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Clinical Trials/NCT05831072
NCT05831072
Completed
Not Applicable

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

Chung Shan Medical University1 site in 1 country19 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression in Adolescence
Sponsor
Chung Shan Medical University
Enrollment
19
Locations
1
Primary Endpoint
Depression (baseline)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
December 7, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yun-Ling Chen

Assistant Professor

Chung Shan Medical University

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

Outcomes

Primary Outcomes

Depression (baseline)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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