Recruiting

Effectiveness of the Safe Haven Application (App) Among Undergraduates

ClinicalTrials.gov IDNCT07340983

PhaseNA

Enrollment68

SponsorNational Cheng-Kung University Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Depression, Anxiety

About this study

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.

Interventions

Behavioral: 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.

Primary outcomes

Depression, Anxiety, and Stress Symptoms (DASS-21) (Baseline, Post-intervention (Month 3), and Follow-up (Month 6))
General Psychological Distress (CHQ-12) (Baseline, Post-intervention (Month 3), and Follow-up (Month 6))
Mental Health Literacy (MHLS-HPG) (Baseline, Post-intervention (Month 3), and Follow-up (Month 6))

Eligibility information

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study locations

National Cheng Kung University, Tainan, 70101 Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.