Post-Traumatic Stress DisorderVIGITRAUMANCT04953273
A Case Management Algorithm for Women Victims of Violence
A study testing Vigitrauma in people with Post-Traumatic Stress Disorder and Violence-Related Symptom, run by University Hospital, Lille at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Traumatic Stress Disorder, Violence-Related Symptom
- What is being tested?
- Vigitrauma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 8 sitesFrance
- Study dates
- 6 Jul 2021to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Do no consent to participate to the study
- Intrafamilial or intimate partner violence
- Do not speak french
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
University Hospital, Amiens
Amiens
Cécile MANAOUIL
Gaetan PRISSETTE
- Not yet recruiting
General Hospital, Boulogne sur Mer
Boulogne-sur-Mer
Stéphane CHOCHOIS
- Not yet recruiting
University Hospital, Caen
Caen
Grégoire MOUTEL
- Not yet recruiting
General Hospital, Creil
Creil
Georges PATRU
Marie-Laure CLINET
- Recruiting
University Hospital, Lille
Lille
Yann DELANNOY
- Not yet recruiting
University Hospital, Rouen
Rouen
Gilles TOURNEL
- Not yet recruiting
General Hospital, Saint-Quentin
Saint-Quentin
Fabien DELFORGE
- Not yet recruiting
General Hospital, Valenciennes
Valenciennes
Eric LAURIER
About this study
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
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.
Read more
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.
- Being tested
- Vigitrauma
- Keywords
- Post-Traumatic Stress Disorder, Women Health, Physical Abuse, Forensic Medicine, Case-Management Algorithm
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VigitraumaOther
Case management algorithm using early phone contact
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Vigitrauma |
| Control group | No intervention | Usual follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Measured: 3 months
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Measured: 6 months
Clinical Outcome
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Measured: 12 months
Secondary outcomes (7)
Severity of post-traumatic stress disorder symptoms
Post-traumatic stress disorder Checklist Scale-5
Measured: 3 months, 6 months and 12 months
General psychopathology
French version of Mini International Neuropsychiatric Interview (DSM 5)
Measured: 3 months, 6 months and 12 months
Severity of somatic symptoms
Physical Health Questionnaire (PHQ-15)
Measured: 3 months, 6 months and 12 months
Medical cost
Nnumber of hospitalizations, consultations, and drugs consummation
Measured: 12 months
Judicial outcome
Number of days of temporary inability to work
Measured: 12 months
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.
Measured: 12 months
Number of suicide attempters
Suicide risk
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start6 Jul 2021
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Arnaud Leroy, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953273
- Sponsor's protocol ID
- 2020_ 01
- Other IDs
- 2020-A02591-38
- Acronym
- VIGITRAUMA
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04953273
- Acronym / sponsor ID
- VIGITRAUMA / 2020_ 01
- Keywords
- Post-Traumatic Stress Disorder, Women Health, Physical Abuse, Forensic Medicine, Case-Management Algorithm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vigitrauma | Experimental | Other: VigitraumaContact 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. |
| Control group | No intervention | –Usual follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Do no consent to participate to the study
- Intrafamilial or intimate partner violence
- Do not speak french
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VigitraumaCase management algorithm using early phone contact | Other | Vigitrauma |
Primary outcome
Clinical Outcome
Time frame: 3 months
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Clinical Outcome
Time frame: 6 months
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
Clinical Outcome
Time frame: 12 months
Rate of patients with a Clinical Global Impression (CGI) severity scale < 4
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnaud Leroy, MD principal investigator
University Hospital, Lille
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigitrauma in people with Post-Traumatic Stress Disorder and Violence-Related Symptom, run by University Hospital, Lille at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Leroy, MD (+33 320444460, arnaud.leroy@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.