Depression in AdolescenceNCT05804877
Online MBCT Program for University Students
A study testing mindfulness-based cognitive therapy and Mental health education in people with Depression in Adolescence, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression in Adolescence
- What is being tested?
- mindfulness-based cognitive therapy and Mental health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Apr 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Depression in Adolescence
- Being tested
- mindfulness-based cognitive therapy, Mental health education
- Keywords
- university student, online program, MBCT, depression, quality of life
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based cognitive therapyBehavioural
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 educationOther
The mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Mental health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week after the intervention, corresponding to Week 9
Secondary outcomes (6)
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).
Measured: BAI score at pre-test (1week before intervention)
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).
Measured: 1 week after the intervention, corresponding to Week 9
OSA -Pretest
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.
Measured: OSA score at pre-test (1week before intervention)
OSA -Posttest
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.
Measured: 1 week after the intervention, corresponding to Week 9
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.
Measured: COPM score at pre-test (1week before intervention)
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.
Measured: 1 week after the intervention, corresponding to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start20 Apr 2023
- Primary completion5 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Ling Chen, Chung Shan Medical University
- Investigators
- Yun-Ling Chen, Doctor, Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804877
- Sponsor's protocol ID
- CS1-22150
- Status last verified
- Nov 2025
- First submitted
- 5 Mar 2023
- Last updated
- 10 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33688840Hofmann 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.
PubMed 18363421Baker 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.
PubMed 10257372Simmons 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.
PubMed 8206699Solis 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.
PubMed 30994854Gan GG, Yuen Ling H. Anxiety, depression and quality of life of medical students in Malaysia. Med J Malaysia. 2019 Feb;74(1):57-61.
PubMed 30846664Surawy 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.
PubMed 25798209Fjorback 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.
PubMed 21534932Joyce 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.
PubMed 29903782Luo 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.
PubMed 34847060Guardino 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.
PubMed 24180264Lau 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.
PubMed 32357125Uthman 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.
PubMed 30617044Josephine 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.
PubMed 28715726Zhang 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.
PubMed 27689560
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Online Mindfulness-based Cognitive Skills Program on Depressive Symptoms and Quality of Life in University Students
- ClinicalTrials.gov ID
- NCT05804877
- Acronym / sponsor ID
- CS1-22150
- Conditions
- Depression in Adolescence
- Keywords
- university student, online program, MBCT, depression, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Posted 10 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online mindfulness-based cognitive therapy program | Experimental | Behavioral: mindfulness-based cognitive therapyThe online mindfulness-based cognitive program was delivered on the platform of LINE to the experimental group 3 times a week for 8 weeks |
| mental health education | Placebo comparator | Other: Mental health educationThe mental health education was delivered on the platform of LINE to the control group 3 times a week for 8 weeks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based cognitive therapyParticipants 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. | Behavioural | online mindfulness-based cognitive therapy program |
| Mental health educationThe 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 |
Primary outcome
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.
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.
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 -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.
6 secondary outcomes
BAI -Pretest
Time frame: BAI score at pre-test (1week before intervention)
BAI -Posttest
Time frame: 1 week after the intervention, corresponding to Week 9
OSA -Pretest
Time frame: OSA score at pre-test (1week before intervention)
OSA -Posttest
Time frame: 1 week after the intervention, corresponding to Week 9
COPM -Pretest
Time frame: COPM score at pre-test (1week before intervention)
COPM -Posttest
Time frame: 1 week after the intervention, corresponding to Week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33688840Ritvo 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 publication: PubMed 18363421Hofmann 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 publication: PubMed 10257372Baker 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 publication: PubMed 8206699Simmons 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 publication: PubMed 30994854Solis 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 publication: PubMed 30846664Gan 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 publication: PubMed 25798209Surawy 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 publication: PubMed 21534932Fjorback 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 publication: PubMed 29903782Joyce 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 publication: PubMed 34847060Luo 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 publication: PubMed 24180264Guardino 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 publication: PubMed 32357125Lau 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.
- World Health Organization(2021).Depression.Link provided by the sponsor.
- 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。Link provided by the sponsor.
- 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。Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Depression in Adolescence
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Assessment of the Seasonality of Depressive Symptoms in Adolescents
Depressive Symptoms
Recruiting
The Mindful Smartphone Use Study
Depression and/or Anxiety Symptoms, Problematic Phone Use Behavior
Recruiting
CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth
Depression
Recruiting
Rise & Thrive: Community-Engagement Intervention for Stress and Depression in Youth.
Depressive Symptoms, Allostatic Load
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Ling Chen, Doctor study director
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based cognitive therapy and Mental health education in people with Depression in Adolescence, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDI-II -Pretest (time frame: BDI-II score at pre-test (1week before intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05804877, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.