DepressionNCT07340983
Effectiveness of the Safe Haven Application (App) Among Undergraduates
A study testing Safe Haven App in people with Depression and Anxiety, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Safe Haven App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University
Tainan, 70101
Ching-Lan Lin, Doctor, +886-6-2757575 ext. 5038, chinglan@mail.ncku.edu.tw
Jou-Ting Lin, Master, +886-6-2757575 ext. 5038, t28121055@gs.ncku.edu.tw
About this study
Official title: The Effectiveness of the Safe Haven APP on Mental Health Among Undergraduates: A Randomized Controlled 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?
Read more
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.
Read the detailed description
Background: Undergraduates face a critical transition period marked by significant stressors and a high prevalence of mental health issues. However, help-seeking behaviors remain low due to stigma and structural barriers. While mobile health (mHealth) apps offer a scalable solution, existing interventions often rely on static content and lack real-time responsiveness to students' fluctuating psychological states. This study introduces "Safe Haven," a Just-in-Time Adaptive Intervention (JITAI) system that integrates self-monitoring with risk stratification to provide tailored support. This study aims to evaluate the effectiveness of the Safe Haven app in reducing psychological distress and enhancing mental health literacy compared to standard campus care alone.
Study Design: This study employs a parallel-group, two-arm randomized controlled trial (RCT). A total of 68 eligible undergraduate students from a national university in southern Taiwan will be recruited. After completing baseline assessments (T0), participants will be randomized in a 1:1 ratio to either the Experimental Group or the Waitlist Control Group.
Intervention Details
Experimental Group (Safe Haven App + TAU): Participants in this group will receive access to the Safe Haven app for a duration of 3 months, in addition to maintaining full access to standard on-campus counseling and mental health services (Treatment-as-Usual, TAU). The Safe Haven app includes five core components:
- Mood and Sleep Tracking Visualizes longitudinal trends in daily mood and sleep reports and weekly psychological assessment scores to support self-monitoring and self-awareness.
- Digital Phenotyping Data Collection Collects active self-report data and optional passive mobility data to support real-time monitoring and mental health risk prediction.
- Risk-Stratified Stepped-Care System Uses machine learning to classify users into five mental health risk levels, each linked to a tiered intervention protocol ranging from self-management support to emergency response.
- chatbot-Based Just-in-Time Support Provides real-time emotional support via an AI chatbot while monitoring user inputs for high-risk indicators and triggering emergency protocols when detected.
- Psychoeducation Modules Delivers animated psychoeducational content with brief quizzes and a gamified reward system, alongside information on campus and community mental health resources.
Waitlist Control Group (TAU Only): Participants in this group will maintain access to standard on-campus counseling and mental health services (TAU) but will not access the Safe Haven app during the 3-month intervention period. To ensure ethical standards, these participants will be offered access to the Safe Haven app after completing the final follow-up assessment (T2).
Study Procedures Data collection will occur at three time points:
- Baseline (T0): Upon recruitment and prior to randomization.
- Post-Intervention (T1): Immediately following the 3-month intervention period. Experimental group participants will also complete the System Usability Scale (SUS) at this time.
- Follow-Up (T2): 3 months after the intervention concludes.
Outcome Measures The primary outcomes are changes in general psychological distress (measured by CHQ-12) and symptoms of depression, anxiety, and stress (measured by DASS-21). Secondary outcomes include changes in mental health literacy (measured by MHLS-HPG) and intervention engagement (measured by app usage logs and SUS scores).
Statistical Analysis Plan Data will be analyzed using IBM SPSS Statistics. The primary analysis will follow the Intention-to-Treat (ITT) principle. Generalized Estimating Equations (GEE) will be utilized to examine longitudinal changes and test the Group × Time interaction effect on outcome measures. GEE models will be adjusted for baseline scores of the respective outcome variables. Additionally, any demographic characteristics showing statistically significant differences between groups at baseline will be included as covariates. For the experimental group, further analyses will examine the association between objective engagement metrics (e.g., completion rates) and clinical improvements to determine dose-response relationships.
- Conditions
- Depression, Anxiety
- Being tested
- Safe Haven App
- Keywords
- undergraduates, mental health, app, mental health literacy
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Haven AppBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post-intervention (Month 3), and Follow-up (Month 6)
Secondary outcomes (2)
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.
Measured: Continuously assessed over the 3-month intervention period and 3-month follow-up period
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.
