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Clinical Trials in Germany / NCT06759402
Recruiting Not applicable

Family-based Telemedicine vs. Inpatient Anorexia Nervosa Treatment (FIAT)

NCT06759402 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2025-01-31
Last updated
2025-02-13

Condition(s) studied

Anorexia NervosaAnorexia in Adolescence

Investigational drug(s) / intervention(s)

Family based treatmentInpatient multimodal therapy

Family based treatment: FBT is an intensive, manualized therapy in which the parents of those affected are closely involved in a resource-oriented manner by FBT-certified therapists. FBT takes place in 3 phases: in phase 1, the parents take responsibility for their child's weight gain. Phase 2 involves the gradual transfer of responsibility for eating back to the patient. Phase 3 focuses on individual issues of the children and adolescents, e.g. catching up on important developmental steps missed due to the illness.

Inpatient multimodal therapy: comprehensive, patient-oriented and multidisciplinary approach to address eating disorders following the S3 joint German treatment guidelines in specialized hospitals. Includes individual psychotherapy, family sessions, body-oriented therapy, nutritional counseling, group therapy sessions, relaxation techniques, mindfulness practices, and skills training. Targeted weight gain per week is at least 500g.

Study 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

Sex
ALL
Min age
8 Years
Max age
17 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Charité- Universitätsmedizin Berlin Berlin State of Berlin Recruiting

More Charite University, Berlin, Germany trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06759402 on ClinicalTrials.gov ↗ ← All trials in Germany