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

Binge-Eating Disorder Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717493
• Other study ID #: BE4510/1-5
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 17, 2012
• Est. completion date: November 1, 2017

Study information

• Verified date: August 2020
• Source: Friedrich-Alexander-Universität Erlange-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: November 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Friedrich-Alexander-Universität Erlange-Nürnberg	German Research Foundation, University Hospital Tuebingen, University of Freiburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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