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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717493
Acronym
ER-BED
Enrollment
99
Registered
2018-10-24
Start date
2012-12-17
Completion date
2017-11-01
Last updated
2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge-Eating Disorder

Keywords

Binge-Eating Disorder, Affect Regulation Training, Emotion Regulation, Transdiagnostic

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.

Interventions

Following the guidelines for the 6-week intensive ART format, we scheduled one 180-minutes session per week (each consisting of two modules à 90min) for a period of six subsequent weeks. Training groups included four to eight participants. The implementation of ART followed standardized treatment protocols (Berking & Whitley, 2014). ART was delivered by doctoral candidates (DCs) in clinical psychology who had completed or were in advanced stages of their clinical training. All therapists had been intensely trained and received weekly supervision from experienced ART trainers. To control adherence a random sample of 5% of all sessions was be videotaped and will be rated with regard to adherence.

Sponsors

German Research Foundation
CollaboratorOTHER
University of Freiburg
CollaboratorOTHER
University Hospital Tuebingen
CollaboratorOTHER
Friedrich-Alexander-Universität Erlangen-Nürnberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessors were blinded with regard to study condition

Intervention model description

Randomized controlled trial; group x time

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of bingespast 28 daysNumber of binges as assessed in the Eating Disorder Examination Interview (EDE; Fairburn & Cooper, 1993; German version: Hilbert & Tuschen-Caffier, 2006)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026