Comparing Generated AI (Emohaa) and Group ACT in Reducing Emotional Distress: 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
- 80
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
Emotional Distress, such as anxiety and depression, is an essential issue worldwide. There have been several evidence-based psychotherapies that are effective in improving emotional distress, such as Acceptance and Commitment Therapy (ACT). However, the scarcity of professionals and the imbalance in the distribution of mental health resources prevent individuals in need from accessing immediate and effective help.
Artificial intelligence (AI) has the potential to promote this problem. The existing studies have provided preliminary support for the application of AI in mental health interventions. One such model, Emohaa, a generated AI model, has been examined for its effectiveness in adult emotional distress. However, despite the limited reliability of the single-group design, parallel randomized controlled trials are scarce to validate this finding further. This present study is to fill this gap.
This study aims to examine the effectiveness of the generated AI (Emohaa) in reducing emotional distress, including anxiety and depression, compared with group ACT and waitlist. In this parallel randomized controlled trial, it is hypothesized that (1) Compared with the waitlist, Emohaa and group ACT could significantly improve participants' emotional distress, including anxiety and depression symptoms; (2) Emohaa would lead to a greater reduction in anxiety and depression symptoms compared with group ACT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Adults with 18-25 ages;
- •Suffering from emotional distress (PHQ-9 > 9 or GAD-7 > 9);
- •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
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: 0, 2, 4, 6, 8, and 10 weeks
PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
Generalized Anxiety Disorder (GAD-7)
时间窗: 0, 2, 4, 6, 8, and 10 weeks
GAD-7 is an easy-to-perform initial screening tool for generalized anxiety disorder. Questions are scored on a Likert scale of 0-3 with 0 being not at all and 3 being nearly every day.
UCLA Loneliness Scale (ULS-3)
时间窗: 0, 2, 4, 6, 8, and 10 weeks
ULS-3 is a brief version of the UCLA Loneliness Scale with 3 items, which was designed to assess loneliness. Questions are scored on a Likert scale of 1-4 with 1 being never and 4 being always.
Self-Concept Clarity Scale (SCCS)
时间窗: 0, 2, 4, 6, 8, and 10 weeks
SCCS is a 12-item scale to measure the clarity of self-concept. Questions are scored on a Likert scale of 1-5 with 1 being strongly disagree and 5 being strongly agree.
Acceptance and Action Questionnaire-2nd Edition (AAQ-II)
时间窗: 0, 2, 4, 6, 8, and 10 weeks
AAQ-II is the second version of the Acceptance and Action Questionnaire with 7 items. Questions are scored on a Likert scale of 1-7 with 1 being never and 7 being always
Insomnia Severity Index (ISI)
时间窗: 0, 2, 4, 6, 8, and 10 weeks
ISI is a 7-item screening tool to measure the severity of sleep problems. Questions are scored on a 0-4 scale with different descriptions
Client Satisfaction Questionnaire (CSQ-8)
时间窗: 2, 4, 6, 8, and 10 weeks
CSQ-8 is an easy-to-perform initial screening tool for client satisfaction with mental health services. Questions are scored on a Likert scale of 1-4 with 1 being low satisfaction and 4 being high satisfaction.
Digital Working Alliance Inventory (DWAI)
时间窗: 6, 8, and 10 weeks
DWAI is an 8-item scale to measure the working alliance between participants and the AI model revised by the Working Alliance Inventory. Questions are scored on a Likert scale of 1-7 with 1 being totally disagree and 7 being totally agree.
次要结局
未报告次要终点
研究者
Yi Feng
Associate Private Investigator
Central University of Finance and Economics, China