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Online MBCT Program for University Students

Primary Purpose

Depression in Adolescence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mindfulness-based cognitive therapy
Mental health education
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Adolescence focused on measuring university student, online program, MBCT, depression, quality of life

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    online mindfulness-based cognitive therapy program

    mental health education

    Arm Description

    The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental 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

    Outcomes

    Primary Outcome Measures

    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 -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.
    WHOQOL-BREF-TW -pretest
    The World Health Organization Quality of Life-BREF-Taiwan version (WHOQOL-BREF-TW) is a 28-item self-report questionnaire designed to measure the quality of life. Items are scored from 1 to 5; higher scores indicate greater quality of life.
    WHOQOL-BREF-TW -posttest
    The World Health Organization Quality of Life-BREF-Taiwan version (WHOQOL-BREF-TW) is a 28-item self-report questionnaire designed to measure the quality of life. Items are scored from 1 to 5; higher scores indicate greater quality of life.

    Secondary Outcome Measures

    BAI -pretest
    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 -posttest
    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).
    OSA -pretest
    The Occupational Self Assessment (OSA) is designed to capture clients' perceptions of their own occupational competence and of the occupations they consider important. These interval level scores range from 21 - 84 on both the Competence Key Form and the Value Key Form. Higher interval scores represent higher levels of client perception of occupational competence and higher degrees of value or importance.
    OSA -posttest
    The Occupational Self Assessment (OSA) is designed to capture clients' perceptions of their own occupational competence and of the occupations they consider important. These interval level scores range from 21 - 84 on both the Competence Key Form and the Value Key Form. Higher interval scores represent higher levels of client perception of occupational competence and higher degrees of value or importance.
    COPM -pretest
    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.
    COPM -posttest
    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.

    Full Information

    First Posted
    March 5, 2023
    Last Updated
    April 6, 2023
    Sponsor
    Chung Shan Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05804877
    Brief Title
    Online MBCT Program for University Students
    Official Title
    Efficacy of an Online Mindfulness-based Cognitive Skills Program on Depressive Symptoms and Quality of Life in University Students
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chung Shan Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression in Adolescence
    Keywords
    university student, online program, MBCT, depression, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    online mindfulness-based cognitive therapy program
    Arm Type
    Experimental
    Arm Description
    The online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks
    Arm Title
    mental health education
    Arm Type
    Placebo Comparator
    Arm Description
    The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    mindfulness-based cognitive therapy
    Intervention Description
    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
    Other
    Intervention Name(s)
    Mental health education
    Intervention Description
    The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks
    Primary Outcome Measure Information:
    Title
    BDI-II -pretest
    Description
    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.
    Time Frame
    BDI-II score at pre-test (1week before intervention)
    Title
    BDI-II -posttest
    Description
    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.
    Time Frame
    BDI-II score at post-test (1week after intervention)
    Title
    WHOQOL-BREF-TW -pretest
    Description
    The World Health Organization Quality of Life-BREF-Taiwan version (WHOQOL-BREF-TW) is a 28-item self-report questionnaire designed to measure the quality of life. Items are scored from 1 to 5; higher scores indicate greater quality of life.
    Time Frame
    WHOQOL-BREF-TW score at pre-test (1week before intervention)
    Title
    WHOQOL-BREF-TW -posttest
    Description
    The World Health Organization Quality of Life-BREF-Taiwan version (WHOQOL-BREF-TW) is a 28-item self-report questionnaire designed to measure the quality of life. Items are scored from 1 to 5; higher scores indicate greater quality of life.
    Time Frame
    WHOQOL-BREF-TW score at post-test (1week after intervention)
    Secondary Outcome Measure Information:
    Title
    BAI -pretest
    Description
    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).
    Time Frame
    BAI score at pre-test (1week before intervention)
    Title
    BAI -posttest
    Description
    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).
    Time Frame
    BAI score at post-test (1week after intervention)
    Title
    OSA -pretest
    Description
    The Occupational Self Assessment (OSA) is designed to capture clients' perceptions of their own occupational competence and of the occupations they consider important. These interval level scores range from 21 - 84 on both the Competence Key Form and the Value Key Form. Higher interval scores represent higher levels of client perception of occupational competence and higher degrees of value or importance.
    Time Frame
    OSA score at pre-test (1week before intervention)
    Title
    OSA -posttest
    Description
    The Occupational Self Assessment (OSA) is designed to capture clients' perceptions of their own occupational competence and of the occupations they consider important. These interval level scores range from 21 - 84 on both the Competence Key Form and the Value Key Form. Higher interval scores represent higher levels of client perception of occupational competence and higher degrees of value or importance.
    Time Frame
    OSA score at post-test (1week after intervention)
    Title
    COPM -pretest
    Description
    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.
    Time Frame
    COPM score at pre-test (1week before intervention)
    Title
    COPM -posttest
    Description
    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.
    Time Frame
    COPM score at post-test (1week after intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yun-Ling Chen, Doctor
    Phone
    +886958226869
    Email
    yunling.annie@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ting-Hui Lin, Bachelor
    Phone
    +886975756893
    Email
    whitney1119@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yun-Ling Chen, Doctor
    Organizational Affiliation
    Chung Shan Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33688840
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    18363421
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    10257372
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    8206699
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    30994854
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    30846664
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    25798209
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21534932
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    29903782
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    34847060
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    24180264
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    32357125
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    30617044
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28715726
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27689560
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    33502326
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    14647540
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    29078199
    Citation
    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. Erratum In: Behav Res Ther. 2022 Dec;159:104225.
    Results Reference
    result
    Links:
    URL
    https://www.who.int/news-room/fact-sheets/detail/depression
    Description
    World Health Organization(2021).Depression.
    URL
    https://www.depression.org.tw/knowledge/info.asp?/97.html
    Description
    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。
    URL
    http://mohocentertaiwan.blogspot.com/2009/02/blog-post_9504.html
    Description
    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。

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