Young People Aged 18-25 With Depression or Anxiety Mood Participate in an LLM-based Digital Dialogue Intervention Study

NCT ID: NCT06346496

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 657 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2024-01-15

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

AI conversation intervention

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.

Group Type: EXPERIMENTAL

Douyin Xinqing AI dialog bot

Intervention Type: OTHER

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.

Waiting group

The waiting group received the same intervention as the intervention group after a 28-day waiting period.

Group Type: OTHER

Douyin Xinqing AI dialog bot for delayed intervention

Intervention Type: OTHER

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.

Interventions

Douyin Xinqing AI dialog bot

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.

Intervention Type: OTHER

Douyin Xinqing AI dialog bot for delayed intervention

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Unwilling to continue to participate in the study
• Insufficient clocking in

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Psychology, Chinese Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhengkui Liu, PhD

Role: STUDY_CHAIR

Institute of Psychology, Chinese Academy of Sciences

Kankan Wu, PhD

Role: STUDY_DIRECTOR

Institute of Psychology, Chinese Academy of Sciences

Locations

Institute of Psychology, Chinese Academy of Sciences

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40910958 (View on PubMed)

Other Identifiers

H23133

Identifier Type: -

Identifier Source: org_study_id