Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Other: Eatline
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject over 15 years of age Diagnosis of AN (restrictive and/or purgative) according to DSM-5 criteria Included after a first inpatient hospitalization in specialized care Providing informed, dated and signed consent (for a minor, consent must be signed by both parents who have parental authority ) With medical insurance Can be reached by telephone Exclusion Criteria: Uncompensated psychiatric pathology Refusal to participate in the study The inability to consent to care (patient or his/her legal representative) Pregnancy Major incapable subject or under guardianship or judicial protection Homelessness No mastery of reading and writing

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eatline group<br> | Other: Eatline<br>* 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<br>|
| Sham Comparator: control group<br> | Other: Control<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body mass index (BMI) |  | from discharge of the first hospitalization to 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in BMI from the first hospitalization |  | from the first hospitalization to 6 months and at 1 year | 
| Mini International Neuropsychiatric Interview (MINI) |  | at baseline, at 6 months , at 1 year | 
| SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders) |  | at baseline, at 6 months , at 1 year | 
| The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory) |  | at baseline, at 6 months , at 1 year | 
| The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire) |  | at baseline, at 6 months , at 1 year | 
| The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale) |  | at baseline, at 6 months , at 1 year | 
| Rate of patients lost to follow-up visits |  | during the one year | 
| Rate of patients with at least one re-hospitalization or earlier consultations than expected |  | during the one year | 
| Medico-economic evaluation with the MEDEC questionnaire |  | at 6 months, at 1 year |