LLM-based AI Dialogue BotNCT06346496
Young People Aged 18-25 With Depression or Anxiety Mood Participate in an LLM-based Digital Dialogue Intervention Study
A study testing Douyin Xinqing AI dialog bot and Douyin Xinqing AI dialog bot for delayed intervention in people with LLM-based AI Dialogue Bot and Depression, run by Institute of Psychology, Chinese Academy of Sciences at 1 site in China.
Trial summary
This study is a 28-day randomized controlled trial (RCT). Residents were randomly assigned to an intervention group or a waiting group according to the order in which they were successfully contacted by the staff, and each user was asked to engage in a total of 28 days of dialog intervention with the Douyin companion… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- LLM-based AI Dialogue Bot, Depression, Anxiety
- What is being tested?
- Douyin Xinqing AI dialog bot and Douyin Xinqing AI dialog bot for delayed intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 657 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-25 years old
- Proficient in Chinese
- Not dyslexic
- Scoring at least 5 on the PHQ-9 or GAD-7
- Not having a serious physical or diagnosed mental illness
Who cannot join
- Unwilling to continue to participate in the study
- Insufficient clocking in
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Psychology, Chinese Academy of Sciences
Beijing, Beijing Municipality
About this study
Official title: Effect of an AI Agent Trained on a Large Language Model (LLM) as an Intervention for Depression and Anxiety Symptoms in Young Adults: a 28-day Randomized Controlled Trial
This study is a 28-day randomized controlled trial (RCT). Residents were randomly assigned to an intervention group or a waiting group according to the order in which they were successfully contacted by the staff, and each user was asked to engage in a total of 28 days of dialog intervention with the Douyin companion bot and complete three psychological questionnaires (on Days 1, 14, and 28); however, the intervention group began to receive the dialog intervention after completing the first questionnaire, and the waiting group began to receive the dialog intervention after completing the third questionnaire. During the first four weeks, the waiting group was treated as a blank control. The two groups of subjects completed the three questionnaires at exactly the same point in time. Each user's depression, anxiety, and positive and negative emotions were measured using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Scale (GAD-7) and the Positive and Negative Affect Schedule (PANAS), respectively.
- Conditions
- LLM-based AI Dialogue Bot, Depression, Anxiety
- Being tested
- Douyin Xinqing AI dialog bot, Douyin Xinqing AI dialog bot for delayed intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Douyin Xinqing AI dialog botOther
Douyin Xinqing is an AI dialog bot. Users can start chatting with the Douyin companion bot by clicking on the "Direct Message" on the homepage of their accounts on Douyin app.
After a user sends any message to the Douyin companion bot, it first asks the user about his or her mood and guides him or her to start chatting around his or her emotions. According to the situation described by the user, the companion bot expresses empathy, asks questions to guide the user to talk, and provides suggestions at the appropriate time. Users can also record their emotions every day and look back regularly to observe changes in their inner feelings. In addition, the Douyin companion bot can also identify crisis situations such as suicide and severe mental illness and, if necessary, guide users to call the hotline to obtain professional psychological assistance.
Douyin Xinqing AI dialog bot for delayed interventionOther
Only the users in the waiting group had the task of waiting for the first four weeks, and they completed the three questionnaires at exactly the same point in time as those in the intervention group. Only after the first four weeks of intervention did the waiting group begin to receive the 28-day conversational intervention, and no additional questionnaires were interspersed in between.
