Digital InterventionHealth EducationPersonalization Algorithm
Digital Intervention: game-based digital intervention app
Health Education: traditional health education app
Personalization Algorithm: a proprietary algorithm that adaptively adjust the treatment module and parameters to personalize the treatment regime
Study summary
The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.
Participants will be asked to engage with the digital intervention platform for a period of two months.
Eligibility
Sex
ALL
Min age
10 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) will be used to assess participants' eligibility based on the diagnostic criteria for depression outlined in the DSM-5(the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).
* no prior use of antidepressants or antipsychotic medications.
* having a HAMD (Hamilton Depression scale) score \>= 8 upon enrollment
* demonstrate normal cognitive function.
* voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.
* being able to read and typeset Chinese.
Exclusion Criteria:
* with severe consciousness disorders and a history of psychiatric illness, traumatic brain injury, substance dependence, or acute poisoning
* with concurrent psychiatric disorders (as determined by clinical assessment)
* at high risk of suicide
Primary outcome measure(s)
Change from Baseline in Depression on the 50-point 16-item Hamilton Depression Rating Scale (HAM-D) at Week 8 — baseline and immediately after 8-week intervention HAM-D is a clinician-administered depression assessment scale. To adapt to adolescent participants, item 14 (genital symptoms) was removed. Thus, the score was calculated based on the 16 items. Possible scores range from 0 (no symptoms) to 50 (worst symptom). Change = (Week 8 Score - Baseline Score).
Response Rate - 50 Percent or Greater Reduction in the 50-point 16-item Hamilton Depression Rating Scale (HAM-D) at Week 8 — baseline and immediately after 8-week intervention HAM-D is a clinician-administered depression assessment scale. To adapt to adolescent participants, item 14 (genital symptoms) was removed. Thus, the score was calculated based on the 16 items. Possible scores range from 0 (no symptoms) to 50 (worst symptom). The response rate was defined as the number of participants with a 50% or greater reduction in HAM-D score from baseline to week 8.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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