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.
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.
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.
Adult patients (aged 18 years and older) with a confirmed diagnosis of type 2 diabetes mellitus receiving ongoing outpatient care at the Metabolism Clinic of National Taiwan University Hospital. Approximately 350 participants will be recruited using convenience sampling during routine clinic visits. All participants must be able to read and understand Chinese questionnaires, complete self-administered forms, and provide written informed consent. The study does not include healthy volunteers or individuals without type 2 diabetes.
Other
Cross-sectional
Not listed
Shalom Scale Total Score (Psychological Well-Being)
The Shalom Scale for Psychological Well-Being will be used to measure psychological well-being. Higher scores indicate better spiritual/psychological well-being. The total score will be analyzed as a continuous variable.
PHQ-9 Total Score (Depression Severity)
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess the severity of depressive symptoms. Total scores range from 0 to 27, where higher scores indicate more severe depression.
EQ-5D-5L Index Score (Health Utility)
The EQ-5D-5L index score will be used to assess health-related quality of life using the Taiwan value set. Index scores typically range from below 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better health status.
EQ-5D-5L Visual Analog Scale (VAS)
The EQ-5D-5L Visual Analog Scale (VAS) will be used to assess patients' self-rated overall health status. Scores range from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better perceived health.
Associations Between Demographic/Clinical Variables and Psychological Well-Being
Associations between psychological well-being and demographic or clinical variables will be examined using correlation and multivariable regression analyses. Pearson correlation (r) will be used to assess bivariate associations between the Shalom Scale total score and PHQ-9 total score, EQ-5D-5L index score, and HbA1c (%). Multiple linear regression analyses will be performed to estimate standardized beta coefficients (β) for predictors of Shalom Scale total score, including age, sex, diabetes duration, BMI, HbA1c, presence of complications, family support, sleep quality, and exercise frequency. Results will be reported as correlation coefficients (r) or standardized β coefficients (unitless).
Exploratory Subgroup Analyses of Psychological Well-Being, Depression, and Quality of Life
Exploratory subgroup analyses will be conducted to examine differences in psychological well-being, depression severity, and health-related quality of life across demographic or clinical subgroups. Subgroups of interest include sex (male vs. female), age group (e.g., \<65 vs. ≥65 years), diabetes duration (short vs. long duration), and presence of diabetes-related complications. Group comparisons will be performed using t-tests or ANOVA as appropriate. Results will be reported as mean differences in scores between subgroups.
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