| Study group | Role | What they receive |
|---|---|---|
| AI conversation intervention | Experimental | Participants in the intervention group received a 28-day AI conversation intervention after completing the baseline questionnaire. We asked users in the intervention group to use the web link every day, upload the start and end times of their conversations with the AI bot and screenshots of their chats; users who chatted for more than 5 minutes were considered to have successfully punched in for that day. Participants who clocked more than 8 days in the first 14 days were allowed to complete the second questionnaire at the two-week mark. Similarly, participants who quit more than eight times between days 15 and 28 could complete the third questionnaire at the four-week mark. Therefore, all users in the intervention group who completed the third questionnaire received at least 16 AI conversation interventions. Receives: Other: Douyin Xinqing AI dialog bot |
| Waiting group | Other | The waiting group received the same intervention as the intervention group after a 28-day waiting period. Receives: Other: Douyin Xinqing AI dialog bot for delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Depression was assessed with the Patient Health Questionnaire (PHQ-9). The PHQ-9 contains nine items scored on a scale from 0 (not at all) to 3 (almost every day) based on the self-reported frequency of depressive symptoms in the past 2 weeks. The total score ranges from 0 to 27, and scores above 10 indicate probable depression symptoms.
Measured: The day before the start of the intervention, day 14 and day 28 after the start of the intervention
Anxiety
Anxiety was assessed with the Chinese version of the Generalized Anxiety Disorder Scale (GAD-7). The 7 items are rated on a 4-point scale ranging from 0 (never) to 3 (almost every day) to assess the frequency of anxiety symptoms in the past 2 weeks. The total score ranges from 0 to 21, and according to the established criteria, scores above 10 indicate probable anxiety symptoms.
Measured: The day before the start of the intervention, day 14 and day 28 after the start of the intervention
Positive and negative moods
Positive and negative moods were assessed with the Positive and Negative Affect Schedule (PANAS). The scale was categorized into two dimensions, positive (PA) and negative (NA), and each dimension was scored independently, with 9 items per dimension. All the items are rated on a 5-point scale ranging from 1 (few) to 5 (very much). The higher the subject's score on a subscale is, the stronger the associated emotion experienced.
Measured: The day before the start of the intervention, day 14 and day 28 after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start20 Nov 2023
- Primary completion18 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LLM-based AI Dialogue BotStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Psychology, Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhengkui Liu, PhD, Study chair, Institute of Psychology, Chinese Academy of SciencesKankan Wu, PhD, Study director, Institute of Psychology, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346496
- Sponsor's protocol ID
- H23133
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao Y, Qian W, Chen Y, Wu D, Luo Y, Gao C, Wu K, Liu Z. Effect of an AI agent trained on a large language model (LLM) as an intervention for depression and anxiety symptoms in young adults: A 28-day randomized controlled trial. Appl Psychol Health Well Being. 2025 Oct;17(5):e70067. doi: 10.1111/aphw.70067.
PubMed 40910958
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an AI Agent Trained on a Large Language Model (LLM) as an Intervention for Depression and Anxiety Symptoms in Young Adults: a 28-day Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06346496
- Acronym / sponsor ID
- H23133
- Conditions
- LLM-based AI Dialogue Bot, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Institute of Psychology, Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 4 Apr 2024 (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.
This study is a 28-day randomized controlled trial (RCT). Residents were randomly assigned to an intervention group or a waiting group according to the order in which they were successfully contacted by the staff, and each user was asked to engage in a total of 28 days of dialog intervention with the Douyin companion bot and complete three psychological questionnaires (on Days 1, 14, and 28); however, the intervention group began to receive the dialog intervention after completing the first questionnaire, and the waiting group began to receive the dialog intervention after completing the third questionnaire. During the first four weeks, the waiting group was treated as a blank control. The two groups of subjects completed the three questionnaires at exactly the same point in time. Each user's depression, anxiety, and positive and negative emotions were measured using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Scale (GAD-7) and the Positive and Negative Affect Schedule (PANAS), respectively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI conversation intervention | Experimental | Other: Douyin Xinqing AI dialog botParticipants in the intervention group received a 28-day AI conversation intervention after completing the baseline questionnaire. We asked users in the intervention group to use the web link every day, upload the start and end times of their conversations with the AI bot and screenshots of their chats; users who chatted for more than 5 minutes were considered to have successfully punched in for that day. Participants who clocked more than 8 days in the first 14 days were allowed to complete the second questionnaire at the two-week mark. Similarly, participants who quit more than eight times between days 15 and 28 could complete the third questionnaire at the four-week mark. Therefore, all users in the intervention group who completed the third questionnaire received at least 16 AI conversation interventions. |
