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临床试验/NCT03717493
NCT03717493已完成2 期

Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder

Friedrich-Alexander-Universität Erlangen-Nürnberg0 个研究点目标入组 99 人开始时间: 2012年12月17日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
99
主要终点
Number of binges

研究概览

简要总结

The effectiveness of a systematic affect regulation training (ART; Berking, 2010) is evaluated with regard to reducing symptoms of binge eating disoder in a randomized controlled trial.

详细描述

Evidence suggests that deficits in affect regulation play an important role in the development and maintenance of binge eating disorder (BED). Thus, we aim to clarify whether BED symptoms can be reduced with the help of a training of general affect regulation skills. For this purpose, we randomly allocated N = 99 individuals meeting criteria for BED either to an affect regulation training (ART) or to a wait list control condition (WLC). Primary outcome is the reduction of binges during the treatment-vs.-waiting period as assessed with the Eating Disorder Examination (EDE) interview. Secondary outcomes include BED symptom severity at follow-up and change in emotion regulation skills. To clarify whether potential differences between groups regarding change in binge eating result from a greater increase of affect regulation skills in ART, we will test whether potential group differences regarding binges will be mediated by differences between groups regarding change in affect regulation skills.

Change of randomization procedure: Over the course of the study, serious difficulties occurred with regard to recruiting participants as quickly as necessary to avoid drop-outs due to participants' unwillingness to wait until eight individuals were recruited for randomization. To solve the problem, we switched from the original block randomization to a procedure in which the next patient eligible for the study was allocated to the treatment condition until the minimum group size of four was reached.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Assessors were blinded with regard to study condition

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of BED according to DSM-5 criteria
  • age over 18 and below 69
  • 25 < BMI < 45
  • ability and willingness to provide informed consent

排除标准

  • high risk of suicide
  • co-occurring psychotic, bipolar disorders, alcohol/substance dependence within the past six months and/or borderline personality disorder
  • medical disorders that would affect weight and/or the ability to participate
  • insufficient German language skills (as assessments and treatment were conducted in German)
  • current participation in psychotherapeutic treatment other than those offered in the study
  • current participation in a weight control program
  • taking medication that would affect weight
  • pregnancy.

结局指标

主要结局

Number of binges

时间窗: past 28 days

Number of binges as assessed in the Eating Disorder Examination Interview (EDE; Fairburn \& Cooper, 1993; German version: Hilbert \& Tuschen-Caffier, 2006)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias Berking, Ph.D.

Head of department of clinical psychology, principle investigator

University of Erlangen-Nürnberg

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