Description

College of Health Sciences
Department of Public Health

ASSIGNMENT COVER SHEET
Course name:

Healthcare Research Methods

Course number:

PHC215

CRN
Q1: Select a topic on any health-related condition of your
interest and prepare research proposal under following
points

Assignment title or task:

1. Title of project – max. 20 words (0.5 mark)
2. Background (Literature review) and significance of study –
180-200 words (3+1 marks)
3. Aim and objectives – approx. 100 words (1+1 mark)
4. Methodology
4.1 Study design, study population and study setting –
approx. 80-100 words (1.5 marks)
4.2 Eligibility criteria: Inclusion and exclusion criteria
(0.5+0.5 mark)
4.3 Data collection method (1 mark)
5. Statistical test applicable for the study – approx. 50 words
(1 mark)
6. Timeline for the project – (1 mark)
7. References – 4-5 references APA format – (1 mark)
Q2: Write a paragraph describing the importance of the
validity and reliability of data collection tool in a primary
study – 80-100 words (2 marks)

Students Name:
Submission date:

16/4/2025

Instructor name:
Grade:
Due Date: Sunday, 19th April 2025 (11:59 p.m.)

14 out of 15

College of Health Sciences
Department of Public Health

Assignment guidelines:
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Assignment must be submitted with properly filled cover sheet (Name, ID, Submission date)
in word document, Pdf is not accepted
Avoid plagiarism
Word count 500-750 words (Reference not included)
Font should be 12 Time New Roman
Color should be black
Line spacing should be 1.5

Title of Project:

College of Health Sciences
Department of Public Health

Assessing the Relationship Between Gut Microbiota and Mental Health: A Study on Anxiety and
Depression
Background and Significance of the Study:
The gut-brain axis has emerged as a crucial area of research in understanding mental health
disorders such as anxiety and depression. The human gut microbiota, comprising trillions of
microorganisms, plays a significant role in regulating neurotransmitter production, immune
function, and inflammation—all linked to mental health. Recent studies suggest that imbalances
in gut microbiota (dysbiosis) may contribute to mood disorders by affecting the production of
serotonin and gamma-aminobutyric acid (GABA), key neurotransmitters involved in emotional
regulation (Simpson et al., 2021).
A study published in Nature Microbiology found that individuals with depression often exhibit
lower levels of beneficial gut bacteria such as Lactobacillus and Bifidobacterium. Similarly,
animal models indicate that gut microbiota transplantation from depressed individuals to healthy
mice can induce depressive-like behaviors. Despite growing evidence, the exact mechanisms
linking gut microbiota and mental health remain unclear, necessitating further research.
This study is significant as it could lead to novel non-pharmacological interventions for mental
health disorders, such as dietary modifications, probiotics, and microbiome-targeted therapies.
Understanding this relationship can enhance treatment strategies for anxiety and depression,
providing alternative approaches to traditional medication and psychotherapy.
Aim and Objectives:
Aim:
To explore the association between gut microbiota composition and symptoms of anxiety and
depression in young adults.
Objectives:

College of Health Sciences
Department of Public Health

To analyze differences in gut microbiota composition between individuals with and without
anxiety and depression.
To investigate the correlation between gut microbiota diversity and the severity of depressive and
anxious symptoms.
To examine dietary patterns and their influence on gut microbiota and mental health.
To identify potential probiotic strains that may positively impact mental well-being.
4. Methodology
4.1 Study Design, Study Population, and Study Setting
This study will adopt a cross-sectional observational design to explore the relationship
between gut microbiota composition and symptoms of anxiety and depression. A cross-sectional
approach is suitable for identifying associations between variables at a single point, providing
insights into potential correlations between mental health and gut microbiota diversity.
The study will be conducted in university health centers and mental health clinics in an urban
setting, ensuring accessibility to a diverse population. The target population will consist of young
adults, as this age group experiences a high prevalence of anxiety and depression and is undergoing
significant lifestyle and dietary changes that may influence gut microbiota (Simpson et al., 2021).
4.2 Eligibility Criteria
Inclusion Criteria:
Participants must meet the following criteria to be included in the study:
Age between 18 and 30 years.
Willing to provide stool samples for microbiota analysis.
Able to complete mental health assessment questionnaires.

