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

August 24, 2024 updated by: Foo Chai Nien, Universiti Tunku Abdul Rahman

Biomarkers, Traditional Chinese Medicine Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression Among University Students in UTAR, Malaysia

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

397

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Recruiting
        • Universiti Tunku Abdul Rahman
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

University students

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
University students
University students in Universiti Tunku Abdul Rahman Sungai Long Campus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic, TCM body constitution, psychological factors and dietary pattern are significant predictors for depression among university students.
Time Frame: Baseline
Univariate and multivariate logistic regression will be performed.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of depression among university students.
Time Frame: Baseline

Patient Health Questionnaire (PHQ-9):

Non depressed = 0 - 9; Depressed = 10 - 27
Baseline
Protein significantly expressed between depressed and non-depressed students.
Time Frame: Baseline
Liquid chromatography-mass spectrometry (LC-MS) will be performed.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Tunku Abdul Rahman

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPSR/RMC/UTARRF/2019-C2/F01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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