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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05831072
Enrollment
19
Registered
2023-04-26
Start date
2023-04-01
Completion date
2023-12-07
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in Adolescence

Keywords

mindfulness-based cognitive therapy, depressive symptoms, coping strategy, quality of life, university students

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.

Interventions

BEHAVIORALMindfulness-cognitive oriented group program

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.

Sponsors

Chung Shan Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life (follow-up)1-month follow-upThe 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.
Depression (screening)screeningBeck 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 (baseline)baselineBeck 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)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)1-month follow-upBeck 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 (baseline)baselineBrief 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 (post-intervention)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 (follow-up)1-month follow-upBrief 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)baselineThe 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)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.

Secondary

MeasureTime frameDescription
Occupational balance (post-intervention)post-intervention (up to 4 weeks)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.
Occupational balance (follow-up)1-month follow-upOccupational 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.
Role checklist (baseline)baselineRole 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.
Role checklist (post-intervention)post-intervention (up to 4 weeks)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.
Role checklist (follow-up)1-month follow-upRole 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.
Occupational questionnaire (baseline)baselineOccupational 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.
Occupational questionnaire (post-intervention)post-intervention (up to 4 weeks)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.
Occupational questionnaire (follow-up)1-month follow-upOccupational 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.
Occupational balance (baseline)baselineOccupational 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026