- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05804877
Online MBCT Program for University Students
Efficacy of an Online Mindfulness-based Cognitive Skills Program on Depressive Symptoms and Quality of Life in 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taichung
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Taichung, Taichung, Taiwan, 402
- Chung Shan Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
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.
|
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Placebo Comparator: 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
|
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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BDI-II score at pre-test (1week before intervention)
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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.
|
1 week after the intervention, corresponding to Week 9
|
|
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. |
WHOQOL-BREF-TW score at pre-test (1week before intervention)
|
|
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. |
1 week after the intervention, corresponding to Week 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
BAI score at pre-test (1week before intervention)
|
|
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).
|
1 week after the intervention, corresponding to Week 9
|
|
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.
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OSA score at pre-test (1week before intervention)
|
|
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.
|
1 week after the intervention, corresponding to Week 9
|
|
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.
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COPM score at pre-test (1week before intervention)
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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.
|
1 week after the intervention, corresponding to Week 9
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yun-Ling Chen, Doctor, Chung Shan Medical University
Publications and helpful links
General Publications
- Ritvo P, Knyahnytska Y, Pirbaglou M, Wang W, Tomlinson G, Zhao H, Linklater R, Bai S, Kirk M, Katz J, Harber L, Daskalakis Z. Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 10;23(3):e24380. doi: 10.2196/24380.
- Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008 Apr;69(4):621-32. doi: 10.4088/jcp.v69n0415.
- Baker F, Intagliata J. Quality of life in the evaluation of community support systems. Eval Program Plann. 1982;5(1):69-79. doi: 10.1016/0149-7189(82)90059-3.
- Simmons S. Quality of life in community mental health care--a review. Int J Nurs Stud. 1994 Apr;31(2):183-93. doi: 10.1016/0020-7489(94)90044-2.
- Solis AC, Lotufo-Neto F. Predictors of quality of life in Brazilian medical students: a systematic review and meta-analysis. Braz J Psychiatry. 2019 Nov-Dec;41(6):556-567. doi: 10.1590/1516-4446-2018-0116.
- Gan GG, Yuen Ling H. Anxiety, depression and quality of life of medical students in Malaysia. Med J Malaysia. 2019 Feb;74(1):57-61.
- Surawy C, McManus F, Muse K, Williams JM. Mindfulness-Based Cognitive Therapy (MBCT) for Health Anxiety (Hypochondriasis): Rationale, Implementation and Case Illustration. Mindfulness (N Y). 2015;6(2):382-392. doi: 10.1007/s12671-013-0271-1.
- Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.
- Joyce S, Shand F, Tighe J, Laurent SJ, Bryant RA, Harvey SB. Road to resilience: a systematic review and meta-analysis of resilience training programmes and interventions. BMJ Open. 2018 Jun 14;8(6):e017858. doi: 10.1136/bmjopen-2017-017858.
- Luo Y, Xia W, Cheung AT, Ho LLK, Zhang J, Xie J, Xiao P, Li HCW. Effectiveness of a Mobile Device-Based Resilience Training Program in Reducing Depressive Symptoms and Enhancing Resilience and Quality of Life in Parents of Children With Cancer: Randomized Controlled Trial. J Med Internet Res. 2021 Nov 29;23(11):e27639. doi: 10.2196/27639.
- Guardino CM, Dunkel Schetter C, Bower JE, Lu MC, Smalley SL. Randomised controlled pilot trial of mindfulness training for stress reduction during pregnancy. Psychol Health. 2014;29(3):334-49. doi: 10.1080/08870446.2013.852670. Epub 2013 Nov 1.
- Lau N, O'Daffer A, Colt S, Yi-Frazier JP, Palermo TM, McCauley E, Rosenberg AR. Android and iPhone Mobile Apps for Psychosocial Wellness and Stress Management: Systematic Search in App Stores and Literature Review. JMIR Mhealth Uhealth. 2020 May 22;8(5):e17798. doi: 10.2196/17798.
- Uthman OA, Nduka CU, Abba M, Enriquez R, Nordenstedt H, Nalugoda F, Kengne AP, Ekstrom AM. Comparison of mHealth and Face-to-Face Interventions for Smoking Cessation Among People Living With HIV: Meta-Analysis. JMIR Mhealth Uhealth. 2019 Jan 7;7(1):e203. doi: 10.2196/mhealth.9329.
- Josephine K, Josefine L, Philipp D, David E, Harald B. Internet- and mobile-based depression interventions for people with diagnosed depression: A systematic review and meta-analysis. J Affect Disord. 2017 Dec 1;223:28-40. doi: 10.1016/j.jad.2017.07.021. Epub 2017 Jul 10.
- Zhang MW, Ho RC. Moodle: The cost effective solution for internet cognitive behavioral therapy (I-CBT) interventions. Technol Health Care. 2017;25(1):163-165. doi: 10.3233/THC-161261. No abstract available.
- Sun Y, Li Y, Wang J, Chen Q, Bazzano AN, Cao F. Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Jan 27;23(1):e23410. doi: 10.2196/23410.
- Pan AW, Chung L, Hsin-Hwei G. Reliability and validity of the Canadian Occupational Performance Measure for clients with psychiatric disorders in Taiwan. Occup Ther Int. 2003;10(4):269-77. doi: 10.1002/oti.190.
- Winnebeck E, Fissler M, Gartner M, Chadwick P, Barnhofer T. Brief training in mindfulness meditation reduces symptoms in patients with a chronic or recurrent lifetime history of depression: A randomized controlled study. Behav Res Ther. 2017 Dec;99:124-130. doi: 10.1016/j.brat.2017.10.005. Epub 2017 Oct 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS1-22150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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