Evaluating The Impact of A Mental Health App on Depression and Resilience Among Medical Students: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Depressive symptoms
研究概览
简要总结
This randomized controlled trial aims to determine whether access to a mental health app improves resilience and reduces depressive symptoms among medical students over a three-month period.
Compared to the control group, researchers hypothesized that medical students in the intervention group are expected to show:
- Significant reductions in depressive symptoms and greater improvements in resilience after three months of usage.
- Significant reduction in thoughts of self-harm and anxiety, and improvement in self-esteem after three months of usage.
Researchers will compare two groups to evaluate the app's impact on wellbeing:
- Intervention group: Receives immediate full access to the mental health app.
- Control group: Receives basic, without full access to the mental health app.
Participants will explore and experience the various features offered in the mental health app over a three-month period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 30;
- •Enrolled in medical school (preclinical or clinical years);
- •Owns a smartphone;
- •Able to read and understand English.
排除标准
- •Does not consent to study.
研究组 & 干预措施
Intervention Group
Participants in the intervention group will receive immediate full access to the mental health app services during the study period.
干预措施: Full digital mental health intervention (Behavioral)
Control Group
Participants in the control group will receive basic, without full access to the mental health app services during the study period (active control).
干预措施: Basic digital mental health intervention (Behavioral)
结局指标
主要结局
Depressive symptoms
时间窗: Baseline and 3 months
Depressive symptoms will be assessed using the Patient Health Questionnaire-9, developed by Kroenke et al. (2001). This 9-item instrument assesses the frequency of depressive symptoms over the past two weeks. Each item is rated on a 4-point scale, yielding a total severity score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Resilience
时间窗: Baseline and 3 months
Resilience will be measured using the Brief Resilience Scale developed by Smith et al. (2008). This 6-item instrument assesses the ability to recover from stress. Each item is rated on a 5-point Likert scale, yielding a total score ranging from 6 to 30, with higher scores indicating greater resilience.
次要结局
- Anxiety(Baseline and 3 months)
- Self-esteem(Baseline and 3 months)
- Subjective wellbeing(Baseline and 3 months)
研究者
Jane Lim Tze Yn
Principal Investigator; Psychiatrist
National University of Malaysia