Efficacy of a Mobile Phone Application for Early Intervention of Depression and Anxiety in Young College Students
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Depression symptoms
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of a mobile phone application for the early intervention of depression and anxiety among young university students in Chile. The main question it aims to answer is:
- Can a mobile app reduce depressive and anxious symptomatology in college students?
Researchers will compare the intervention arm (mobile app users) to the control group (receives psychoeducational material and mental health care resources) to see if the app leads to significant improvements in depressive and anxious symptoms and well-being.
Participants will:
- Be randomly assigned to either the intervention or control group.
- Use the mobile application, which includes psychoeducational materials, cognitive-behavioral therapy modules, and periodic personalized feedback.
- Complete assessments at baseline, post-intervention, and 3 and 6 months after randomization using online tools such as the PHQ-9 for depressive symptoms and the GAD-7 for anxious symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PHQ-9 and GAD-7 score between 5 and 14 points
- •Have a stable internet connection
- •To provide informed consent
排除标准
- •High risk of suicide according to C-SSRS
- •Currently undergoing psychological, psychiatric and/or psychopharmacological treatment
- •Bipolar disorder, psychotic disorder or substance use disorder assessed with the respective modules of the MINI interview.
结局指标
主要结局
Depression symptoms
时间窗: 6-weeks post-randomization
PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome
Anxiety symptoms
时间窗: 6-weeks post-randomization
GAD-7, total score varies between 0 and 21, higher values represent a worse outcome
次要结局
- Well-being(6-months post-randomization)
- User Satisfaction(6-weeks post-randomization)
- Depression symptoms(6-months post-randomization)
- Anxiety symptoms(6-months post-randomization)