Measured: Post-intervention (Month 3), and Follow-up (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start16 Sep 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Lan Lin, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340983
- Sponsor's protocol ID
- B-ER-113-260
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Safe Haven APP on Mental Health Among Undergraduates: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07340983
- Acronym / sponsor ID
- B-ER-113-260
- Conditions
- Depression, Anxiety
- Keywords
- undergraduates, mental health, app, mental health literacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Undergraduates face a critical transition period marked by significant stressors and a high prevalence of mental health issues. However, help-seeking behaviors remain low due to stigma and structural barriers. While mobile health (mHealth) apps offer a scalable solution, existing interventions often rely on static content and lack real-time responsiveness to students' fluctuating psychological states. This study introduces "Safe Haven," a Just-in-Time Adaptive Intervention (JITAI) system that integrates self-monitoring with risk stratification to provide tailored support. This study aims to evaluate the effectiveness of the Safe Haven app in reducing psychological distress and enhancing mental health literacy compared to standard campus care alone.
Study Design: This study employs a parallel-group, two-arm randomized controlled trial (RCT). A total of 68 eligible undergraduate students from a national university in southern Taiwan will be recruited. After completing baseline assessments (T0), participants will be randomized in a 1:1 ratio to either the Experimental Group or the Waitlist Control Group.
Intervention Details
Experimental Group (Safe Haven App + TAU): Participants in this group will receive access to the Safe Haven app for a duration of 3 months, in addition to maintaining full access to standard on-campus counseling and mental health services (Treatment-as-Usual, TAU). The Safe Haven app includes five core components:
- Mood and Sleep Tracking Visualizes longitudinal trends in daily mood and sleep reports and weekly psychological assessment scores to support self-monitoring and self-awareness.
- Digital Phenotyping Data Collection Collects active self-report data and optional passive mobility data to support real-time monitoring and mental health risk prediction.
- Risk-Stratified Stepped-Care System Uses machine learning to classify users into five mental health risk levels, each linked to a tiered intervention protocol ranging from self-management support to emergency response.
- chatbot-Based Just-in-Time Support Provides real-time emotional support via an AI chatbot while monitoring user inputs for high-risk indicators and triggering emergency protocols when detected.
- Psychoeducation Modules Delivers animated psychoeducational content with brief quizzes and a gamified reward system, alongside information on campus and community mental health resources.
Waitlist Control Group (TAU Only): Participants in this group will maintain access to standard on-campus counseling and mental health services (TAU) but will not access the Safe Haven app during the 3-month intervention period. To ensure ethical standards, these participants will be offered access to the Safe Haven app after completing the final follow-up assessment (T2).
Study Procedures Data collection will occur at three time points:
- Baseline (T0): Upon recruitment and prior to randomization.
- Post-Intervention (T1): Immediately following the 3-month intervention period. Experimental group participants will also complete the System Usability Scale (SUS) at this time.
- Follow-Up (T2): 3 months after the intervention concludes.
Outcome Measures The primary outcomes are changes in general psychological distress (measured by CHQ-12) and symptoms of depression, anxiety, and stress (measured by DASS-21). Secondary outcomes include changes in mental health literacy (measured by MHLS-HPG) and intervention engagement (measured by app usage logs and SUS scores).
Statistical Analysis Plan Data will be analyzed using IBM SPSS Statistics. The primary analysis will follow the Intention-to-Treat (ITT) principle. Generalized Estimating Equations (GEE) will be utilized to examine longitudinal changes and test the Group × Time interaction effect on outcome measures. GEE models will be adjusted for baseline scores of the respective outcome variables. Additionally, any demographic characteristics showing statistically significant differences between groups at baseline will be included as covariates. For the experimental group, further analyses will examine the association between objective engagement metrics (e.g., completion rates) and clinical improvements to determine dose-response relationships.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Safe Haven AppParticipants in this group will receive the Safe Haven app intervention for 3 months in addition to standard campus care (treatment-as-usual, TAU). |
| 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe Haven AppA 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. | Behavioural | Experimental Group |
Primary outcome
Depression, Anxiety, and Stress Symptoms (DASS-21)
Time frame: 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)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Intervention Engagement: Objective Usage Metrics
Time frame: Continuously assessed over the 3-month intervention period and 3-month follow-up period
Intervention Engagement: Subjective Usability (System Usability Scale)
Time frame: Post-intervention (Month 3), and Follow-up (Month 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ching-Lan Lin principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Haven App in people with Depression and Anxiety, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Lan Lin (+886-6-2757575 ext. 5038, chinglan@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety, and Stress Symptoms (DASS-21) (time frame: Baseline, Post-intervention (Month 3), and Follow-up (Month 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.