Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder
Condition: Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Affect Regulation Training
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Randomized controlled trial; group x time
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Binge-Eating Disorder; Affect Regulation Training; Emotion Regulation; Transdiagnostic