NCT04102475

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2021-03-18
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2019-09-25
• Last updated: 2026-04-07

Locations

6 sites across 1 country: France