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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 657
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Unwilling to continue to participate in the study
- •Insufficient clocking in
研究组 & 干预措施
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.
干预措施: Douyin Xinqing AI dialog bot (Other)
Waiting group
The waiting group received the same intervention as the intervention group after a 28-day waiting period.
干预措施: Douyin Xinqing AI dialog bot for delayed intervention (Other)
结局指标
主要结局
Depression
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点