Psychological well-being, depression, and quality of life in adults with type 2 diabetes
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
This project will see if psychological well-being and depressive symptoms are linked to health-related quality of life in adults with type 2 diabetes attending an outpatient clinic.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07241325 on ClinicalTrials.gov |
What this trial studies
This prospective cross-sectional observational project will enroll about 350 adults with type 2 diabetes from the outpatient metabolic clinic at National Taiwan University Hospital. Participants who can read Chinese will complete the EQ-5D-5L, PHQ-9, and the Shalom Scale along with demographic and clinical measures such as BMI, HbA1c, disease duration, and psychosocial support indicators. The analysis will use descriptive statistics, Pearson correlations, ANOVA, and multiple linear regression to identify factors associated with psychological well-being. Findings are intended to inform tailored mental health and quality-of-life interventions for this patient population.
Who should consider this trial
Good fit: Adults aged 18 or older with diagnosed type 2 diabetes who receive outpatient care at NTUH, can read and complete Chinese questionnaires, and can provide written informed consent.
Not a fit: People with major psychiatric disorders, moderate to severe cognitive impairment, acute diabetic complications, hospitalization, or severe communication barriers are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help tailor mental health and support services to improve quality of life for people with type 2 diabetes.
How similar studies have performed: Previous observational studies have found links between depressive symptoms, psychological well-being, and quality of life in type 2 diabetes, so this study builds on established findings in a Taiwanese clinic population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Taipei
- National Taiwan University Hospital - Metabolism — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Ching-Yuan Wang — National Taiwan University Hospital, Department of Internal Medicine (Metabolism)
- Study coordinator: Yi-Chieh Chung, Msn, Rn
- Email: ejchung@gmail.com
- Phone: +886-2-2312-3456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.