Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder (ER-BED)

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.

Study Overview

• Status: Completed
• Conditions: Binge-Eating Disorder
• Intervention / Treatment: Behavioral: Affect Regulation Training

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Affect Regulation Training (ART); 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.	Behavioral: Affect Regulation Training; 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.
No Intervention: Waitlist Control Condition (WLC); In order to control for the effects of time, we compared changes during ART with changes during WLC. Participants in the WLC condition received no treatment within the study but were offered to participate in ART after completing all assessments.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Collaborators: German Research Foundation; University Hospital Tuebingen; University of Freiburg

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2012
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Emotion Regulation; Transdiagnostic; Binge-Eating Disorder; Affect Regulation Training
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Hyperphagia; Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: BE4510/1-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified IPD will be made available upon request
• IPD Sharing Time Frame: From October 2018 to October 2028
• IPD Sharing Access Criteria: Credible reason for request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No