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

NCT07241325 | Recruiting

• 1 other identifier: 202508155RIND
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At enrollment (single outpatient visit; questionnaires completed in approximately 30-40 minutes).

Secondary Outcomes (3)

• PHQ-9 Total Score (Depression Severity)

  Day 1

• EQ-5D-5L Index Score (Health Utility)

  Day 1

• EQ-5D-5L Visual Analog Scale (VAS)

  Day 1

Other Outcomes (2)

• Associations Between Demographic/Clinical Variables and Psychological Well-Being

  Day 1

• Exploratory Subgroup Analyses of Psychological Well-Being, Depression, and Quality of Life

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital - Metabolism

Taipei, 100229, Taiwan

RECRUITING

Related Publications (3)

• Shalom S., Wang Y.T., Wang C.H., Hu R.Z. (2013). Development and validation of the Shalom Scale for psychological well-being in Chinese populations. Fu Jen Medical Journal, 11(3), 197-204.

  RESULT

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 RESULT

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Ching-Yuan Wang

  National Taiwan University Hospital, Department of Internal Medicine (Metabolism)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YI-CHIEH CHUNG, MSN, RN

CONTACT

+886-2-2312-3456; ejchung@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 21, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months after publication of the main results; available for up to 5 years thereafter.
• Access Criteria: Qualified researchers may request access by submitting a written proposal and institutional data-sharing agreement to the Principal Investigator. Approval will be required from the National Taiwan University Hospital Research Ethics Committee prior to data release.

Locations

TW (1)