Online MBCT Program for University Students

Sponsor
Chung Shan Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05804877
Collaborator
(none)
46
2
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mindfulness-based cognitive therapy
  • Other: Mental health education
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of an Online Mindfulness-based Cognitive Skills Program on Depressive Symptoms and Quality of Life in University Students
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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.

Placebo Comparator: 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

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

Outcome Measures

Primary Outcome Measures

  1. BDI-II -pretest [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.

  2. BDI-II -posttest [BDI-II score at post-test (1week after 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.

  3. WHOQOL-BREF-TW -pretest [WHOQOL-BREF-TW score at pre-test (1week before intervention)]

    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.

  4. WHOQOL-BREF-TW -posttest [WHOQOL-BREF-TW score at post-test (1week after intervention)]

    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

  1. BAI -pretest [BAI score at pre-test (1week before intervention)]

    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).

  2. BAI -posttest [BAI score at post-test (1week after intervention)]

    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).

  3. OSA -pretest [OSA score at pre-test (1week before intervention)]

    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.

  4. OSA -posttest [OSA score at post-test (1week after intervention)]

    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.

  5. COPM -pretest [COPM score at pre-test (1week before intervention)]

    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.

  6. COPM -posttest [COPM score at post-test (1week after intervention)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chung Shan Medical University

Investigators

  • Study Director: Yun-Ling Chen, Doctor, Chung Shan Medical University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Yun-Ling Chen, Assistant Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier:
NCT05804877
Other Study ID Numbers:
  • CS1-22150
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yun-Ling Chen, Assistant Professor, Chung Shan Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2023