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Pragmatic randomized controlled trial of the graded intervention model based on the collaborative management platform for patients with comorbidity of depression and Type 2 diabetes

Pragmatic randomized controlled trial of the graded intervention model based on the collaborative management platform for patients with comorbidity of depression and Type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108627
Enrollment
Unknown
Registered
2025-09-02
Start date
2025-09-02
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive disorder, diabetes

Interventions

Realistic diagnostic group (control group):Only conventional T2DM and/or depression treatment is accepted
Tiered intervention model group (intervention group):Graded Intervention Collaborative Management Platform

Sponsors

Beijing An Ding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Case source: depressed patients with type 2 diabetes mellitus in outpatient or inpatient hospitalization of Beijing Anding Hospital. Inclusion Criteria: 1. Age>=18 years old; 2. Type 2 diabetes mellitus diagnosed in a second-level hospital or above; 3. The diagnosis of depressive disorder is made by a psychiatrist using the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5) structured clinical interview; Depressive symptoms are present, and the patient's Health Questionnaire-9 (PHQ-9) score is >=5 (range 0-27); 4. Glycated hemoglobin (HbA1c) 7%-12% or insulin resistance; 5. The patient or the patient's family holds a smartphone with Android system and can use it proficiently; 6. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Current or previous DSM-5 diagnosis of other major mental disorders other than major depressive disorder, such as schizophrenia and other psychotic disorders, bipolar disorder, neurodevelopmental disorder, and neurocognitive disorder; 2. Presence of serious physical diseases, such as end-stage renal disease (dialysis or need for transplantation), malignancy or life-threatening disease, or previous cardiovascular events (i.e., myocardial infarction, unstable angina, or stroke); 3. Any other situation that the investigator deems unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Comparison of treatment efficacy between two groups of depression;The treatment compliance of patients in the end point trial group and the control group;Two groups of diabetes control status;

Secondary

MeasureTime frame
The rate of achieving target blood glucose control (HbA1c<7%) in the intervention group was higher than that in the control group;Changes in the disease family burden scale (FBS) from baseline in patients in the study endpoint group and control group were compared:;adverse outcomes;Compare the change in the total score of the questionnaire on physician and patient acceptability in the end-point trial group from baseline;Incidence of adverse events;

Countries

China

Contacts

Public ContactYan Fang

Beijing An Ding Hospital, Capital Medical University

yanfang2019@ccmu.edu.cn+86 10 5834 0210

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026