F50
Conditions
Interventions
Group 1: Intervention group: 12-week access to “eatappie” (a CE-certified psychotherapy app for self-use)
Accompanying parent survey (voluntary)
Group 2: Waiting-list control group: passive control gr
Sponsors
Mind Generation GmbH
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Consent: • Participation by adolescents requires the consent of their legal guardians. Legal guardians must be capable of giving consent and have sufficient knowledge of German to understand the study information for parents and the privacy policy for parents. • Adolescents who are legally competent, have sufficient knowledge of German to understand the study conditions and privacy information, and who, after receiving comprehensive information, agree to participate in the study and consent to the use of their data, may participate in the study. Confirmation of these criteria is provided through a self-declaration. The study information and privacy policy are written in plain language so that they are suitable for both younger adolescents aged 12 and older adolescents aged 17. 2. The adolescents must meet the diagnostic criteria for one of the following disorders according to ICD-10: • F50.00 Anorexia nervosa • F50.01 Anorexia nervosa, active type • F50.08 Other and unspecified anorexia nervosa • F50.1 Atypical Anorexia Nervosa • F50.2 Bulimia Nervosa • F50.3 Atypical Bulimia Nervosa 3. The adolescents must have access to a smartphone with at least temporary internet access during the study phase. 5. At the start of the study, the adolescents must not be undergoing psychotherapy for their eating disorder. Confirmation of the following statement is required: “I am not currently undergoing psychotherapy for my eating disorder.” 6. To complete the diagnostic assessment, the adolescents need internet access and a valid email address.
Exclusion criteria
Exclusion criteria: • Acute suicidal ideation • Current severe depressive episode (F32.2, F32.3) • Mania (F30) • Body Mass Index below the 3rd percentile for age and biological sex • Intellectual disability (ICD-10: F70-F79) • Other eating disorders (F50.4; F50.5; F50.8) • Schizophrenia, schizotypal, or delusional disorders (F20-F29) • Somatic comorbidity requiring a specific dietary regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in eating disorder-specific psychopathology: measured at T0 (baseline, prior to randomization), T1 (post-intervention after 12 weeks or after the waiting period), and T2 (follow-up after 6 weeks; intervention group only) in a group comparison between the intervention group and the waiting list control group using the EDE-Q (Eating Disorder Examination Questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in body weight or physical stability: measured at T-1 (inclusion), T0 (baseline), T1 (post-intervention), and T2 (6-week follow-up; intervention group only) using BMI percentiles. 2) Change in health-related quality of life: measured at T0, T1, and T2 using the KIDSCREEN-27 (questionnaire on health-related quality of life in children and adolescents). 3) Use of medical services (e.g., hospital stays, unplanned doctor visits): measured at T1 and T2 (intervention group only) using a study-specific questionnaire (self-report). 4) Change in treatment motivation: measured at T0 and T1 using FEVER (questionnaire to assess readiness for change; based on the University of Rhode Island Change Assessment, URICA). Exploratory endpoints: 5) Changes in parents’ assessment of their adolescent child’s eating disorder symptoms: measured at T0, T1, and T2 (only in the IG) using the chEDE-QP (Child Eating Disorder Examination-Questionnaire - Parent) 6) Frequency and severity of negative effects after completion of treatment: measured at T1 (only in the intervention group) using the NEQ (Negative Effects Questionnaire). 7) Adherence/use of the intervention: recorded continuously during the intervention period based on app usage metadata (e.g., logins, duration of use, progress in completing tasks). | — |
Countries
Germany
Contacts
Public ContactDaniela Hagmann
Universitätsklinik für Psychiatrie und Psychotherapie Abteilung Psychiatrie, Psychosomatik und Psychotherapie im Kindes- und Jugendalter
Outcome results
None listed