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

Anorexia Nervosa Clinical Trial

— EATLINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102475
• Other study ID #: 2017_73
• Secondary ID: 2018-A02536-49
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2021
• Est. completion date: March 2026

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Olivier Cottencin, MD,PhD
• Phone: 3 20 44 58 38
• Email: olivier.cottencin[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Eatline
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
• Control
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

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in body mass index (BMI)		from discharge of the first hospitalization to 12 months.
Secondary	change in BMI from the first hospitalization		from the first hospitalization to 6 months and at 1 year
Secondary	Mini International Neuropsychiatric Interview (MINI)		at baseline, at 6 months , at 1 year
Secondary	SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders)		at baseline, at 6 months , at 1 year
Secondary	The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory)		at baseline, at 6 months , at 1 year
Secondary	The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire)		at baseline, at 6 months , at 1 year
Secondary	The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)		at baseline, at 6 months , at 1 year
Secondary	Rate of patients lost to follow-up visits		during the one year
Secondary	Rate of patients with at least one re-hospitalization or earlier consultations than expected		during the one year
Secondary	Medico-economic evaluation with the MEDEC questionnaire		at 6 months, at 1 year