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

NCT06759402 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-02-13

No results posted yet for this 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.

Conditions

  • Anorexia Nervosa
  • Anorexia in Adolescence

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Bielefeld University

    collaborator OTHER
  • Techniker Krankenkasse

    collaborator OTHER
  • BARMER

    collaborator OTHER
  • AOK Niedersachsen

    collaborator UNKNOWN
  • Mobil Krankenkasse

    collaborator UNKNOWN
  • Meine Krankenkasse

    collaborator UNKNOWN
  • Medicalnetworks CJ GmbH & Co.KG

    collaborator UNKNOWN
  • AOK Baden-Württemberg

    collaborator INDUSTRY
  • DAK Gesundheit

    collaborator OTHER
  • BIG-direkt

    collaborator UNKNOWN
  • mhplus

    collaborator UNKNOWN
  • Bahn-BKK

    collaborator UNKNOWN
  • OFFIS - Institut für Informatik

    collaborator UNKNOWN
  • Prof. Daniel Le Grange, UCSF

    collaborator UNKNOWN
  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Christoph U Correll, MD · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06759402 on ClinicalTrials.gov