NCT06858371

Brief Summary

The purpose of this randomized controlled trial (RCT) is to find out whether using AI Chatbots can help the public better understand depression, reduce negative attitudes towards it, and encourage more people to seek help when needed. The study will also explore whether the Chatbot can help individuals feel more confident in supporting others who might be experiencing depression. Participants will be randomly assigned to either:

  1. 1.AI-PsyTeacher Group: Participants interact with the AI psychology teacher "Liran" to complete three progressive tasks (identifying depression symptoms, learning coping strategies, and understanding prevention). This group assesses the independent role of AI in mental health education.
  2. 2.AI-Integrated Intervention Group: Participants first learn with the AI psychology teacher "Liran" and then interact with the AI-simulated depressed patient "Beibei" to complete three tasks (identifying issues, teaching coping strategies, and creating a prevention plan). This group examines the combined effect of AI teaching and patient simulation.
  3. 3.Traditional Psychoeducation Group (Control): Participants gain depression-related knowledge by reading traditional educational materials and watching a first-person experience video. This group serves as the control to compare AI interventions.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

February 10, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 24, 2025

Last Update Submit

March 3, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • Depression Literacy Scale (D-Lit)

    The Depression Literacy Scale is a 22-question survey that assesses a person's depression literacy. The questions are rated on a scale of "true", "false", or "I don't know". Each correct answer is worth one point, with higher scores indicating a higher level of depression literacy.

    pre-intervention, immediately after the intervention, 1-week follow-up, 4-week follow-up, 12-week follow-up

  • Depression Literacy Questionnaire

    The Depression Literacy Questionnaire assesses mental health literacy specific to depression. It is a self-developed, 31-item questionnaire designed to assess participants' confidence in providing support to individuals experiencing depression. Each item is rated on a 5-point Likert scale, ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"), with higher scores indicating greater depression literacy.

    pre-intervention, immediately after the intervention, 1-week follow-up, 4-week follow-up, 12-week follow-up

  • Depression Stigma Scale (DSS)

    The Depression Stigma Scale is designed to measure stigma associated with depression. It has two subscales which measure two different types of stigma: personal and perceived. The Personal Stigma Subscale measures stigma in the respondents own attitudes towards depression by asking them to indicate how strongly they personally agree with nine statements about depression. The Perceived Stigma Subscale measures the respondent's perception about the attitudes of others towards depression by asking them to indicate what they think most other people believe about the same nine statements. Responses to each item are measured on a five-point scale (ranging from zero 'strongly disagree' to four 'strongly agree'). Higher scores indicate higher levels of depression stigma.

    pre-intervention, immediately after the intervention, 1-week follow-up, 4-week follow-up, 12-week follow-up

  • Acquisition Questionnaire (AQ-9)

    The Attribution Questionnaire (AQ) is a 9-item self-report assessment tool designed to measure public stigma towards people with mental illnesses. This version assesses emotional reaction and discriminatory responses based on answers to a hypothetical vignette about a man with depression named Xiao Li. Responses assessing stigma towards Xiao Li are in the form of 9 items rated on a Likert scale ranging from 1 (not at all) to 9 (very much).

    pre-intervention, immediately after the intervention, 1-week follow-up, 4-week follow-up, 12-week follow-up

  • General Help-Seeking Questionnaire (GHSQ)

    The General Help-Seeking Questionnaire (GHSQ) in this study is an adapted 12-item version designed to fit Chinese cultural contexts. It assesses an individual's intentions to seek help for personal or emotional problems from both formal sources (e.g., mental health professionals, doctors) and informal sources (e.g., family, friends). Each item is rated on a 7-point Likert scale, ranging from 1 ("Extremely Unlikely") to 7 ("Extremely Likely"), with higher scores indicating a greater likelihood of seeking help.

    pre-intervention, immediately after the intervention, 1-week follow-up, 4-week follow-up, 12-week follow-up

  • System Usability Scale (SUS)

    The System Usability Scale (SUS) in this study is an adapted 9-item version designed to assess the usability of AI-based chatbots. It evaluates participants' perceptions of the ease of use, effectiveness, efficiency, and overall user experience of the chatbots. The scale uses a 5-point Likert scale, ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"), with higher scores indicating better perceived usability. Participants will complete the adapted SUS separately for both the AI Depression Education Teacher and the AI Depression Patient Simulation ("Beibei"). The adapted SUS maintains the core usability assessment principles of the original scale while being tailored for AI-driven conversational agents.

