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Clinical Trials/NCT03717493
NCT03717493
Completed
Phase 2

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

Friedrich-Alexander-Universität Erlangen-Nürnberg0 sites99 target enrollmentDecember 17, 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Binge-Eating Disorder
Sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
Enrollment
99
Primary Endpoint
Number of binges
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 17, 2012
End Date
November 1, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthias Berking, Ph.D.

Head of department of clinical psychology, principle investigator

University of Erlangen-Nürnberg

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Number of binges

Time Frame: past 28 days

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

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