Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
aom97133
Study information
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
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anorexia nervosa
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Morgan and Russell outcome category (good or intermediate outcome versus poor outcome) at 18 months.
Secondary outcome measures
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
Overall trial start date
30/01/1999
Overall trial end date
31/07/2002
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60: 30 in each arm
Participant 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
Recruitment start date
30/01/1999
Recruitment end date
31/07/2002
Locations
Countries of recruitment
France
Trial participating centre
Psychiatry Service
Paris
75014
France
Sponsor information
Organisation
Public Assistance Hospitals of Paris (France)
Sponsor details
c/o Mr Christophe Aucan
DRCD Hôpital Saint Louis
Carré Historique - Secteur gris - porte 23
1 Avenue Claude Vellefaux
Cedex 10
Paris
75475
France
Sponsor type
Hospital/treatment centre
Website
http://rechercheclinique.aphp.fr/-Notre-equipe-.html?rubrique
Funders
Funder type
Government
Funder name
French Ministry of Health (France) (CRC 97012)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Assistance-Publique des Hopitaux de Paris (France) (aom97133)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17272948
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22238574
Publication citations
-
Protocol
Godart N, Perdereau F, Rein Z, Curt F, Kaganski I, Lucet R, Corcos M, Fermanian J, Flament M, Jeammet P, Resolving a disagreement in a clinical team: overcoming conflicting views about the role of family therapy in an outpatient treatment programme for anorexia nervosa., Eat Weight Disord, 2006, 11, 4, 185-194.
-
Results
Godart N, Berthoz S, Curt F, Perdereau F, Rein Z, Wallier J, Horreard AS, Kaganski I, Lucet R, Atger F, Corcos M, Fermanian J, Falissard B, Flament M, Eisler I, Jeammet P, A randomized controlled trial of adjunctive family therapy and treatment as usual following inpatient treatment for anorexia nervosa adolescents., PLoS ONE, 2012, 7, 1, e28249, doi: 10.1371/journal.pone.0028249.