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Anxiety LiteracyNCT07316374

AI Chatbots for Anxiety Mental Health Literacy

A study testing AI Anxiety Literacy Education, AI Anxiety Friend Simulation and Text-Based Anxiety Psychoeducation in people with Anxiety Literacy and Anxiety Disorders, run by Peking University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to examine whether AI-based chatbots can improve anxiety-related mental health literacy in adults with varying levels of anxiety. The study aims to learn whether interactive AI chatbots can improve understanding of anxiety, attitudes toward anxiety, help-seeking intentions… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
AI Anxiety Literacy Education, AI Anxiety Friend Simulation and Text-Based Anxiety Psychoeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
1 Dec 2025to 30 Apr 2026
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 65 years.
  • Able to use digital devices (e.g., smartphone or computer) to complete AI-based conversations and questionnaires.
  • Willing to participate in a one-week online intervention.
  • Proficient in Chinese and able to understand study instructions and provide informed consent.
  • Participants with varying levels of anxiety symptoms are eligible.

Who cannot join

  • Self-reported history of severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder).
  • Currently receiving psychological or psychiatric treatment.
  • Severe mental health symptoms requiring immediate clinical intervention.
  • Inability to use mobile or internet-enabled devices independently.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking university

    Beijing

Other trials in China

About this study

Official title: Evaluation of AI-Based Chatbots for Improving Anxiety-Related Mental Health Literacy: A Randomized Controlled Trial

The goal of this clinical trial is to examine whether AI-based chatbots can improve anxiety-related mental health literacy in adults with varying levels of anxiety. The study aims to learn whether interactive AI chatbots can improve understanding of anxiety, attitudes toward anxiety, help-seeking intentions, confidence in supporting others, and anxiety symptoms, compared with standard text-based educational materials.

The main questions it aims to answer are:

Read more
  1. Does an AI-based psychoeducation chatbot improve anxiety-related mental health literacy compared with text-based psychoeducation?
  2. Does adding interactive anxiety simulation conversations further improve mental health literacy and related outcomes compared with psychoeducation alone?

Researchers will compare participants who use an AI psychoeducation chatbot alone, participants who use an AI psychoeducation chatbot combined with anxiety simulation chatbots, and participants who receive text-based psychoeducation, to see whether the AI-based interventions lead to greater improvements in mental health literacy and related outcomes.

Participants will:

  1. Complete baseline questionnaires assessing anxiety-related knowledge, attitudes, and symptoms
  2. Be randomly assigned to one of three groups: AI psychoeducation chatbot, AI psychoeducation chatbot plus anxiety simulation chatbots, or text-based psychoeducation
  3. Use the assigned intervention over a one-week period
  4. Complete follow-up questionnaires immediately after the intervention and at later follow-up time points
Being tested
AI Anxiety Literacy Education, AI Anxiety Friend Simulation, Text-Based Anxiety Psychoeducation
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI Anxiety Literacy EducationBehavioural

    AI Anxiety Literacy Education is an AI-powered, psychologically informed chatbot designed to improve mental health literacy related to anxiety through conversational education.

    The chatbot delivers structured modules covering the definition of anxiety, common cognitive, emotional, physical, and behavioral symptoms, contributing factors, treatment options, and practical self-help strategies.

    Content is presented in non-clinical language and adapted to user responses through guided questions and feedback, encouraging users to reflect on their own experiences.

  • AI Anxiety Friend SimulationBehavioural

    AI Anxiety Friend Simulation is an AI-powered conversational intervention designed to allow participants to practice recognizing and responding to anxiety-related experiences in a simulated interaction. The chatbot role-plays individuals experiencing different anxiety presentations and communicates in a natural, everyday manner that may include uncertainty, emotional reactions, or defensiveness.

    Participants are guided to identify anxiety symptoms, explore causes, and propose supportive responses. The chatbot provides feedback and prompts reflection based on participants' responses. Participants access the simulation online and complete multiple simulated conversations over a one-week period.

  • Text-Based Anxiety PsychoeducationBehavioural

    Text-Based Anxiety Psychoeducation consists of written educational materials providing information about anxiety in a non-clinical, accessible format. The materials cover the definition of anxiety, common cognitive, emotional, physical, and behavioral symptoms, contributing factors, and general coping and self-help strategies. Participants access the materials online and are instructed to review all content within a one-week period. The materials are static and do not provide interactive feedback or personalized responses.

Study groups in NCT07316374
Study groupRoleWhat they receive
AI Educator OnlyExperimentalParticipants will interact with the AI-powered psychoeducation chatbot for one week. The chatbot delivers structured conversational modules covering anxiety concepts, symptoms, causes, treatment options, and self-help strategies.
Receives: Behavioral: AI Anxiety Literacy Education
AI Educator + AI Anxiety Friend SimulatorsExperimentalParticipants will first complete all AI Educator modules and then interact with five AI Anxiety Friend Simulators over one week. Each simulator represents a distinct anxiety presentation and prompts participants to identify symptoms, explore mechanisms, and propose support strategies.
Receives: Behavioral: AI Anxiety Literacy Education; Behavioral: AI Anxiety Friend Simulation
Text-Based PsychoeducationActive comparatorParticipants will receive standard text-based psychoeducation materials about anxiety, including definitions, symptoms, causes, and coping strategies, to be completed within one week.
Receives: Behavioral: Text-Based Anxiety Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety Literacy Scale (ALS)

    The Anxiety Literacy Scale is a 22-item questionnaire designed to assess individuals' knowledge about anxiety. Each statement is answered using a binary response format (true or false). For each item, participants are also asked to rate their certainty in their response on a 5-point Likert scale. Correct responses are summed to produce a total knowledge score, with higher scores indicating greater anxiety-related mental health literacy. Certainty ratings are used to assess participants' confidence in their knowledge and to examine the calibration between knowledge accuracy and subjective certainty.

