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Recruiting NCT04953273

A Case Management Algorithm for Women Victims of Violence

No phase Interventional Post-Traumatic Stress Disorder Violence-Related Symptom

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vigitrauma.
Who it may be relevant to
Registry conditions: Post-Traumatic Stress Disorder, Violence-Related Symptom. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

  • Other Vigitrauma
    Case management algorithm using early phone contact

Primary outcome measures

  • Clinical Outcome [Time frame: 3 months]
  • Clinical Outcome [Time frame: 6 months]
  • Clinical Outcome [Time frame: 12 months]
Secondary outcome measures (7)
  • Severity of post-traumatic stress disorder symptoms [Time frame: 3 months, 6 months and 12 months]
  • General psychopathology [Time frame: 3 months, 6 months and 12 months]
  • Severity of somatic symptoms [Time frame: 3 months, 6 months and 12 months]
  • Medical cost [Time frame: 12 months]
  • Judicial outcome [Time frame: 12 months]
  • Suicidal ideation intensity [Time frame: 12 months]
  • Number of suicide attempters [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 8 centers
  • University Hospital, Amiens — Amiens
  • General Hospital, Boulogne sur Mer — Boulogne-sur-Mer
  • University Hospital, Caen — Caen
  • General Hospital, Creil — Creil
  • University Hospital, Lille — Lille
  • University Hospital, Rouen — Rouen
  • General Hospital, Saint-Quentin — Saint-Quentin
  • General Hospital, Valenciennes — Valenciennes

Identifiers

NCT: NCT04953273 · 2020_ 01 · 2020-A02591-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