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

Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg (Other)

Overall Status

Completed

CT.gov ID

NCT03717493

Collaborator

German Research Foundation (Other), University of Freiburg (Other), University Hospital Tuebingen (Other)

Enrollment

Arms

58.5

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Binge-Eating Disorder	Behavioral: Affect Regulation Training	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Randomized controlled trial; group x timeRandomized controlled trial; group x time

Masking:

Single (Outcomes Assessor)

Masking Description:

Assessors were blinded with regard to study condition

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 17, 2012

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.