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

Friedrich-Alexander-Universität Erlangen-Nürnberg

Status and phase: Completed; Phase 3; Phase 2

Conditions: Binge-Eating Disorder

Treatments: Behavioral: Affect Regulation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03717493

BE4510/1-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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99 participants in 2 patient groups

Affect Regulation Training (ART)

Experimental group

Description:

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.

Treatment:

Behavioral: Affect Regulation Training

Waitlist Control Condition (WLC)

No Intervention group

Description:

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.