AI-CBT Intervention GroupNCT07897084
AI-Based CBT Chatbot for Adolescent Social Anxiety
A study testing AI-CBT intervention group in people with AI-CBT Intervention Group and Waitlist Control Group, run by Central China Normal University.
Trial summary
The goal of this clinical trial is to learn if a CBT-based AI chatbot works to reduce social anxiety in teenagers. It will also look at how the chatbot works, including changes in thinking patterns, emotion management, and safety behaviors. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- AI-CBT Intervention Group, Waitlist Control Group
- What is being tested?
- AI-CBT intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 30 Dec 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 10 and 19 years old
- Meets screening cutoff for social anxiety symptoms, defined as SIAS-6 score ≥ 7 or SPS-6 score ≥ 2
- Fluent in Mandarin Chinese
- Has basic ability to use a smartphone or computer
- Provides assent and written informed consent from a parent or legal guardian
Who cannot join
- Presence of suicide risk, defined as active suicidal ideation with intent or plan, or previous suicide attempt within the past 6 months
- Clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or substance use disorder
- Received systematic CBT for any condition within the past 3 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of AI Chatbots Based on Cognitive Behavioral Therapy on Adolescent Social Anxiety: A Randomized Controlled Trial
The goal of this clinical trial is to learn if a CBT-based AI chatbot works to reduce social anxiety in teenagers. It will also look at how the chatbot works, including changes in thinking patterns, emotion management, and safety behaviors. The main questions it aims to answer are:
Does the AI-CBT chatbot lower social anxiety symptoms in teenagers? Do changes in cognitive biases, emotion regulation, and safety behaviors explain why the chatbot works? Researchers will compare the AI-CBT group to a waitlist group to see if the chatbot works to reduce social anxiety.
Read more
Participants will:
Use the AI-CBT chatbot to complete one module every 3 days, for a total of 6 modules.
Complete questionnaires before the intervention, after the intervention, and 1 month after the intervention.
Be on a waitlist and receive no intervention during the study period, then be offered the chatbot after the study ends.
- Conditions
- AI-CBT Intervention Group, Waitlist Control Group
- Being tested
- AI-CBT intervention group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-CBT intervention groupBehavioural
The intervention is a generative AI chatbot delivering a guided self-help program integrating Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT). Participants complete one module every 3 days over approximately 18 days, for a total of 6 modules covering psychoeducation, cognitive techniques, exposure, social skills training, mindfulness and acceptance, and values-based action. Each module includes interactive exercises and chatbot-guided reflection adapted to the participant's responses, followed by a between-session homework assignment to be completed before the next module. Participants interact via text on a smartphone or computer, with no human therapist involved during the intervention period. The research team monitors for safety flags and contacts participants if distress is detected.
| Study group | Role | What they receive |
|---|---|---|
| AI-CBT intervention group | Experimental | Not described Receives: Behavioral: AI-CBT intervention group |
| waitlist control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Interaction Anxiety symptom measured by the Social Interaction Anxiety Scale (SIAS-6).
The Social Interaction Anxiety Scale (SIAS-6) is designed to assess the individual's widespread anxiety in initiating and maintaining social connections (for example, "I have difficulty making eye contact with others") . It consists of 6 items and uses a 5-point scoring system (0 = "completely not conforms", 4 = "extremely conforms"). The total score ranges from 0 to 24, and the higher the scale score, the more severe the symptoms.
Measured: From enrollment to 1 month after the end of intervention (approximately 48 days)
Social Phobia symptom measured by the Social Phobia Scale (SPS-6).
The Social Phobia Scale (SPS-6) is designed to assess an individual's level of anxiety when performing various tasks in the presence of others (for example, "I felt conspicuous when queuing"). It consists of 6 items and uses a 5-point scoring system (0 = "completely not conforms", 4 = "extremely conforms"). The total score ranges from 0 to 24, with a higher score indicating more severe symptoms.
