RecruitingNCT07241325

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

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


Sponsor

National Taiwan University Hospital

Enrollment

500 participants

Start Date

Sep 19, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria4

  • 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.

Locations(1)

National Taiwan University Hospital - Metabolism

Taipei, Taiwan

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NCT07241325


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