Trials / Recruiting
RecruitingNCT06759402
Family-based Telemedicine vs. Inpatient Anorexia Nervosa Treatment (FIAT)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Charite University, Berlin, Germany · Academic / Other
- Sex
- All
- Age
- 8 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-01-31
- Primary completion
- 2027-03-31
- Completion
- 2027-12-31
- First posted
- 2025-01-06
- Last updated
- 2025-02-13
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06759402. Inclusion in this directory is not an endorsement.