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临床试验/NCT04636840
NCT04636840已完成1 期

Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2020年12月18日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
161
试验地点
1
主要终点
Eating Disorder Psychopathology

研究概览

简要总结

Clinical or subclinical eating disorders (EDs) impact 10% of individuals in their lifetime and are marked by significant functional impairment, early mortality, chronicity, and emotional distress. ED symptoms often emerge in adolescence, with peak onset age in the teenage years. Early recognition and treatment of these devastating illnesses are needed to prevent long-term consequences and a chronic course. Most (80%) individuals with EDs, including teens with EDs (TwEDs), do not receive treatment. Due to major barriers to access and to the delivery of treatment for TwEDs, there is a need for a new model of service delivery that can identify and help TwEDs. We demonstrated our ability to harness social media to identify and efficiently recruit large numbers of TwEDs. Our team has successfully developed a guided self-help cognitive behavioral therapy (CBT)-based mobile app for previous studies and have adapted this app to address the specific needs of TwEDs. In proposed study, we will test this updated mHealth intervention, which includes simplified language and tailored content relevant to adolescent issues and a social networking feature designed to facilitate group exchanges. This mHealth intervention will be investigated among 161 TwEDs recruited from Instagram/Facebook to test preliminary efficacy and feasibility of this mHealth intervention to improved eating disorder symptoms among TwEDs not currently engaged in treatment. We will also garnering feedback via a mixed methods approach on the efficiency, technical effectiveness, and satisfaction with mHealth intervention content and features. Participants will be randomized to one of 3 study arms, including a control group (self-help version of the app), a group with access to the coached mobile app only, and a group with access to the coached mobile app plus social networking feature. We hypothesized that those with access to the coached mobile app intervention will have improved ED outcomes in comparison to the control group, and that those with access to the additional social networking feature will have the most improvement in ED symptoms out of all three groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • US Resident
  • Owns or has daily access to an iOS or Android smartphone
  • English-speaking
  • Screen Positive for a DSM-5 subclinical/clinical eating disorder other than anorexia nervosa (AN) or at high risk for an eating disorder

排除标准

  • Currently Engaged in eating disorder treatment
  • Screen Positive for Anorexia Nervosa
  • Wards of the State or Foster Children

研究组 & 干预措施

Control Group

No Intervention

Access to a self-help version of Space From Body and Eating Concerns Program on SilverCloud Health App

Experimental Group A- Mobile App with Social Networking Feature

Experimental

Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App with private social media group for social networking support.

干预措施: Space From Body and Eating Concerns- Teen (Device)

Experimental Group B- Mobile App Only

Experimental

Access to a coached Space From Body and Eating Concerns program on SilverCloud Health App.

干预措施: Space From Body and Eating Concerns- Teen (Device)

结局指标

主要结局

Eating Disorder Psychopathology

时间窗: Baseline, 6 weeks, 3 months, 6 months

Eating disorder psychopathology was assessed using the self-report Eating Disorder Examination Questionnaire (EDE-Q). The EDE-Q Global score was calculated as the mean of the Restraint, Eating Concern, Shape Concern, and Weight Concern subscales (items scored 0-6), with higher scores indicating greater severity of eating disorder symptoms.

次要结局

  • Quality of Life Scores(Baseline, 6 weeks, 3 months, 6 months)
  • Total Time Spent on the App(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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