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Completed

NCT Number: NCT05804877

Online MBCT Program for University Students

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, 402, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Cognitive Therapy

Behavioral

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.

Mental health education

Other

The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks

Primary outcomes

  1. BDI-II -Pretest

    Time frame: 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.

  2. BDI-II -Posttest

    Time frame: 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.

  3. WHOQOL-BREF-TW -Pretest

    Time frame: 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.

  4. WHOQOL-BREF-TW -Posttest

    Time frame: 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.

Secondary outcomes

  1. BAI -Pretest

    Time frame: 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).

  2. BAI -Posttest

    Time frame: 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).

  3. OSA -Pretest

    Time frame: 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.

  4. OSA -Posttest

    Time frame: 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.

  5. COPM -Pretest

    Time frame: 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.

  6. COPM -Posttest

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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