Actively Recruiting

Phase Not Applicable
Age: 8Years - 17Years
All Genders
ID06759402

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

Led by Charite University, Berlin, Germany · Updated on 2025-02-13

200

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

B

Bielefeld University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are comparing two treatments for adolescents with anorexia nervosa to see which is more effective and cost-efficient. The study focuses on family-based treatment delivered through telehealth (FBT) versus inpatient multimodal therapy (IMT) in specialized hospitals. The results aim to influence future guidelines and insurance coverage for these therapies in Germany. The study is funded by the German Ministry of Health and involves multiple hospitals and public health insurance companies. Participants will receive either family-based therapy via telemedicine, where parents play a central role in supporting their child through three phases of treatment, or inpatient multimodal therapy that includes individual and family psychotherapy, nutritional counseling, body-oriented therapy, group sessions, relaxation, mindfulness, and skills training. The inpatient therapy targets a weight gain of at least 500 grams per week. The FBT typically lasts about 10 months, while the inpatient treatment averages 4 months, with follow-up assessments up to 12 months. During the study, participants will be monitored for changes in weight relative to expected body mass index over 12 months. Additional assessments include eating disorder symptoms, compulsive exercise, depression, menstrual status, medication use, motivation for change, illness insight, quality of life, treatment satisfaction, suicidality, and healthcare costs. Evaluations occur at the start, end of treatment, and at 6 and 12 months after baseline. The study involves regular questionnaires and health economic data collection to carefully track outcomes and safety over the year-long period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 8Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of restrictive or bulimic subtypes of anorexia nervosa (ICD-10: F50.00; F50.01)
  • Indication for inpatient treatment according to S3 guideline
  • Weight below the 3rd BMI percentile or weight below the 10th percentile with psychiatric comorbidity, rapid weight loss, or lack of weight gain during outpatient treatment over the last three months
  • Planned inpatient treatment
  • Insured with one of the participating health insurance companies
  • Stable internet connection
Not Eligible

You will not qualify if you...

  • Weight below 67% of median BMI
  • 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 a health insurance company not participating in the study
  • Judicial placement order for inpatient treatment
  • Known current child protection issues or family court proceedings

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for screening and enrollment

Outpatient Treatment

Duration - Approximately 10 months

Participants receive family-based treatment (FBT) via telemedicine, involving three phases focusing on parental responsibility and gradual transfer to the patient for eating behaviors and individual developmental issues.

Regular telemedicine sessions as scheduled by therapists

Inpatient Treatment

Duration - Approximately 4 months

Participants undergo inpatient multimodal therapy including individual psychotherapy, family sessions, body-oriented therapy, nutritional counseling, group therapy, relaxation techniques, mindfulness, and skills training aiming for targeted weight gain.

Multiple visits daily as part of inpatient care

Follow-up Monitoring

Duration - Up to 12 months from baseline

Participants are monitored up to 12 months from baseline for changes in health status, psychological outcomes, and quality of life after treatment completion.

Assessment visits at 6 months and 12 months after baseline

Trial Site Locations

Total: 1 location

1

Charité- Universitätsmedizin Berlin

Berlin, State of Berlin, Germany, 13353

Actively Recruiting

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Research Team

V

Verena K. Haas, Dr. oec. troph.

P

Piet E. Adler, M.Sc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Adolescents with full or subthreshold anorexia nervosa in a naturalistic sample: treatment interventions and patient satisfaction.

Katarina Lindstedt, Emma Forss, Marie Elwin...

https://pubmed.ncbi.nlm.nih.gov/32391079

Comparing family-based treatment with inpatient treatment in youth with anorexia nervosa eligible for hospitalization: A 12-month feasibility study.

Verena Haas, Katja Wechsung, Vivien Kaiser...

https://pubmed.ncbi.nlm.nih.gov/38082440