Post-Traumatic Stress Disorder Clinical Trial
— VIGITRAUMAOfficial title:
Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence
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.
Status | Recruiting |
Enrollment | 756 |
Est. completion date | July 2026 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital, Amiens | Amiens | |
France | General Hospital, Boulogne sur Mer | Boulogne-sur-Mer | |
France | University Hospital, Caen | Caen | |
France | General Hospital, Creil | Creil | |
France | University Hospital, Lille | Lille | |
France | University Hospital, Rouen | Rouen | |
France | General Hospital, Saint-Quentin | Saint-Quentin | |
France | General Hospital, Valenciennes | Valenciennes |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Outcome | Rate of patients with a Clinical Global Impression (CGI) severity scale < 4 | 3 months | |
Primary | Clinical Outcome | Rate of patients with a Clinical Global Impression (CGI) severity scale < 4 | 6 months | |
Primary | Clinical Outcome | Rate of patients with a Clinical Global Impression (CGI) severity scale < 4 | 12 months | |
Secondary | Severity of post-traumatic stress disorder symptoms | Post-traumatic stress disorder Checklist Scale-5 | 3 months, 6 months and 12 months | |
Secondary | General psychopathology | French version of Mini International Neuropsychiatric Interview (DSM 5) | 3 months, 6 months and 12 months | |
Secondary | Severity of somatic symptoms | Physical Health Questionnaire (PHQ-15) | 3 months, 6 months and 12 months | |
Secondary | Medical cost | Nnumber of hospitalizations, consultations, and drugs consummation | 12 months | |
Secondary | Judicial outcome | Number of days of temporary inability to work | 12 months | |
Secondary | Suicidal ideation intensity | 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. | 12 months | |
Secondary | Number of suicide attempters | Suicide risk | 12 months |
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