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

NCT ID: NCT05831072

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-12-07

Brief Summary

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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

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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.

Conditions

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Depression in Adolescence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness-cognitive oriented group

Participants will receive a 4-week intervention of mindfulness-cognitive oriented group program.

Group Type EXPERIMENTAL

Mindfulness-cognitive oriented group program

Intervention Type BEHAVIORAL

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.

Interventions

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Mindfulness-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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yun-Ling Chen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yun-Ling Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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Demarzo M, Montero-Marin J, Puebla-Guedea M, Navarro-Gil M, Herrera-Mercadal P, Moreno-Gonzalez S, Calvo-Carrion S, Bafaluy-Franch L, Garcia-Campayo J. Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study. Front Psychol. 2017 Aug 8;8:1343. doi: 10.3389/fpsyg.2017.01343. eCollection 2017.

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Reference Type RESULT
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Musa ZA, Soh KL, Mukhtar F, Soh KY, Oladele TO, Soh KG. Impact of Mindfulness-Based Cognitive Therapy on Depressive Symptoms Reduction among Depressed Patients in Nigeria: A Randomized Controlled Trial. Issues Ment Health Nurs. 2021 Jul;42(7):667-675. doi: 10.1080/01612840.2020.1821139. Epub 2020 Sep 30.

Reference Type RESULT
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PMID: 31997369 (View on PubMed)

Ritvo P, Knyahnytska Y, Pirbaglou M, Wang W, Tomlinson G, Zhao H, Linklater R, Bai S, Kirk M, Katz J, Harber L, Daskalakis Z. Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 10;23(3):e24380. doi: 10.2196/24380.

Reference Type RESULT
PMID: 33688840 (View on PubMed)

Schanche E, Vollestad J, Visted E, Svendsen JL, Osnes B, Binder PE, Franer P, Sorensen L. The effects of mindfulness-based cognitive therapy on risk and protective factors of depressive relapse - a randomized wait-list controlled trial. BMC Psychol. 2020 Jun 5;8(1):57. doi: 10.1186/s40359-020-00417-1.

Reference Type RESULT
PMID: 32503649 (View on PubMed)

Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693.

Reference Type RESULT
PMID: 31995132 (View on PubMed)

Sun Y, Li Y, Wang J, Chen Q, Bazzano AN, Cao F. Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Jan 27;23(1):e23410. doi: 10.2196/23410.

Reference Type RESULT
PMID: 33502326 (View on PubMed)

Winnebeck E, Fissler M, Gartner M, Chadwick P, Barnhofer T. Brief training in mindfulness meditation reduces symptoms in patients with a chronic or recurrent lifetime history of depression: A randomized controlled study. Behav Res Ther. 2017 Dec;99:124-130. doi: 10.1016/j.brat.2017.10.005. Epub 2017 Oct 12.

Reference Type RESULT
PMID: 29078199 (View on PubMed)

Zemestani M, Fazeli Nikoo Z. Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. Arch Womens Ment Health. 2020 Apr;23(2):207-214. doi: 10.1007/s00737-019-00962-8. Epub 2019 Apr 13.

Reference Type RESULT
PMID: 30982086 (View on PubMed)

Other Identifiers

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CS1-22140

Identifier Type: -

Identifier Source: org_study_id

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