Optimizing an Automated Chatbot to Achieve Efficient, Scalable Treatment for Eating Disorders
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- ED psychopathology; ED Examination-Questionnaire (EDE-Q)
研究概览
简要总结
The purpose of this study is to optimize an automated digital chatbot intervention for adults with clinical or subclinical eating disorders.
详细描述
Eating disorders (EDs) are common-affecting an estimated 10% of individuals in their lifetimes-and have disabling consequences being associated with high psychiatric comorbidity, impairment, and mortality. Despite this, less than 20% of individuals with an ED ever receive treatment. When individuals do seek treatment, many are not evidence-based and come with high costs and burden on the healthcare system. One solution to this is a chatbot intervention that is evidence-based, affordable, and accessible for people with EDs. This project will assess four candidate components of a cognitive behavioral therapy (CBT)-based chatbot to determine the optimal chatbot package. CBT is the recommended first-line treatment for EDs, yet there is no research to date on which components are most effective or needed for meaningful change in ED psychopathology. In this study the intervention will be divided into four components targeting: (1) over-evaluation of weight and shape; (2) dietary restraint; (3) emotion dysregulation; and (4) resisting urges to binge. The investigators will recruit 800 adults with a binge/purge-type ED who are not currently in treatment and randomly assign participants to one of 16 experimental conditions (each combination from 1 to all 4 components) or the waitlist-control group. Participants will be assessed on changes in ED psychopathology, ED behavior frequencies, comorbid symptoms (i.e., depression, anxiety), and clinical impairment at 1-, 2-, and 6-months following randomization. An optimized package of these candidate components that is most effective, while remaining efficient, will be identified using multiphase optimization strategy (MOST). The investigators' established relationships with industry and non-profit partners will ensure this optimized package has high potential for scalability and dissemination into the community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years old
- •Owns a smartphone
- •Speaks English
- •US resident
- •Screens for a clinical or subclinical eating disorder
- •Low suicidality
- •Not currently in treatment for an eating disorder
- •Does not have a medical condition or take medications that impact appetite/weight
- •Not currently pregnant
排除标准
- •Below 18 years of age
- •Does not own a smartphone
- •Does not speak English
- •Lives outside the US
- •Screens as: at risk for an eating disorder, anorexia nervosa, atypical anorexia nervosa, avoidant/restrictive food intake disorder, or not at risk for an ED
- •High suicidality
- •In treatment for an eating disorder
- •Has a medical condition or takes medication(s) that impact appetite/weight
- •Currently pregnant
研究组 & 干预措施
Chatbot targeting ED; UB; and WSC
Participant will have access to the chatbot components addressing emotion dysregulation, resisting urges to binge, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the emotion dysregulation, resisting urges to binge, and weight and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
Referral to seek services
Those randomized to receive all chatbot components "off" will receive a referral to seek services.
Chatbot targeting dietary restraint (DR)
Participant will have access to the chatbot component addressing dietary restraint. Participant will receive scheduled targeted practice for the dietary restraint component. At any time, participant will have access to initiate practice in assigned study component.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting weight & shape over-evaluation (WSC)
Participant will have access to the chatbot component addressing weight & shape over-evaluation. Participant will receive scheduled targeted practice for the weight & shape over-evaluation component. At any time, participant will have access to initiate practice in assigned study component.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting emotion dysregulation (ED)
Participant will have access to the chatbot component addressing emotion dysregulation. Participant will receive scheduled targeted practice for the emotion dysregulation component. At any time, participant will have access to initiate practice in assigned study component.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting resisting urges to binge (UB)
Participant will have access to the chatbot component addressing resisting urges to binge. Participant will receive scheduled targeted practice for the resisting urges to binge component. At any time, participant will have access to initiate practice in assigned study component.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting WSC and DR
Participant will have access to the chatbot components addressing weight & shape over-evaluation and dietary restraint. Participant will receive scheduled targeted practice for the weight & shape over-evaluation and dietary restraint components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting WSC and ED
Participant will have access to the chatbot components addressing weight & shape over-evaluation and emotion deregulation. Participant will receive scheduled targeted practice for the weight & shape over-evaluation and emotion dysregulation components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting WSC and UB
Participant will have access to the chatbot components addressing weight & shape over-evaluation and resisting urges to binge. Participant will receive scheduled targeted practice for the weight & shape over-evaluation and resisting urges to binge components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting DR and ED
Participant will have access to the chatbot components addressing dietary restraint and emotion deregulation. Participant will receive scheduled targeted practice for the dietary restraint and emotion dysregulation components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting DR and UB
Participant will have access to the chatbot components addressing dietary restraint and resisting urges to binge. Participant will receive scheduled targeted practice for the dietary restraint and resisting urges to binge components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting ED and UB
Participant will have access to the chatbot components addressing emotion dysregulation and resisting urges to binge. Participant will receive scheduled targeted practice for the emotion dysregulation and resisting urges to binge components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting ED; UB; and DR
Participant will have access to the chatbot components addressing emotion dysregulation, resisting urges to binge, and dietary restraint. Participant will receive scheduled targeted practice for the emotion dysregulation, resisting urges to binge, and dietary restraint components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting ED; DR; and WSC
Participant will have access to the chatbot components addressing emotion dysregulation, dietary restraint, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the emotion dysregulation, dietary restraint, and weight and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting UB; DR; and WSC
Participant will have access to the chatbot components addressing resisting urges to binge, dietary restraint, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the resisting urges to binge, emotion dysregulation, dietary restraint and weight, and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components
干预措施: Digital Chatbot Program (Behavioral)
Chatbot targeting UB; DR; ED; and WSC
Participant will have access to the chatbot components addressing resisting urges to binge, dietary restraint, emotion dysregulation, and weight and shape over-evaluation. Participant will receive scheduled targeted practice for the resisting urges to binge, emotion dysregulation, dietary restraint, emotion dysregulation, and weight and shape over-evaluation components. At any time, participant will have access to initiate practice in assigned study components.
干预措施: Digital Chatbot Program (Behavioral)
结局指标
主要结局
ED psychopathology; ED Examination-Questionnaire (EDE-Q)
时间窗: 6 months
The EDE-Q is a 28-item inventory derived from an ED diagnostic interview, which asks self-reported concerns with weight and shape, and engagement in ED behaviors, over the last 28 days. Each item is scored from 0-6, with 0 being "No days" and 6 being "Every day". An average is taken of all items participants respond to for a total global score (with possible scores ranging from 0 to 6), where higher scores indicate greater symptomology.
次要结局
- ED behaviors from the EDE-Q; Muscle Building Subscale from the Eating Pathology Symptoms Inventory (EPSI)(6 months)
- Depression; Patient Health Questionnaire (PHQ-9)(6 months)
- Anxiety; Generalized Anxiety Disorder (GAD-7)(6 months)
- Clinical Impairment; Clinical Impairment Assessment (CIA)(6 months)
研究者
Ellen E. Fitzsimmons-Craft
Associate Professor of Psychological & Brain Sciences and Psychiatry
Washington University School of Medicine