Clinical trial NCT05804877: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Depression in Adolescence
Keywords: university student
online program
MBCT
depression
quality of life
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: BDI-II -pretest
timeFrame: BDI-II score at pre-test (1week before intervention)
measure: BDI-II -posttest
timeFrame: BDI-II score at post-test (1week after intervention)
measure: WHOQOL-BREF-TW -pretest
timeFrame: WHOQOL-BREF-TW score at pre-test (1week before intervention)
measure: WHOQOL-BREF-TW -posttest
timeFrame: WHOQOL-BREF-TW score at post-test (1week after intervention)
Secondary outcomes:
measure: BAI -pretest
timeFrame: BAI score at pre-test (1week before intervention)
measure: BAI -posttest
timeFrame: BAI score at post-test (1week after intervention)
measure: OSA -pretest
timeFrame: OSA score at pre-test (1week before intervention)
measure: OSA -posttest
timeFrame: OSA score at post-test (1week after intervention)
measure: COPM -pretest
timeFrame: COPM score at pre-test (1week before intervention)
measure: COPM -posttest
timeFrame: COPM score at post-test (1week after intervention)
Other outcomes:
Locations:
Study officials:
affiliation: Chung Shan Medical University
name: Yun-Ling Chen, Doctor
role: STUDY_DIRECTOR
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