| Waiting group | Other | Other: Douyin Xinqing AI dialog bot for delayed interventionThe waiting group received the same intervention as the intervention group after a 28-day waiting period. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-25 years old
- Proficient in Chinese
- Not dyslexic
- Scoring at least 5 on the PHQ-9 or GAD-7
- Not having a serious physical or diagnosed mental illness
Key exclusion criteria (2 listed)
- Unwilling to continue to participate in the study
- Insufficient clocking in
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 |
|---|---|---|
| Douyin Xinqing AI dialog botDouyin Xinqing is an AI dialog bot. Users can start chatting with the Douyin companion bot by clicking on the "Direct Message" on the homepage of their accounts on Douyin app. After a user sends any message to the Douyin companion bot, it first asks the user about his or her mood and guides him or her to start chatting around his or her emotions. According to the situation described by the user, the companion bot expresses empathy, asks questions to guide the user to talk, and provides suggestions at the appropriate time. Users can also record their emotions every day and look back regularly to observe changes in their inner feelings. In addition, the Douyin companion bot can also identify crisis situations such as suicide and severe mental illness and, if necessary, guide users to call the hotline to obtain professional psychological assistance. | Other | AI conversation intervention |
| Douyin Xinqing AI dialog bot for delayed interventionOnly the users in the waiting group had the task of waiting for the first four weeks, and they completed the three questionnaires at exactly the same point in time as those in the intervention group. Only after the first four weeks of intervention did the waiting group begin to receive the 28-day conversational intervention, and no additional questionnaires were interspersed in between. | Other | Waiting group |
Primary outcome
Depression
Time frame: The day before the start of the intervention, day 14 and day 28 after the start of the intervention
Depression was assessed with the Patient Health Questionnaire (PHQ-9). The PHQ-9 contains nine items scored on a scale from 0 (not at all) to 3 (almost every day) based on the self-reported frequency of depressive symptoms in the past 2 weeks. The total score ranges from 0 to 27, and scores above 10 indicate probable depression symptoms.
Anxiety
Time frame: The day before the start of the intervention, day 14 and day 28 after the start of the intervention
Anxiety was assessed with the Chinese version of the Generalized Anxiety Disorder Scale (GAD-7). The 7 items are rated on a 4-point scale ranging from 0 (never) to 3 (almost every day) to assess the frequency of anxiety symptoms in the past 2 weeks. The total score ranges from 0 to 21, and according to the established criteria, scores above 10 indicate probable anxiety symptoms.
Positive and negative moods
Time frame: The day before the start of the intervention, day 14 and day 28 after the start of the intervention
Positive and negative moods were assessed with the Positive and Negative Affect Schedule (PANAS). The scale was categorized into two dimensions, positive (PA) and negative (NA), and each dimension was scored independently, with 9 items per dimension. All the items are rated on a 5-point scale ranging from 1 (few) to 5 (very much). The higher the subject's score on a subscale is, the stronger the associated emotion experienced.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 40910958Zhao Y, Qian W, Chen Y, Wu D, Luo Y, Gao C, Wu K, Liu Z. Effect of an AI agent trained on a large language model (LLM) as an intervention for depression and anxiety symptoms in young adults: A 28-day randomized controlled trial. Appl Psychol Health Well Being. 2025 Oct;17(5):e70067. doi: 10.1111/aphw.70067.
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. This study is not recruiting at the moment.
Zhengkui Liu, PhD study chair
Institute of Psychology, Chinese Academy of Sciences
Kankan Wu, PhD study director
Institute of Psychology, Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Douyin Xinqing AI dialog bot and Douyin Xinqing AI dialog bot for delayed intervention in people with LLM-based AI Dialogue Bot and Depression, run by Institute of Psychology, Chinese Academy of Sciences 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 2 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: finished, as of the sponsor's last update on 9 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression (time frame: The day before the start of the intervention, day 14 and day 28 after the start of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06346496, which also lists 1 linked publication.
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 9 Apr 2024.