    Measured: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up

  2. Anxiety Stigma Scale

    The Anxiety Stigma Scale is designed to measure stigma associated with Anxiety. 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 anxiety by asking them to indicate how strongly they personally agree with ten statements about anxiety.

    The Perceived Stigma Subscale measures the respondent's perception about the attitudes of others towards anxiety by asking them to indicate what they think most other people believe about the same ten 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.

    Measured: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up

  3. Adapted General Help-Seeking Questionnaire

    The General Help-Seeking Questionnaire (GHSQ) in this study is an adapted 17-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.

    Measured: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up

  4. Confidence in Helping Others

    The Confidence in Helping Others Scale is a self-developed, 13-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 symptoms, offering emotional support, and encouraging help-seeking.

    Measured: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up

  5. Mental Health Self-efficacy Scale

    The Mental Health Self-efficacy Scale is a 6-item questionnaire designed to measure participants' confidence in effectively manage stress, anxiety or depression about themself. Each item is rated on a 10-point Likert scale, ranging from 1 ("Not at all confident") to 10 ("Totally confident"), with higher scores indicating greater confidence in self-efficacy about mental health.

    Measured: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up

  6. Bot Usability Scale

    The Bot Usability Scale (BUS) in this study is an adapted 11-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 BUS separately for both the AI Educator and the AI Anxiety Friend Simulators. The adapted BUS maintains the core usability assessment principles of the original scale while being tailored for AI-driven conversational agents.

    Measured: post-intervention (1-week)

Secondary outcomes (6)
  1. General Anxiety Disorder (GAD-7)

    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms over the past two weeks. Each item corresponds to common symptoms of generalized anxiety disorder (GAD) and is rated on a 4-point Likert scale, ranging from 0 ("Not at all") to 3 ("Nearly every day"), with higher scores indicating greater symptom severity.

    Measured: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up

  2. Patient Health Questionnaire (PHQ-9)

    The Patient Health Questionnaire (PHQ-9) consists of 9 items designed to assess the severity of depressive symptoms over the past two weeks. Each item corresponds to one of the nine DSM-5 criteria for major depressive disorder and is rated on a 4-point Likert scale, ranging from 0 ("Not at all") to 3 ("Nearly every day"), with higher scores indicating greater symptom severity.

    Measured: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up

  3. Intolerance of Uncertainty Scale

    Intolerance of Uncertainty Scale is designed to measure participants' attidudes about uncertaunty. It is a self-developed, 12-item questionnaire, ranging from 1 ("not at all characteristic for me")) to 5 ("entirely characteristic of me"), with higher scores indicating greater intolerance.

    Measured: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up

  4. Negative Effects Scale, NES

    Sometimes programs that aim to improve mental health can also have unwanted effects.The Negative Effects Scale (NES) is a 6-item self-report assessment tool designed to measure the participants' perceptions of unwanted experience. Each item is rated on a 5-point Likert scale, ranging from 1 (" Not at al") to 5 ("Extremely severe"), with higher scores indicating a greater negative Effects.

    Measured: post-intervention (1-week)

  5. Basic Empathy Scale in Adults (BES-A)

    The Basic Empathy Scale in Adults (BES-A) is a 20-item self-report questionnaire designed to assess an individual's capacity for empathy, including both cognitive empathy (understanding others' emotions) and affective empathy (sharing others' emotions). Each item is rated on a 5-point Likert scale, ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree"), with higher scores indicating greater empathy.

    Measured: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up

  6. Mental Health Behavior

    This questionnaire is self-conducted and assesses the frequency of various mental health-related behaviors over the past month. Participants rate each behavior based on how often they engaged in it, using a 5-point scale (0 = Never, 4 = More than 4 times per week). The results provide insight into individuals' proactive engagement in mental well-being practices.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2026
  2. Study start1 Dec 2025
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

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
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07316374
Sponsor's protocol ID
Anxiety Literacy AI Chatbot
Status last verified
Dec 2025
First submitted
16 Dec 2025
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AI Anxiety Literacy Education, AI Anxiety Friend Simulation and Text-Based Anxiety Psychoeducation in people with Anxiety Literacy and Anxiety Disorders, run by Peking University at 1 site in China.

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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 5 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 China. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety Literacy Scale (ALS) (time frame: pre-intervention, post-intervention (1-week), 4-week follow-up, 12-week follow-up). The study lists 6 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 5 Jan 2026.

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