跳至主要内容
临床试验/NCT05831072
NCT05831072已完成不适用

Efficacy of Mindfulness-cognitive Oriented Group Intervention Program on Depressive Symptoms, Coping Strategies and Quality of Life in University Students

Chung Shan Medical University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Depression (baseline)

研究概览

简要总结

The goal of this study is to reduce depressive symptoms as well as increase the positive coping strategy and quality of life in depressed university students. The main question it aims to answer is:

• The efficacy of 4-week mindfulness-cognitive oriented group program

The participants will be requested to participate in a 4-week program and do the mindfulness practice at home.

详细描述

In this study, the investigators will recruit university students through a poster at Chung Shan Medical University and the Internet.

For the screening, students will be requested to complete the assessments of the Saint Louis University Mental Status and Beck Depression Inventory-II. Students who have suitable cognitive capacity and minor and above level of depressive symptoms will be included in the study. The participants will receive a mindfulness-cognitive oriented group program for 4 weeks.

All the subjects will fill out the self-reported questionnaires at baseline, after the intervention, and one-month after the intervention. The assessments include Beck Depression Inventory-II, Brief Coping Orientation to Problems Experienced Inventory, World Health Organization Quality-of-Life Scale-BREF, Occupational Balance Questionnaire, Role Checklist, and Occupational Questionnaire.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • currently enrolled as a student at Chung Shan Medical University
  • between 18 and 30 years old
  • The Saint Louis University Mental Status (SLUMS) total score is greater than 26
  • the total score of Beck Depression Inventory-II (BDI-II) Chinese version is above 13
  • fluency in spoken Mandarin

排除标准

  • the score of item 9 (suicidal ideation) of Beck Depression Inventory-II (BDI-II) Chinese version > 0
  • a current diagnosis of depressive disorder
  • a current diagnosis of a major physical illness (e.g., cancer, cerebrovascular disease (stroke), spinal cord injury, congenital or genetic disease, chronic renal failure, autoimmune disease, burns) or psychological disease (psychotic or other psychiatric disorders, bipolar disorder, substance-related or addiction disorder, neurodevelopmental disorder, neurocognitive disorder, substance- or drug-induced depression)
  • currently taking psychiatric medication or receiving psychotherapy

结局指标

主要结局

Depression (baseline)

时间窗: baseline

Beck Depression Inventory - II (BDI-II) contains 21 items (each of them is scored on a scale of 0-3) in order to measure the depressive symptoms of participants. Higher scores indicates greater level of depression. 0-13 is considered a none or minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe level of depression.

Depression (post-intervention)

时间窗: post-intervention (up to 4 weeks)

Beck Depression Inventory - II (BDI-II) contains 21 items (each of them is scored on a scale of 0-3) in order to measure the depressive symptoms of participants. Higher scores indicates greater level of depression. 0-13 is considered a none or minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe level of depression.

Depression (follow-up)

时间窗: 1-month follow-up

Beck Depression Inventory - II (BDI-II) contains 21 items (each of them is scored on a scale of 0-3) in order to measure the depressive symptoms of participants. Higher scores indicates greater level of depression. 0-13 is considered a none or minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe level of depression.

Depression (screening)

时间窗: screening

Beck Depression Inventory - II (BDI-II) contains 21 items (each of them is scored on a scale of 0-3) in order to measure the depressive symptoms of participants. Higher scores indicates greater level of depression. 0-13 is considered a none or minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe level of depression.

Coping style (post-intervention)

时间窗: post-intervention (up to 4 weeks)

Brief Coping Orientation to Problems Experienced Inventory (Brief COPE) is a 28-item self-report questionnaire that using a 4-point rating scale in each item. It determines individual's primary coping styles with stressful life event, including approaching coping strategy, positive avoiding coping strategy and negative avoiding coping strategy. Scores are presented for three overarching coping styles as average scores, indicating the degree to which the respondent has been engaging in that coping style.

Coping style (baseline)

时间窗: baseline

Brief Coping Orientation to Problems Experienced Inventory (Brief COPE) is a 28-item self-report questionnaire that using a 4-point rating scale in each item. It determines individual's primary coping styles with stressful life event, including approaching coping strategy, positive avoiding coping strategy and negative avoiding coping strategy. Scores are presented for three overarching coping styles as average scores, indicating the degree to which the respondent has been engaging in that coping style.

Coping style (follow-up)

时间窗: 1-month follow-up

Brief Coping Orientation to Problems Experienced Inventory (Brief COPE) is a 28-item self-report questionnaire that using a 4-point rating scale in each item. It determines individual's primary coping styles with stressful life event, including approaching coping strategy, positive avoiding coping strategy and negative avoiding coping strategy. Scores are presented for three overarching coping styles as average scores, indicating the degree to which the respondent has been engaging in that coping style.

Quality of life (baseline)

时间窗: baseline

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. A higher score indicates a higher quality of life.

Quality of life (post-intervention)

时间窗: post-intervention (up to 4 weeks)

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. A higher score indicates a higher quality of life.

Quality of life (follow-up)

时间窗: 1-month follow-up

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. A higher score indicates a higher quality of life.

次要结局

  • Occupational balance (post-intervention)(post-intervention (up to 4 weeks))
  • Role checklist (baseline)(baseline)
  • Occupational questionnaire (post-intervention)(post-intervention (up to 4 weeks))
  • Role checklist (follow-up)(1-month follow-up)
  • Occupational questionnaire (baseline)(baseline)
  • Occupational balance (baseline)(baseline)
  • Occupational balance (follow-up)(1-month follow-up)
  • Role checklist (post-intervention)(post-intervention (up to 4 weeks))
  • Occupational questionnaire (follow-up)(1-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yun-Ling Chen

Assistant Professor

Chung Shan Medical University

研究点 (2)

Loading locations...

相似试验