A Case Management Algorithm for Women Victims of Violence (VIGITRAUMA)

University Hospital, Lille

Status: Enrolling

Conditions: Post-Traumatic Stress Disorder; Violence-Related Symptom

Treatments: Other: Vigitrauma

Study type: Interventional

Funder types: Other

Identifiers

NCT04953273

2020-A02591-38 (Other Identifier)

2020_ 01

Details and patient eligibility

About

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.

Enrollment: 756 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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756 participants in 2 patient groups

Vigitrauma

Experimental group

Description:

Contact by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call if necessary. If the subject is not contacted after the second phone call, he will receive a postcard.

Treatment:

Other: Vigitrauma

Control group

No Intervention group

Description:

Usual follow-up.