Gut Microbiome and Depressive Symptoms: Examining Temporal Relationships and the Effect of Psychological Interventions

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010094

Enrollment

250

Registered

2024-12-27

Start date

2025-02-03

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

None listed

Interventions

Others : This study consists of three groups: 1) a non-depressed group, 2) a depressed control group, and 3) a depressed intervention group. The app-based psychological intervention is provided only t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants who wish to join the study and have signed the consent form 2. Participants who scored 1 or below on the suicidal ideation item during the screening test using PHQ-9 3. Participants who have no difficulty using a smartphone 4. Participants who are not currently receiving other mental health-related services (e.g., medication, psychotherapy, counseling) 5. The target group consists of college students and employees.

Exclusion criteria

Exclusion criteria: 1. Individuals outside the age criteria 2. Non-smartphone users 3. Individuals currently receiving other mental health-related services (e.g., medication, psychotherapy, counseling) 4. Participants who reported moderate or higher suicidal ideation (a score of 2 or above) on the specific sub-item assessing suicidal thoughts in the PHQ-9 screening test 5. neither college students nor employees

Design outcomes

Primary

Measure	Time frame
Gut Microbiota Questionnaire (To collect data necessary for understanding the gut microbiome environment, such as antibiotic usage, frequency of specific food intake, and stool characteristics);Korean Version of the Patient Health Questionnaire-9 (PHQ-9) (To assess the severity of depressive symptoms, facilitate intervention, and observe changes in PHQ-9 scores over time);Stool Collection and Gut Microbiota Gene Sequencing (To analyze gut microbiota and compare compositional differences);Korean Version of the Beck Depression Inventory-II (K-BDI-II) (To assess the severity of depressive symptoms in a depressed group, facilitate intervention, and observe changes in K-BDI-II scores over time)	—

Measure

Time frame

Gut Microbiota Questionnaire (To collect data necessary for understanding the gut microbiome environment, such as antibiotic usage, frequency of specific food intake, and stool characteristics);Korean Version of the Patient Health Questionnaire-9 (PHQ-9) (To assess the severity of depressive symptoms, facilitate intervention, and observe changes in PHQ-9 scores over time);Stool Collection and Gut Microbiota Gene Sequencing (To analyze gut microbiota and compare compositional differences);Korean Version of the Beck Depression Inventory-II (K-BDI-II) (To assess the severity of depressive symptoms in a depressed group, facilitate intervention, and observe changes in K-BDI-II scores over time)

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Secondary

Measure	Time frame
Basic Information Record Form (To collect participant information such as gender and age, which may influence gut microbiota composition);Mental Health Questionnaire (To identify factors that may influence study results, such as the use of psychological services, psychiatric diagnoses, and the use of psychiatric medications);Physical Health Questionnaire (To determine the presence of health conditions, such as physical illnesses or medical history, that may affect the study);Korean Version of the Insomnia Severity Index (ISI-K) (To identify sleep-related issues that may affect individuals' physiological and physical variables);Health Behavior Questionnaire (To assess factors such as physical activity, alcohol consumption, and smoking that may influence gut microbiota);GAD-7 (To consider the association between GAD-7 scores and gut microbiota, as it is known that anxiety may influence gut microbiota;Positive and Negative Emotional Experiences (To consider the association between positive and negative emotional experience scores and gut microbiota, as these factors are known to influence gut microbiota);Quality of Life Scale (To consider the association between quality of life scores and gut microbiota, as this factor is known to influence gut microbiota);Interoceptive Sensory Questionnaire (ISQ-8) (To consider the association between interoception and gut microbiota, as this factor is known to influence gut microbiota);UCLA Loneliness Scale (To consider the association between loneliness scores and gut microbiota, as this factor is known to influence gut microbiota);The Meaning in Life Questionnaire (MLQ)(T(To consider the association between meaning in life scores and gut microbiota, as this factor is known to influence gut microbiota));Behavior Regulation in Exercise Questionnaire(to consider the association between exercise behavior regulation scores and gut microbiota, as this factor is known to influence gut microbiota);Ten-Item Personality Invertory (TIPI)(To c	—

Measure

Time frame

Basic Information Record Form (To collect participant information such as gender and age, which may influence gut microbiota composition);Mental Health Questionnaire (To identify factors that may influence study results, such as the use of psychological services, psychiatric diagnoses, and the use of psychiatric medications);Physical Health Questionnaire (To determine the presence of health conditions, such as physical illnesses or medical history, that may affect the study);Korean Version of the Insomnia Severity Index (ISI-K) (To identify sleep-related issues that may affect individuals' physiological and physical variables);Health Behavior Questionnaire (To assess factors such as physical activity, alcohol consumption, and smoking that may influence gut microbiota);GAD-7 (To consider the association between GAD-7 scores and gut microbiota, as it is known that anxiety may influence gut microbiota;Positive and Negative Emotional Experiences (To consider the association between positive and negative emotional experience scores and gut microbiota, as these factors are known to influence gut microbiota);Quality of Life Scale (To consider the association between quality of life scores and gut microbiota, as this factor is known to influence gut microbiota);Interoceptive Sensory Questionnaire (ISQ-8) (To consider the association between interoception and gut microbiota, as this factor is known to influence gut microbiota);UCLA Loneliness Scale (To consider the association between loneliness scores and gut microbiota, as this factor is known to influence gut microbiota);The Meaning in Life Questionnaire (MLQ)(T(To consider the association between meaning in life scores and gut microbiota, as this factor is known to influence gut microbiota));Behavior Regulation in Exercise Questionnaire(to consider the association between exercise behavior regulation scores and gut microbiota, as this factor is known to influence gut microbiota);Ten-Item Personality Invertory (TIPI)(To c

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Countries

Korea, Republic of

Contacts

Public ContactDayi Jung

Yonsei University

dayiya0220@gmail.com+82-2-2123-4886

Outcome results