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

NCT05831072 | Completed

• 1 other identifier: CS1-22140
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression in Adolescence

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (9)

• Occupational balance (baseline)

  baseline

• Occupational balance (post-intervention)

  post-intervention (up to 4 weeks)

• Occupational balance (follow-up)

  1-month follow-up

• Role checklist (baseline)

  baseline

• Role checklist (post-intervention)

  post-intervention (up to 4 weeks)

Study Arms (1)

Mindfulness-cognitive oriented group

EXPERIMENTAL

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

Behavioral: Mindfulness-cognitive oriented group program

Interventions

Mindfulness-cognitive oriented group program 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.

Mindfulness-cognitive oriented group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, 402, Taiwan

Location

Related Publications (14)

• Cladder-Micus MB, Speckens AEM, Vrijsen JN, T Donders AR, Becker ES, Spijker J. Mindfulness-based cognitive therapy for patients with chronic, treatment-resistant depression: A pragmatic randomized controlled trial. Depress Anxiety. 2018 Oct;35(10):914-924. doi: 10.1002/da.22788. Epub 2018 Aug 8.

  PMID: 30088834 RESULT

• Compas BE, Connor-Smith JK, Saltzman H, Thomsen AH, Wadsworth ME. Coping with stress during childhood and adolescence: problems, progress, and potential in theory and research. Psychol Bull. 2001 Jan;127(1):87-127.

  PMID: 11271757 RESULT

• 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.

  PMID: 28848465 RESULT

• Farb N, Anderson A, Ravindran A, Hawley L, Irving J, Mancuso E, Gulamani T, Williams G, Ferguson A, Segal ZV. Prevention of relapse/recurrence in major depressive disorder with either mindfulness-based cognitive therapy or cognitive therapy. J Consult Clin Psychol. 2018 Feb;86(2):200-204. doi: 10.1037/ccp0000266. Epub 2017 Dec 21.

  PMID: 29265831 RESULT

• Foroughi A, Sadeghi K, Parvizifard A, Parsa Moghadam A, Davarinejad O, Farnia V, Azar G. The effectiveness of mindfulness-based cognitive therapy for reducing rumination and improving mindfulness and self-compassion in patients with treatment-resistant depression. Trends Psychiatry Psychother. 2020 Jun;42(2):138-146. doi: 10.1590/2237-6089-2019-0016. Epub 2020 Jul 17.

  PMID: 32696895 RESULT

• Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, Barrett B, Byng R, Evans A, Mullan E, Teasdale JD. Mindfulness-based cognitive therapy to prevent relapse in recurrent depression. J Consult Clin Psychol. 2008 Dec;76(6):966-78. doi: 10.1037/a0013786.

  PMID: 19045965 RESULT

• 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.

  PMID: 32996802 RESULT

• Probst T, Schramm E, Heidenreich T, Klein JP, Michalak J. Patients' interpersonal problems as moderators of depression outcomes in a randomized controlled trial comparing mindfulness-based cognitive therapy and a group version of the cognitive-behavioral analysis system of psychotherapy in chronic depression. J Clin Psychol. 2020 Jul;76(7):1241-1254. doi: 10.1002/jclp.22931. Epub 2020 Jan 30.

  PMID: 31997369 RESULT

• 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.

  PMID: 33688840 RESULT

• 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.

  PMID: 32503649 RESULT

• 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.

  PMID: 31995132 RESULT

• 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.

  PMID: 33502326 RESULT

• 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.

  PMID: 29078199 RESULT

• 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.

  PMID: 30982086 RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Yun-Ling Chen, Doctor

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 26, 2023
• Study Start: April 1, 2023
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)