Clinical trial NCT05831072: Efficacy of Mindfulness-cognitive Oriented Group Intervention Program on Depressed University Students
Official title: Efficacy of Mindfulness-cognitive Oriented Group Intervention Program on Depressive Symptoms, Coping Strategies and Quality of Life in University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression in Adolescence
Keywords: mindfulness-based cognitive therapy
depressive symptoms
coping strategy
quality of life
university students
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Students who have suitable cognitive capacity and minor and above level of depressive symptoms will be included in the study. Each single group will be 16 students or below.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Depression (screening)
timeFrame: screening
measure: Depression (baseline)
timeFrame: baseline
measure: Depression (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Depression (follow-up)
timeFrame: 1-month follow-up
measure: Coping style (baseline)
timeFrame: baseline
measure: Coping style (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Coping style (follow-up)
timeFrame: 1-month follow-up
measure: Quality of life (baseline)
timeFrame: baseline
measure: Quality of life (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Quality of life (follow-up)
timeFrame: 1-month follow-up
Secondary outcomes:
measure: Occupational balance (baseline)
timeFrame: baseline
measure: Occupational balance (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Occupational balance (follow-up)
timeFrame: 1-month follow-up
measure: Role checklist (baseline)
timeFrame: baseline
measure: Role checklist (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Role checklist (follow-up)
timeFrame: 1-month follow-up
measure: Occupational questionnaire (baseline)
timeFrame: baseline
measure: Occupational questionnaire (post-intervention)
timeFrame: post-intervention (up to 4 weeks)
measure: Occupational questionnaire (follow-up)
timeFrame: 1-month follow-up
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University
name: Yun-Ling Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
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