Depressive Symptoms, Health-related Quality of Life, Psychological Well-being, Spiritual Well-being, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Type 2 Diabetes Mellitus, Psychological Well-Being, Depression, PHQ-9, EQ-5D-5L, Shalom Scale, Spiritual Well-Being, Psychosocial Support, Cross-Sectional, Observational, Taiwan
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Taiwan University Hospital
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older with full legal capacity. 2. Clinically diagnosed with Type 2 Diabetes Mellitus and receiving ongoing outpatient care. 3. Able to read and understand Chinese questionnaires and complete self-administered forms. 4. Understand the study purpose and procedures and provide written informed consent.
Exclusion criteria
1. Presence of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depressive disorder). 2. Moderate to severe cognitive impairment or dementia, as assessed by the clinical physician, making it impossible to complete the questionnaires. 3. Currently experiencing acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) or hospitalization. 4. Severe language or other communication barriers preventing expression of consent or understanding of study content.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shalom Scale Total Score (Psychological Well-Being) | At enrollment (single outpatient visit; questionnaires completed in approximately 30-40 minutes). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-9 Total Score (Depression Severity) | Day 1 | 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) | Day 1 | 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) | Day 1 | 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. |
Countries
Taiwan
Contacts
CONTACTYI-CHIEH CHUNG, MSN, RN
PRINCIPAL_INVESTIGATORChing-Yuan Wang
National Taiwan University Hospital, Department of Internal Medicine (Metabolism)
Outcome results
None listed