Psychological Well-Being, Depression, and Health-Related Quality of Life in Adults With Type 2 Diabetes: A Cross-Sectional Study

Официальное название

A Cross-Sectional Observational Study to Evaluate Psychological Well-Being, Depression, and Health-Related Quality of Life and Their Demographic and Clinical Correlates in Adults With Type 2 Diabetes Attending an Outpatient Metabolic Clinic

Обзор

This prospective cross-sectional observational study aims to explore the relationships among psychological well-being, depression, and quality of life in patients with type 2 diabetes attending the outpatient metabolic clinic at National Taiwan University Hospital. The study will collect data using standardized instruments, including the EQ-5D Health-Related Quality of Life Questionnaire, the PHQ-9 Depression Scale, and the Shalom Scale of Psychological Well-Being, along with demographic and clinical variables such as age, sex, education, body mass index, HbA1c, disease duration, and psychosocial support indicators. Descriptive statistics, Pearson correlation analyses, ANOVA, and multiple linear regression modeling will be performed to identify factors associated with psychological well-being. The findings are expected to provide evidence-based insights to inform tailored interventions and improve the mental health and quality of life of patients with type 2 diabetes.

Подробное описание

This is a prospective, cross-sectional observational study designed to examine the relationships among psychological well-being, depression, and quality of life in adult patients with type 2 diabetes attending the outpatient metabolic clinic at National Taiwan University Hospital. The study seeks to identify demographic, clinical, and psychosocial factors associated with psychological well-being in this population.

Eligible participants will be ≥18 years old, diagnosed with type 2 diabetes, able to complete self-administered Chinese questionnaires, and willing to provide written informed consent. Patients with major psychiatric disorders, moderate to severe cognitive impairment, acute diabetic complications, or significant communication barriers will be excluded.

Data collection will include demographic variables (e.g., age, sex, education, marital status, religious belief, economic status, family support, sleep quality, exercise habits) and clinical indicators (e.g., diabetes duration, BMI, HbA1c, diabetic complications, estimated glomerular filtration rate). Three standardized instruments will be administered:

EQ-5D-5L to measure health-related quality of life

PHQ-9 to assess depressive symptoms

Shalom Scale to evaluate psychological well-being

The planned sample size is 350 participants. Recruitment will be conducted by the research team during clinic hours. Written informed consent will be obtained before any data collection.

Statistical analyses will include descriptive statistics to summarize participant characteristics and scale scores, Pearson correlation analyses to examine associations between variables, one-way ANOVA to compare psychological well-being across subgroups, and multiple linear regression modeling to identify predictors of psychological well-being.

The study period is from September 2025 to December 2026. This research is investigator-initiated and self-funded. The results will provide an evidence-based foundation for designing tailored clinical and psychosocial interventions to improve mental health and quality of life in patients with type 2 diabetes.

Первичные конечные точки

• Shalom Scale Total Score (Psychological Well-Being) [Срок оценки: At enrollment (single outpatient visit; questionnaires completed in approximately 30-40 minutes).]

Вторичные конечные точки (3)

• PHQ-9 Total Score (Depression Severity) [Срок оценки: Day 1]
• EQ-5D-5L Index Score (Health Utility) [Срок оценки: Day 1]
• EQ-5D-5L Visual Analog Scale (VAS) [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Adults aged 18 years or older with full legal capacity.
• Clinically diagnosed with Type 2 Diabetes Mellitus and receiving ongoing outpatient care.
• Able to read and understand Chinese questionnaires and complete self-administered forms.
• Understand the study purpose and procedures and provide written informed consent.

Критерии исключения

• Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depressive disorder).
• Moderate to severe cognitive impairment or dementia, as assessed by the clinical physician, making it impossible to complete the questionnaires.
• Currently experiencing acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) or hospitalization.
• Severe language or other communication barriers preventing expression of consent or understanding of study content.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital - Metabolism — Taipei

Публикации

• Shalom S., Wang Y.T., Wang C.H., Hu R.Z. (2013). Development and validation of the Shalom Scale for psychological well-being in Chinese populations. Fu Jen Medical Journal, 11(3), 197-204.
• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. PMID 10109801
• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. PMID 11556941

Идентификаторы

NCT: NCT07241325 · 202508155RIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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