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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
756
Case management algorithm using early phone contact
University Hospital, Amiens
Amiens, France
NOT_YET_RECRUITINGGeneral Hospital, Boulogne sur Mer
Boulogne-sur-Mer, France
NOT_YET_RECRUITINGUniversity Hospital, Caen
Caen, France
NOT_YET_RECRUITINGGeneral Hospital, Creil
Creil, France
NOT_YET_RECRUITINGUniversity Hospital, Lille
Lille, France
RECRUITINGUniversity Hospital, Rouen
Rouen, France
NOT_YET_RECRUITINGGeneral Hospital, Saint-Quentin
Saint-Quentin, France
NOT_YET_RECRUITINGGeneral Hospital, Valenciennes
Valenciennes, France
NOT_YET_RECRUITINGClinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4
Time frame: 3 months
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4
Time frame: 6 months
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4
Time frame: 12 months
Severity of post-traumatic stress disorder symptoms
Post-traumatic stress disorder Checklist Scale-5
Time frame: 3 months, 6 months and 12 months
General psychopathology
French version of Mini International Neuropsychiatric Interview (DSM 5)
Time frame: 3 months, 6 months and 12 months
Severity of somatic symptoms
Physical Health Questionnaire (PHQ-15)
Time frame: 3 months, 6 months and 12 months
Medical cost
Nnumber of hospitalizations, consultations, and drugs consummation
Time frame: 12 months
Judicial outcome
Number of days of temporary inability to work
Time frame: 12 months
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.
Time frame: 12 months
Number of suicide attempters
Suicide risk
Time frame: 12 months
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