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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04953273
Other study ID # 2020_ 01
Secondary ID 2020-A02591-38
Status Recruiting
Phase N/A
First received
Last updated
Start date July 6, 2021
Est. completion date July 2026

Study information

Verified date April 2022
Source University Hospital, Lille
Contact Arnaud Leroy, MD
Phone +33 320444460
Email arnaud.leroy@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Vigitrauma
Case management algorithm using early phone contact

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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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