NCT05804877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

December 10, 2025

Completed
Last Updated

December 10, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

March 5, 2023

Results QC Date

February 10, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

university studentonline programMBCTdepressionquality of life

Outcome Measures

Primary Outcomes (4)

  • 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.

    1 week after the intervention, corresponding to Week 9

  • WHOQOL-BREF-TW -Pretest

    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

    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 Outcomes (6)

  • BAI -Pretest

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

  • BAI -Posttest

    1 week after the intervention, corresponding to Week 9

  • OSA -Pretest

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

  • OSA -Posttest

    1 week after the intervention, corresponding to Week 9

  • COPM -Pretest

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

  • +1 more secondary outcomes

Study Arms (2)

online mindfulness-based cognitive therapy program

EXPERIMENTAL

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

mental health education

PLACEBO COMPARATOR

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

Interventions

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.

online mindfulness-based cognitive therapy program

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

mental health education

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, Taichung, 402, Taiwan

Location

Related Publications (18)

  • 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.

Related Links

MeSH Terms

Conditions

Depression

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Yun-Ling Chen
Organization
Chung Shan Medical University

Study Officials

  • Yun-Ling Chen, Doctor

    Chung Shan Medical University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 5, 2023

First Posted

April 7, 2023

Study Start

April 20, 2023

Primary Completion

July 5, 2023

Study Completion

September 1, 2023

Last Updated

December 10, 2025

Results First Posted

December 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations