NCT06346496

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 657 (actual)
• Sponsor: Institute of Psychology, Chinese Academy of Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2023-11-20
• Primary completion: 2023-12-18
• Completion: 2024-01-15
• First posted: 2024-04-04
• Last updated: 2024-04-09

Locations

1 site across 1 country: China