Family-based Telemedicine vs. Inpatient Anorexia Nervosa Treatment (FIAT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorCharite University, Berlin, Germany
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
weight <67%mBMI
acute self harm or danger to others
acute psychosis or suicidal tendencies
current substance abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Family based treatment
BehavioralFBT 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 therapy
Behavioralcomprehensive, 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: FBTExperimental treatment 1 intervention
Group B: IMTActive comparator 1 intervention
Trial outcomes
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.
Time frame
12 monthsSecondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
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.Sponsors and contacts
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Charite University, Berlin, Germany
Lead sponsor
Bielefeld University
Collaborator
Techniker Krankenkasse
Collaborator
BARMER
Collaborator
AOK Niedersachsen
Collaborator
Mobil Krankenkasse
Collaborator
Meine Krankenkasse
Collaborator
Medicalnetworks CJ GmbH & Co.KG
Collaborator
AOK Baden-Württemberg
Collaborator
DAK Gesundheit
Collaborator
BIG-direkt
Collaborator
mhplus
Collaborator
Bahn-BKK
Collaborator
OFFIS - Institut für Informatik
Collaborator
Prof. Daniel Le Grange, UCSF
Collaborator
Source ClinicalTrials.gov