About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Parallel
Treatments tested in this trial
school-based depression literacy program
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Change in Depression Literacy
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
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.
Secondary outcomes
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.
Other outcomes
System Usability of the AI Chatbot
Assessed by the System Usability Scale (SUS). The SUS is a 10-item questionnaire evaluated on a 5-point Likert scale, designed to measure the usability, learnability, and user satisfaction of the AI Chatbot integrated into the intervention program. The item scores are converted and summed to a final score ranging from 0 to 100, where higher scores represent better system usability and user acceptance. Note: This measure is administered exclusively to participants in the experimental group, as they are the sole users of the AI Chatbot.
Sponsors and contacts
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Chang Hsiu-Ju
Lead sponsor
National Yang Ming Chiao Tung University
Sponsor institution
Shin Kong Wu Ho-Su Memorial Hospital
Collaborator
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