Profiling the Dynamic of Binge Eating Disorder (PRODY-BED)

NCT05726721 | Recruiting

• 1 other identifier: PRODY-BED
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this observational study is to explore if different and specific profiles can be identified in adults with binge eating disorder (BED) depending on their additional eating pathology, emotion regulation and executive functions. The main questions it aims to answer are:

• Is there different and specific subgroups of patients with BED according to baseline profiles in emotion regulation, executive function and additional eating pathology (including restriction, chaotic eating, grazing and eating on external cues)?
• Are subgroups of individuals with BED (based on identified profiles) associated with outcome at end of treatment and follow-up?
• What is the trajectories in remission rates of specific symptom dimensions (eating disorder pathology, emotion regulation, executive function, and depressive symptoms) in individuals with BED and is there specific trajectory profiles in these dimensions?
• Is early changes in specific symptom dimensions (eating pathology, emotion regulation, executive function, or depression) associated with outcome of BED? Participants will be asked to fill in questionnaires before treatment as usual, 10 weeks into treatment, at end of treatment and at 6- and 12-month follow-up.

Conditions

Binge-Eating Disorder; Emotion Regulation; Executive Dysfunction; Eating Behavior; Depressive Symptoms

Keywords

psychotherapy; Adults; binge eating disorder; emotion regulation; executive function

Outcome Measures

Primary Outcomes (4)

• Subgroups of BED-profiles

  Subgroups of BED-profiles depending on degree and type of additional eating pathology measured by DEBQ (Dutch Eating Behaviour Questionnaire), emotion regulation problems measured by DERS-16 (Difficulties in Emotion Regulation Scale), and executive problems mesured by BRIEF-A .

  Baseline data

• Binge eating episodes EoT

  Number of binge eating episodes

  At end of therapy up to 30 weeks

• Binge eating episodes FU6m

  Number of binge eating episodes

  At 6-month follow-up

• Binge eating episodes FU12m

  Number of binge eating episodes

  At 12-month follow-up

Secondary Outcomes (17)

• Eating disorder pathology

  At end of treatment up to 30 weeks

• Eating disorder pathology

  At 6-month follow-up

• Eating disorder pathology

  At 12-month follow-up

• Functional impairment

  At end of treatment up to 30 weeks

• Functional impairment

  At 6-month follow-up

Interventions

Treatment as usual, Psychotherapy OTHER

The three treament sites will offer psychotherapy as usual. All including elements of cognitive behavioral therapy and some sites also additional elements from either narrative therapy or interpersonal therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged 18+ years diagnosed with BED, accepted for treatment at one of the three sites, and accepting participation.

You may qualify if:

• Age 18+,
• diagnosed with Binge eating Disorder,

You may not qualify if:

• Severe psychiatric comorbidity (e.g. psychosis, severe developmental disorder, severe cogntive impairement)

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Aalborg University Hospital: collaborator
• Kompetencecenter for Spiseforstyrrelser: collaborator

Study Sites (3)

Aarhus University Hospital, Psychiaty

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, 9000, Denmark

NOT YET RECRUITING

Kompetencecenter

Copenhagen NV, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Binge-Eating Disorder; Emotional Regulation; Feeding Behavior; Depression

Interventions

Therapeutics; Psychotherapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior; Behavior, Animal; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Loa Clausen, PhD

  Aarhus University Hospital, Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loa Clausen, PhD

CONTACT

+4529119734; loaclaus@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: February 14, 2023
• Study Start: July 3, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)