Measured: From enrollment to 1 month after the end of intervention (approximately 48 days)
Secondary outcomes (9)
Cognitive bias measured by the Negative Cognitive Processing Bias Scale for Adolescents (NCPBSA)
The Negative Cognitive Processing Bias Scale for Adolescents (NCPBSA) is used to measure the three negative cognitive processing biases of attention, interpretation, and memory in adolescents (Feng et al., 2024). NCPBSA consists of 15 items (for example, "When several classmates are discussing issues that I don't know, I feel that they are excluding me"), and uses a 4-point scoring method (1 = "completely not conforms", 4 = "extremely conforms"). The total score ranges from 15 to 60, and the higher the score, the more severe the negative cognitive processing bias.
Measured: From enrollment to 1 month after the end of intervention (approximately 48 days)
Safety behaviors measured by the Social Behaviour Questionnaire (SBQ)
The Social Behaviour Questionnaire (SBQ) is used to measure the frequency of safe behaviors that individuals employ when feeling anxious in social situations (Clark, 2005). SBQ consists of 28 items (for example, "Avoid making eye contact with others"), and uses a 4-point scoring system (0 = "Never", 3 = "Always"). The total score ranges from 0 to 84, with higher scores indicating a higher frequency of using safe behaviors.
Measured: From enrollment to 1 month after the end of intervention (approximately 48 days)
Social skill measured by the Social Skill Inventory (SSI)
The Social Skill Inventory (SSI) is used to measure individuals' self-assessment of their social skills (Riggio, 1986). Based on previous studies (Okano \& Nomura, 2023; Strahan, 2003), this study only selected the Social Control subscale (SC) to evaluate the skills of playing an appropriate role and effectively presenting oneself in different social situations, as it is significantly associated with lower self-evaluations among individuals with social anxiety. The SC consists of 15 items (for example, "I find it difficult to look at others when discussing personal matters"), using a 5-point scoring method (1 = "Not at all like me", 5 = "Extremely like me"). The total score ranges from 15 to 75, with a higher score indicating poorer social skills.
Measured: From enrollment to 1 month after the end of intervention (approximately 48 days)
Rumination measured by the rumination subscale of the Cognitive Emotion Regulation Questionnaire (CERQ)
The Cognitive Emotion Regulation Questionnaire (CERQ) is used to measure the cognitive emotion regulation strategies employed by individuals when dealing with stressful situations (Garnefski \& Kraaij, 2006). CERQ encompasses five adaptive strategies (acceptance, positive re-engagement, planned re-engagement, positive reappraisal, and perspective transformation) and four non-adaptive strategies (self-blame, rumination, catastrophic thinking, and blaming others). Referencing previous studies (Liu et al., 2025), this study only selects the rumination subscale to assess rumination thinking. The rumination subscale consists of 2 items (for example, "I repeatedly think about how I felt in that situation"), using a 5-point scoring method (1 = "Never", 5 = "Always"). The total score ranges from 2 to 10, with a higher score indicating stronger rumination thinking.
Measured: From enrollment to 1 month after the end of intervention (approximately 48 days)
Experiential avoidance measured by the Brief Experiential Avoidance Questionnaire (BEAQ)
The Brief Experiential Avoidance Questionnaire (BEAQ) is used to measure an individual's dispositional avoidance, that is, the tendency to use avoidance behaviors in painful situations (Gámez et al., 2014). BEAQ covers six dimensions: behavioral avoidance, pain aversion, procrastination, distraction/inhibition, repression/ denial, and pain persistence, and includes 15 items (for example, "When feeling embarrassed, I will immediately do something to eliminate this feeling"). It uses a 6-point scoring method (1 = "Strongly Disagree", 6 = "Strongly Agree"). The total score ranges from 15 to 90, and the higher the score, the stronger the tendency for experiential avoidance.
