NCT04953273 A Case Management Algorithm for Women Victims of Violence
| NCT ID | NCT04953273 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Post-Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 756 participants |
| Start Date | 2021-07-06 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 756 participants in total. It began in 2021-07-06 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A considerable body of research has demonstrated that women who are victims of interpersonal violence are at substantially elevated risk for the development of post-traumatic stress disorder (PTSD). In France, victims can request a medico-legal examination in a clinical forensic medicine unit. Although these units are also a place for initial psychological examination, women often don't attend future scheduled appointments. Decision-making algorithm using phone contact are effective in suicide prevention. Our aim is to assess the effectiveness of case management algorithm using early phone contact compared to a control group treated as usual on clinical outcome after consultation requested in a clinical forensic medicine unit by female victims of violence. Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for women victims of violence. Victims randomized in VIGITRAUMA group will be contacted by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call can be done. If the subject is not contacted after the second phone call, he will receive a postcard. Control group will benefit from usual follow-up. All the subjects included will be then evaluated at 3 months, 6 months and 1 year during a phone call.
Eligibility 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
Contact & Investigator
Arnaud Leroy, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04953273 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Post-Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04953273 currently recruiting?
Yes, NCT04953273 is actively recruiting participants. Contact the research team at arnaud.leroy@chru-lille.fr for enrollment information.
Where is the NCT04953273 trial being conducted?
This trial is being conducted at Amiens, France, Boulogne-sur-Mer, France, Caen, France, Creil, France and 4 additional locations.
Who is sponsoring the NCT04953273 clinical trial?
NCT04953273 is sponsored by University Hospital, Lille. The principal investigator is Arnaud Leroy, MD at University Hospital, Lille. The trial plans to enroll 756 participants.