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

ClinicalTrials.gov IDNCT07241325

PhaseNot Applicable

Enrollment500

SponsorNational Taiwan University Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes Mellitus (T2DM), Health-related Quality of Life, Depressive Symptoms, Psychological Well-being, Spiritual Well-being

About this study

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.

Primary outcomes

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

Eligibility information

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.

Study locations

National Taiwan University Hospital - Metabolism, Taipei, 100229 Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.