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

Phase 2

Completed

• Conditions: Binge-Eating Disorder
• Interventions: Behavioral: Affect Regulation Training

• Registration Number: NCT03717493
• Lead Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg

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.

Study Timeline

• Study Start: 2012-12-17
• Primary Completion: 2017-05-01
• Study Completion: 2017-11-01
• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Affect Regulation Training (ART)	Affect Regulation Training	Affect Regulation Training (ART; Berking \& Whitley, 2014) is a transdiagnostic, group-based intervention aiming to enhance general affect regulation skills in individuals who meet criteria for mental disorders or are at-risk of developing mental-health problems.

Primary Outcome Measures

Name	Time	Method
Number of binges	past 28 days	Number of binges as assessed in the Eating Disorder Examination Interview (EDE; Fairburn \& Cooper, 1993; German version: Hilbert \& Tuschen-Caffier, 2006)