AzTrials
AzTrials

Anorexia NervosaTHERAFAMBESTNCT03350594

Family Therapy and Anorexia Nervosa : Which is the Best Approach?

A study testing Systemic Family Therapy and Multiple Family Therapy in people with Anorexia Nervosa, run by Institut Mutualiste Montsouris at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Anorexia Nervosa
What is being tested?
Systemic Family Therapy and Multiple Family Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
5 sitesFrance
Study dates
11 May 2018to 18 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

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 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites
  • Hôpital Salvator - APHM Marseille

    Marseille, 13354

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, 34295

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Maison de Solenn - Maison des Adolescents Cochin

    Paris, 75014

  • Clinique Médicale et Pédagogique Edouard RIST

    Paris, 75016

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Systemic Family Therapy, Multiple Family Therapy
Keywords
Anorexia Nervosa, Multiple Family Therapy, Systemic Family Therapy, Adolescence, Randomised controled trial
Medical subject headings
Anorexia Nervosa

What participants receive

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

  • Systemic Family TherapyBehavioural

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

  • Multiple Family TherapyBehavioural

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

Study groups in NCT03350594
Study groupRoleWhat they receive
Systemic Family TherapyActive comparatorSyFT 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)
Receives: Behavioral: Systemic Family Therapy
Multiple Family TherapyExperimentalEach 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.
Receives: Behavioral: Multiple Family Therapy

What is being measured

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

  1. Body Mass Index

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

    Measured: Baseline, 12 months

Secondary outcomes (8)
  1. Change from Baseline overall clinical outcome at 12 months and 18 months

    Assess with the Morgan and Russell outcome categories. A quantitative score (0-12) was obtained through four subscales: Food intake, Menstrual state, Mental state, Psychosexual state and Socioeconomic state. The higher the score, the better the clinical state.

    We use BMI percentiles that are a good relevant index. Hence, to take the ages of our patients into account, we refer to the INSERM (French National Institute for Health and Medical Research) weight curves for the French population, in which a BMI 10th percentile indexes AN.

    We define the Morgan and Russell outcome categories as follows: 1) Good outcome: weight>10th BMI percentile and regular menstruation; 2) Intermediate outcome: weight>10th BMI percentile but amenorrhea (i.e., the absence of menstruation for at least the past three months); 3) Poor outcome: weight <10th BMI percentile and/or presence of bulimic symptoms.

    We will pool the Good and Intermediate outcome categories.

    Measured: Baseline, 12 months, 18 months

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

    Patients will complete the Eating Disorder Inventory-2 (EDI-2) and the Eating Disorder Diagnostic Scale (EDDS) to assess their current eating disorder (ED) symptomatology. The EDI-2 consists of 91 questions that make up 11 subscales measuring ED pathology and psychopathology. A higher total score represents a higher burden of disease level of symptomatology. The EDDS is a 22-item questionnaire measuring anorexia nervosa, bulimia nervosa and binge eating disorder. The scale consists of a combination of Likert scores (ranging from 0 (not at all) to 6 (extremely)), dichotomous scores, frequency scores and open-ended questions like weight and height. It is a diagnostic scale and a symptom composite scale. An overall eating disorder symptom composite score is computed by standardizing and summing up scores across all items.

    Measured: Baseline, 12 months, 18 months

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

    Several criterias will be evaluate to assess patient's emotional symptoms, using the following questionnaires : HADS (Hospital Anxiety and Depression Scale) and BID-13 (Beck Depressive Inventory-13) to evaluate anxiety and depression, BVAQ-B (Bermond-Vorst Alexithymia Questionnaire) to evaluate alexithymic features, MOCI (Maudsley Obsessional-Compulsive Inventory) to evaluate obsessive-compulsive symptoms, LSAS-CA (Liebowitz Social Anxiety Scale for Children and Adolescents) to measure social anxiety, RES (Rosenberg Self-Esteem) to measure self-esteem, OSI (Ottawa Self-Injury) to measure occurrence, frequency, level of motivation to stop, types and functions and potential addictive features of self-injury, and C-SSRS (Columbia-Suicide Severity Rating Scale) to distinguish the domains of suicidal ideation and suicidal behaviour.

