Clinical trial NCT06759402: Family-based Telemedicine vs. Inpatient Anorexia Nervosa Treatment (FIAT)
Official title: Family-based Telemedicine vs. Inpatient Anorexia Nervosa Treatment (FIAT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Anorexia in Adolescence
Keywords: Psychotherapy
Family Based Treatment
RCT
Inpatient Treatment
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Bielefeld University
name: Techniker Krankenkasse
name: BARMER
name: AOK Niedersachsen
name: Mobil Krankenkasse
name: Meine Krankenkasse
name: Medicalnetworks CJ GmbH & Co.KG
name: AOK Baden-Württemberg
name: DAK Gesundheit
name: BIG-direkt
name: mhplus
name: Bahn-BKK
name: OFFIS - Institut für Informatik
name: Prof. Daniel Le Grange, UCSF
First posted: 2025-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicentred, longitudinal, randomized controlled non-inferiority trial
Primary purpose: TREATMENT

Brief summary: The FIAT study is funded by the Innovationsfonds of the German Ministry of Health via the DLR Project Management Agency. The study will be conducted in up to 21 hospitals across Germany and in collaboration with 10 German public health insurance companies. The primary aim of this study is to compare Family-Based Treatment delivered via telehealth (FBT) with inpatient multimodal therapy (IMT) with respect to treatment outcomes and health economic data. The results of the study will serve as a basis for the decision on the inclusion of FBT in the German S3 guidelines and the future reimbursement of FBT by public health insurances in Germany.


Eligibility criteria: Inclusion Criteria:

* restrictive and bulimic subtypes of anorexia nervosa (ICD-10: F50.00; F50.01)
* inpatient treatment indication according to S3 guideline
* weight \< 3. BMI-percentile or
* weight \<10. percentile and psychiatric comorbidity/rapid weight loss/lack of weight gain during outpatient treatment over last three month
* planned inpatient treatment
* insured with one of the participating health insurance companies
* stable internet connection

Exclusion Criteria:

* weight \<67%mBMI
* acute self harm or danger to others
* acute psychosis or suicidal tendencies
* current substance abuse
* child abuse or domestic violence in the family
* insured with other health insurance company
* judicial placement order for inpatient treatment
* known, currently existing child protection problems or proceedings by the family court

Primary outcomes:
measure: Change in %mBMI
timeFrame: 12 months
Secondary outcomes:
measure: Specific psychopathology for anorexia nervosa
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Compulsive exercise
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Depression
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Occurrence of adverse events
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Menstrual status
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Medication
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Motivation for change
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Insight into illness
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Change in eating disorder quality of life
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Change in quality of life
timeFrame: 6 months after baseline and 12 months after baseline.
measure: Emotional and financial burden on the legal guardians
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
measure: Financial burden on the legal guardians
timeFrame: 6 months after baseline and 12 months after baseline.
measure: Utilization and costs of healthcare services
timeFrame: 6 months after baseline and 12 months after baseline.
measure: Satisfaction with treatment for patients
timeFrame: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)
measure: Satisfaction with treatment for parents (Likert scale items)
timeFrame: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)
measure: Satisfaction with treatment for parents (Free-text items)
timeFrame: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)
measure: Suicidality
timeFrame: At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité- Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christoph U Correll, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krautter, Tonja, and James Lock. "Is manualized family-based treatment for adolescent anorexia nervosa acceptable to patients? Patient satisfaction at the end of treatment." Journal of Family Therapy 26.1 (2004): 66-82.
citation: Lindstedt K, Forss E, Elwin M, Kjellin L, Gustafsson SA. Adolescents with full or subthreshold anorexia nervosa in a naturalistic sample: treatment interventions and patient satisfaction. Child Adolesc Psychiatry Ment Health. 2020 May 2;14:16. doi: 10.1186/s13034-020-00323-9. eCollection 2020.
citation: Haas V, Wechsung K, Kaiser V, Schmidt J, Raile K, Busjahn A, Le Grange D, Correll CU. Comparing family-based treatment with inpatient treatment in youth with anorexia nervosa eligible for hospitalization: A 12-month feasibility study. Int J Eat Disord. 2024 Feb;57(2):388-399. doi: 10.1002/eat.24098. Epub 2023 Dec 11.