Post-Traumatic Stress Disorder, Violence-Related Symptom
Conditions
Keywords
Post-Traumatic Stress Disorder, Women Health, Physical Abuse, Forensic Medicine, Case-Management Algorithm
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.
Interventions
OTHERVigitrauma
Case management algorithm using early phone contact
Sponsors
University Hospital, Lille
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome | 3 months | Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of post-traumatic stress disorder symptoms | 3 months, 6 months and 12 months | Post-traumatic stress disorder Checklist Scale-5 |
| General psychopathology | 3 months, 6 months and 12 months | French version of Mini International Neuropsychiatric Interview (DSM 5) |
| Severity of somatic symptoms | 3 months, 6 months and 12 months | Physical Health Questionnaire (PHQ-15) |
| Medical cost | 12 months | Nnumber of hospitalizations, consultations, and drugs consummation |
| Judicial outcome | 12 months | Number of days of temporary inability to work |
| 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. |
| Number of suicide attempters | 12 months | Suicide risk |
Countries
France
Contacts
CONTACTArnaud Leroy, MD
CONTACTAnne-Laure Demarty
PRINCIPAL_INVESTIGATORArnaud Leroy, MD
University Hospital, Lille
Outcome results
None listed