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

NCT ID: NCT06759402

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anorexia Nervosa Anorexia in Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicentred, longitudinal, randomized controlled non-inferiority trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FBT

family-based therapy as a stepped care model using telemedicine

Group Type EXPERIMENTAL

Family based treatment

Intervention Type BEHAVIORAL

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.

IMT

inpatient multimodal therapy

Group Type ACTIVE_COMPARATOR

Inpatient multimodal therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bielefeld University

OTHER

Sponsor Role collaborator

Techniker Krankenkasse

OTHER

Sponsor Role collaborator

BARMER

OTHER

Sponsor Role collaborator

AOK Niedersachsen

UNKNOWN

Sponsor Role collaborator

Mobil Krankenkasse

UNKNOWN

Sponsor Role collaborator

Meine Krankenkasse

UNKNOWN

Sponsor Role collaborator

Medicalnetworks CJ GmbH & Co.KG

UNKNOWN

Sponsor Role collaborator

AOK Baden-Württemberg

INDUSTRY

Sponsor Role collaborator

DAK Gesundheit

OTHER

Sponsor Role collaborator

BIG-direkt

UNKNOWN

Sponsor Role collaborator

mhplus

UNKNOWN

Sponsor Role collaborator

Bahn-BKK

UNKNOWN

Sponsor Role collaborator

OFFIS - Institut für Informatik

UNKNOWN

Sponsor Role collaborator

Prof. Daniel Le Grange, UCSF

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med Christoph Correll

Clinic Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph U Correll, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité- Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Verena K. Haas, Dr. oec. troph.

Role: CONTACT

+4930 450 566 399

Piet E. Adler, M.Sc.

Role: CONTACT

+4930 450 566 597

Facility Contacts

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Verena K. Haas, Dr. oec. troph.

Role: primary

+4930 450 566 399

Piet E. Adler, M.Sc.

Role: backup

+4930 450 566 597

References

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Krautter, Tonja, and James Lock. "Is manualized family-based treatment for adolescent anorexia nervosa acceptable to patients? Patient satisfaction at the end of treatment." Journal of Family Therapy 26.1 (2004): 66-82.

Reference Type BACKGROUND

Lindstedt K, Forss E, Elwin M, Kjellin L, Gustafsson SA. Adolescents with full or subthreshold anorexia nervosa in a naturalistic sample: treatment interventions and patient satisfaction. Child Adolesc Psychiatry Ment Health. 2020 May 2;14:16. doi: 10.1186/s13034-020-00323-9. eCollection 2020.

Reference Type BACKGROUND
PMID: 32391079 (View on PubMed)

Haas V, Wechsung K, Kaiser V, Schmidt J, Raile K, Busjahn A, Le Grange D, Correll CU. Comparing family-based treatment with inpatient treatment in youth with anorexia nervosa eligible for hospitalization: A 12-month feasibility study. Int J Eat Disord. 2024 Feb;57(2):388-399. doi: 10.1002/eat.24098. Epub 2023 Dec 11.

Reference Type BACKGROUND
PMID: 38082440 (View on PubMed)

Other Identifiers

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EA2/114/24

Identifier Type: -

Identifier Source: org_study_id

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