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

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ClinicalTrials.gov Identifier: NCT03717493
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborators:
German Research Foundation
University of Freiburg
University Hospital Tuebingen
Information provided by (Responsible Party):
Prof. Dr. Matthias Berking, University of Erlangen-Nürnberg

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Randomized 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 : December 17, 2012
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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.



Primary Outcome Measures :
  1. Number of binges [ Time Frame: past 28 days ]
    Number of binges as assessed in the Eating Disorder Examination Interview (EDE; Fairburn & Cooper, 1993; German version: Hilbert & Tuschen-Caffier, 2006)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients were asked to report their gender.
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Prof. Dr. Matthias Berking, Head of department of clinical psychology, principle investigator, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT03717493     History of Changes
Other Study ID Numbers: BE4510/1-5
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified IPD will be made available upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: From October 2018 to October 2028
Access Criteria: Credible reason for request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Matthias Berking, University of Erlangen-Nürnberg:
Binge-Eating Disorder
Affect Regulation Training
Emotion Regulation
Transdiagnostic
Additional relevant MeSH terms:
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Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms