Developing an Artificial Intelligence (AI)-Powered Exposure Therapy Chatbot for Adolescents and Young Adults With Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of times participants use web-app.
研究概览
简要总结
The goal of this study is to develop and refine an artificial intelligence (AI)-powered Exposure Therapy for Eating Disorders chatbot web-app that effectively engages adolescents and young adults and decreases anxiety about weight gain. Participants will use the web-app as a supplemental therapeutic tool during their first six weeks of treatment in a Partial Hospitalization Program. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the chatbot web-app; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain.
详细描述
The overarching goal of this study is to develop and refine an AI-powered Exposure Therapy for Eating Disorders (Exp-ED) chatbot app that effectively engages adolescents and young adults (AYAs) with eating disorders (EDs) and decreases anxiety about weight gain. The investigators will enroll 20 AYAs (ages 12-26 years) entering the Partial Hospitalization Program (PHP) for EDs at the Penn State Milton S. Hershey Medical Center. The initial version of the Exp-ED chatbot app will be developed by an interdisciplinary team with expertise in exposure therapy for EDs (Dr. Essayli), AI (Dr. Nawab), and implementation science (Dr. Lenker). Participants will use the Exp-ED chatbot app as a supplemental therapeutic tool during their first six weeks of PHP treatment. Participants will complete assessments every two weeks, including: (1) semi-structured interviews about their experience with the Exp-ED chatbot app, including design issues and engagement barriers; (2) implementation outcome measures (e.g., feasibility, usability, acceptability); and (3) anxiety about weight gain. Success will be evaluated using pre-determined benchmarks derived from previous mental health chatbot research. This project has two aims:
Aim 1: Iteratively adapt an exposure therapy chatbot app for AYAs with EDs. The investigators will conduct monthly reviews of mixed-methods data and use the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to systematically document and evaluate modifications to the chatbot app. Each revised version will be tested with new participants, creating an iterative development process that continues throughout the project period. All adaptation decisions and their empirical foundations will be documented to create a comprehensive record of the app's development via implementation science frameworks.
Aim 2. Evaluate the feasibility, usability, acceptability, and preliminary efficacy of the Exp-ED chatbot app. H2.1: The investigators will recruit ≥50% of eligible AYAs with EDs. H2.2: Over the six-week project period, participants will use the app ≥18 times. H2.3: Participants will engage with the chatbot for ≥100 minutes total. H2.4: Participants will rate the Exp-ED chatbot app as acceptable (score ≥68 on the System Usability Scale). H2.5: Participants will report a ≥50% reduction in anxiety about weight gain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is between or equal to 12-26 years
- •Admitted to the Penn State Health Eating Disorder Partial Hospital Program (PHP) or Intensive Outpatient Program (IOP)
- •Have a personal smartphone
- •Have a diagnosis of anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), or other specified feeding or eating disorder (OSFED)
- •Be English speaking
排除标准
- •Diagnosis of avoidant/restrictive food intake disorder (ARFID)
- •Have acute suicidality
- •Diagnosis of an intellectual disability
研究组 & 干预措施
"Exp-ED" Digital Exposure-Therapy Chatbot app
Exp-ED will target anxiety about weight gain through an exposure based treatment.
干预措施: "Exp-ED" Digital Exposure-Therapy Chatbot app (Behavioral)
结局指标
主要结局
Number of times participants use web-app.
时间窗: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The investigators will measure the number of times participants use the web-app
Number of minutes participants engage with the web-app.
时间窗: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The investigators will measure the number of minutes participants engage with the web-app
Percent of eligible Adolescents and Young Adults Consented
时间窗: Through study completion, an average of 1 year
The investigators will measure the percent of eligible adolescents and young adults who consent to the study.
System Usability Scale Survey (SUS)
时间窗: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The System Usability Scale Survey (SUS) is a 10-item self-report questionnaire that examines the participant's attitude towards the web-app. Scores range from 10-50, with higher scores indicating a better overall experience with the app.
Weight Gain Anxiety Questionnaire
时间窗: Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The Weight Gain Anxiety Questionnaire is a 12-item self-report questionnaire that targets anxiety about weight gain. The scores are measured on a 0-100 scale, with the higher the score indicating more distress about weight gain, with the exception for question 12 which is reverse scored.
Number of minutes participants engage with the web-app.
时间窗: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The investigators will measure the number of minutes participants engage with the web-app
Number of times participants use web-app.
时间窗: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The investigators will measure the number of times participants use the web-app
Percent of eligible Adolescents and Young Adults Consented
时间窗: Through study completion, an average of 1 year
The investigators will measure the percent of eligible adolescents and young adults who consent to the study.
Weight Gain Anxiety Questionnaire
时间窗: Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The Weight Gain Anxiety Questionnaire is a 12-item self-report questionnaire that targets anxiety about weight gain. The scores are measured on a 0-100 scale, with the higher the score indicating more distress about weight gain, with the exception for question 12 which is reverse scored.
System Usability Scale Survey (SUS)
时间窗: End of Week 2, End of Week 4, End-of-Treatment (Week 6)
The System Usability Scale Survey (SUS) is a 10-item self-report questionnaire that examines the participant's attitude towards the web-app. Scores range from 10-50, with higher scores indicating a better overall experience with the app.
次要结局
- Eating Disorder Fear Questionnaire (EDFQ)(Baseline, End-of-Treatment (Week 6))
- Fear of Food Measure (FOFM)(Baseline, End-of-Treatment (Week 6))
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline, End-of-Treatment (Week 6))
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, End-of-Treatment (Week 6))
- Eating Anxiety Questionnaire(Baseline, End of Week 2, End of Week 4, End-of-Treatment (Week 6))
- Clinical Impairment Assessment (CIA)(Baseline, End-of-Treatment (Week 6))
- Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)(Baseline, End-of-Treatment (Week 6))
研究者
Jamal Essayli
Assistant Professor
Milton S. Hershey Medical Center