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

NCT04102475 | Terminated

• 2 other identifiers: 2017_732018-A02536-49
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 6

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• change in body mass index (BMI)

  from discharge of the first hospitalization to 12 months.

Secondary Outcomes (9)

• 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

Study Arms (2)

eatline group

EXPERIMENTAL

Other: Eatline

control group

SHAM COMPARATOR

Other: Control

Interventions

Eatline OTHER

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

eatline group

Control OTHER

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

control group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (6)

Centre Hospitalier Général

Hénin-Beaumont, France

Location

Hôpital Fontan2, CHU

Lille, France

Location

Hôpital Saint Vincent de Paul, GHICL

Lille, France

Location

Cliniqie Lautreamont

Loos, France

Location

CHU de Montpellier

Montpellier, France

Location

Centre Hospitalier Universitaire

Nantes, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Olivier Cottencin, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 25, 2019
• Study Start: March 18, 2021
• Primary Completion: March 8, 2025
• Study Completion: March 8, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

FR (6)