Online MBCT Program for University Students

Depression in Adolescence Clinical Trial

Official title:

Efficacy of an Online Mindfulness-based Cognitive Skills Program on Depressive Symptoms and Quality of Life in University Students

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05804877
• Other study ID #: CS1-22150
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: Chung Shan Medical University
• Contact: Yun-Ling Chen, Doctor
• Phone: +886958226869
• Email: yunling.annie[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

• 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression in Adolescence

Intervention

Behavioral:
• 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.

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

References & Publications (18)

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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. — View Citation

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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. — View 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. — View Citation

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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):e — View 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 — View 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. — View 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 Controll — View 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. — View 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. — View 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. — View 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. — View 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. — View 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;99:124-13 — View 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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.	BDI-II score at post-test (1week after intervention)
Primary	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 score at pre-test (1week before intervention)
Primary	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.	WHOQOL-BREF-TW score at post-test (1week after intervention)
Secondary	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 score at pre-test (1week before intervention)
Secondary	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).	BAI score at post-test (1week after intervention)
Secondary	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 score at pre-test (1week before intervention)
Secondary	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.	OSA score at post-test (1week after intervention)
Secondary	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 score at pre-test (1week before intervention)
Secondary	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.	COPM score at post-test (1week after intervention)

External Links

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•   World Health Organization(2021).Depression.