Anxiety, Depression
Conditions
Brief 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.
Interventions
BEHAVIORALDigital Intervention
game-based digital intervention app
BEHAVIORALHealth Education
traditional health education app
Sponsors
Adai Technology (Beijing) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 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). * having a HAMD(Hamilton Depression scale) score upon enrollment * demonstrate normal cognitive function. * voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.
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) * with concurrent psychiatric disorders (as determined by the assessing clinician) * at high risk of suicide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Rating Scale | baseline and immediately after 8-week intervention | Score Range: 0 (best outcome) to 56 (worst outcome) Higher scores indicate more severe anxiety symptoms. |
| Hamilton Depression Rating Scale | baseline and immediately after 8-week intervention | Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADHD(attention deficit hyperactivity disorder) Rating Scale-IV | baseline and immediately after 8-week intervention | Score Range: 0 (best outcome) to 54 (worst outcome) Higher scores indicate more severe ADHD symptoms. |
| PHQ-9 (Patient Health Questionnaire-9) | baseline and weekly assessments during the treatment period, assessed up to 8 weeks | PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms. |
| GAD-7 (Generalized Anxiety Disorder-7) | baseline and weekly assessments during the treatment period, assessed up to 8 weeks | GAD-7 Score Range: 0 (best outcome) to 21 (worst outcome); higher scores indicate more severe generalized anxiety symptoms. |
Countries
China
Contacts
Primary ContactLiqun Zhang
Outcome results
None listed