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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06346496
• Other study ID #: H23133
• Status: Completed
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: October 2023
• Source: Institute of Psychology, Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. completion date: January 15, 2024
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Institute of Psychology, Chinese Academy of Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Psychology, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The day before the start of the intervention, day 14 and day 28 after the start of the intervention
Primary	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.	The day before the start of the intervention, day 14 and day 28 after the start of the intervention
Primary	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.	The day before the start of the intervention, day 14 and day 28 after the start of the intervention