Effectiveness of the Safe Haven Application (App) Among Undergraduates

NCT07340983 | Recruiting DMC

• 1 other identifier: B-ER-113-260
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Depression

Keywords

undergraduates; mental health; app; mental health literacy

Outcome Measures

Primary Outcomes (3)

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

  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.

  Baseline, Post-intervention (Month 3), and Follow-up (Month 6)

• General Psychological Distress (CHQ-12)

  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.

  Baseline, Post-intervention (Month 3), and Follow-up (Month 6)

• Mental Health Literacy (MHLS-HPG)

  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.

  Baseline, Post-intervention (Month 3), and Follow-up (Month 6)

Secondary Outcomes (2)

• 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)

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in this group will receive the Safe Haven app intervention for 3 months in addition to standard campus care (treatment-as-usual, TAU).

Behavioral: Safe Haven App

Waitlist Control Group

NO INTERVENTION

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.

Interventions

Safe Haven App BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University

Tainan, 70101, Taiwan

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Ching-Lan Lin

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Lan Lin

CONTACT

+886-6-2757575; chinglan@mail.ncku.edu.tw

Jou-Ting Lin

CONTACT

+886-6-2757575; t28121055@gs.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel-group, two-arm randomized controlled trial (RCT). Participants are randomly assigned in a 1:1 ratio to either the experimental group (receiving the Safe Haven app in addition to standard campus care) or the waitlist control group (receiving standard campus care only). The study consists of a 3-month intervention period with assessments at baseline (T0), post-intervention (T1), and 3-month follow-up (T2).

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: September 16, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)