Trial Outcomes & Findings for Online MBCT Program for University Students (NCT NCT05804877)

NCT ID: NCT05804877

Last Updated: 2025-12-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

BDI-II score at pre-test (1week before intervention)

Results posted on

2025-12-10

Participant Flow

dates of the recruitment period:2022/02/14\~2022/03/14 recruitment location: School website or Online platform

Participants who (1) have a psychiatric diagnosis, (2) are currently receiving counseling, (3)are not from the medical university in Taiwan, and (4) are unwilling to participate in the study will be excluded.

Participant milestones

Participant milestones
Measure
online mindfulness-based cognitive therapy program
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks mindfulness-based cognitive therapy, 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.
mental health education
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
Overall Study
STARTED
26
26
Overall Study
COMPLETED
23
23
Overall Study
NOT COMPLETED
3
3

Reasons for withdrawal

Reasons for withdrawal
Measure
online mindfulness-based cognitive therapy program
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks mindfulness-based cognitive therapy, 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.
mental health education
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
Overall Study
Lost to Follow-up
1
3
Overall Study
Withdrawal by Subject
1
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Online Mindfulness-based Cognitive Therapy Program
n=26 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
Mental Health Education
n=26 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
Total
n=52 Participants
Total of all reporting groups
Age, Continuous
20.88 years
STANDARD_DEVIATION 1.56 • n=26 Participants
21.92 years
STANDARD_DEVIATION 1.02 • n=26 Participants
21.40 years
STANDARD_DEVIATION 0.19 • n=52 Participants
Sex: Female, Male
Female
17 Participants
n=26 Participants
22 Participants
n=26 Participants
39 Participants
n=52 Participants
Sex: Female, Male
Male
9 Participants
n=26 Participants
4 Participants
n=26 Participants
13 Participants
n=52 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Departments
Department of Occupational Therapy
11 Participants
n=26 Participants
7 Participants
n=26 Participants
18 Participants
n=52 Participants
Departments
Department of Speech Language Pathology and Audiology
5 Participants
n=26 Participants
7 Participants
n=26 Participants
12 Participants
n=52 Participants
Departments
Department of Nursing
2 Participants
n=26 Participants
1 Participants
n=26 Participants
3 Participants
n=52 Participants
Departments
Department of Nutrition
1 Participants
n=26 Participants
3 Participants
n=26 Participants
4 Participants
n=52 Participants
Departments
Department of Public Health
1 Participants
n=26 Participants
2 Participants
n=26 Participants
3 Participants
n=52 Participants
Departments
School of Medicine
0 Participants
n=26 Participants
2 Participants
n=26 Participants
2 Participants
n=52 Participants
Departments
Department of Physical Therapy
1 Participants
n=26 Participants
1 Participants
n=26 Participants
2 Participants
n=52 Participants
Departments
Department of Medical Sociology and Social Work
0 Participants
n=26 Participants
1 Participants
n=26 Participants
1 Participants
n=52 Participants
Departments
Department of Medical Laboratory and Biotechnology
1 Participants
n=26 Participants
0 Participants
n=26 Participants
1 Participants
n=52 Participants
Departments
Department of Medical Imaging and Radiological Sciences
1 Participants
n=26 Participants
0 Participants
n=26 Participants
1 Participants
n=52 Participants
Departments
Department of Health Industry Technology Management
1 Participants
n=26 Participants
1 Participants
n=26 Participants
2 Participants
n=52 Participants
Departments
Department of Medical Informatics
1 Participants
n=26 Participants
1 Participants
n=26 Participants
2 Participants
n=52 Participants
Departments
Department of Applied Foreign Languages
1 Participants
n=26 Participants
0 Participants
n=26 Participants
1 Participants
n=52 Participants
Grades
freshman
3 Participants
n=26 Participants
0 Participants
n=26 Participants
3 Participants
n=52 Participants
Grades
sophomore
5 Participants
n=26 Participants
4 Participants
n=26 Participants
9 Participants
n=52 Participants
Grades
junior
9 Participants
n=26 Participants
8 Participants
n=26 Participants
17 Participants
n=52 Participants
Grades
senior
9 Participants
n=26 Participants
12 Participants
n=26 Participants
21 Participants
n=52 Participants
Grades
sixth year of undergraduate school
0 Participants
n=26 Participants
2 Participants
n=26 Participants
2 Participants
n=52 Participants
Course units
17.12 units
STANDARD_DEVIATION 5.59 • n=26 Participants
15.34 units
STANDARD_DEVIATION 4.94 • n=26 Participants
16.23 units
STANDARD_DEVIATION 0.74 • n=52 Participants
Clubs
Yes
6 Participants
n=26 Participants
6 Participants
n=26 Participants
12 Participants
n=52 Participants
Clubs
No
20 Participants
n=26 Participants
20 Participants
n=26 Participants
40 Participants
n=52 Participants
Part-time jobs
Yes
10 Participants
n=26 Participants
10 Participants
n=26 Participants
20 Participants
n=52 Participants
Part-time jobs
No
16 Participants
n=26 Participants
16 Participants
n=26 Participants
32 Participants
n=52 Participants
Livings status
Living with classmates/friends
9 Participants
n=26 Participants
11 Participants
n=26 Participants
20 Participants
n=52 Participants
Livings status
Living alone
10 Participants
n=26 Participants
6 Participants
n=26 Participants
16 Participants
n=52 Participants
Livings status
Living with family/relatives
5 Participants
n=26 Participants
8 Participants
n=26 Participants
13 Participants
n=52 Participants
Livings status
other
2 Participants
n=26 Participants
1 Participants
n=26 Participants
3 Participants
n=52 Participants
Economic status
Family allowance
23 Participants
n=26 Participants
23 Participants
n=26 Participants
46 Participants
n=52 Participants
Economic status
Self-sufficient
1 Participants
n=26 Participants
1 Participants
n=26 Participants
2 Participants
n=52 Participants
Economic status
Family allowance + Self-sufficiency
2 Participants
n=26 Participants
2 Participants
n=26 Participants
4 Participants
n=52 Participants

