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

NCT ID: NCT04102475

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

eatline group

Group Type: EXPERIMENTAL

Eatline

Intervention Type: 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

control group

Group Type: SHAM_COMPARATOR

Control

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Cottencin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Centre Hospitalier Général

Hénin-Beaumont, , France

Site Status: NOT_YET_RECRUITING

Hôpital Fontan2, CHU

Lille, , France

Site Status: RECRUITING

Hôpital Saint Vincent de Paul, GHICL

Lille, , France

Site Status: NOT_YET_RECRUITING

Cliniqie Lautreamont

Loos, , France

Site Status: NOT_YET_RECRUITING

CHU de Montpellier

Montpellier, , France

Site Status: NOT_YET_RECRUITING

Centre Hospitalier Universitaire

Nantes, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Olivier Cottencin, MD,PhD

Role: CONTACT

olivier.cottencin@chru-lille.fr

3 20 44 58 38 ext. +33

Facility Contacts

Olivier COTTENCIN

Role: primary

olivier.cottencin@chru-lille.fr

00 33 3 20 44 58 38

Other Identifiers

2018-A02536-49

Identifier Type: OTHER

Identifier Source: secondary_id

2017_73

Identifier Type: -

Identifier Source: org_study_id