A Case Management Algorithm for Women Victims of Violence

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Do no consent to participate to the study

Intrafamilial or intimate partner violence

Do not speak french

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vigitrauma

    Other intervention

    Case management algorithm using early phone contact

Treatment groups

756 Participants
are divided into 2 treatment groups
Group A: VigitraumaExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Clinical Outcome

Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4

Time frame
3 months
2

Clinical Outcome

Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4

Time frame
6 months
3

Clinical Outcome

Rate of patients with a Clinical Global Impression (CGI) severity scale \< 4

Time frame
12 months

Secondary outcomes

1

Severity of post-traumatic stress disorder symptoms

Post-traumatic stress disorder Checklist Scale-5

Time frame
3 months, 6 months and 12 months
2

General psychopathology

French version of Mini International Neuropsychiatric Interview (DSM 5)

Time frame
3 months, 6 months and 12 months
3

Severity of somatic symptoms

Physical Health Questionnaire (PHQ-15)

Time frame
3 months, 6 months and 12 months
4

Medical cost

Nnumber of hospitalizations, consultations, and drugs consummation

Time frame
12 months

Other outcomes

Sponsors and contacts

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University Hospital, Lille

Lead sponsor

Ministry of Health, France

Collaborator