Type 2 Diabetes Mellitus (T2DM)PWDQ-T2DNCT07241325
Psychological Well-Being, Depression, and Health-Related Quality of Life in Adults With Type 2 Diabetes: A Cross-Sectional Study
An observational study of Type 2 Diabetes Mellitus (T2DM) and Health-related Quality of Life, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Health-related Quality of Life, Depressive Symptoms
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2025to 1 Oct 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital - Metabolism
Taipei, 100229
YI-CHIEH CHUNG, Registered Nurse, +886-2-2312-3456 ext. 65371, ejchung@gmail.com
About this study
Official title: 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 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.
Read the detailed description
This is a prospective, cross-sectional observational study designed to examine the relationships among psychological well-being, depression, and quality of life in adult patients with type 2 diabetes attending the outpatient metabolic clinic at National Taiwan University Hospital. The study seeks to identify demographic, clinical, and psychosocial factors associated with psychological well-being in this population.
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
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment (single outpatient visit; questionnaires completed in approximately 30-40 minutes).
Secondary outcomes (3)
PHQ-9 Total Score (Depression Severity)
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess the severity of depressive symptoms. Total scores range from 0 to 27, where higher scores indicate more severe depression.
Measured: Day 1
EQ-5D-5L Index Score (Health Utility)
The EQ-5D-5L index score will be used to assess health-related quality of life using the Taiwan value set. Index scores typically range from below 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better health status.
Measured: Day 1
EQ-5D-5L Visual Analog Scale (VAS)
The EQ-5D-5L Visual Analog Scale (VAS) will be used to assess patients' self-rated overall health status. Scores range from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better perceived health.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start19 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Yuan Wang, Principal investigator, National Taiwan University Hospital, Department of Internal Medicine (Metabolism)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241325
- Sponsor's protocol ID
- 202508155RIND
- Acronym
- PWDQ-T2D
- Status last verified
- Dec 2025
- First submitted
- 24 Sep 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that may be shared include questionnaire scores and coded demographic and clinical variables (e.g., age group, sex, diabetes duration, BMI category, HbA1c range, presence of complications). No directly identifiable information (such as names, ID numbers, or contact information) will be included. Data will be stored and shared only under institutional data-sharing agreements, following approval by the National Taiwan University Hospital Research Ethics Committee.
Publications
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.
PubMed 10109801Kroenke 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.
PubMed 11556941
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07241325
- Acronym / sponsor ID
- PWDQ-T2D / 202508155RIND
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, cross-sectional observational study designed to examine the relationships among psychological well-being, depression, and quality of life in adult patients with type 2 diabetes attending the outpatient metabolic clinic at National Taiwan University Hospital. The study seeks to identify demographic, clinical, and psychosocial factors associated with psychological well-being in this population.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shalom Scale Total Score (Psychological Well-Being)
Time frame: At enrollment (single outpatient visit; questionnaires completed in approximately 30-40 minutes).
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.
3 secondary outcomes
PHQ-9 Total Score (Depression Severity)
Time frame: Day 1
EQ-5D-5L Index Score (Health Utility)
Time frame: Day 1
EQ-5D-5L Visual Analog Scale (VAS)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Results publicationShalom 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.
- Results publication: PubMed 10109801EuroQol 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.
- Results publication: PubMed 11556941Kroenke 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that may be shared include questionnaire scores and coded demographic and clinical variables (e.g., age group, sex, diabetes duration, BMI category, HbA1c range, presence of complications). No directly identifiable information (such as names, ID numbers, or contact information) will be included. Data will be stored and shared only under institutional data-sharing agreements, following approval by the National Taiwan University Hospital Research Ethics Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ching-Yuan Wang principal investigator
National Taiwan University Hospital, Department of Internal Medicine (Metabolism)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Health-related Quality of Life, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YI-CHIEH CHUNG, MSN, RN (+886-2-2312-3456 ext. 65371, ejchung@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shalom Scale Total Score (Psychological Well-Being) (time frame: At enrollment (single outpatient visit; questionnaires completed in approximately 30-40 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07241325, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.