Dialectical Behavioral Therapy As a Therapeutic Tool in Patients with Binge Eating Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Binge Eating Severity
研究概览
简要总结
Binge eating disorder (BED) is one of the recently acknowledged eating disorders, with many theories underlying its pathology whether biological or psychological. From the biological perspective, changes in plasma ghrelin were hypothesized to have a major role in developing and maintaining the disorder, while from the psychopathological perspectives, abnormalities in emotion regulation were found in many patients.
Since Dialectical Behavioral Therapy (DBT) is known to target emotion dysregulation, the main aim of this study is to assess the efficacy of DBT versus treatment as usual (TAU) in BED patients, and whether plasma ghrelin level will be affected after treatment in both arms.
详细描述
Binge eating disorder (BED) is one of the recently acknowledged eating disorders, with many theories underlying its pathology whether biological or psychological. From the biological perspective, changes in plasma ghrelin were hypothesized to have a major role in developing and maintaining the disorder, while from the psychopathological perspectives, abnormalities in emotion regulation were found in many patients.
Since Dialectical Behavioral Therapy (DBT) is known to target emotion dysregulation, the main aim of this study is to assess the efficacy of DBT versus treatment as usual (TAU) in BED patients, and whether plasma ghrelin level will be affected after treatment in both arms, with patients being randomly allocated in both 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years.
- •Patients diagnosed as BED according to the Diagnostic and Statistical Manual of Mental Disorders- Fifth Version (DSM-5), after providing a written informed consent
- •Overweight or obese patients (body mass index ≥ 25), or patients with a history of overweight or obesity
排除标准
- •Patients with known psychotic disorders or substance use disorders
- •Patients diagnosed with current major depressive or anxiety disorders
- •Patients diagnosed with borderline personality disorder
- •Patients who are actively suicidal
- •Patients with medical conditions that can affect or alter the frequency of eating and metabolism (e.g., Thyroid disorders, Diabetes Mellitus, Malignancy)
- •Patients presenting with medical complications of BED
- •The presence of purging or compensatory behaviors
- •Current pregnancy or breastfeeding
研究组 & 干预措施
TAU (Group B)
TAU to be applied over 20 weeks
干预措施: Plasma Ghrelin (Diagnostic Test)
DBT (Group A)
DBT to be applied over 20 weeks
干预措施: DBT (Behavioral)
DBT (Group A)
DBT to be applied over 20 weeks
干预措施: Plasma Ghrelin (Diagnostic Test)
TAU (Group B)
TAU to be applied over 20 weeks
干预措施: TAU (Drug)
结局指标
主要结局
Binge Eating Severity
时间窗: 30 weeks (20 weeks intervention and 10 weeks follow up)
measure the change in BED severity using binge eating scale, with range of scores from 0 to 46. A score of 17 is a cut-off for mild or no binge eating, while 27 or more represents severe binge eating
Emotion regulation
时间窗: 30 weeks (20 weeks intervention and 10 weeks follow up)
measure the change in emotion regulation using Difficulties in Emotion Regulation Scale. Higher scores reflect worse emotional regulation
次要结局
- Plasma Ghrelin Level(20 weeks)