Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization (EATLINE)
Primary Purpose
Anorexia Nervosa
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eatline
Control
Sponsored by
About this trial
This is an interventional other trial for Anorexia Nervosa
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
Sites / Locations
- Centre Hospitalier Général
- Hôpital Fontan2, CHURecruiting
- Hôpital Saint Vincent de Paul, GHICL
- Cliniqie Lautreamont
- CHU de Montpellier
- Centre Hospitalier Universitaire
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
eatline group
control group
Arm Description
Outcomes
Primary Outcome Measures
change in body mass index (BMI)
Secondary Outcome Measures
change in BMI from the first hospitalization
Mini International Neuropsychiatric Interview (MINI)
SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders)
The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory)
The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire)
The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)
Rate of patients lost to follow-up visits
Rate of patients with at least one re-hospitalization or earlier consultations than expected
Medico-economic evaluation with the MEDEC questionnaire
Full Information
NCT ID
NCT04102475
First Posted
September 24, 2019
Last Updated
February 28, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT04102475
Brief Title
Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization
Acronym
EATLINE
Official Title
Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
eatline group
Arm Type
Experimental
Arm Title
control group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Eatline
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
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
Primary Outcome Measure Information:
Title
change in body mass index (BMI)
Time Frame
from discharge of the first hospitalization to 12 months.
Secondary Outcome Measure Information:
Title
change in BMI from the first hospitalization
Time Frame
from the first hospitalization to 6 months and at 1 year
Title
Mini International Neuropsychiatric Interview (MINI)
Time Frame
at baseline, at 6 months , at 1 year
Title
SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders)
Time Frame
at baseline, at 6 months , at 1 year
Title
The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory)
Time Frame
at baseline, at 6 months , at 1 year
Title
The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire)
Time Frame
at baseline, at 6 months , at 1 year
Title
The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)
Time Frame
at baseline, at 6 months , at 1 year
Title
Rate of patients lost to follow-up visits
Time Frame
during the one year
Title
Rate of patients with at least one re-hospitalization or earlier consultations than expected
Time Frame
during the one year
Title
Medico-economic evaluation with the MEDEC questionnaire
Time Frame
at 6 months, at 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Cottencin, MD,PhD
Phone
3 20 44 58 38
Ext
+33
Email
olivier.cottencin@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Cottencin, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Général
City
Hénin-Beaumont
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Fontan2, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier COTTENCIN
Phone
00 33 3 20 44 58 38
Email
olivier.cottencin@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Olivier COTTENCIN, MD, PhD
Facility Name
Hôpital Saint Vincent de Paul, GHICL
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Cliniqie Lautreamont
City
Loos
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization
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