PRIMARY outcome

Timeframe: BDI-II score at pre-test (1week before intervention)

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.

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=23 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=23 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
BDI-II -Pretest
12.54 score on a scale
Standard Deviation 10.31
14.42 score on a scale
Standard Deviation 11.5

PRIMARY outcome

Timeframe: 1 week after the intervention, corresponding to Week 9

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.

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=23 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=23 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
BDI-II -Posttest
7 score on a scale
Standard Deviation 7.83
9.87 score on a scale
Standard Deviation 10.1

PRIMARY outcome

Timeframe: WHOQOL-BREF-TW score at pre-test (1week before intervention)

The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) is a 28-item self-report questionnaire with a five point rating scale for each item (from 1 to 5). There are four domains in WHOQOL-BREF, including physical health, psychological health, social relationships, and environment. The Physical Health domain consists of 7 items, with a total score range of 7 to 35; the Psychological domain includes 6 items, ranging from 6 to 30; the Social Relationships domain comprises 4 items, with scores ranging from 4 to 20; and the Environment domain contains 9 items, with a range of 9 to 45. Two additional items are assessed separately: Question 1 evaluates an individual's overall perception of quality of life, while Question 2 assesses their overall perception of health. Each of these two items is scored on a scale from 1 to 5. Domain scores are scaled in a positive direction, meaning that higher scores indicate better quality of life in the corresponding domain.

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=23 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=23 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
WHOQOL-BREF-TW -Pretest
Overall quality of Life
3.38 score on a scale
Standard Deviation 0.75
3.15 score on a scale
Standard Deviation 0.73
WHOQOL-BREF-TW -Pretest
General Health facet
2.88 score on a scale
Standard Deviation 0.59
2.65 score on a scale
Standard Deviation 0.75
WHOQOL-BREF-TW -Pretest
Physical Health
26.31 score on a scale
Standard Deviation 3.96
23.85 score on a scale
Standard Deviation 4.4
WHOQOL-BREF-TW -Pretest
Psychological
18.38 score on a scale
Standard Deviation 4.73
17.81 score on a scale
Standard Deviation 4.11
WHOQOL-BREF-TW -Pretest
Social relationships
14.54 score on a scale
Standard Deviation 2.79
13.96 score on a scale
Standard Deviation 1.95
WHOQOL-BREF-TW -Pretest
Environment
33.81 score on a scale
Standard Deviation 4.54
32 score on a scale
Standard Deviation 4.72

PRIMARY outcome

Timeframe: 1 week after the intervention, corresponding to Week 9

The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) is a 28-item self-report questionnaire with a five point rating scale for each item (from 1 to 5). There are four domains in WHOQOL-BREF, including physical health, psychological health, social relationships, and environment. The Physical Health domain consists of 7 items, with a total score range of 7 to 35; the Psychological domain includes 6 items, ranging from 6 to 30; the Social Relationships domain comprises 4 items, with scores ranging from 4 to 20; and the Environment domain contains 9 items, with a range of 9 to 45. Two additional items are assessed separately: Question 1 evaluates an individual's overall perception of quality of life, while Question 2 assesses their overall perception of health. Each of these two items is scored on a scale from 1 to 5. Domain scores are scaled in a positive direction, meaning that higher scores indicate better quality of life in the corresponding domain.

