Depressive SymptomsNCT07790731
Using a School-Based Depression Literacy Psychoeducation Program With AI Chatbot to Improve Depression Literacy and Help-Seeking Among High School Students
A study testing school-based depression literacy program in people with Depressive Symptoms and Mental Health (Depression), run by Chang Hsiu-Ju at 1 site in Taiwan.
Trial summary
The primary purpose of this randomized controlled trial is to evaluate the effectiveness of an AI chatbot enhanced school-based depression literacy psychoeducational program, combined with a resource navigation booklet, on high school students in Taiwan. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Mental Health (Depression)
- What is being tested?
- school-based depression literacy program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2026to 25 May 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students aged 15 to 19 enrolled in participating high schools in Taiwan. Fluent in speaking, reading, and writing traditional Chinese, capable of independently completing self-report questionnaires. Willing to participate and provide signed informed assent, alongside signed informed consent from a parent or legal guardian.
Who cannot join
- Diagnosed with severe cognitive impairment or developmental delay that prevents understanding the curriculum or completing the questionnaires. Currently experiencing an acute psychiatric crisis or exhibiting high risk for self-harm/suicide (e.g., active suicidal ideation, or scoring >= 15 on the baseline Patient Health Questionnaire-9 [PHQ-9], or scoring >= 1 on item 9 of the PHQ-9). These individuals will be referred to immediate standard psychiatric or school counseling care.
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
National Yang Ming Chiao Tung University
Taipei, Taiwan, 155
Lin, +886983720209, l314202018.ns14@nycu.edu.tw
About this study
Official title: Effects of an AI Chatbot-Enhanced School-Based Depression Literacy Psychoeducation Intervention on Adolescents' Help-Seeking Attitudes: A Randomized Controlled Trial
The primary purpose of this randomized controlled trial is to evaluate the effectiveness of an AI chatbot enhanced school-based depression literacy psychoeducational program, combined with a resource navigation booklet, on high school students in Taiwan.
Despite the high prevalence of depression among adolescents, the treatment gap remains significantly large due to low mental health literacy and high stigma. This study aims to bridge this gap by implementing a 4-week structured psychoeducational intervention. The investigators hypothesize that participants in the experimental group will demonstrate a significant improvement in depression literacy, a reduction in stigmatizing attitudes toward depression, and more positive attitudes toward seeking professional psychological help compared to those in the control group (regular classes as usual). Outcomes will be assessed at baseline and immediately post-intervention.
Read the detailed description
Depression is a leading cause of disability among adolescents globally, yet a significant treatment gap remains, with up to 70 to 90 percent of adolescents experiencing depressive symptoms failing to receive adequate professional care. Major barriers to accessing appropriate treatment include a widespread lack of mental health literacy and pervasive public and personal stigma surrounding psychological disorders. This study aims to address these barriers by investigating whether a structured psychoeducational intervention can effectively improve depression literacy, reduce stigma, and enhance positive attitudes toward seeking professional psychological help among high school students.
This study employs a quantitative, randomized controlled trial design to evaluate the effectiveness of the proposed psychoeducation intervention. The study population consists of 15 to 19-year-old students recruited from public and private high schools in Taiwan, who will be randomly assigned to either an experimental group or a control group.
Participants assigned to the experimental group will receive an AI chatbot enhanced structured, school-based depression literacy psychoeducation program consisting of four weekly 50-minute sessions. The curriculum is designed to cover the etiology of depression, symptom recognition, and strategies for stigma reduction, and will conclude with the distribution of a physical resource navigation booklet that serves as an actionable emotional first-aid kit detailing local help-seeking channels. Conversely, participants in the control group will receive regular classed as usual, maintaining their standard school curriculum and routine health education classes without exposure to this specific depression literacy intervention.