Measured: From enrollment to 1 month after the end of intervention (approximately 48 days)
Expressive suppression measured by the expressive suppression subscale of the Emotion Regulation Questionnaire (ERQ)
The Emotion Regulation Questionnaire (ERQ) is used to measure the frequency with which individuals employ emotion regulation strategies (Gross \& John, 2003). ERQ covers two dimensions: cognitive reappraisal and expressive suppression. Based on previous studies, this research only selects the Expressive Suppression (ES) subscale, which consists of 4 items (for example, "I control my emotions and do not let them show.") and uses a 7-point scoring method (1 = "completely not conforms", 7 = "completely conforms"). The total score ranges from 4 to 28, and the higher the score, the higher the frequency of expressive suppression usage.
Measured: From enrollment to 1 month after the end of intervention (approximately 48 days)
Heart Rate Level
At baseline and post-intervention, participants completed the Trier Social Stress Test (TSST), which includes a 5-minute preparation period, a 5-minute impromptu speech, and a 3-minute mental arithmetic task designed to simulate a high-pressure social evaluation scenario. Throughout the test, a portable physiological polygraph was used to continuously record heart rate (HR) as an indicator of sympathetic nervous system arousal.
Measured: From enrollment to post-intervention (approximately 18 days)
Heart Rate Variability Level
At baseline and post-intervention, participants completed the Trier Social Stress Test (TSST), which includes a 5-minute preparation period, a 5-minute impromptu speech, and a 3-minute mental arithmetic task designed to simulate a high-pressure social evaluation scenario. Throughout the test, a portable physiological polygraph was used to continuously record Heart Rate Variability (HRV). Analyses focused on high-frequency (HF) power and the low-frequency/high-frequency (LF/HF) ratio, which serve as core indicators of parasympathetic activity and autonomic balance, respectively, reflecting the flexibility and stability of emotional regulation.
Measured: From enrollment to post-intervention (approximately 18 days)
Skin Conductance Level
At baseline and post-intervention, participants completed the Trier Social Stress Test (TSST), which includes a 5-minute preparation period, a 5-minute impromptu speech, and a 3-minute mental arithmetic task designed to simulate a high-pressure social evaluation scenario. Throughout the test, a portable physiological polygraph was used to continuously record Electrodermal Activity (EDA). As a direct and sensitive indicator of sympathetic nervous system activation, EDA reflects emotional sweating responses.
Measured: From enrollment to post-intervention (approximately 18 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI-CBT Intervention GroupStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central China Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong Ren, Central China Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897084
- Sponsor's protocol ID
- CCNU-IRB-202512014A
- Other IDs
- 2024YFC3308400
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of AI Chatbots Based on Cognitive Behavioral Therapy on Adolescent Social Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07897084
- Acronym / sponsor ID
- CCNU-IRB-202512014A
- Conditions
- AI-CBT Intervention Group, Waitlist Control Group
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Central China Normal UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Oct 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 goal of this clinical trial is to learn if a CBT-based AI chatbot works to reduce social anxiety in teenagers. It will also look at how the chatbot works, including changes in thinking patterns, emotion management, and safety behaviors. The main questions it aims to answer are:
Does the AI-CBT chatbot lower social anxiety symptoms in teenagers? Do changes in cognitive biases, emotion regulation, and safety behaviors explain why the chatbot works? Researchers will compare the AI-CBT group to a waitlist group to see if the chatbot works to reduce social anxiety.
Participants will:
Use the AI-CBT chatbot to complete one module every 3 days, for a total of 6 modules.
Complete questionnaires before the intervention, after the intervention, and 1 month after the intervention.
