NCT06759402

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

December 9, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

January 31, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

December 9, 2024

Last Update Submit

February 11, 2025

Conditions

Anorexia NervosaAnorexia in Adolescence

Keywords

PsychotherapyFamily Based TreatmentRCTInpatient Treatment

Outcome Measures

Primary Outcomes (1)

  • Change in %mBMI

    The %mBMI is calcualted based on bodyweight and height, measured by the study team. Change is the difference between the baseline and 12 month %mBMI.

    12 months

Secondary Outcomes (17)

  • Specific psychopathology for anorexia nervosa

    At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.

  • Compulsive exercise

    At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.

  • Depression

    At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.

  • Occurrence of adverse events

    At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.

  • Menstrual status

    At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.

  • +12 more secondary outcomes

Study Arms (2)

FBT

EXPERIMENTAL

family-based therapy as a stepped care model using telemedicine

Behavioral: Family based treatment

IMT

ACTIVE COMPARATOR

inpatient multimodal therapy

Behavioral: Inpatient multimodal therapy

Interventions

Family based treatmentBEHAVIORAL

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.

FBT
Inpatient multimodal therapyBEHAVIORAL

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.

IMT

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité- Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

RECRUITING

Related Publications (3)

  • 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.

    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.

    PMID: 32391079BACKGROUND

  • 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.

    PMID: 38082440BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Christoph U Correll, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Verena K. Haas, Dr. oec. troph.

CONTACT

+4930 450 566 399verena.haas@charite.de

Piet E. Adler, M.Sc.

CONTACT

+4930 450 566 597piet.adler@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: multicentred, longitudinal, randomized controlled non-inferiority trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinic Director

Study Record Dates

First Submitted

December 9, 2024

First Posted

January 6, 2025

Study Start

January 31, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)