NCT03350594

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

May 11, 2018

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

5.5 years

First QC Date

November 3, 2017

Last Update Submit

March 9, 2022

Conditions

Anorexia Nervosa

Keywords

Anorexia NervosaMultiple Family TherapySystemic Family TherapyAdolescenceRandomised controled trial

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    Change from baseline Body Mass Index (Weight in KG / Height in m²) at 12 months

    Baseline, 12 months

Secondary Outcomes (8)

  • Change from Baseline overall clinical outcome at 12 months and 18 months

    Baseline, 12 months, 18 months

  • Change from baseline nature and seriousness of eating-disorder symptoms at 12 months and 18 months

    Baseline, 12 months, 18 months

  • Change from baseline patient's Emotional symptoms at 12 months and 18 months

    Baseline, 12 months, 18 months

  • Change from baseline parent's Emotional symptoms at 12 months and at 18 months

    Baseline, 12 months, 18 months

  • Change from baseline quality of family relationships at 12 months and 18 months

    Baseline, 12 months, 18 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Change from baseline Cost-efficiency analysis at 12 months and 18 months

    12 months, 18 months

Study Arms (2)

Systemic Family Therapy

ACTIVE COMPARATOR

SyFT involves the patient, the parents, and siblings over the age of 6 living at home. Therapists do not manage the issues relating to AN, which are taken on by referent psychiatrist who can be called on in case of any concern. Without denying personal suffering and its intra-psychic and meta-psychological impact, or the somatic and biological aspect of the pathology, the emphasis is on interactions around the symptom. There will be free exchanges along the lines between therapist and family, within the family and between therapists. Session is possible with sibling alone or the parents alone or in inter-generational mode (other family relatives)

Behavioral: Systemic Family Therapy

Multiple Family Therapy

EXPERIMENTAL

Each session will involve 5 families of patients suffering from AN including the parents and non-systematically the siblings. There will be exchanges in groups and mediation via different exercises involving different sub-groups according to the theme: complete families, patients on their own for problems specific to them, or " cross-parenting " exercises whereby parents adopt another patient for the duration of the exercise. This organization enables mutual support and social propping, favoring the emergence of family resources. Direct exchanges between families (between parents, siblings, or mixes) with and between therapists are also sought.

Behavioral: Multiple Family Therapy

Interventions

Systemic Family TherapyBEHAVIORAL

Patient will have 10 sessions of Systemic Family Therapy during 12 months with his/her family.

Systemic Family Therapy
Multiple Family TherapyBEHAVIORAL

Patient and his/fer family will have 10 sessions of Multiple Family Therapy during 12 months.

Multiple Family Therapy

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Salvator - APHM Marseille

Marseille, 13354, France

RECRUITING

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

RECRUITING

Institut Mutualiste Montsouris

Paris, 75014, France

RECRUITING

Maison de Solenn - Maison des Adolescents Cochin

Paris, 75014, France

RECRUITING

Clinique Médicale et Pédagogique Edouard RIST

Paris, 75016, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31039797DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Benjamin CARROT, MD

    Institut Mutualiste Montsouris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin CARROT, MD

CONTACT

0156616926benjamin.carrot@imm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 22, 2017

Study Start

May 11, 2018

Primary Completion

November 11, 2023

Study Completion

May 10, 2024

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

FR(5)