The Effectiveness of the Safe Haven APP on Mental Health Among Undergraduates: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Depression, Anxiety, and Stress Symptoms (DASS-21)
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the effectiveness of the Safe Haven app in reducing mental health symptoms and enhancing mental health literacy in undergraduates at a national university in southern Taiwan. The main questions it aims to answer are:
Does the Safe Haven app lead to significantly greater reductions in general psychological distress, depression, anxiety, and stress compared to standard campus care?
Does the app result in greater improvements in mental health literacy among participants?
Researchers will compare an experimental group (receiving the Safe Haven app in addition to standard campus care) to a waitlist control group (receiving standard campus care only) to see if the intervention provides superior improvements in mental health outcomes over time.
Participants will:
Complete online assessments at three time points: baseline (T0), post-intervention (3 months, T1), and follow-up (3 months post-intervention, T2).
Experimental Group: Download the Safe Haven app to complete daily mood self-monitoring and weekly assessments, and receive psychoeducational content, personalized suggestions for 3 months.
Control Group: Maintain access to standard campus care and receive access to the app after the final follow-up assessment.
详细描述
Background: Undergraduates face a critical transition period marked by significant stressors and a high prevalence of mental health issues. However, help-seeking behaviors remain low due to stigma and structural barriers. While mobile health (mHealth) apps offer a scalable solution, existing interventions often rely on static content and lack real-time responsiveness to students' fluctuating psychological states. This study introduces "Safe Haven," a Just-in-Time Adaptive Intervention (JITAI) system that integrates self-monitoring with risk stratification to provide tailored support. This study aims to evaluate the effectiveness of the Safe Haven app in reducing psychological distress and enhancing mental health literacy compared to standard campus care alone.
Study Design: This study employs a parallel-group, two-arm randomized controlled trial (RCT). A total of 68 eligible undergraduate students from a national university in southern Taiwan will be recruited. After completing baseline assessments (T0), participants will be randomized in a 1:1 ratio to either the Experimental Group or the Waitlist Control Group.
Intervention Details
Experimental Group (Safe Haven App + TAU): Participants in this group will receive access to the Safe Haven app for a duration of 3 months, in addition to maintaining full access to standard on-campus counseling and mental health services (Treatment-as-Usual, TAU). The Safe Haven app includes five core components:
- Mood and Sleep Tracking Visualizes longitudinal trends in daily mood and sleep reports and weekly psychological assessment scores to support self-monitoring and self-awareness.
- Digital Phenotyping Data Collection Collects active self-report data and optional passive mobility data to support real-time monitoring and mental health risk prediction.
- Risk-Stratified Stepped-Care System Uses machine learning to classify users into five mental health risk levels, each linked to a tiered intervention protocol ranging from self-management support to emergency response.
- chatbot-Based Just-in-Time Support Provides real-time emotional support via an AI chatbot while monitoring user inputs for high-risk indicators and triggering emergency protocols when detected.
- Psychoeducation Modules Delivers animated psychoeducational content with brief quizzes and a gamified reward system, alongside information on campus and community mental health resources.
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
- None
盲法说明
Due to the nature of the intervention (a mobile health application), it is not feasible to blind participants or the research team to the group allocation. However, to minimize bias, outcome data will be collected via online self-report questionnaires (Google Forms) to reduce assessor bias. Furthermore, data analysis will be conducted using de-identified datasets where group allocation is coded to ensure objectivity during statistical processing.
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •registered undergraduates aged 18-24 years
- •own a personal smart device (mobile phone or tablet)
- •ability to read Chinese
- •willingness to install the study app and complete the follow-up assessments.
排除标准
- •are on leave of absence or not officially enrolled during the study period
- •are participating in another mental health intervention program or using similar mental health apps.
研究组 & 干预措施
Experimental Group
Participants in this group will receive the Safe Haven app intervention for 3 months in addition to standard campus care (treatment-as-usual, TAU).
干预措施: Safe Haven App (Behavioral)
Waitlist Control Group
Participants in this group will maintain access to standard campus care (TAU) only during the 3-month study period. They will be offered access to the Safe Haven app after the final follow-up assessment.
结局指标
主要结局
Depression, Anxiety, and Stress Symptoms (DASS-21)
时间窗: Baseline, Post-intervention (Month 3), and Follow-up (Month 6)
The Depression Anxiety Stress Scales-21 (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three subscales contains 7 items, scored on a 4-point Likert scale ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). Scores for Depression, Anxiety, and Stress are calculated by summing the scores for the relevant items. Subscale scores range from 0 to 21 (or 0 to 42 if multiplied by 2). Higher scores indicate greater severity of symptoms.
General Psychological Distress (CHQ-12)
时间窗: Baseline, Post-intervention (Month 3), and Follow-up (Month 6)
The Chinese Health Questionnaire-12 (CHQ-12) is a self-report screening instrument used to assess general psychological distress and minor psychiatric morbidity. It consists of 12 items related to somatic and psychological symptoms. Higher scores indicate higher levels of psychological distress and poorer mental health status.
Mental Health Literacy (MHLS-HPG)
时间窗: Baseline, Post-intervention (Month 3), and Follow-up (Month 6)
The Mental Health Literacy Scale (MHLS-HPG) is a self-report measure assessing recognition, knowledge, and attitudes regarding mental health. It evaluates the ability to recognize disorders, knowledge of risk factors and professional help, and attitudes that promote help-seeking. Higher scores indicate higher levels of mental health literacy and more positive attitudes toward help-seeking.
次要结局
- Intervention Engagement: Objective Usage Metrics(Continuously assessed over the 3-month intervention period and 3-month follow-up period)
- Intervention Engagement: Subjective Usability (System Usability Scale)(Post-intervention (Month 3), and Follow-up (Month 6))