Efficacy of an Online Mindfulness-based Cognitive Skills Program on Depressive Symptoms and Quality of Life in University Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- WHOQOL-BREF-TW -Pretest
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
WHOQOL-BREF-TW -Pretest
时间窗: 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
时间窗: 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.
BDI-II -Pretest
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- BAI -Pretest(BAI score at pre-test (1week before intervention))
- BAI -Posttest(1 week after the intervention, corresponding to Week 9)
- COPM -Posttest(1 week after the intervention, corresponding to Week 9)
- BAI -Pretest(BAI score at pre-test (1week before intervention))
- BAI -Posttest(1 week after the intervention, corresponding to Week 9)
- OSA -Pretest(OSA score at pre-test (1week before intervention))
- OSA -Posttest(1 week after the intervention, corresponding to Week 9)
- COPM -Pretest(COPM score at pre-test (1week before intervention))
- COPM -Posttest(1 week after the intervention, corresponding to Week 9)
研究者
Yun-Ling Chen
Assistant Professor
Chung Shan Medical University