None listed
Conditions
Interventions
Medical Device : This is a single-arm study in which all participants will use ANZEILAX-BLUE, a smartphone-based digital therapeutic. ANZEILAX-BLUE is an application-based digital therapeutic develope
Sponsors
Wonkwang University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged 13 to 39 years who meet at least one of the following diagnoses: Major depressive episode (ICD-10 code: F32), Recurrent depressive disorder (ICD-10 code: F33), Persistent mood [affective] disorder (ICD-10 code: F34.1), Other recurrent mood [affective] disorders (ICD-10 code: F38.1), or Unspecified mood [affective] disorder (ICD-10 code: F39). 2. Individuals with a Beck Depression Inventory-II (BDI-II) score indicating at least mild depression (score =14). 3. Individuals currently prescribed and taking medication for the improvement of depressive symptoms. 4. Individuals who fully understand the purpose, content, and procedures of the clinical trial and voluntarily provide written informed consent. 5. Individuals who have had no changes in psychiatric medication from 28 days prior to study enrollment through the present. 6. For minors, individuals whose legally authorized representative has provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals who are unable to read the informed consent form. 2. Individuals who are not proficient in using a smartphone. 3. Patients currently receiving treatment for severe psychiatric disorders requiring hospitalization, including severe depressive disorder, suicidality, bipolar disorder, or schizophrenia. 4. Individuals with neurological disorders such as brain injury, epilepsy, or cognitive impairment. 5. Individuals with intellectual disability. 6. Individuals with substance use disorder or alcohol use disorder. 7. Individuals who are currently receiving cognitive behavioral therapy for depression, anxiety, or mood disorders, or who have participated in such therapy within the past 6 months. 8. Individuals who have attempted suicide within 3 months prior to screening and are considered by a psychiatrist to be at high risk for suicide with a clear suicidal plan. 9. Individuals currently enrolled in another clinical study. 10. Individuals deemed unsuitable for participation in this clinical trial at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Beck Depression Inventory-II (BDI-II) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Generalized Anxiety Disorder-7 (GAD-7) score;Change in Hamilton Depression Rating Scale (HAM-D) score;Change in Clinical Global Impression-Severity (CGI-S) score;Change in Clinical Global Impression-Improvement (CGI-I) score;Change in Pittsburgh Sleep Quality Index (PSQI) score;Change in Rosenberg Self-Esteem Scale (RSES) score;Change in Columbia-Suicide Severity Rating Scale (C-SSRS) score;Changes in brain function measured by functional near-infrared spectroscopy (fNIRS);Treatment adherence to ANZEILAX-BLUE;Treatment satisfaction | — |
Countries
Korea, Republic of
Contacts
Public ContactChanmo Yang
Wonkwang University Hospital
Outcome results
None listed