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

NCT03717493 | Completed Phase 2

• 1 other identifier: BE4510/1-5
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Binge-Eating Disorder

Keywords

Binge-Eating Disorder; Affect Regulation Training; Emotion Regulation; Transdiagnostic

Outcome Measures

Primary Outcomes (1)

• Number of binges

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

  past 28 days

Study Arms (2)

Affect Regulation Training (ART)

EXPERIMENTAL

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

Waitlist Control Condition (WLC)

NO INTERVENTION

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.

Interventions

Affect Regulation Training 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.

Affect Regulation Training (ART)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: Patients were asked to report their gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of BED according to DSM-5 criteria
• age over 18 and below 69
• \< BMI \< 45
• ability and willingness to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Friedrich-Alexander-Universität Erlangen-Nürnberg: lead
• German Research Foundation: collaborator
• University of Freiburg: collaborator
• University Hospital Tuebingen: collaborator

MeSH Terms

Conditions

Binge-Eating Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors were blinded with regard to study condition
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical psychology, principle investigator

Model Details: Randomized controlled trial; group x time

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: December 17, 2012
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From October 2018 to October 2028
• Access Criteria: Credible reason for request