Effectiveness of the Safe Haven Application (App) Among Undergraduates
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-24
SponsorNational Cheng-Kung University Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Safe Haven App
BehavioralA 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Post-intervention (Month 3), and Follow-up (Month 6)2
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.
Time frame
Baseline, Post-intervention (Month 3), and Follow-up (Month 6)3
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.
Time frame
Baseline, Post-intervention (Month 3), and Follow-up (Month 6)Secondary outcomes
1
Intervention Engagement: Objective Usage Metrics
Objective engagement is measured via app usage logs to calculate two key ratios: Daily Engagement Ratio: Defined as the number of days the participant logged into the app divided by the total number of days in the intervention period. Weekly Engagement Ratio: Defined as the number of weeks in which the participant logged in at least once divided by the total intervention duration (12 weeks). Higher ratios indicate higher levels of behavioral engagement with the intervention.
Time frame
Continuously assessed over the 3-month intervention period and 3-month follow-up period2
Intervention Engagement: Subjective Usability (System Usability Scale)
Subjective engagement and satisfaction are assessed using the System Usability Scale (SUS). The SUS consists of 10 items scored on a 5-point Likert scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). The final score is converted to a range of 0 to 100. A score above 68 is considered to indicate above-average usability. Higher scores represent better user experience and subjective engagement.
Time frame
Post-intervention (Month 3), and Follow-up (Month 6)Sponsors and contacts
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Source ClinicalTrials.gov