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

Not Applicable

Recruiting

• Conditions: Anorexia Nervosa
• Interventions: Other: Eatline; Other: Control

• Registration Number: NCT04102475
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-25
• Study Start: 2021-03-18
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eatline group	Eatline	-
control group	Control	-

Primary Outcome Measures

Name	Time	Method
change in body mass index (BMI)	from discharge of the first hospitalization to 12 months.

Secondary Outcome Measures

Name	Time	Method
The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)	at baseline, at 6 months , 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
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
change in BMI from the first hospitalization	from the first hospitalization to 6 months and at 1 year
Medico-economic evaluation with the MEDEC questionnaire	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

Trial Locations

Locations (6)

Hôpital Fontan2, CHU; 🇫🇷 Lille, France

Centre Hospitalier Général; 🇫🇷 Hénin-Beaumont, France

Hôpital Saint Vincent de Paul, GHICL; 🇫🇷 Lille, France

Cliniqie Lautreamont; 🇫🇷 Loos, France

CHU de Montpellier; 🇫🇷 Montpellier, France

Centre Hospitalier Universitaire; 🇫🇷 Nantes, France