NCT04953273

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
756

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2021Jul 2026

First Submitted

Initial submission to the registry

June 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

5 years

First QC Date

June 4, 2021

Last Update Submit

April 4, 2022

Conditions

Post-Traumatic Stress DisorderViolence-Related Symptom

Keywords

Post-Traumatic Stress DisorderWomen HealthPhysical AbuseForensic MedicineCase-Management Algorithm

Outcome Measures

Primary Outcomes (3)

  • Clinical Outcome

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

    3 months

  • Clinical Outcome

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

    6 months

  • Clinical Outcome

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

    12 months

Secondary Outcomes (7)

  • Severity of post-traumatic stress disorder symptoms

    3 months, 6 months and 12 months

  • General psychopathology

    3 months, 6 months and 12 months

  • Severity of somatic symptoms

    3 months, 6 months and 12 months

  • Medical cost

    12 months

  • Judicial outcome

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Vigitrauma

EXPERIMENTAL

Contact by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call if necessary. If the subject is not contacted after the second phone call, he will receive a postcard.

Other: Vigitrauma

Control group

NO INTERVENTION

Usual follow-up.

Interventions

VigitraumaOTHER

Case management algorithm using early phone contact

Vigitrauma

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • 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

You may not qualify if:

  • Do no consent to participate to the study
  • Intrafamilial or intimate partner violence
  • Do not speak french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Hospital, Amiens

Amiens, France

NOT YET RECRUITING

General Hospital, Boulogne sur Mer

Boulogne-sur-Mer, France

NOT YET RECRUITING

University Hospital, Caen

Caen, France

NOT YET RECRUITING

General Hospital, Creil

Creil, France

NOT YET RECRUITING

University Hospital, Lille

Lille, France

RECRUITING

University Hospital, Rouen

Rouen, France

NOT YET RECRUITING

General Hospital, Saint-Quentin

Saint-Quentin, France

NOT YET RECRUITING

General Hospital, Valenciennes

Valenciennes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Arnaud Leroy, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnaud Leroy, MD

CONTACT

+33 320444460arnaud.leroy@chru-lille.fr

Anne-Laure Demarty

CONTACT

+33 320444145anne-laure.demarty@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2021

First Posted

July 7, 2021

Study Start

July 6, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

FR(8)