Study Design
The FIAT study is a multi-centre, randomised controlled trial (RCT) using a non-inferiority design. It is coordinated by the Charité-Universitätsmedizin Berlin with participation from up to 23 clinics across Germany. With 200 participants (8-17 years) with AN, it will be the first and largest study in continental Europe to investigate FBTSCM. Families whose children are scheduled to receive inpatient treatment are eligible to participate. Participating families will be randomly assigned to either FBTSCM or IMT.
Forms of therapy being compared in the FIAT study: IMT and FBTSCM
1. Inpatient Multimodal Therapy (IMT)
In Germany, IMT usually lasts 3-6 months. In addition to individual consultations with their psychotherapist, the therapy program includes eating support from the nursing staff, group therapies, nutritional advice and other therapies (e.g. body therapy, art therapy, music therapy, movement therapy). Discussions with parents/carers and “home leave” from the hospital, to support the transition back home, are also part of IMT.
2. Family-Based Therapy in the Stepped Care Model (FBTSCM)
In FBTSCM, the patient remains at home and therapy sessions with the family take place online via video conference. This allows families from rural areas to participate as long as they can attend regular face-to-face appointments at the participating treatment centre. FBTSCM typically lasts an average of 10 months. The FBT team provides all psychotherapeutic, psychiatric and medical care on an outpatient basis. The therapy involves the whole family, with parents playing a central role, particularly in the first phase (e.g. accompanying the patient at mealtimes and refeeding). The “SCM” stands for Stepped Care Model, in which the intensity of the treatment is gradually increased in the absence of success, up to short inpatient stays of a maximum of six weeks. If progress is insufficient, the patient is transferred to regular inpatient care in order to facilitate weight normalisation and avoid chronicity.
After completing the intervention, patients in the FIAT study will continue with standard outpatient care.
„Because I was always in the ward, I had no choice but to accept that something had to change about my eating disorder. The nursing team was very helpful with this, as were the exchanges with other people affected.“
Feedback from a patient who received IMT at the Charité - Universitätsmedizin Berlin.