Clinical trial Recruiting at 1 site Interventional Ages 18 to 24

Safe Haven app to reduce depression and anxiety in undergraduates

Official title: The Effectiveness of the Safe Haven APP on Mental Health Among Undergraduates: A Randomized Controlled Trial

Run by National Cheng-Kung University Hospital · NCT07340983 · Data updated 2026-11-12

This trial will see if the Safe Haven smartphone app helps undergraduates with depression or anxiety feel less distressed and improve their mental health knowledge.

Quick facts

Study typeInterventional
Ages18 Years to 24 Years
SexAll
Enrollment68 (estimated)
SponsorNational Cheng-Kung University Hospital
Academic / other
Locations1 site (Tainan)
StatusRecruiting
StartedSeptember 16, 2025
Main results expectedOctober 31, 2026
Study endsJanuary 31, 2027
Registry record updatedJanuary 21, 2026
Trial IDNCT07340983 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Enrolled undergraduates aged 18–24 who can read Chinese, own a personal smartphone or tablet, and are willing to install the app and complete follow-up assessments are the intended participants.

Probably not a fit

Students who are on leave or not officially enrolled during the study, already participating in another mental health program or using similar apps, or who lack a compatible device or Chinese literacy are not eligible and would not benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm randomized controlled trial at a national university in southern Taiwan that will enroll 68 eligible undergraduates and randomize them 1:1 to Safe Haven plus usual campus care or to a waitlist control receiving usual campus care only. The Safe Haven intervention is a Just-in-Time Adaptive Intervention (JITAI) app that combines mood and sleep tracking, risk stratification, and tailored support delivered over a 3-month period. Outcomes include changes in general psychological distress, depression, anxiety, stress, and mental health literacy measured at baseline, immediately post-intervention (3 months), and at a 3-month follow-up. Researchers will compare symptom and literacy changes over time between the two groups to determine whether the app provides additional benefit beyond standard campus services.

Why it matters

Potential benefit: If successful, the app could provide an easy-to-access, scalable tool to reduce distress and improve mental health literacy among undergraduates.

How similar studies have gone: Prior app-based mental health interventions for students have shown modest improvements in symptoms and knowledge, and JITAI approaches are promising though large-scale efficacy data remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • National Cheng Kung University
    Tainan, Taiwan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.