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=23 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=23 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
WHOQOL-BREF-TW -Posttest
Overall quality of Life
3.87 score on a scale
Standard Deviation 0.69
3.48 score on a scale
Standard Deviation 0.73
WHOQOL-BREF-TW -Posttest
General Health facet
3.04 score on a scale
Standard Deviation 1.02
3.13 score on a scale
Standard Deviation 0.92
WHOQOL-BREF-TW -Posttest
Physical Health
28.13 score on a scale
Standard Deviation 4.32
25.74 score on a scale
Standard Deviation 3.6
WHOQOL-BREF-TW -Posttest
Psychological
21.13 score on a scale
Standard Deviation 5.15
18.7 score on a scale
Standard Deviation 3.76
WHOQOL-BREF-TW -Posttest
Social relationships
15.52 score on a scale
Standard Deviation 2.5
14.7 score on a scale
Standard Deviation 2.18
WHOQOL-BREF-TW -Posttest
Environment
36.39 score on a scale
Standard Deviation 5.32
32.61 score on a scale
Standard Deviation 4.52

SECONDARY outcome

Timeframe: BAI score at pre-test (1week before intervention)

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).

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=26 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=26 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
BAI -Pretest
9.31 score on a scale
Standard Deviation 7.36
8.65 score on a scale
Standard Deviation 7.65

SECONDARY outcome

Timeframe: 1 week after the intervention, corresponding to Week 9

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).

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=23 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=23 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
BAI -Posttest
5.52 score on a scale
Standard Deviation 7.38
6.52 score on a scale
Standard Deviation 6.71

SECONDARY outcome

Timeframe: OSA score at pre-test (1week before intervention)

The Occupational Self-Assessment (OSA) evaluates self-perceived occupational competence and environmental support. The questionnaire includes two sections: Self-Competence and Environment. The Self-Competence section has 21 items divided into three subscales-Skills/Performance (11 items), Habituation (5 items), and Volition (5 items)-and the Environment section has 8 items assessing perceived environmental support. Each item is rated on a 4-point scale, where 1 indicates the lowest and 4 the highest level of perceived competence or support. The possible score ranges are 11-44 for Skills/Performance, 5-20 for Habituation, 5-20 for Volition, and 8-32 for Environment. Higher scores represent greater self-perceived occupational competence and stronger environmental support.

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=26 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=26 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
OSA -Pretest
Skills/Performance
33.62 score on a scale
Standard Deviation 4.73
30.73 score on a scale
Standard Deviation 4.62
OSA -Pretest
Habituation
14.42 score on a scale
Standard Deviation 2.76
12.96 score on a scale
Standard Deviation 2.81
OSA -Pretest
Volition
13.88 score on a scale
Standard Deviation 2.63
12.69 score on a scale
Standard Deviation 2.9
OSA -Pretest
Environment
27.42 score on a scale
Standard Deviation 3.7
26.65 score on a scale
Standard Deviation 3.82

SECONDARY outcome

Timeframe: 1 week after the intervention, corresponding to Week 9

The Occupational Self-Assessment (OSA) evaluates self-perceived occupational competence and environmental support. The questionnaire includes two sections: Self-Competence and Environment. The Self-Competence section has 21 items divided into three subscales-Skills/Performance (11 items), Habituation (5 items), and Volition (5 items)-and the Environment section has 8 items assessing perceived environmental support. Each item is rated on a 4-point scale, where 1 indicates the lowest and 4 the highest level of perceived competence or support. The possible score ranges are 11-44 for Skills/Performance, 5-20 for Habituation, 5-20 for Volition, and 8-32 for Environment. Higher scores represent greater self-perceived occupational competence and stronger environmental support.

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=23 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=23 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
OSA -Posttest
Skills/Performance
35.3 score on a scale
Standard Deviation 4.99
32.65 score on a scale
Standard Deviation 4.46
OSA -Posttest
Habituation
16.35 score on a scale
Standard Deviation 2.74
13.83 score on a scale
Standard Deviation 2.37
OSA -Posttest
Volition
15.96 score on a scale
Standard Deviation 2.85
14.04 score on a scale
Standard Deviation 3.31
OSA -Posttest
Environment
28.7 score on a scale
Standard Deviation 3.78
26.96 score on a scale
Standard Deviation 4.37

SECONDARY outcome

Timeframe: COPM score at pre-test (1week before intervention)

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.

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=26 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=26 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
COPM -Pretest
Performance
5.93 score on a scale
Standard Deviation 1.51
4.62 score on a scale
Standard Deviation 1.46
COPM -Pretest
Satisfaction
5.39 score on a scale
Standard Deviation 1.84
4.22 score on a scale
Standard Deviation 1.77

SECONDARY outcome

Timeframe: 1 week after the intervention, corresponding to Week 9

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.

Outcome measures

Outcome measures
Measure
online mindfulness-based cognitive therapy program
n=23 Participants
The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks, 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.
mental health education
n=23 Participants
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks.
COPM -Posttest
Performance
7.03 score on a scale
Standard Deviation 1.65
6.01 score on a scale
Standard Deviation 1.37
COPM -Posttest
Satisfaction
6.85 score on a scale
Standard Deviation 1.85
6.06 score on a scale
Standard Deviation 1.66

Adverse Events

mental health education

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

online mindfulness-based cognitive therapy program

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yun-Ling Chen

Chung Shan Medical University

Phone: +886958226869

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place