Depressive disorder, diabetes
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Beijing An Ding Hospital, Capital Medical University