    immediately after the intervention

  • Confidence in Helping Others Scale

    The Confidence in Helping Others Scale is a self-developed, 19-item questionnaire designed to measure participants' confidence in providing support to individuals experiencing mental health issues. Each item is rated on a 5-point Likert scale, ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"), with higher scores indicating greater confidence in recognizing depressive symptoms, offering emotional support, and encouraging help-seeking.

    pre-intervention, immediately after the intervention, 1-week follow-up, 4-week follow-up, 12-week follow-up

Secondary Outcomes (4)

  • Patient Health Questionnaire (PHQ)

    pre-intervention, immediately after the intervention, 1-week follow-up, 4-week follow-up, 12-week follow-up

  • General Anxiety Disorder (GAD-7)

    pre-intervention, immediately after the intervention, 1-week follow-up, 4-week follow-up, 12-week follow-up

  • Basic Empathy Scale in Adults (BES-A)

    pre-intervention, immediately after the intervention, 1-week follow-up, 4-week follow-up, 12-week follow-up

  • Mental Health-Related Behavior Questionnaire

    pre-intervention, 4-week follow-up, 12-week follow-up

Study Arms (3)

AI Depression Education Teacher + AI Depression Patient Simulation Group

EXPERIMENTAL

Participants in this group will interact with two AI-based chatbots, one after the other: First Chatbot (Psychoeducation Phase): The first chatbot is designed to provide psychoeducation about depression. Participants will interact with the chatbot to learn key information, such as common symptoms of depression, causes, treatment options, coping strategies, and how to provide emotional support to others experiencing depression. The goal of this phase is to improve participants' understanding of depression and reduce stigma. Second Chatbot (Empathy and Support Practice Phase): After completing the psychoeducation phase, participants will interact with a second chatbot simulating a person experiencing depression. This chatbot will simulate real-life conversations, allowing participants to practice empathetic communication, recognize signs of depression, and offer appropriate emotional support.

Behavioral: AI Depression Literacy and Support Training

Control Group

ACTIVE COMPARATOR

Participants in this group will not receive any intervention or access to the Chatbots. Participants will be directed to a depression-related article and a video describing the lived experience of a depression patient. Participants in this group will complete the same baseline and post-study assessments as those in the intervention group, which include measures of depression literacy, attitudes toward depression, help-seeking intentions, and confidence in helping others.

Behavioral: Psychoeducation Material Group

AI Depression Education Teacher Only Group

EXPERIMENTAL

Participants will interact with the AI Depression Education Teacher, an interactive chatbot designed to provide psychoeducation on depression. The chatbot covers topics such as depression symptoms, causes, treatment options, and ways to support individuals experiencing depression. Participants engage in structured conversations and receive real-time feedback to reinforce learning.

Behavioral: AI Depression Literacy Education

Interventions

The intervention consists of two AI-based chatbots designed to enhance depression literacy, reduce stigma, and improve confidence in supporting others with depression. AI Depression Education Teacher - This chatbot provides interactive psychoeducation on depression, covering symptoms, causes, treatments, and ways to support others. Participants engage in a structured conversation to enhance their understanding and receive real-time feedback. AI Depression Patient Simulation ("Beibei") - Participants interact with a simulated individual experiencing depression to practice empathetic communication and support strategies. Through guided conversations, they learn to recognize depressive symptoms, offer emotional support, and encourage help-seeking. This two-phase intervention provides both knowledge and practical experience in a safe, interactive environment. Participants will engage with both chatbots sequentially within a one-hour session.

AI Depression Education Teacher + AI Depression Patient Simulation Group

This intervention consists of interaction with an AI chatbot, i.e., AI Depression Education Teacher, which provides interactive psychoeducation on depression, covering symptoms, causes, treatments, and ways to support others.

AI Depression Education Teacher Only Group

The intervention contains standard psychoeducation materials about depression. Participants will be directed to: A depression-related article - Provides general information about depression, including its symptoms, causes, and treatment options. A video describing the lived experience of a depression patient - Shares a personal story to help participants understand the real-life impact of depression.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 65.
  • General population, non-clinical individuals.
  • No history of diagnosed mental disorders or current mental health diagnosis.
  • Ability to complete AI interactions and related tasks via the internet or mobile devices.
  • Native Chinese speakers.
  • Willingness to participate in the study and sign an informed consent form.

You may not qualify if:

  • History of mental disorders or self-reported current mental health issues.
  • Currently undergoing psychological counseling.
  • Inability to use mobile or internet devices properly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university

Beijing, China

Location

MeSH Terms

Interventions

Training Support

Intervention Hierarchy (Ancestors)

Financial SupportEconomicsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2025

First Posted

March 5, 2025

Study Start

February 10, 2025

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

March 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations