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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18+,

diagnosed with Binge eating Disorder,

and offered treatment at on of the inclusion sites.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Treatment as usual, Psychotherapy

    Other intervention

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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 .

Time frame
Baseline data
2

Binge eating episodes EoT

Number of binge eating episodes

Time frame
At end of therapy up to 30 weeks
3

Binge eating episodes FU6m

Number of binge eating episodes

Time frame
At 6-month follow-up
4

Binge eating episodes FU12m

Number of binge eating episodes

Time frame
At 12-month follow-up

Secondary outcomes

1

Eating disorder pathology

Overall self-reported eating disorder pathology measured by the total score of Eating Disoder Examination Questionnaire (EDE-Q), minimum score 0, maximum score 6, higher scores indicating eating pathology

Time frame
At end of treatment up to 30 weeks
2

Eating disorder pathology

Overall self-reported eating disorder pathology measured by the total score of EDE-Q, minimum score 0, maximum score 6, higher scores indicating eating pathology

Time frame
At 6-month follow-up
3

Eating disorder pathology

Overall self-reported eating disorder pathology measured by the total score of EDE-Q, minimum score 0, maximum score 6, higher scores indicating eating pathology

Time frame
At 12-month follow-up
4

Functional impairment

Self-reported functional impairment measured by the total score of WSAS, minimum score 0, maximum score 8, higher scores indicating more impairment

Time frame
At end of treatment up to 30 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aarhus University Hospital

Lead sponsor

Aalborg University Hospital

Collaborator

Kompetencecenter for Spiseforstyrrelser

Collaborator