Psychological Well-Being, Depression, and Health-Related Quality of Life in Adults With Type 2 Diabetes: A Cross-Sectional Study
NCT ID: NCT07241325
Last Updated: 2026-01-28
Study Results
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Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2025-09-19
2026-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ching-Yuan Wang
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital, Department of Internal Medicine (Metabolism)
Locations
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National Taiwan University Hospital - Metabolism
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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202508155RIND
Identifier Type: -
Identifier Source: org_study_id
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