NCT07411807

Study of the Effectiveness of a Systematic Minimal Early Intervention on Care Engagement in Adults With Eating Disorders Requesting Specialized Treatment.

Study of the Effectiveness of a Systematic Minimal Early Intervention on Care Engagement in Adults With Eating Disorders Requesting Specialized Treatment: A Monocentric Pilot Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (estimated)
• Sponsor: Centre Hospitalier St Anne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Eating disorders (EDs) are complex psychiatric conditions-such as anorexia nervosa and bulimia nervosa-often emerging in young adulthood and associated with high morbidity and mortality. Despite their severity, access to specialized care remains difficult, delayed by shame, stigma, and a lack of insight among patients, as well as long waiting times and limited specialized resources. The AGIS-TCA pilot study aims to evaluate the effectiveness of a systematic minimal early intervention designed to reduce the number of patients lost to follow-up between their request for specialized care and the actual start of treatment. This monocentric, low-risk interventional study will be conducted at the Clinique des Maladies Mentales et de l'Encéphale (CMME), GHU Paris Psychiatrie \& Neurosciences. The intervention includes three early, structured telephone calls and five online support group sessions offered during the waiting period for care. The main objective is to determine whether this proactive approach decreases attrition rates ("lost to follow-up") compared with a historical cohort. Secondary objectives include assessing the acceptability of early phone contact, adherence to support groups, and describing the clinical and sociodemographic profiles of patients requesting care or lost to follow-up. The expected benefit is to facilitate timely access to care for vulnerable patients, prevent symptom worsening, and strengthen engagement in treatment pathways. Risks and constraints are minimal, as participation involves only remote interactions without any invasive procedures.

Detailed description

Eating disorders (EDs) such as anorexia nervosa and bulimia nervosa are severe psychiatric illnesses characterized by pathological eating behaviors and body-weight control strategies that significantly affect physical and mental health. These disorders typically emerge around age 18 and affect up to 2 million people in France. Despite the recognized importance of early treatment, many patients experience delays in accessing specialized care due to structural barriers (long waiting times, lack of resources) and individual factors (shame, denial, and poor insight into the illness). At the Clinique des Maladies Mentales et de l'Encéphale (CMME), GHU Paris Psychiatrie \& Neurosciences, approximately 20-25% of patients who request specialized care for an eating disorder are lost to follow-up before starting treatment. These individuals often fail to complete their application or do not attend the initial evaluation. The AGIS-TCA (Action Globale d'Intervention Systématique - Troubles du Comportement Alimentaire) study addresses this critical period between the request for care and the beginning of treatment. The study tests the effectiveness and acceptability of a minimal, systematic, early intervention that supports patients during this waiting phase. The intervention consists of: Three structured telephone calls (AT1, AT2, AT3) conducted at approximately day 7, day 45, and day 90 after the validation of the care request. These calls aim to maintain contact, provide information, assess needs, and strengthen motivation. Five online support and education group sessions, each lasting 60 minutes and held biweekly, led by a multidisciplinary team (specialized nurse, physician, dietitian, psychologist, psychomotor therapist, and peer support worker). Topics include medical aspects of EDs, body image, emotions, dietetics, and relationships with relatives. This proactive "outreach" approach is compared to a historical control cohort from the previous year, managed under standard procedures (no systematic follow-up during the waiting period). The primary endpoint is the rate of patients lost to follow-up (patients who requested care but did not attend evaluation or start treatment within 10 months). Secondary endpoints include: Participation rate in support groups. Acceptance rate of early telephone contact. Sociodemographic and clinical characterization of patients requesting care and those lost to follow-up. The study is monocentric, non-randomized, and involves minimal risk. It includes 215 adult participants living in the Île-de-France region who have requested care for anorexia or bulimia at the CMME. Expected benefits include improved engagement in care, reduced loss to follow-up, and earlier access to specialized treatment. The intervention is non-invasive, free of physical constraints, and participation or withdrawal has no impact on future access to care. If effective and acceptable, the results of this pilot study could support the implementation of similar early intervention programs across other specialized eating disorder centers and form the basis for a multicenter study assessing long-term clinical outcomes and cost-effectiveness.

Conditions

• Eating Disorders

Interventions

Type	Name	Description
OTHER	Program (Systematic Minimal Early Intervention for Eating Disorders)	The AGIS-TCA intervention consists of a structured early proactive support program designed to maintain patient engagement during the waiting period before specialized treatment for eating disorders

Timeline

• Start date: 2025-12-29
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: France