Condition category
Mental and Behavioural Disorders
Date applied
11/05/2011
Date assigned
10/08/2011
Last edited
02/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nathalie Godart

ORCID ID

Contact details

Psychiatry Service
Mutualist Montsouris Institute
42 Boulevard Jourdan
Paris
75014
France

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

  1. 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.

  2. 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.

Additional files

Editorial Notes