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临床试验/NCT07094503
NCT07094503招募中2 期

Improving Access to Services, Preventing Eating Disorders, and Addressing Comorbid Depression and Anxiety in Diverse Adolescents

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年6月18日最近更新:
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
400
试验地点
1
主要终点
ED risk factors; Weight Concerns Scale

研究概览

简要总结

The purpose of this study is to test an eating disorders prevention digital chatbot program in a diverse group of adolescents.

详细描述

Eating disorders (EDs) are impacting youth at extreme rates, with up to 22% of adolescents reporting ED symptoms, and are associated with very high psychiatric comorbidity. Since adolescence is a critical period for the onset of eating disorders, prevention during this stage is essential to reducing lifetime prevalence. Interventions have been developed to prevent the onset of these devastating disorders, but these programs are generally not publicly available and rarely offer support for addressing comorbidity or the unique needs of vulnerable subpopulations (e.g., low-income populations, sexual and gender minorities, racial/ethnic minorities, those from rural areas), who are even less likely to have access to high-quality care. One scalable, engaging, easy-to use, and convenient approach to increasing access to evidence-based EDs prevention for underserved groups involves using a chatbot. This project will adapt our team's existing EDs prevention chatbot for use with adolescents, including those from diverse backgrounds, and evaluate its effectiveness. Our deep industry and non-profit partnerships will ensure scalability and ultimate real-world impact.

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
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 13 - 19 years old
  • Owns a smartphone
  • Speaks English
  • US resident
  • Screens as at-risk for an eating disorder
  • Not currently in treatment for an eating disorder

排除标准

  • Below 13 or older than 19 years of age
  • Does not own a smartphone
  • Does not speak English
  • Lives outside the US
  • Screens as:
  • Having a subclinical or clinical ED
  • Not at risk for an ED
  • In treatment for an ED

研究组 & 干预措施

Chatbot Intervention Condition

Experimental

Participants receive access to the digital chatbot program featuring 5 CBT based modules for 3 months. Modules include psychoeducation and CBT-based exercises on regular eating and improving body image.

干预措施: Wysa Digital Chatbot Program (Behavioral)

Waitlist Control

No Intervention

Participants receive access to the digital chatbot program after 6 months and completion of the study.

结局指标

主要结局

ED risk factors; Weight Concerns Scale

时间窗: 6 - months

Weight concerns scale as found in the Stanford Washington Eating Disorder (SWED) screen is a 5-item validated self-report questionnaire which measures concern with weight and dieting. Each item is scored on a 5-100 scale, then an average is computed across all 5 items for a 0-100 score.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen E. Fitzsimmons-Craft

Associate Professor of Psychological & Brain Sciences

Washington University School of Medicine

研究点 (1)

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