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NCT Number: NCT04953273

A Case Management Algorithm for Women Victims of Violence

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vigitrauma

Other

Case management algorithm using early phone contact

Primary outcomes

  1. Clinical Outcome

    Time frame: 3 months

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

  2. Clinical Outcome

    Time frame: 6 months

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

  3. Clinical Outcome

    Time frame: 12 months

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

Secondary outcomes

  1. Severity of post-traumatic stress disorder symptoms

    Time frame: 3 months, 6 months and 12 months

    Post-traumatic stress disorder Checklist Scale-5

  2. General psychopathology

    Time frame: 3 months, 6 months and 12 months

    French version of Mini International Neuropsychiatric Interview (DSM 5)

  3. Severity of somatic symptoms

    Time frame: 3 months, 6 months and 12 months

    Physical Health Questionnaire (PHQ-15)

  4. Medical cost

    Time frame: 12 months

    Nnumber of hospitalizations, consultations, and drugs consummation

  5. Judicial outcome

    Time frame: 12 months

    Number of days of temporary inability to work

  6. Suicidal ideation intensity

    Time frame: 12 months

    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.

  7. Number of suicide attempters

    Time frame: 12 months

    Suicide risk

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Laure Demarty

CONTACT

[email protected]

+33 320444145

Arnaud Leroy, MD

CONTACT

[email protected]

+33 320444460

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: VIGITRAUMA

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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