Online MBCT Program for University Students

NCT ID: NCT05804877

Last Updated: 2025-12-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2023-09-01

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).

Conditions

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Depression in Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

mindfulness-based cognitive therapy

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Mental health education

Intervention Type OTHER

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

Interventions

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mindfulness-based cognitive therapy

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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yun-Ling Chen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yun-Ling Chen, Doctor

Role: STUDY_DIRECTOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, Taichung, Taiwan

Site Status

Countries

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Taiwan

References

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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.

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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.

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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.

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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.

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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.

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PMID: 8206699 (View on PubMed)

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

Reference Type RESULT
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Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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https://www.who.int/news-room/fact-sheets/detail/depression

World Health Organization(2021).Depression.

https://www.depression.org.tw/knowledge/info.asp?/97.html

社團法人臺灣憂鬱症防治協會(2021)。青少年憂鬱防治與心理健康促進:需要你我共同參與。

http://mohocentertaiwan.blogspot.com/2009/02/blog-post_9504.html

台灣人類職能模式研究與應用發展中心-職能治療(MOHO center in Taiwan)(2009)。職能自我評估-中文版。

Other Identifiers

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CS1-22150

Identifier Type: -

Identifier Source: org_study_id

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