Digital Intervention for Depression and Anxiety in Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Hamilton Anxiety Rating Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Digital Intervention
Intervention: Digital Intervention (Behavioral)
Health Education
Intervention: Health Education (Behavioral)
Outcomes
Primary Outcomes
Hamilton Anxiety Rating Scale
Time Frame: 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
Time Frame: baseline and immediately after 8-week intervention
Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms.
Secondary Outcomes
- PHQ-9 (Patient Health Questionnaire-9)(baseline and weekly assessments during the treatment period, assessed up to 8 weeks)
- GAD-7 (Generalized Anxiety Disorder-7)(baseline and weekly assessments during the treatment period, assessed up to 8 weeks)
- ADHD(attention deficit hyperactivity disorder) Rating Scale-IV(baseline and immediately after 8-week intervention)