Efficacy of Mindfulness-cognitive Oriented Group Intervention Program on Depressed University Students

Study 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.

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

Conditions
-----------------
Depression in Adolescence

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-cognitive oriented group program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-cognitive oriented group<br>Participants will receive a 4-week intervention of mindfulness-cognitive oriented group program. | Behavioral: Mindfulness-cognitive oriented group program<br>* Mindfulness-cognitive oriented group program is a 4-week program based on the theory of mindfulness-based cognitive therapy (MBCT). The main elements of MBCT such as mindfulness breathing, raisin meditation for mindful eating, body scan and mindfulness walking are included. In addition to the weekly intervention, participants are also required to do the mindfulness practice at home.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression (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. | screening | 
| Depression (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. | baseline | 
| Depression (post-intervention) | 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. | post-intervention (up to 4 weeks) | 
| Depression (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. | 1-month follow-up | 
| Coping style (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. | baseline | 
| Coping style (post-intervention) | 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. | post-intervention (up to 4 weeks) | 
| Coping style (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. | 1-month follow-up | 
| Quality of life (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. | baseline | 
| Quality of life (post-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. A higher score indicates a higher quality of life. | post-intervention (up to 4 weeks) | 
| Quality of life (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. | 1-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occupational balance (baseline) | Occupational Balance Questionnaire (OBQ) is a 11-item questionnaire with a four point response scale for each item (from 0 to 3) by the level of agreemtent with each of the affirmations. The OBQ is used to measure the perception of current occupational balance in daily life. The total score is ranged from 0 to 33. A higher score indicates a greater occupational balance. | baseline | 
| Occupational balance (post-intervention) | Occupational Balance Questionnaire (OBQ) is a 11-item questionnaire with a four point response scale for each item (from 0 to 3) by the level of agreemtent with each of the affirmations. The OBQ is used to measure the perception of current occupational balance in daily life. The total score is ranged from 0 to 33. A higher score indicates a greater occupational balance. | post-intervention (up to 4 weeks) | 
| Occupational balance (follow-up) | Occupational Balance Questionnaire (OBQ) is a 11-item questionnaire with a four point response scale for each item (from 0 to 3) by the level of agreemtent with each of the affirmations. The OBQ is used to measure the perception of current occupational balance in daily life. The total score is ranged from 0 to 33. A higher score indicates a greater occupational balance. | 1-month follow-up | 
| Role checklist (baseline) | Role checklist is used to assess the major roles that organize participant's daily life and the value of each role. The roles included the student, worker, volunteer, caregiver, home maintainer, friend, family member, religious participant, hobbyist, and participant in organizations. A higher number of roles means participating more roles in daily life. A higher score in the value of roles means more productive behaviors participants needed or desired. | baseline | 
| Role checklist (post-intervention) | Role checklist is used to assess the major roles that organize participant's daily life and the value of each role. The roles included the student, worker, volunteer, caregiver, home maintainer, friend, family member, religious participant, hobbyist, and participant in organizations. A higher number of roles means participating more roles in daily life. A higher score in the value of roles means more productive behaviors participants needed or desired. | post-intervention (up to 4 weeks) | 
| Role checklist (follow-up) | Role checklist is used to assess the major roles that organize participant's daily life and the value of each role. The roles included the student, worker, volunteer, caregiver, home maintainer, friend, family member, religious participant, hobbyist, and participant in organizations. A higher number of roles means participating more roles in daily life. A higher score in the value of roles means more productive behaviors participants needed or desired. | 1-month follow-up | 
| Occupational questionnaire (baseline) | Occupational questionnaire (OQ) is used to record daily occupations on 30-minute interval for a typical day. Each activity need to be classified as work, activity of daily living, recreation or rest and be rated for the competence, value, and interest using a five point rating scale. It indicates how well the participants do the activity, how important the activity is as well as how enjoyable the activity is. The higher score means better satisfaction, value and enjoyment of activity that the participant did. | baseline | 
| Occupational questionnaire (post-intervention) | Occupational questionnaire (OQ) is used to record daily occupations on 30-minute interval for a typical day. Each activity need to be classified as work, activity of daily living, recreation or rest and be rated for the competence, value, and interest using a five point rating scale. It indicates how well the participants do the activity, how important the activity is as well as how enjoyable the activity is. The higher score means better satisfaction, value and enjoyment of activity that the participant did. | post-intervention (up to 4 weeks) | 
| Occupational questionnaire (follow-up) | Occupational questionnaire (OQ) is used to record daily occupations on 30-minute interval for a typical day. Each activity need to be classified as work, activity of daily living, recreation or rest and be rated for the competence, value, and interest using a five point rating scale. It indicates how well the participants do the activity, how important the activity is as well as how enjoyable the activity is. The higher score means better satisfaction, value and enjoyment of activity that the participant did. | 1-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mindfulness-based cognitive therapy, depressive symptoms, coping strategy, quality of life, university students