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

Charité University Medicine Berlin

Status: Enrolling

Conditions: Anorexia in Adolescence; Anorexia Nervosa

Treatments: Behavioral: Family based treatment; Behavioral: Inpatient multimodal therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06759402

EA2/114/24

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

FBT

Experimental group

Description:

family-based therapy as a stepped care model using telemedicine

Treatment:

Behavioral: Family based treatment

IMT

Active Comparator group

Description:

inpatient multimodal therapy

Treatment:

Behavioral: Inpatient multimodal therapy