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Completed

NCT Number: NCT06346496

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

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.

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Key information

Conditions

LLM-based AI Dialogue Bot Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Psychology, Chinese Academy of Sciences

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Douyin Xinqing AI dialog bot

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.

Douyin Xinqing AI dialog bot for delayed intervention

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Institute of Psychology, Chinese Academy of Sciences

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 4, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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