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Biomarkers, TCM Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression Among University Students

Sponsor
Universiti Tunku Abdul Rahman (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076643
Collaborator
(none)
397
Enrollment
1
Location
13.5
Anticipated Duration (Months)
29.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to determine the predictors of depression among university students in Universiti Tunku Abdul Rahman (UTAR) Sungai Long Campus.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    University students are a high at risk group for development of depression. Identifying the determinants of depression could help in the diagnosis and treatment of this disorder. This study will incorporate questionnaire and blood sample data collection procedures on 397 subjects. Written consent will be obtained from the subjects. Eligible subjects will be given self-administered questionnaires which include Patient health questionnaire (PHQ-9), Constitution in Chinese medicine questionnaire (CCMQ), Dysfunctional Attitude Scale (DAS), Depression Anxiety Stress Scales (DASS-21) - stress and anxiety subscales, Perceived stress scale-10 (PSS-10), Rosenberg self-esteem scale (RSES), and Food frequency questionnaire (FFQ). Once the subjects completed the questionnaires, blood samples will be collected from them by a trained phlebotomist. In addition, 10 most high at risk of depression subjects (with PHQ-9 scores 10 and above) and 10 healthy subjects (with PHQ-9 scores lower than 10) will be selected randomly for protein expression to further identify the proteins that significantly expressed among them.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    397 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Biomarkers, Traditional Chinese Medicine Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression Among University Students in UTAR, Malaysia
    Actual Study Start Date :
    Mar 17, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    University students

    University students in Universiti Tunku Abdul Rahman Sungai Long Campus

    Outcome Measures

    Primary Outcome Measures

    1. Genetic, TCM body constitution, psychological factors and dietary pattern are significant predictors for depression among university students. [Baseline]

      Univariate and multivariate logistic regression will be performed.

    Secondary Outcome Measures

    1. Prevalence of depression among university students. [Baseline]

      Patient Health Questionnaire (PHQ-9): Non depressed = 0 - 9; Depressed = 10 - 27

    2. Protein significantly expressed between depressed and non-depressed students. [Baseline]

      Liquid chromatography-mass spectrometry (LC-MS) will be performed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Malaysian citizen

    • Able to read and communicate in English

    Exclusion Criteria:

    • Special education disability (deaf and blind)

    • Physical support

    • History of infectious diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universiti Tunku Abdul Rahman Kajang Selangor Malaysia 43000

    Sponsors and Collaborators

    • Universiti Tunku Abdul Rahman

    Investigators

    • Principal Investigator: Chai Nien Foo, Universiti Tunku Abdul Rahman

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Foo Chai Nien, Assistant Professor, Universiti Tunku Abdul Rahman
    ClinicalTrials.gov Identifier:
    NCT05076643
    Other Study ID Numbers:
    • IPSR/RMC/UTARRF/2019-C2/F01
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of May 24, 2022