Anorexia Nervosa (AN) is a highly challenging disease which consequences are serious. Relapse rate is estimated between 38 and 41% during the year following hospitalization. The efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. However, no study has ever used phone contact as a relapse prevention intervention tool in AN. Objective: To evaluate efficacy of a phone contact procedure to increase body weight at 12 months after a first hospitalization for AN, by comparison to standard medical follow-up. Secondary objectives are to evaluate effect of phone contact procedure on: change in body weight at 6 month, general psychopathology disorder, psychopathology disorder specific to AN, rate of usual follow-up visit, and medico-economic impact. Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for subject over 15 years old presenting with diagnosis of AN. Patients randomized in EATLINE group will be contacted by phone at 15 days, 1, 2, 4 and 9 months after discharge from hospitalization. Patients in control group will benefit from usual follow-up. Expected outcomes and perspectives:that there will be a significant decrease in relapse due to phone contact procedure compared to control group. Results would justify additional devices at the end of hospitalization, until development of various connected tools allowing to "stay in contact" with patients in order to optimize the current therapeutic possibilities of AN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
19
After discharge from a first hospitalization: Phone calls at 15 days, 1, 2, 4 and 9 months by a trained psychologist. The phone interview will be guided by the same standardized frame, which was developed by a group of experts and tested with a group of patients. The purpose of this intervention is to provide a therapeutic and motivational approach, with positive reinforcement and reassurance. * Added to treatment as usual (TAU): outpatient visits (at least monthly consultations) or scheduled hospitalizations * 6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition
After discharge from the first hospitalization: * No specific phone calls * TAU: outpatient visits (at least monthly consultations) or scheduled hospitalizations * 6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition
Centre Hospitalier Général
Hénin-Beaumont, France
Hôpital Fontan2, CHU
Lille, France
Hôpital Saint Vincent de Paul, GHICL
Lille, France
Cliniqie Lautreamont
Loos, France
CHU de Montpellier
Montpellier, France
Centre Hospitalier Universitaire
Nantes, France
change in body mass index (BMI)
Time frame: from discharge of the first hospitalization to 12 months.
change in BMI from the first hospitalization
Time frame: from the first hospitalization to 6 months and at 1 year
Mini International Neuropsychiatric Interview (MINI)
Time frame: at baseline, at 6 months , at 1 year
SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders)
Time frame: at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory)
Time frame: at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire)
Time frame: at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)
Time frame: at baseline, at 6 months , at 1 year
Rate of patients lost to follow-up visits
Time frame: during the one year
Rate of patients with at least one re-hospitalization or earlier consultations than expected
Time frame: during the one year
Medico-economic evaluation with the MEDEC questionnaire
Time frame: at 6 months, at 1 year
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