A Case Management Algorithm for Women Victims of Violence

Post-Traumatic Stress Disorder Clinical Trial

— VIGITRAUMA  

Official title:

Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence

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
• 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
• 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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Violence-Related Symptom

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