Profiling the Dynamic of Binge Eating Disorder (PRODY-BED)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment as usual, Psychotherapy.
- Who it may be relevant to
- Registry conditions: Binge-Eating Disorder, Emotion Regulation, Executive Dysfunction, Eating Behavior. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Profiling the Dynamic of Binge Eating Disorder (BED): a Longitudinal Study Examining the Influence of Emotion Regulation, Executive Function, Eating Pattern on BED and Outcome (PRODY-BED)
Overview
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.
Detailed description
Binge eating disorder (BED) is a severe eating disorder characterized by recurrent episodes of binge eating, where control over eating is lost and huge amounts of food are eaten within a short period of time. Hence, weight issues are often inevitable and overweight is common, as are social, mental as well as physical problems.
The etiology of binge eating disorder is an interplay of neurobiological and environmental factors. Overall pathological eating, including grazing, external, emotional or restrictive eating, is associated with binge eating, and so is dysregulation in the reward center, impairment of executive functions and emotion regulation. The investigators suggest that it is possible to identify specific profiles driving binge eating, depending on the severity of these dimensions, and that these profiles might predict the outcome of treatment. The investigators also suggest that early change in general eating pattern, emotion regulation, and depressive symptoms is associated with binge eating outcome. These assumptions will be tested in a sample of adults in treatment for BED at one of three sites using questionnaires before, during and after treatment, incl. 6- and 12-month follow-ups.
Interventions
- Other Treatment as usual, Psychotherapy
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
Primary outcome measures
- Subgroups of BED-profiles [Time frame: Baseline data]
- Binge eating episodes EoT [Time frame: At end of therapy up to 30 weeks]
- Binge eating episodes FU6m [Time frame: At 6-month follow-up]
- Binge eating episodes FU12m [Time frame: At 12-month follow-up]
Secondary outcome measures (12)
- Eating disorder pathology [Time frame: At end of treatment up to 30 weeks]
- Eating disorder pathology [Time frame: At 6-month follow-up]
- Eating disorder pathology [Time frame: At 12-month follow-up]
- Functional impairment [Time frame: At end of treatment up to 30 weeks]
- Functional impairment [Time frame: At 6-month follow-up]
- Functional impairment [Time frame: At 12-month follow-up]
- Well-being [Time frame: At end of treatment up to 30 weeks]
- Well-being [Time frame: At 6-month follow-up]
- Well-being [Time frame: At 12-month follow-up]
- Trajectories of binge eating [Time frame: From baseline to 12-month follow-up]
- Trajectories of restrictive eating [Time frame: From baseline to 12-month follow-up]
- Trajectories of emotional eating [Time frame: From baseline to 12-month follow-up]
Eligibility criteria
Inclusion criteria
- Age 18+,
- diagnosed with Binge eating Disorder,
- and offered treatment at on of the inclusion sites.
Exclusion criteria
- Severe psychiatric comorbidity (e.g. psychosis, severe developmental disorder, severe cogntive impairement)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 3 centers
- Aarhus University Hospital, Psychiaty — Aarhus
- Aalborg University Hospital — Aalborg
- Kompetencecenter — Copenhagen NV
Identifiers
NCT: NCT05726721 · PRODY-BED