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

NCT ID: NCT03717493

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-17
• Study Completion Date: 2017-11-01

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.

Conditions

Binge-Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Affect Regulation Training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

University of Freiburg

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Friedrich-Alexander-Universität Erlangen-Nürnberg

OTHER

Sponsor Role: lead

Responsible Party

Matthias Berking, Ph.D.

Head of department of clinical psychology, principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BE4510/1-5

Identifier Type: -

Identifier Source: org_study_id