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

Primary Purpose

Binge-Eating Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Affect Regulation Training
Sponsored by
Friedrich-Alexander-Universität Erlangen-Nürnberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder focused on measuring Binge-Eating Disorder, Affect Regulation Training, Emotion Regulation, Transdiagnostic

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Affect Regulation Training (ART)

    Waitlist Control Condition (WLC)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of binges
    Number of binges as assessed in the Eating Disorder Examination Interview (EDE; Fairburn & Cooper, 1993; German version: Hilbert & Tuschen-Caffier, 2006)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 22, 2018
    Last Updated
    August 26, 2020
    Sponsor
    Friedrich-Alexander-Universität Erlangen-Nürnberg
    Collaborators
    German Research Foundation, University of Freiburg, University Hospital Tuebingen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03717493
    Brief Title
    Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder
    Acronym
    ER-BED
    Official Title
    Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 17, 2012 (Actual)
    Primary Completion Date
    May 1, 2017 (Actual)
    Study Completion Date
    November 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Friedrich-Alexander-Universität Erlangen-Nürnberg
    Collaborators
    German Research Foundation, University of Freiburg, University Hospital Tuebingen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Binge-Eating Disorder
    Keywords
    Binge-Eating Disorder, Affect Regulation Training, Emotion Regulation, Transdiagnostic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Factorial Assignment
    Model Description
    Randomized controlled trial; group x time
    Masking
    Outcomes Assessor
    Masking Description
    Assessors were blinded with regard to study condition
    Allocation
    Randomized
    Enrollment
    99 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Affect Regulation Training (ART)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Waitlist Control Condition (WLC)
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Affect Regulation Training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of binges
    Description
    Number of binges as assessed in the Eating Disorder Examination Interview (EDE; Fairburn & Cooper, 1993; German version: Hilbert & Tuschen-Caffier, 2006)
    Time Frame
    past 28 days

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Patients were asked to report their gender.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Deidentified IPD will be made available upon request
    IPD Sharing Time Frame
    From October 2018 to October 2028
    IPD Sharing Access Criteria
    Credible reason for request

    Learn more about this trial

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

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