Bulimia nervosa, binge-eating disorder, and atypical forms according to ICD-11
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Presence of at least three objective BE episodes within the past three months, accompanied by clinically significant distress and/or relevant impairment in psychosocial functioning due to the BE episodes, assessed via a clinical interview (EDE-II) - Presence of a transdiagnostic binge eating–related disorder (bulimia nervosa [BN], binge eating disorder [BED]) or atypical forms of low frequency and/or limited duration according to ICD-11 criteria, assessed via a clinical interview (EDE-II) - Access to a webcam, microphone, and a stable internet connection - Sufficient proficiency in German - Residence in Germany - Informed consent from participants and—if participants are under 18 years of age—additional consent from their legal guardians (usually both parents)
Exclusion criteria
Exclusion criteria: - Anorexia nervosa - Acute risk of harm to self and/or others - Severe psychopathological symptoms beyond eating disorder pathology (e.g., severe depressive episode, acute suicidality, psychotic disorder, substance use disorder, dissociative disorders, pronounced non-suicidal self-injury [NSSI], previously diagnosed borderline personality disorder, or previously diagnosed complex post-traumatic stress disorder). Mild to moderate comorbidities do not lead to exclusion as long as eating disorder pathology represents the primary condition. - Indication for inpatient treatment - Current eating disorder–specific interventions within a concurrently ongoing outpatient psychotherapy - Use of medication aimed at influencing hunger, satiety, or weight regulation, or at reducing binge eating. Other medications must have been taken at a stable dosage for at least two weeks prior to randomization. - Changes in eating behavior and body weight that are due exclusively to physical or organic causes - Inability of participants to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the frequency of binge eating (BE) episodes within the past 28 days based on ICD-11 criteria, assessed via a clinical interview (Eating Disorder Examination, EDE-II) four weeks after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the frequency of BE episodes within the past 28 days at the 3- and 6-month follow-up (EDE-II); change in the frequency of BE episodes within the past week, assessed with the Weekly Binges Questionnaire (WBQ); change in current food craving and perceived loss of control (LOC), assessed using visual analogue scales (VAS); change in binge episode size, reported as the proportion of BE episodes within the past 28 days rated as “small,” “medium,” or “large,” assessed with the Binge Size Assessment Tool (B-SAT); change in daily caloric intake, determined based on self-recorded logs of all meals and snacks consumed on the respective day; change in eating disorder psychopathology, assessed with the Eating Disorder Examination Questionnaire (EDE-Q-II); change in muscularity-oriented eating behavior, assessed with the Muscularity-Oriented Eating Test (MOET); change in abstinence from BE episodes within the past 28 days; determination of clinically meaningful change based on response and remission rates; change in body weight and BMI percentile—and for participants over 18 years of age, BMI—measured by a pediatrician or general practitioner using a calibrated medical scale or based on self-report; change in general psychopathology, assessed with the short form of the Pediatric Symptom Checklist–Youth (PSC-Y-17); change in the severity of depressive symptoms, assessed with the Patient Health Questionnaire–Adolescent Version (PHQ-A); change in health-related quality of life, assessed with the KIDSCREEN-10 Index. | — |
Countries
Germany