | 
| OSA -posttest | The Occupational Self Assessment (OSA) is designed to capture clients' perceptions of their own occupational competence and of the occupations they consider important. These interval level scores range from 21 - 84 on both the Competence Key Form and the Value Key Form. Higher interval scores represent higher levels of client perception of occupational competence and higher degrees of value or importance. | OSA score at post-test (1week after intervention) | 
| COPM -pretest | The Canadian Occupational Performance Measure (COPM) is an individualized measure designed for use by occupational therapists to detect self-perceived change in occupational performance problems over time. The therapist calculates an average COPM performance score and satisfaction score. These typically range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction. | COPM score at pre-test (1week before intervention) | 
| COPM -posttest | The Canadian Occupational Performance Measure (COPM) is an individualized measure designed for use by occupational therapists to detect self-perceived change in occupational performance problems over time. The therapist calculates an average COPM performance score and satisfaction score. These typically range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction. | COPM score at post-test (1week after intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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university student, online program, MBCT, depression, quality of life