NCT06454123尚未招募不适用
A Feasibility Study of a Digital Therapeutic for Adults With Recurrent Binge Eating and Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- System Usability Sale (SUS)
研究概览
简要总结
The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.
详细描述
This single-arm, open-label clinical trial will test the feasibility, usability, acceptability, and preliminary efficacy of a digital therapeutic in reducing binge eating and weight in 30 adults with comorbid recurrent binge eating and obesity.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking male or female patients, 18-70 years
- •Patients with recurrent binge eating (≥12 episodes in 3 months) and obesity (BMI ≥30)
- •Understand written and spoken English
- •Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
- •Willing and able to complete enrollment procedures
- •Able to understand the nature of the study and provide written informed consent
排除标准
- •Patients with active psychosis
- •Patients who are acutely intoxicated at the time of enrollment
- •Currently enrolled in other treatment studies for the symptoms and behaviors targeted
- •Patients who are cognitively impaired
- •Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the digital therapeutic
结局指标
主要结局
System Usability Sale (SUS)
时间窗: Week 12
The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability.
次要结局
未报告次要终点
研究者
相似试验
终止
不适用
Digital Therapeutic for Adolescent Depressive Symptoms in Hematology, Oncology, and Weight ManagementDepressive DisorderDepressive SymptomsDepressive EpisodeAdolescent BehaviorAdolescent - Emotional ProblemHematologic DiseasesOncologyWeight, BodyDepressionNCT05351866Limbix Health, Inc.7
招募中
不适用
A Digital Treatment for Adolescents With Eating DisordersEating DisordersNCT06306586Haukeland University Hospital60
终止
不适用
Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and GastroenterologyDepressive SymptomsCardiologyGastrointestinal DiseasesDepressive DisorderDepressive EpisodeMajor Depressive DisorderAdolescent BehaviorAdolescent - Emotional ProblemDepressionNCT05461599Limbix Health, Inc.2
已完成
不适用
Examining the Feasibility of Wysa in HindiMental Health IssueDiabetes DistressNCT06320756Wysa79
招募中
不适用
Digital-technology Based Interventions on Treatment of Migraine.Primary Headache DisordersMigraineNCT05458817Tartu University Hospital600