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Anorexia NervosaFIATNCT06759402

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

A study testing Family based treatment and Inpatient multimodal therapy in people with Anorexia Nervosa and Anorexia in Adolescence, run by Charite University, Berlin, Germany at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 17 years
Conditions the study is for
Anorexia Nervosa, Anorexia in Adolescence
What is being tested?
Family based treatment and Inpatient multimodal therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteGermany
Study dates
31 Jan 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Verena K. Haas, Dr. oec. troph. contact

+4930 450 566 399

verena.haas@charite.de

Piet E. Adler, M.Sc. contact

+4930 450 566 597

piet.adler@charite.de

Germany1 site, 1 recruiting
  • Charité- Universitätsmedizin Berlin

    Berlin, State of Berlin, 13353

    Verena K. Haas, Dr. oec. troph., +4930 450 566 399, verena.haas@charite.de

    Piet E. Adler, M.Sc., +4930 450 566 597, piet.adler@charite.de

    Recruiting

Other trials in Germany

About this study

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.

Being tested
Family based treatment, Inpatient multimodal therapy
Keywords
Psychotherapy, Family Based Treatment, RCT, Inpatient Treatment
Medical subject headings
Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family based treatmentBehavioural

    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.

  • Inpatient multimodal therapyBehavioural

    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.

Study groups in NCT06759402
Study groupRoleWhat they receive
FBTExperimentalfamily-based therapy as a stepped care model using telemedicine
Receives: Behavioral: Family based treatment
IMTActive comparatorinpatient multimodal therapy
Receives: Behavioral: Inpatient multimodal therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (17)
  1. Specific psychopathology for anorexia nervosa

    Measured by the eating disorder examination-questionnaire (EDE-Q). The scores of the EDE-Q are presented on a scale between 0 and 6, where higher scores mean higher presence of symptoms.

    Measured: 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.

  2. Compulsive exercise

    Measured by the compulsive exercise test (CET). Items are rated on a 6-point Likert type scale from 0 (never true) to 5 (always true), with higher scores correspond with stronger symptoms.

    Measured: 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.

  3. Depression

    Measured by the Revised Children's Anxiety and Depression Scale (RCADS). Scores are presented between 0 (never) to 3 (always). The total score is converted into a T-score. Higher T-scores indicate higher presence of symptoms.

    Measured: 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.

  4. Occurrence of adverse events

    Measured by the modified over aggression scale (MOAS) in addition with a set serious adverse events list. Higher scores on the MOAS indicate more severe cases of aggressive behaviors.

    Measured: 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.

  5. Menstrual status

    Measured by structural interview.

    Measured: 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.

  6. Medication

    Measured by structural interview.

    Measured: 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.

  7. Motivation for change

    Measured by the anorexia nervosa stages of change questionnaire (ANSOCQ). Each item can scored between 1 and 5. Higher scores indicate higher levels of motivation.

    Measured: 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.

  8. Insight into illness

    One item "On a scale of 1 to 10, how severe would you rate yourself as suffering from anorexia?" where a higher score indicates more insight into the illness.

    Measured: 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.

  9. Change in eating disorder quality of life

    Measured by the eating disorder quality of life (EDQOL). Each item can be scored on a 6-point scale ranging from 0 ("never") to 5 ("always"). Higher scores indicate lower quality of life.

    Measured: 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.

  10. Change in quality of life

    Measured by the EQ-5D-Y-5L. Items are scored on 5 levels ("no problems" to "extreme problems") except one, which is scored on a vertical visual analogue scale (endpoints are "the best health you can imagine" and "the worst health you can imagine"). Higher scores indicate more problems.

    Measured: 6 months after baseline and 12 months after baseline.

  11. Emotional and financial burden on the legal guardians

    Measured by the caregiver strain questionnaire (CGSQ-SF11). Items are scored on a 5-point Likert scale (0= not at all, 4= very much). Higher scores indicate greater strain.

    Measured: 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. Financial burden on the legal guardians

    Measured by a structured questionnaire about financial strain during treatment. The first question ("Has your child's treatment put a financial strain on you?") is scored on a 4-point Likert scale (1= not at all; 4= extremely). A higher score indicates greater financial strain. The second question ("Have you had any loss of earnings due to your child's illness?") is binary scored (yes/no) and follows up the "yes" condition with the question "how many days were you not able to work?".

    Measured: 6 months after baseline and 12 months after baseline.

  13. Utilization and costs of healthcare services

    Measured by the Client Service Receipt Inventory (CSRI). Assessing the use of various services in the respective units (e.g., days or hours).

    Measured: 6 months after baseline and 12 months after baseline.

  14. Satisfaction with treatment for patients

    Measured by an adapted version of the treatment satisfaction questionnaire by Lindstedt et al. (2020). The following topics are assessed and scored:

    1. Helpfulness of therapy-elements. Higher scores indicate less helpfulness
    2. Patient-therapist-interaction. Higher scores indicate less positive experiences of interaction.
    3. Treatment goals importance. Higher scores indicate less importance of proposed treatment goals.
    4. Achievement of treatment goals. Higher scores indicate less achievement of proposed treatment goals.
    5. Change in symptoms (before treatment vs. after treatment). Higher scores indicate more positive change in symptoms.

    Measured: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)

  15. Satisfaction with treatment for parents (Likert scale items)

    Measured by an adapted version of the treatment satisfactory questionnaire by Krautter \& Lock (2004). The questions assess the subjective effectiveness of the treatment and treatment satisfaction. Items are scored on all topics on a 5-point Likert scale (0= very ineffective; 4= very effective). Higher scores indicate higher effectiveness. Additionally, the following questions are scored on a 5-point Likert scale (0= not at all; 4= yes, totally) :

    1. "Do you agree that the team that treated your child is competent?"
    2. "Would you recommend this treatment?"

    Measured: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)

  16. Satisfaction with treatment for parents (Free-text items)

    Measured by an adapted version of the treatment satisfactory questionnaire by Krautter \& Lock (2004). The questions assess the subjective effectiveness of the treatment and treatment satisfaction. Two open questions ("What did you find helpful in this treatment?"; "What did you not find helpful in this treatment?") can be answered via free-text.

    Measured: At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months)

  17. Suicidality

    Measured by asking first whether any suicidal thoughts or behaviors were present in the past 28 days (yes/no). The yes condition is followed up by several questions assessing the presence (yes/no) of:

    • passive suicidal thoughts.
    • active suicidal thoughts.
    • active suicidal thoughts with plan.
    • active suicidal thoughts with plan and preparation.
    • active suicidal thoughts with plan and intention to act upon it.
    • suicidal behaviors, stopped by oneself.
    • suicidal behaviors, stopped by others.
    • suicidal behaviors, carried out, light physical damage.
    • suicidal behaviors, carried out, medium physical damage.
    • suicidal behaviors, carried out, severe physical damage.
    • suicidal behaviors, carried out, death.

    Both children and parents are asked. The children answer for their own thoughts/behaviors, the parents for their child's thoughts/behaviors.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start31 Jan 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicentred, longitudinal, randomized controlled non-inferiority trial
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06759402
Sponsor's protocol ID
EA2/114/24
Acronym
FIAT
Status last verified
Feb 2025
First submitted
9 Dec 2024
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 32391079
  • 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.

    PubMed 38082440

Questions about this trial

What is this clinical trial studying?

A study testing Family based treatment and Inpatient multimodal therapy in people with Anorexia Nervosa and Anorexia in Adolescence, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Verena K. Haas, Dr. oec. troph. (+4930 450 566 399, verena.haas@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in %mBMI (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06759402, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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