Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder (ER-BED)
|ClinicalTrials.gov Identifier: NCT03717493|
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : August 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Binge-Eating Disorder||Behavioral: Affect Regulation Training||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|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|
|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|
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.
- 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)