Clinical trial NCT05726721: Profiling the Dynamic of Binge Eating Disorder (PRODY-BED)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Binge-Eating Disorder
Emotion Regulation
Executive Dysfunction
Eating Behavior
Depressive Symptoms
Keywords: psychotherapy
Adults
binge eating disorder
emotion regulation
executive function
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Kompetencecenter for Spiseforstyrrelser
First posted: 2023-02-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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)

Primary outcomes:
measure: Subgroups of BED-profiles
timeFrame: Baseline data
measure: Binge eating episodes EoT
timeFrame: At end of therapy up to 30 weeks
measure: Binge eating episodes FU6m
timeFrame: At 6-month follow-up
measure: Binge eating episodes FU12m
timeFrame: At 12-month follow-up
Secondary outcomes:
measure: Eating disorder pathology
timeFrame: At end of treatment up to 30 weeks
measure: Eating disorder pathology
timeFrame: At 6-month follow-up
measure: Eating disorder pathology
timeFrame: At 12-month follow-up
measure: Functional impairment
timeFrame: At end of treatment up to 30 weeks
measure: Functional impairment
timeFrame: At 6-month follow-up
measure: Functional impairment
timeFrame: At 12-month follow-up
measure: Well-being
timeFrame: At end of treatment up to 30 weeks
measure: Well-being
timeFrame: At 6-month follow-up
measure: Well-being
timeFrame: At 12-month follow-up
measure: Trajectories of binge eating
timeFrame: From baseline to 12-month follow-up
measure: Trajectories of restrictive eating
timeFrame: From baseline to 12-month follow-up
measure: Trajectories of emotional eating
timeFrame: From baseline to 12-month follow-up
measure: Trajectories of eating on external cues
timeFrame: From baseline to 12-month follow-up
measure: Trajectories of grazing
timeFrame: From baseline to 12-month follow-up
measure: Trajectories of emotional regulation
timeFrame: From baseline to 12-month follow-up
measure: Trajectories of executive function
timeFrame: From baseline to 12-month follow-up
measure: Trajectories of depression
timeFrame: From baseline to 12-month follow-up
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Psychiaty
state: Central Denmark Region
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen NV
country: Denmark
facility: Kompetencecenter
Study officials:
affiliation: Aarhus University Hospital, Psychiatry
name: Loa Clausen, PhD
role: PRINCIPAL_INVESTIGATOR
References: