Effectiveness of the Safe Haven Application (App) Among Undergraduates

Condition(s) studied

Investigational drug(s) / intervention(s)

Safe Haven App: A Just-in-Time Adaptive Intervention (JITAI) mobile app that integrates self-monitoring, risk stratification, and tailored psychoeducation modules. The system provides real-time feedback and stepped-care support based on the user's psychological status.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Depression, Anxiety, and Stress Symptoms (DASS-21) — 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) — 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) — 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.

Trial sites (1)

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