A Case Management Algorithm for Women Victims of Violence
- Conditions
- Post-Traumatic Stress DisorderViolence-Related Symptom
- Interventions
- Other: Vigitrauma
- Registration Number
- NCT04953273
- Lead Sponsor
- University Hospital, Lille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 756
- 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
- Do no consent to participate to the study
- Intrafamilial or intimate partner violence
- Do not speak french
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vigitrauma Vigitrauma 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.
- Primary Outcome Measures
Name Time Method Clinical Outcome 12 months Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4
- Secondary Outcome Measures
Name Time Method Severity of somatic symptoms 3 months, 6 months and 12 months Physical Health Questionnaire (PHQ-15)
Severity of post-traumatic stress disorder symptoms 3 months, 6 months and 12 months Post-traumatic stress disorder Checklist Scale-5
Suicidal ideation intensity 12 months The Beck Scale for Suicide Ideation (SSI) The Scale for Suicide Ideation (SSI; Beck, et al., 1979) is a brief 21-item scale that assesses the person's current intensity of attitudes, plans, and behaviors to commit suicide.
Medical cost 12 months Nnumber of hospitalizations, consultations, and drugs consummation
Judicial outcome 12 months Number of days of temporary inability to work
Number of suicide attempters 12 months Suicide risk
General psychopathology 3 months, 6 months and 12 months French version of Mini International Neuropsychiatric Interview (DSM 5)
Trial Locations
- Locations (8)
University Hospital, Amiens
🇫🇷Amiens, France
General Hospital, Boulogne sur Mer
🇫🇷Boulogne-sur-Mer, France
General Hospital, Creil
🇫🇷Creil, France
University Hospital, Lille
🇫🇷Lille, France
General Hospital, Saint-Quentin
🇫🇷Saint-Quentin, France
General Hospital, Valenciennes
🇫🇷Valenciennes, France
University Hospital, Rouen
🇫🇷Rouen, France
University Hospital, Caen
🇫🇷Caen, France