About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Do no consent to participate to the study
Intrafamilial or intimate partner violence
Do not speak french
Trial design
Parallel
Treatments tested in this trial
Vigitrauma
Other interventionCase management algorithm using early phone contact
Treatment groups
Trial outcomes
Primary outcomes
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4
Secondary outcomes
Severity of post-traumatic stress disorder symptoms
Post-traumatic stress disorder Checklist Scale-5
General psychopathology
French version of Mini International Neuropsychiatric Interview (DSM 5)
Severity of somatic symptoms
Physical Health Questionnaire (PHQ-15)
Medical cost
Nnumber of hospitalizations, consultations, and drugs consummation
Sponsors and contacts
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University Hospital, Lille
Lead sponsor
Ministry of Health, France
Collaborator