Case management for women victims of violence
Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 756 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 8 sites (Amiens and 7 other locations) |
| Trial ID | NCT04953273 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have sought consultation in a clinical forensic medicine unit after experiencing violence.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amiens and 7 other locations
- 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, Lille — Lille, France (Recruiting)
- University Hospital, Rouen — Rouen, France (Not_yet_recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.