Digital Intervention for Depression and Anxiety in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Rating Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Hamilton Anxiety Rating Scale
时间窗: 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
时间窗: baseline and immediately after 8-week intervention
Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms.
次要结局
- 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)