A Randomized, Multicenter, Treatment-as-usual Controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Eating Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 134
- 试验地点
- 4
- 主要终点
- Binge Eating Frequency
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders.
The main questions it aims to answer are:
- Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders?
- Is the WELT-ED safe for use in the target population without causing adverse effects?
Participants will:
- Undergo assessments to determine their baseline health status and severity of eating disorder symptoms.
- Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks).
- Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 19 and 65 years
- •Diagnosed with an eating disorder according to ICD-
- •F50.0 Anorexia nervosa F50.1 Atypical anorexia nervosa F50.2 Bulimia nervosa F50.3 Atypical bulimia nervosa F50.4 Overeating associated with other psychological disturbances F50.5 Vomiting associated with other psychological disturbances F50.8 Other eating disorders F50.9 Eating disorder, unspecified)
- •Have a binge eating frequency (as per item 14 of the EDE-Q) of 4 or more times over the past 4 weeks (28 days) at the time of screening.
- •Able to use a mobile application (app) on a smartphone without difficulty.
- •After receiving and understanding sufficient information about this clinical trial, voluntarily decides to participate and provides written consent.
排除标准
- •Previously received Cognitive Behavioral Therapy for the treatment of an eating disorder.
- •Have a history of bariatric surgery (e.g., adjustable gastric band, sleeve gastrectomy, biliopancreatic diversion, Roux-en-Y gastric bypass).
- •Have a BMI less than 17 kg/m^2 or more than 40 kg/m^2 at the time of screening.
- •Diagnosed with a major psychiatric disorder according to the MINI.
- •Have a past or current diagnosis of schizophrenia or bipolar disorder.
- •At risk of suicide (C-SSRS score of 4 or higher) or have attempted suicide in the past 2 weeks.
- •Have active and progressive physical illnesses (e.g., congestive heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorders (e.g., cerebrovascular disease), neurodegenerative diseases (e.g., dementia, multiple sclerosis), unstable medical conditions, or a life expectancy of less than 6 months.
- •Pregnant or planning to become pregnant during the trial period.
- •Participated in another clinical trial within 4 weeks prior to screening.
- •Have a history of alcohol or substance abuse.
- •Considered by the investigator to be unsuitable for participation in this clinical trial for any other reason.
研究组 & 干预措施
WELT-ED (CBT based DTx)
Participants in this group will receive a shortened version of the standard treatment plus access to the DTx app for 8 weeks.
The DTx app is designed to provide therapeutic interventions based on CBT principles, aiming to help participants manage and reduce their eating disorder symptoms.
Participants are expected to engage with the app, completing tasks such as self-monitoring food diaries. The app will collect data on adherence, including diary completion rates and app login frequency.
Additional Support: Aside from app usage, participants will receive counseling and support therapy during visits at baseline, the 4-week mark, and the 8-week mark.
They will continue any pre-existing medication for eating disorders.
干预措施: WELT-ED (CBT based DTx) (Device)
Standard Treatment
Participants will receive the standard treatment protocol for eating disorders, which includes regular counseling and support therapy at all scheduled visits.
This treatment is comprehensive and follows the conventional approach to managing eating disorders, without the use of the DTx app.
Participants will continue any pre-existing medication for eating disorders.
干预措施: Standard Treatment (Behavioral)
结局指标
主要结局
Binge Eating Frequency
时间窗: from baseline (pre-use) to the 8-week point.
Change of Binge Eating Frequency (item 14 of the Eating Disorder Examination Questionnaire, EDE-Q)
次要结局
- Eating Disorder Examination Questionnaire (EDE-Q)(8 weeks)
- Generalized anxiety disorder 7-item scale (GAD-7)(8 weeks)
- The EuroQol Visual Analogue Scale (EQ-VAS)(8 weeks)
- Clinical Impairment Assessment (CIA)(8 weeks)
- Clinical Global Impression of Improvement (CGI-I)(8 weeks)
- Clinical Global Impression of Severity (CGI-S)(8 weeks)
- Patient health questionnaire-9 (PHQ-9)(8 weeks)