College of Health Sciences
Department of Public Health

No use of antibiotics or probiotics in the past three months, as these can significantly alter gut
microbiota composition.
Exclusion Criteria:
Participants will be excluded if they meet any of the following conditions:
Diagnosed with gastrointestinal disorders such as Irritable Bowel Syndrome (IBS), Crohn’s
disease, or ulcerative colitis, which could influence gut microbiota independently of mental health
status.
Current use of psychotropic medications that significantly impact gut microbiota.
History of substance abuse or severe psychiatric disorders requiring hospitalization.
Pregnancy or lactation, as hormonal changes during this period, may alter gut microbiota
composition.
4.3 Data Collection Method
Mental Health Assessment
Participants will complete standardized self-report mental health questionnaires, including the
Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-9 (PHQ-9). These
validated tools will assess the severity of anxiety and depressive symptoms, respectively.
Gut Microbiota Analysis
Each participant will provide a self-collected stool sample using a home-based collection kit.
Samples will be processed using 16S rRNA sequencing, a widely used technique to analyze
microbial diversity and composition. This sequencing will help identify the presence of beneficial
and harmful bacterial strains and their potential link to anxiety and depression symptoms
(Taherdoost, 2021).
Dietary and Lifestyle Questionnaire

College of Health Sciences
Department of Public Health

Participants will complete a structured questionnaire assessing dietary habits, sleep
patterns, stress levels, and physical activity. These factors influence mental health and gut
microbiota and will help control for potential confounders in the study.
5. Statistical Test Applicable for the Study
Data analysis will be conducted using SPSS and R software to ensure accuracy and
reliability. The Spearman correlation test will examine the association between gut microbiota
diversity and mental health scores. Since gut microbiota data is often non-normally distributed,
the Mann-Whitney U test will be applied to compare microbial diversity between individuals with
and without anxiety or depression. (Liang et al., 2022).
6. Timeline for the Project
The project will take approximately 10 months to complete. The first month will be
allocated to finalizing the research design, obtaining ethical approval, and developing recruitment
strategies. The data collection phase will span three months, during which participants will be
recruited, mental health assessments will be completed, and stool samples for microbiota analysis
will be provided. After data collection, two months will be dedicated to laboratory analysis,
including 16S rRNA sequencing to identify microbial diversity. The following two months will
focus on statistical data analysis, where correlations between microbiota composition and mental
health symptoms will be evaluated. Finally, the last two months will involve report writing,
manuscript preparation, and dissemination of findings through academic conferences and journal
publications. The project timeline ensures efficient completion of each stage while maintaining the
integrity of data collection and analysis.
7- References
Simpson, C. A., Diaz-Arteche, C., Eliby, D., Schwartz, O. S., Simmons, J. G., & Cowan, C. S.
(2021). The gut microbiota in anxiety and depression–A systematic review. Clinical
psychology review, 83, 101943.

College of Health Sciences
Department of Public Health

Liang, J., Zhao, Y., Xi, Y., Xiang, C., Yong, C., Huo, J., … & Lin, Q. (2022). Association
between depression, anxiety symptoms, and gut microbiota in Chinese elderly with
functional constipation. Nutrients, 14(23), 5013. Retrieved from

Taherdoost, H. (2021). Data collection methods and tools for research; a step-by-step guide to
choose data collection technique for academic and business research
projects. International Journal of Academic Research in Management (IJARM), 10(1),
10-38.
Karunarathna, I., Gunasena, P., Hapuarachchi, T., & Gunathilake, S. (2024). Comprehensive
data collection: Methods, challenges, and the importance of accuracy. Uva Clinical
Research, 1-24.

_Methods_Challenges_and_the_Importance_of_Accuracy

Question 2
In conducting primary research, the data collection questionnaire or schedule is essential
for validity and reliability to make the study scientifically Sound. Internal validity confirms that
the tool measures the exact concept it has to quantify. Without them, the research may collect
unnecessary information, leading to wrong conclusions regarding the phenomenon under study

College of Health Sciences
Department of Public Health

(Karunarathna et al., 2024). Through this lens, reliability is a key element that affirms that the tool
is stable and consistent in its performance if applied consecutively or employed by different
researchers or operators. When a tool is unreliable, it yields unpredictable results, making them
unreliable, inconclusive, and practically unrepeatable (Ahmed & Ishtiaq, 2021).

College of Health Sciences
Department of Public Health

References
Ahmed, I., & Ishtiaq, S. (2021). Reliability and validity: importance in medical
research. Methods, 12(1), 2401-2406.

nks/61600df90bf51d48175251ee/Reliability-and-validity-Importance-in-MedicalResearch.pdf
Karunarathna, I., Gunasena, P., Hapuarachchi, T., & Gunathilake, S. (2024). Comprehensive
data collection: Methods, challenges, and the importance of accuracy. Uva Clinical
Research, 1-24.

_Methods_Challenges_and_the_Importance_of_Accuracy

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