Be on a waitlist and receive no intervention during the study period, then be offered the chatbot after the study ends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-CBT intervention group | Experimental | Behavioral: AI-CBT intervention group |
| waitlist control group | No intervention | – |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 10 and 19 years old
- Meets screening cutoff for social anxiety symptoms, defined as SIAS-6 score ≥ 7 or SPS-6 score ≥ 2
- Fluent in Mandarin Chinese
- Has basic ability to use a smartphone or computer
- Provides assent and written informed consent from a parent or legal guardian
Key exclusion criteria (3 listed)
- Presence of suicide risk, defined as active suicidal ideation with intent or plan, or previous suicide attempt within the past 6 months
- Clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or substance use disorder
- Received systematic CBT for any condition within the past 3 months
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 |
|---|---|---|
| AI-CBT intervention groupThe intervention is a generative AI chatbot delivering a guided self-help program integrating Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT). Participants complete one module every 3 days over approximately 18 days, for a total of 6 modules covering psychoeducation, cognitive techniques, exposure, social skills training, mindfulness and acceptance, and values-based action. Each module includes interactive exercises and chatbot-guided reflection adapted to the participant's responses, followed by a between-session homework assignment to be completed before the next module. Participants interact via text on a smartphone or computer, with no human therapist involved during the intervention period. The research team monitors for safety flags and contacts participants if distress is detected. | Behavioural | AI-CBT intervention group |
Primary outcome
Social Interaction Anxiety symptom measured by the Social Interaction Anxiety Scale (SIAS-6).
Time frame: From enrollment to 1 month after the end of intervention (approximately 48 days)
The Social Interaction Anxiety Scale (SIAS-6) is designed to assess the individual's widespread anxiety in initiating and maintaining social connections (for example, "I have difficulty making eye contact with others") . It consists of 6 items and uses a 5-point scoring system (0 = "completely not conforms", 4 = "extremely conforms"). The total score ranges from 0 to 24, and the higher the scale score, the more severe the symptoms.
Social Phobia symptom measured by the Social Phobia Scale (SPS-6).
Time frame: From enrollment to 1 month after the end of intervention (approximately 48 days)
The Social Phobia Scale (SPS-6) is designed to assess an individual's level of anxiety when performing various tasks in the presence of others (for example, "I felt conspicuous when queuing"). It consists of 6 items and uses a 5-point scoring system (0 = "completely not conforms", 4 = "extremely conforms"). The total score ranges from 0 to 24, with a higher score indicating more severe symptoms.
9 secondary outcomes
Cognitive bias measured by the Negative Cognitive Processing Bias Scale for Adolescents (NCPBSA)
Time frame: From enrollment to 1 month after the end of intervention (approximately 48 days)
Safety behaviors measured by the Social Behaviour Questionnaire (SBQ)
Time frame: From enrollment to 1 month after the end of intervention (approximately 48 days)
Social skill measured by the Social Skill Inventory (SSI)
Time frame: From enrollment to 1 month after the end of intervention (approximately 48 days)
Rumination measured by the rumination subscale of the Cognitive Emotion Regulation Questionnaire (CERQ)
Time frame: From enrollment to 1 month after the end of intervention (approximately 48 days)
Experiential avoidance measured by the Brief Experiential Avoidance Questionnaire (BEAQ)
Time frame: From enrollment to 1 month after the end of intervention (approximately 48 days)
Expressive suppression measured by the expressive suppression subscale of the Emotion Regulation Questionnaire (ERQ)
Time frame: From enrollment to 1 month after the end of intervention (approximately 48 days)
Heart Rate Level
Time frame: From enrollment to post-intervention (approximately 18 days)
Heart Rate Variability Level
Time frame: From enrollment to post-intervention (approximately 18 days)
Skin Conductance Level
Time frame: From enrollment to post-intervention (approximately 18 days)
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 Oct 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing AI-CBT intervention group in people with AI-CBT Intervention Group and Waitlist Control Group, run by Central China Normal University.
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 3 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Professor. Zhihong Ren, PhD (86-13627131550, ren@ccnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Interaction Anxiety symptom measured by the Social Interaction Anxiety Scale (SIAS-6). (time frame: From enrollment to 1 month after the end of intervention (approximately 48 days)). The study lists 2 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 Oct 2026.