Clinical trial NCT03717493: Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder
Official title: Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Binge-Eating Disorder
Keywords: Binge-Eating Disorder
Affect Regulation Training
Emotion Regulation
Transdiagnostic
Lead sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: University of Freiburg
name: University Hospital Tuebingen
First posted: 2018-10-24
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized controlled trial; group x time
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of binges
timeFrame: past 28 days
Secondary outcomes:
Other outcomes:
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