The Intervention Effect of Generative Artificial Intelligence (Emohaa) and Individual Psychological Counseling on Emotional Distress in Young Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of an AI-based mental health chatbot, Emohaa, in reducing symptoms of depression, anxiety, insomnia, and academic burnout among young adults experiencing emotional distress. A total of 222 participants will be randomly assigned to one of three groups: (1) AI chatbot intervention, (2) traditional counseling, or (3) waitlist control. The study spans six time points from baseline through one-month follow-up. Primary and secondary outcomes will be measured via validated self-report questionnaires. The intervention is delivered entirely online through a WeChat-integrated platform, ensuring high accessibility and scalability.
详细描述
This three-arm randomized controlled trial will investigate the efficacy of Emohaa, a generative artificial intelligence (AI)-based chatbot designed to deliver empathetic conversational support to young adults experiencing emotional distress. The study will enroll 222 participants, randomly allocated (1:1:1) into one of the following arms:
AI Chatbot Group: Participants will interact weekly with Emohaa via a WeChat-integrated interface for 30-minute sessions over a 6-week period. The chatbot uses fine-tuned large language models to simulate emotionally supportive conversations and provide personalized, non-directive psychological support.
Traditional Counseling Group: Participants will receive six weekly sessions (face-to-face or remote) with trained counselors using structured, supportive counseling protocols derived from cognitive-behavioral therapy (CBT).
Waitlist Control Group: Participants will not receive any intervention during the study period but will be offered access to Emohaa after study completion.
Assessment Schedule and Outcome Measures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranges from 15 to 30
- •Suffering from emotional distress (PHQ-9 > 14 or GAD-7 > 12)
- •Ability to use the mobile phone to interact with AI
- •Consent to participate in the study
排除标准
- •High risk of self-injury and suicide
- •Presence of psychotic symptoms (i.e., delusions)
- •Serious substance use problems
- •Other mental or physical illnesses requiring urgent medical assistance
- •Received other psychological or pharmacological interventions in the last month.
研究组 & 干预措施
Waiting List Group
Participants will not receive any intervention during the study period but will be offered access to Emohaa after study completion.
Generative Artificial Intelligence Intervention Group
Participants will interact weekly with Emohaa via a WeChat-integrated interface for 30-minute sessions over a 6-week period. The chatbot uses fine-tuned large language models to simulate emotionally supportive conversations and provide personalized, non-directive psychological support.
干预措施: Generative Artificial Intelligence Intervention (Behavioral)
Individual Psychological Counseling Group
Participants will receive six weekly sessions (face-to-face or remote) with trained counselors using structured, supportive counseling protocols derived from cognitive-behavioral therapy (CBT).
干预措施: Individual Psychological Counseling (Behavioral)
结局指标
主要结局
Depression
时间窗: From enrollment to the end of treatment at 10 weeks
The Patient Health Questionnaire-9 (PHQ-9) was employed in this study to measure depressive symptoms. This scale consists of 9 items, each rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with scores of 0-4 indicating no depressive symptoms, 5-9 indicating mild symptoms, 10-14 indicating moderate symptoms, and 15 or above indicating severe depressive symptoms. Previous research has demonstrated good reliability and validity for the Chinese version of the PHQ-9.
Anxiety
时间窗: From enrollment to the end of treatment at 10 weeks
The Generalized Anxiety Disorder-7 (GAD-7) was used to assess anxiety symptoms in this study. This scale consists of 7 items, each rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with scores of 0-4 indicating no anxiety symptoms, 5-9 indicating mild symptoms, 10-14 indicating moderate symptoms, and 15 or above indicating severe anxiety symptoms. Prior studies have shown that the Chinese version of the GAD-7 has good reliability and validity.
次要结局
- Loneliness(From enrollment to the end of treatment at 10 weeks)
研究者
Yi Feng
Associate researcher
Central University of Finance and Economics, China