    Measured: Baseline, 12 months, 18 months

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

    Several criterias will be evaluate to assess parent's emotional symptoms using the following questionnaires : HADS (Hospital Anxiety and Depression Scale) and BID-13 (Beck Depressive Inventory-13) to evaluate anxiety and depression, BVAQ-B (Bermond-Vorst Alexithymia Questionnaire) to evaluate alexithymic features, RES (Rosenberg Self-Esteem) to measure self-esteem, ECI (Experience Caregiving Inventory) to measure the experience of caring for an individual with a severe mental illness, EDSIS (Eating Disorders Symptom Impact Scale) to measure caregiving burden in eating disorder, MIV-TIG (Mental Illness Version of Texas Inventory Grief) to measure past and current feeling of loss in relatives of people suffering of mental illness.

    Measured: Baseline, 12 months, 18 months

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

    The following questionnaires will be used to assess the family relationships : the Score-15, a self-report outcome measure designed to be sensitive to the kinds of changes in family relationships, and the FAD (Family Assessment Advice) to measure structural, organizational, and transactional characteristics of families.

    Patient will also complete the LEE (Level of Expressed Emotion) while the parents will complete the FQ (Family Questionnaire) assessing the expressed emotion status (criticism, emotional, over-involvement) of relatives of patients.

    Measured: Baseline, 12 months, 18 months

  6. Change from baseline patient's quality of life at 12 months and at 18 months

    We will use the Eating Disorders Quality of Life Questionnaire (EDQOL) and the Social and Occupational Functioning Scale (SOFAS) for patients.

    The EDQOL has 25 items that contribute to four subscales (Psychological, Physical/Cognitive, Work/School, and Financial), which combined produce an overall quality of life score. Each item is coded on a five-point scale and asks the participant to rate the extent to which they perceive their eating disorder to affect their quality of life in different domains. Higher scores indicate lower quality of life.

    The SOFAS is a rating scale used to subjectively assess the social and occupational functioning due to medical conditions. The scale is based on a continuum of functioning, ranging from 0 to 100, with higher scores indicating better functioning.

    Measured: Baseline, 12 months, 18 months

  7. Change from baseline parent's quality of life at 12 months and at 18 months

    Parents will answer the following questionnaires:

    The WHOQOL (World Health Organization Quality of Life) to evaluate quality of life that can be defined as an individual's subjective perception of different aspects of life that are influenced by health status and includes subjective evaluations of physical functioning, mental health, and social/role functioning.

    The LHS (the London Handicap Scale) to determine the effect of chronic disorders on a person's functional ability using a self-completion questionnaire. Each degree of handicap along a 6-point interval was assigned a scale weight. Six scales are rated Mobility, Physical independence : Occupation ; Social integration: Orientation, Economic self-sufficiency. A total score from 0 to 1 and lower score indicate total disability.

    The CarerQoL-7D (Care-related Quality of life) to describe caregiver burden in seven dimensions (ie, fulfillment, relational, mental, social, financial, perceived support, and physical).

    Measured: Baseline, 12 months, 18 months

  8. Change from 12-month Patient and parent satisfaction at 18 months

    Patients and parents will complete quantitative measures: a modified version of the CSQ-8 (Client Satisfaction Questionnaire-8) and a purpose-designed satisfaction interview assessing client satisfaction with a service.

    Measured: 12 months, 18 months

Timeline

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

  1. First posted22 Nov 2017
  2. Study start11 May 2018
  3. Primary completion18 Jul 2025
  4. Study completion18 Jul 2025

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350594
Sponsor's protocol ID
PSY-2016-01
Other IDs
2016-A00818-43
Acronym
THERAFAMBEST
Status last verified
Oct 2026
First submitted
3 Nov 2017
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31039797

Questions about this trial

What is this clinical trial studying?

A study testing Systemic Family Therapy and Multiple Family Therapy in people with Anorexia Nervosa, run by Institut Mutualiste Montsouris at 5 sites in France.

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 6 inclusion and 3 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: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (time frame: Baseline, 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 NCT03350594, which also lists 1 linked publication.

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 2 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in