Profiling the Dynamic of Binge Eating Disorder (BED): a Longitudinal Study Examining the Influence of Emotion Regulation, Executive Function, Eating Pattern on BED and Outcome (PRODY-BED)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Binge eating episodes FU6m
研究概览
简要总结
The goal of this observational study is to explore if different and specific profiles can be identified in adults with binge eating disorder (BED) depending on their additional eating pathology, emotion regulation and executive functions. The main questions it aims to answer are:
- Is there different and specific subgroups of patients with BED according to baseline profiles in emotion regulation, executive function and additional eating pathology (including restriction, chaotic eating, grazing and eating on external cues)?
- Are subgroups of individuals with BED (based on identified profiles) associated with outcome at end of treatment and follow-up?
- What is the trajectories in remission rates of specific symptom dimensions (eating disorder pathology, emotion regulation, executive function, and depressive symptoms) in individuals with BED and is there specific trajectory profiles in these dimensions?
- Is early changes in specific symptom dimensions (eating pathology, emotion regulation, executive function, or depression) associated with outcome of BED? Participants will be asked to fill in questionnaires before treatment as usual, 10 weeks into treatment, at end of treatment and at 6- and 12-month follow-up.
详细描述
Binge eating disorder (BED) is a severe eating disorder characterized by recurrent episodes of binge eating, where control over eating is lost and huge amounts of food are eaten within a short period of time. Hence, weight issues are often inevitable and overweight is common, as are social, mental as well as physical problems.
The etiology of binge eating disorder is an interplay of neurobiological and environmental factors. Overall pathological eating, including grazing, external, emotional or restrictive eating, is associated with binge eating, and so is dysregulation in the reward center, impairment of executive functions and emotion regulation. The investigators suggest that it is possible to identify specific profiles driving binge eating, depending on the severity of these dimensions, and that these profiles might predict the outcome of treatment. The investigators also suggest that early change in general eating pattern, emotion regulation, and depressive symptoms is associated with binge eating outcome. These assumptions will be tested in a sample of adults in treatment for BED at one of three sites using questionnaires before, during and after treatment, incl. 6- and 12-month follow-ups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •diagnosed with Binge eating Disorder,
- •and offered treatment at on of the inclusion sites.
排除标准
- •Severe psychiatric comorbidity (e.g. psychosis, severe developmental disorder, severe cogntive impairement)
结局指标
主要结局
Binge eating episodes FU6m
时间窗: At 6-month follow-up
Number of binge eating episodes
Subgroups of BED-profiles
时间窗: Baseline data
Subgroups of BED-profiles depending on degree and type of additional eating pathology measured by DEBQ (Dutch Eating Behaviour Questionnaire), emotion regulation problems measured by DERS-16 (Difficulties in Emotion Regulation Scale), and executive problems mesured by BRIEF-A .
Binge eating episodes EoT
时间窗: At end of therapy up to 30 weeks
Number of binge eating episodes
Binge eating episodes FU12m
时间窗: At 12-month follow-up
Number of binge eating episodes
次要结局
- Eating disorder pathology(At 12-month follow-up)
- Functional impairment(At 12-month follow-up)
- Well-being(At 12-month follow-up)
- Trajectories of binge eating(From baseline to 12-month follow-up)
- Trajectories of restrictive eating(From baseline to 12-month follow-up)
- Trajectories of emotional eating(From baseline to 12-month follow-up)
- Trajectories of eating on external cues(From baseline to 12-month follow-up)
- Trajectories of grazing(From baseline to 12-month follow-up)
- Trajectories of emotional regulation(From baseline to 12-month follow-up)
- Trajectories of executive function(From baseline to 12-month follow-up)
- Trajectories of depression(From baseline to 12-month follow-up)
研究者
Loa Clausen
Senior Researcher
Aarhus University Hospital