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Contribution of FAMily THERApy to treat patients with anorexia nervosa (apport de la therapie familiale au traitement des patientes anorexiques mentales)
ISRCTN ISRCTN71142875
DOI 10.1186/ISRCTN71142875
ClinicalTrials.gov identifier
EudraCT number
Public title Contribution of FAMily THERApy to treat patients with anorexia nervosa (apport de la therapie familiale au traitement des patientes anorexiques mentales)
Scientific title Comparison of adjunctive FAMily THERApy and treatment as usual following inpatient treatment for anorexia nervosa in adolescents: a single-centre randomised controlled trial
Acronym THERAFAM
Serial number at source aom97133
Study hypothesis The adjunction of family therapy intervention, focusing on the improvement of the intra-familial dynamics, would be associated with a better outcome than that of the usual multi-dimensional treatment program alone
Lay summary Lay summary under review 3
Ethics approval Advisory Committee on Protection of Persons in Biomedical Research (Comité Consultatif de Protection des Personnes dans la Recherche Biomédicale) (CCPRB) approved on 2nd October 1998
Study design Single-centre randomised controlled trial
Countries of recruitment France
Disease/condition/study domain Anorexia nervosa
Participants - inclusion criteria 1. 13 to 21 year-old females with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
2. Diagnosis of anorexia nervosa (AN), aged under 19 at illness onset and with an AN duration more than 3 years at admission to the hospital
3. Hospitalised in our inpatient unit for AN, living in the Paris metropolitan area, and who had never received family therapy (FT). The patient could receive appropriate medication.
Participants - exclusion criteria 1. Inability to speak or read French and/or understand the interview questions
2. Any metabolic pathology interfering with eating or digestion (e.g., diabetes) or psychotic disorder
3. This criterion also concerned the patients parents
Anticipated start date 30/01/1999
Anticipated end date 31/07/2002
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60: 30 in each arm
Interventions Treatment program as usual versus adjunctive family therapy

Treatment as usual (TAU) : consisted in ambulatory care initiated before hospital discharge and was tailored according to the mental and physical state of the patient. It included individual consultations, regular interviews involving the parents, and, if required, individual psychotherapy with another therapist.

At each appointment, the psychiatrist conducted clinical investigation of the patients mental state, eating habits, medical condition, and psychosocial environment. In addition, the psychiatrist provided support, coordinated services (e.g., general practitioner, psychotherapist, dietician or nutritionist, social worker, and school), prescribed medication as necessary, and offered parental support and guidance regarding conflicts they had with their daughter. Parents were advised to be supportive but to leave decisions about food to the adolescent and to discuss the difficulties they observed not directly with their daughter during or after the meal, but at the time of the consultations with the psychiatrist and their daughter. In addition, nutritional/dietetic advice was provided to the patients who were not gaining weight or not gaining sufficient weight.

Family therapy (FT) : was designed by our team as one component of a multi-dimensional outpatient care program. We considered AN as a disorder resulting from multidimensional pathways. In interaction with premorbid personality or predispositions, the intra-familial dynamic was conceptualised as potentially influencing the occurrence and maintenance of the patients eating problems.
The main aims of FT were :
1. To construct and maintain the therapeutic alliance
2. To identify areas of individual responsibility and clarify inter-generational boundaries
3. To promote abilities to protect, contain and provide support to the family
4. To enable appropriate expression and management of conflict
5. To enable the family to rediscover its own resources and strengths
6. To restore a collective sense of family identity
7. To develop the patients autonomy

Accordingly, FT focused not only on issues in the here-and-now, but also on unresolved issues from the past, as well as on expectations of how these might impact the future. Sessions focused on the familial dynamic as a whole and did not address eating behaviors directly (which were addressed by the reference psychiatrist). The sessions included the patient, her parents, and her siblings if they were over the age of 6 and living in the home. They lasted approximately 1h 30min and took place every three or four weeks. To optimise outcome, the frequency of sessions was flexible. FT continued for a period of 18 months.
Primary outcome measure(s) Morgan and Russell outcome category (good or intermediate outcome versus poor outcome) at 18 months.
Secondary outcome measure(s) 1. Global Outcome Assessment Scale (GOAS) total score
2. AN symptoms or their consequences [body mass index (BMI), amenorrhoea, Eating Disorder Inventory (EDI) scores]
3. Social adjustment and the number of hospitalisations in the course of follow-up
Sources of funding 1. French Ministry of Health (France) (CRC 97012)
2. Assistance-Publique des Hopitaux de Paris (France) (aom97133)
Trial website
Publications 1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17272948
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22238574
Contact name Dr  Nathalie  Godart
  Address Psychiatry Service
Mutualist Montsouris Institute
42 Boulevard Jourdan
  City/town Paris
  Zip/Postcode 75014
  Country France
Sponsor Public Assistance Hospitals of Paris (France)
  Address c/o Mr Christophe Aucan
DRCD Hôpital Saint Louis
Carré Historique - Secteur gris - porte 23
1 Avenue Claude Vellefaux
Cedex 10
  City/town Paris
  Zip/Postcode 75475
  Country France
  Sponsor website: http://rechercheclinique.aphp.fr/-Notre-equipe-.html?rubrique
Date applied 11/05/2011
Last edited 02/08/2012
Date ISRCTN assigned 10/08/2011
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