- Conditions
- Depressive Symptoms, Mental Health (Depression)
- Being tested
- school-based depression literacy program
- Keywords
- Depression Literacy, Stigma, Help-Seeking Behavior, Adolescents
- Medical subject headings
- Depression, Psychological Well-Being, Social Stigma, Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
school-based depression literacy programBehavioural
The structured psychoeducational program comprises four weekly 50-minute sessions that target knowledge of depression (causes and symptom recognition) and strategies for stigma reduction. A physical "Resource Navigation Booklet" is provided to serve as an actionable emotional first-aid kit detailing local help-seeking channels.
| Study group | Role | What they receive |
|---|---|---|
| School-based depression literacy psychoeducation program group | Experimental | A 4-week AI chatbot enhanced school-based depression literacy psychoeducation program consisting of four weekly 50-minute sessions and the distribution of a resource navigation booklet. The sessions cover the causes of depression, symptom recognition, and stigma reduction. Receives: Behavioral: school-based depression literacy program |
| control group | No intervention | Participants did not receive the school-based depression literacy program and continued their standard school curriculum and routine health education classes without additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stigmatizing Attitudes toward Depression
Assessed by the Depression Stigma Scale (DSS). The scale measures both personal and perceived stigma. Lower scores indicate lower levels of stigmatizing attitudes toward depression.
Measured: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
Change in Depression Literacy
Assessed by the Depression Literacy Questionnaire (D-Lit). Higher scores indicate better mental health literacy and understanding of depression.
Measured: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
Change in Attitudes Toward Seeking Professional Psychological Help
Assessed by the full 29-item Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPHS). Higher scores indicate more positive attitudes and greater willingness to seek professional mental health services.
Measured: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
Secondary outcomes (1)
Depressive Symptom Severity
Assessed by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report scale with total scores ranging from 0 to 27. Higher scores indicate more severe depressive symptoms. In this study, the PHQ-9 is utilized purely for observational and safety monitoring purposes rather than evaluating treatment efficacy. The initial measurement serves as a baseline reference covariate and a safety screening tool, while the post-test measurement monitors participants' general psychological status following the educational program.
Measured: Baseline (1 week prior to the intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion25 May 2027 (estimated)
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Hsiu-Ju
- Sponsor type
- University, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Responsible party
- Sponsor-investigator, Chang Hsiu-Ju, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790731
- Sponsor's protocol ID
- NYCU115068AF
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD due to privacy concerns, legal restrictions, institutional policies, or no consent from participants. Our ethics approval or consent form does not allow sharing.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an AI Chatbot-Enhanced School-Based Depression Literacy Psychoeducation Intervention on Adolescents' Help-Seeking Attitudes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07790731
- Acronym / sponsor ID
- NYCU115068AF
- Conditions
- Depressive Symptoms, Mental Health (Depression)
- Keywords
- Depression Literacy, Stigma, Help-Seeking Behavior, Adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Chang Hsiu-JuUniversity, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 27 Aug 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 primary purpose of this randomized controlled trial is to evaluate the effectiveness of an AI chatbot enhanced school-based depression literacy psychoeducational program, combined with a resource navigation booklet, on high school students in Taiwan.
Despite the high prevalence of depression among adolescents, the treatment gap remains significantly large due to low mental health literacy and high stigma. This study aims to bridge this gap by implementing a 4-week structured psychoeducational intervention. The investigators hypothesize that participants in the experimental group will demonstrate a significant improvement in depression literacy, a reduction in stigmatizing attitudes toward depression, and more positive attitudes toward seeking professional psychological help compared to those in the control group (regular classes as usual). Outcomes will be assessed at baseline and immediately post-intervention.
Detailed description
Depression is a leading cause of disability among adolescents globally, yet a significant treatment gap remains, with up to 70 to 90 percent of adolescents experiencing depressive symptoms failing to receive adequate professional care. Major barriers to accessing appropriate treatment include a widespread lack of mental health literacy and pervasive public and personal stigma surrounding psychological disorders. This study aims to address these barriers by investigating whether a structured psychoeducational intervention can effectively improve depression literacy, reduce stigma, and enhance positive attitudes toward seeking professional psychological help among high school students.
This study employs a quantitative, randomized controlled trial design to evaluate the effectiveness of the proposed psychoeducation intervention. The study population consists of 15 to 19-year-old students recruited from public and private high schools in Taiwan, who will be randomly assigned to either an experimental group or a control group.
Participants assigned to the experimental group will receive an AI chatbot enhanced structured, school-based depression literacy psychoeducation program consisting of four weekly 50-minute sessions. The curriculum is designed to cover the etiology of depression, symptom recognition, and strategies for stigma reduction, and will conclude with the distribution of a physical resource navigation booklet that serves as an actionable emotional first-aid kit detailing local help-seeking channels. Conversely, participants in the control group will receive regular classed as usual, maintaining their standard school curriculum and routine health education classes without exposure to this specific depression literacy intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School-based depression literacy psychoeducation program group | Experimental | Behavioral: school-based depression literacy programA 4-week AI chatbot enhanced school-based depression literacy psychoeducation program consisting of four weekly 50-minute sessions and the distribution of a resource navigation booklet. The sessions cover the causes of depression, symptom recognition, and stigma reduction. |
| control group | No intervention | –Participants did not receive the school-based depression literacy program and continued their standard school curriculum and routine health education classes without additional intervention. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Students aged 15 to 19 enrolled in participating high schools in Taiwan. Fluent in speaking, reading, and writing traditional Chinese, capable of independently completing self-report questionnaires. Willing to participate and provide signed informed assent, alongside signed informed consent from a parent or legal guardian.
Key exclusion criteria (1 listed)
- Diagnosed with severe cognitive impairment or developmental delay that prevents understanding the curriculum or completing the questionnaires. Currently experiencing an acute psychiatric crisis or exhibiting high risk for self-harm/suicide (e.g., active suicidal ideation, or scoring >= 15 on the baseline Patient Health Questionnaire-9 [PHQ-9], or scoring >= 1 on item 9 of the PHQ-9). These individuals will be referred to immediate standard psychiatric or school counseling care.
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 |
|---|---|---|
| school-based depression literacy programThe structured psychoeducational program comprises four weekly 50-minute sessions that target knowledge of depression (causes and symptom recognition) and strategies for stigma reduction. A physical "Resource Navigation Booklet" is provided to serve as an actionable emotional first-aid kit detailing local help-seeking channels. | Behavioural | School-based depression literacy psychoeducation program group |
Primary outcome
Change in Stigmatizing Attitudes toward Depression
Time frame: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
Assessed by the Depression Stigma Scale (DSS). The scale measures both personal and perceived stigma. Lower scores indicate lower levels of stigmatizing attitudes toward depression.
Change in Depression Literacy
Time frame: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
Assessed by the Depression Literacy Questionnaire (D-Lit). Higher scores indicate better mental health literacy and understanding of depression.
Change in Attitudes Toward Seeking Professional Psychological Help
Time frame: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
Assessed by the full 29-item Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPHS). Higher scores indicate more positive attitudes and greater willingness to seek professional mental health services.
1 secondary outcome
Depressive Symptom Severity
Time frame: Baseline (1 week prior to the intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).
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 27 Aug 2026.
- Individual participant dataSharing planned: No. We do not plan to share IPD due to privacy concerns, legal restrictions, institutional policies, or no consent from participants. Our ethics approval or consent form does not allow sharing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing school-based depression literacy program in people with Depressive Symptoms and Mental Health (Depression), run by Chang Hsiu-Ju 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Aug 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 Hsiu-Ju Chang, PhD (+88628267000 ext. 67096, hsiuju26@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stigmatizing Attitudes toward Depression (time frame: Baseline (1 week prior to intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).). 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 27 Aug 2026.