RecruitingNot ApplicableNCT06759402

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


Sponsor

Charite University, Berlin, Germany

Enrollment

200 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 17 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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

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Interventions

BEHAVIORALFamily 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.

BEHAVIORALInpatient 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.


Locations(1)

Charité- Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

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NCT06759402


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