A Randomized Controlled Trials of Self-help Application for Eating Disorder Through Multifaceted Measurement
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Eating Disorder Cognitions assessed using EDE-Q global scores
研究概览
简要总结
The purpose of this study is to determine whether mobile-based self-help CBT-E treatment for eating disorder can reduce eating disorder symptoms compared to the waitlist group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 13-22 years
- •Owns a smartphone
- •Experienced at least one episode of binge eating over the past 4 weeks
排除标准
- •diagnosed with anorexia nervosa
- •having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis
研究组 & 干预措施
I (Prepectoral)
Participants received the Self-help app-based CBT-E for eating disorder for 8 weeks
干预措施: Arm I (Prepectoral), (Procedure)
II (Subpectoral)
Waiting list Wait-list control(participants will use the smartphone app after the intervention phase) The waitlist group will receive treatment as usual, Patients from the waitlist group will be offered access to App after a 8-weeks period.
干预措施: Arm II (Subpectoral) (Procedure)
结局指标
主要结局
Change in Eating Disorder Cognitions assessed using EDE-Q global scores
时间窗: Baseline, 8 weeks,16 weeks, 28 weeks
The global score of Eating Disorder Examination Questionnaire (EDE-Q) has the 28-item scale of key attitudinal and behavioral ED symptoms. Higher scores indicate higher eating disorder symptomology.
次要结局
- Change in the heart rate variability(Baseline, 8 weeks,16 weeks)
- Change in concerns with body shape assessed using EDE-Q shape concern scores(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in concerns with eating assessed using EDE-Q eating concern scores(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in the body attitudes associated with desiring a thinner assessed using the Eating Disorder Inventory-2, Drive for Thinness(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in assessed the impact an eating disorder has on psychosocial functioning using The Clinical Impairment Assessment Questionnaire (CIA)(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in self-esteem assessed using the Rosenberg self-esteem scale (RSES)(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in concerns with body weight assessed using EDE-Q weight concern scores(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in restrained eating assessed using EDE-Q dietary restraint scores(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in eating disorder symptoms assessed using the Eating Attitude Test(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in addictive-like eating behaviors assessed using the Yale Food Addiction scale(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in addictive-like eating behaviors assessed using the Yale Food Addiction Scale for Children(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in emotion regulation problems assessed using the Difficulties in Emotion Regulation Scale(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in Depression symptoms assessed using the Beck Depression Inventory(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in anxiety symptoms assessed using the State-Trait Anxiety Inventory(Baseline, 8 weeks,16 weeks, 28 weeks)
- Change in eating disorder symptoms assessed using the Korean version of the Eating disorder Diagnostic Scale(Baseline, 8 weeks,16 weeks)
- Change in brain activities recorded with functional near-infrared spectroscopy (fNIRS)(Baseline, 8 weeks)
研究者
Eun Joo Kim
Associate professor
Gangnam Severance Hospital