Clinical trial NCT03350594: Family Therapy and Anorexia Nervosa : Which is the Best Approach?
Official title: Family Therapy and Anorexia Nervosa : Which is the Best Approach? Family Therapy Multicenter Randomised Control Trial of Systemic Family Therapy Versus Multiple Family Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Multiple Family Therapy
Systemic Family Therapy
Adolescence
Randomised controled trial
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: PHRC Interrégionnal 2015
name: Fondation Sandrine Castellotti
name: Fondation de l'Avenir
name: CESP - UMR 1018 / INSERM
name: Direction Générale de l'offre de Soins (DGOS)
name: University Hospital, Rouen
name: Maison des Adolescents de Cochin (APHP)
First posted: 2017-11-22
Enrollment: 150
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate whether the implementation of Multiple Family Therapy (MFT) within a multi-disciplinary treatment program for Anorexia Nervosa (AN) in adolescence is at least as effective in terms of clinical Body Mass Index evolution as single Systemic Family Therapy (SyFT) after 12 months of treatment. We expect that these two techniques will not differ in terms of global efficacy, but that MFT could be more suitable for certain profiles who may be less responsive to SyFT.

Detailed description: While family therapy is considered to have proved itself, its efficacy has been tested with reference to individual therapy by several teams of researchers or in addition to an overall treatment program. Few studies however have compared different types of family studies, and these studies were often on small samples. In addition, efficacy in terms of remission at 12-18 months was below 50% for large samples, and whatever the technique envisaged. Consequently, there is a need for exploration of this type of care provision. It is in this context, and also on account of budget considerations, to avoid hospitalizations, that the Maudsley team developed MFT for AN in the form of intensive day-care. The system is open to debate (there is a selection of highly motivated subjects able to suspend family and professional activities for some 20 days a year, and to find accommodation close to the hospital, and ready to relinquish other types of follow-up. However, MFT is, according to its advocates (families, caregivers) a therapeutic tool that is effective and appreciated by families. Other teams have therefore adapted it to care practices in France, and suited it to children, adolescents or adult in ambulatory care. In addition, we are aware that our care program is not satisfactory (fewer than half the subjects are cured after 12 to 18 months of treatment) and hence perfectible. We would like to use MFT, but this approach, particularly in ambulatory setting, has never been evaluated in comparison with another type of therapy in a randomized trial. We therefore wish to perform a randomized controlled trial to assess the contribution of MFT to the treatment of AN in comparison with SyFT.

The project is original in that, for the first time, it sets out to assess MFT in adolescent AN in ambulatory care in reference to SyFT, to estimate cost parameters relating to the two techniques, and also to identify the profiles of the best responders according to patient characteristics.

Family therapy will be established either after first half of hospitalization (half way to weight gain fixed for discharge), or when the patient seen in consultation is in a stable clinical state with no indication for hospitalization.

Patient will be randomized to MFT or SyFT after agreement to take part in the study. Randomization will be stratified on care provision status at inclusion (ambulatory or hospitalized - the latter being a possible selection bias according to severity) and therapies will start in the month following the randomization.

Patients and their families will have one session a month MFT ou SyFT during 12 months.

Evaluations will take place at the end of therapy at 12 months, then at the 6 months follow-up. Evaluators will be blind to the treatment group and will use a standardized research questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patient suffering from Anorexia Nervosa according to DSM-5 criteria (restricting or purge type Anorexia Nervosa)
* Patient with the paucisymptomatic form of Anorexia Nervosa
* Patient suffering from Anorexia Nervosa before his 19 years old
* Patient aged between 13 and 19
* Patient and his/her parents who accept to participate to the study
* Patient and his/her parents who live in Paris or Rouen and surroundings

Exclusion Criteria:

* Patient who is diagnosed with: psychosis, mentale deficiency, organic cerebral disorder, any pathology that interfere with feeding or its regurgitation
* Patient who does not speak french
* Patient who is already followed in a familial therapy

Primary outcomes:
measure: Body Mass Index
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change from Baseline overall clinical outcome at 12 months and 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from baseline nature and seriousness of eating-disorder symptoms at 12 months and 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from baseline patient's Emotional symptoms at 12 months and 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from baseline parent's Emotional symptoms at 12 months and at 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from baseline quality of family relationships at 12 months and 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from baseline patient's quality of life at 12 months and at 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from baseline parent's quality of life at 12 months and at 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from 12-month Patient and parent satisfaction at 18 months
timeFrame: 12 months, 18 months
Other outcomes:
measure: Change from baseline Cost-efficiency analysis at 12 months and 18 months
timeFrame: 12 months, 18 months
Locations:
city: Marseille
country: France
facility: Hôpital Salvator - APHM Marseille
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Maison de Solenn - Maison des Adolescents Cochin
city: Paris
country: France
facility: Clinique Médicale et Pédagogique Edouard RIST
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Benjamin CARROT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrot B, Duclos J, Barry C, Radon L, Maria AS, Kaganski I, Jeremic Z, Barton-Clegg V, Corcos M, Lasfar M, Gerardin P, Harf A, Moro MR, Blanchet C, Godart N. Multicenter randomized controlled trial on the comparison of multi-family therapy (MFT) and systemic single-family therapy (SFT) in young patients with anorexia nervosa: study protocol of the THERAFAMBEST study. Trials. 2019 Apr 30;20(1):249. doi: 10.1186/s13063-019-3347-y.