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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-11

Study Completion Date

2024-05-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Systemic Family Therapy

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)

Group Type ACTIVE_COMPARATOR

Systemic Family Therapy

Intervention Type BEHAVIORAL

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

Multiple Family Therapy

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.

Group Type EXPERIMENTAL

Multiple Family Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Systemic Family Therapy

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

Intervention Type BEHAVIORAL

Multiple Family Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes