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临床试验/NCT04806165
NCT04806165已完成不适用

Developing an Optimized Conversational Agent or "Chatbot" to Facilitate Mental Health Services Use in Individuals With Eating Disorders

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2021年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
205
试验地点
2
主要终点
Rates of Treatment/Services Utilization for Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening

研究概览

简要总结

Eating disorders (EDs) are serious mental illnesses associated with high morbidity and mortality, clinical impairment, and comorbid psychopathology. Although evidence-based treatments for EDs have been established, the treatment gap is wide. Indeed, <20% of individuals with EDs receive treatment. There is need for a novel solution not only to identify individuals with EDs but also to encourage mental health services use and to address treatment barriers. This study aims to implement a conversational agent or "chatbot" that is optimized to increase mental health services use among individuals with EDs through such features as: 1) education on the seriousness and consequences of EDs; 2) engaging the user in motivational interviewing to overcome barriers to care; 3) providing a personalized recommendation for seeking intervention; 4) repeated check-ins with the user to encourage follow-up with care. This study will utilize a randomized optimization trial with adults who have completed screening on the National Eating Disorders Association (NEDA) website and screen positive for an ED but are not in treatment to determine chatbot feasibility and to generate data on the effect of the chatbot on motivation for treatment and mental health services use. This trial will employ the Multiphase Optimization Strategy framework, using a 2^4 full factorial design, to randomly assign participants to a combination of the four proposed intervention components (n=16 conditions) to isolate the active ingredients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
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

入选标准

  • U.S. resident
  • English-speaking
  • Age 18 years or older
  • Owns a personal smartphone
  • Screens positive for a Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) clinical or subclinical eating disorder
  • Not currently receiving treatment for an eating disorder

排除标准

  • Non-U.S. resident
  • Younger than 18 years old
  • Does not own a personal smartphone
  • Does not screen positive for a DSM-5 clinical or subclinical eating disorder
  • Screens positive for Avoidant Restrictive Food Intake Disorder
  • Currently receiving treatment for an eating disorder

结局指标

主要结局

Rates of Treatment/Services Utilization for Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening

时间窗: 2, 6, 14 Weeks from Engagement with the Intervention

Treatment utilization was measured at each follow-up time point (2, 6, and 14 weeks), which was assessed via the prompt, "Have you tried or used any type of mental health help (e.g., self-help app, telehealth/in-person counseling, etc.) for your concerns related to your eating, shape, or weight in the past \[2, 6, or 14\] weeks?". We defined a participant as having utilized treatment at the first time they responded, "yes" (vs. "no") to this question. The data presented below indicate the rates of self-reported receipt of treatment/services utilization among participants assigned (component on) or not assigned (component off) to each of the four chatbot components (motivational interviewing, psychoeducation, personalized recommendations, repeated administration), as delineated by each time point during which the aforementioned item was assesed.

次要结局

  • Mean Willingness to Seek Psychotherapy(Baseline, 2 Weeks, 6 Weeks, 14 Weeks)
  • Mean Attitude Toward Change for Concerns Related to Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening(Baseline, 2 weeks, 6 weeks, 14 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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