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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

Tracking Information
First Submitted Date  ICMJE October 22, 2018
First Posted Date  ICMJE October 24, 2018
Last Update Posted Date October 29, 2018
Actual Study Start Date  ICMJE December 17, 2012
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder
Official Title  ICMJE Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Binge-Eating Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Affect Regulation Training
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2018)
99
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1, 2017
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Patients were asked to report their gender.
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03717493
Other Study ID Numbers  ICMJE BE4510/1-5
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified IPD will be made available upon request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: From October 2018 to October 2028
Access Criteria: Credible reason for request
Responsible Party Prof. Dr. Matthias Berking, University of Erlangen-Nürnberg
Study Sponsor  ICMJE Friedrich-Alexander-Universität Erlange-Nürnberg
Collaborators  ICMJE
  • German Research Foundation
  • University of Freiburg
  • University Hospital Tuebingen
Investigators  ICMJE Not Provided
PRS Account Friedrich-Alexander-Universität Erlange-Nürnberg
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP