NCT07790731

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Aug 2026May 2027

Study Start

First participant enrolled

August 1, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2027

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Depression LiteracyStigmaHelp-Seeking BehaviorAdolescents

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

    Baseline (1 week prior to the intervention) and Immediate Post-test (within 1-2 weeks after the 4-week intervention).

Other Outcomes (1)

  • System Usability of the AI Chatbot

    Immediate Post-test (within 1-2 weeks after the 4-week intervention).

Study Arms (2)

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.

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.

Interventions

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.

School-based depression literacy psychoeducation program group

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, Taiwan, 155, Taiwan

Location

MeSH Terms

Conditions

DepressionPsychological Well-BeingSocial StigmaHelp-Seeking Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal SatisfactionSocial Behavior

Central Study Contacts

Hsiu-Ju Chang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 27, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

May 25, 2027

Study Completion (Estimated)

May 25, 2027

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations