Case management for women victims of violence
Official title: Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence
Run by University Hospital, Lille · NCT04953273 · Data updated 2026-11-12
This study is testing a new support program for women who have experienced violence to see if it helps them get better mental health care and reduces their risk of PTSD.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 756 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 8 sites (Amiens and 7 other locations) |
| Status | Recruiting |
| Started | July 6, 2021 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT04953273 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older who have sought consultation in a clinical forensic medicine unit after experiencing violence.
✕Probably not a fit
Patients who do not consent to participate or those who have experienced intrafamilial or intimate partner violence may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of a case management algorithm that includes early phone contact for women who have experienced violence and are at risk for post-traumatic stress disorder (PTSD). Participants will be randomized into a group receiving the Vigitrauma intervention or a control group receiving standard care. The study will assess clinical outcomes after initial consultations in clinical forensic medicine units. The goal is to improve follow-up attendance and mental health outcomes for these women.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental health outcomes and support for women victims of violence.
How similar studies have gone: Other studies have shown that decision-making algorithms using phone contact can be effective in improving outcomes for vulnerable populations, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women * 18 years and older * Consultation requested in a clinical forensic medicine unit after being victim of violence * The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence (PTSD criterion A - DSM -5) * With social insurance * Consent to participate to the study Exclusion Criteria: * Do no consent to participate to the study * Intrafamilial or intimate partner violence * Do not speak french
Where it's running
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University Hospital, Lille
Lille, France Recruiting -
University Hospital, Amiens
Amiens, France Not yet recruiting -
General Hospital, Boulogne sur Mer
Boulogne-sur-Mer, France Not yet recruiting -
University Hospital, Caen
Caen, France Not yet recruiting -
General Hospital, Creil
Creil, France Not yet recruiting -
University Hospital, Rouen
Rouen, France Not yet recruiting
Show 2 more locations
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General Hospital, Saint-Quentin
Saint-Quentin, France Not yet recruiting -
General Hospital, Valenciennes
Valenciennes, France Not yet recruiting
Study contacts
- Principal investigator: Arnaud Leroy, MD — University Hospital, Lille
- Study coordinator: Arnaud Leroy, MD
- Email: arnaud.leroy@chru-lille.fr
- Phone: +33 320444460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.