Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.

NCT ID: NCT06226818

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-08

Study Completion Date

2027-02-28

Brief Summary

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Gender-based or sexual violence, or violence against women (VAW), is a global public health problem affecting around 30% of women over the age of 15, with significant consequences for physical and mental health, including depression and post-traumatic stress disorder (PTSD).

In 2019, the French National Authority for Health (HAS) published recommendations in two parts, one for identifying women who are victims of domestic violence, and the other for dealing with a woman who has been exposed to such violence. But violence against women is not limited to the marital sphere. VAW can simply be detected in a consultation using a translated version of the Abuse Assessment Screen (AAS) questionnaire.

Women who are victims of VAW have specific needs linked to the often repeated nature of the violence they experience, and the complex trauma that can ensue. They also tend to combine other risk factors for poor mental health, such as economic insecurity and social isolation. In France, dealing with the specific medical, psychosocial and legal needs of victims-survivors of VAW has come up against a number of obstacles, including a lack of dedicated care facilities, a lack of trained professionals and a lack of coordination between the various parties. Health professionals rarely receive the training they need to deal with VAW-related issues with confidence and professionalism, and often lack the resources to refer female victims to appropriate care.

"La Maison des Femmes" (MdF) was set up in 2016 in Saint-Denis, located in a department where a quarter of the women who consult a family planning centre (FPC) has suffered from VAW. It is a hospital service specifically dedicated to the individualised, multidisciplinary care of victims-survivors of VAW, offering health, social and legal support within the same facility. The MdF comprises 4 units: a FPC, a violence management unit (involving doctors, midwives, psychologists, social workers, lawyers, police officers and support groups), a female genital mutilation management unit (surgeons and sexologists) and a 24/7 reception unit for victims of sexual violence.

Several MdF-inspired care structures have been set up in France. The service provided by these facilities needs to be evaluated, particularly in terms of their ability to improve the physical and mental health, including post-traumatic stress, of women who have been victims of VAW.

Detailed Description

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Conditions

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Domestic and/or Sexual Violence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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experimental group

Women cared for in a women's centre

completion of scales and questionnaires

Intervention Type OTHER

Patient questionnaires Abuse assessment Screen, Evaluation of the PCL-5 score, Measurement of insomnia severity indexes (ISI), quality of life scores (WHOQOL-BREF), anxiety and depression using the HAD scale (Hospital Anxiety and Depression), self-esteem score using the Rosenberg scale, feeling of security and well-being using five-point Likert scales.

Questionnaire on daily and occasional smoking, alcohol consumption using the Alcohol Use Disorders Identification Test-Concise (AUDIT-C), cannabis dependence using the Cannabis Abuse Screening Test (CAST) and use of other psychoactive substances.

comparator group

Women in a health centre or family planning centre.

completion of scales and questionnaires

Intervention Type OTHER

Patient questionnaires Abuse assessment Screen, Evaluation of the PCL-5 score, Measurement of insomnia severity indexes (ISI), quality of life scores (WHOQOL-BREF), anxiety and depression using the HAD scale (Hospital Anxiety and Depression), self-esteem score using the Rosenberg scale, feeling of security and well-being using five-point Likert scales.

Questionnaire on daily and occasional smoking, alcohol consumption using the Alcohol Use Disorders Identification Test-Concise (AUDIT-C), cannabis dependence using the Cannabis Abuse Screening Test (CAST) and use of other psychoactive substances.

Interventions

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completion of scales and questionnaires

Patient questionnaires Abuse assessment Screen, Evaluation of the PCL-5 score, Measurement of insomnia severity indexes (ISI), quality of life scores (WHOQOL-BREF), anxiety and depression using the HAD scale (Hospital Anxiety and Depression), self-esteem score using the Rosenberg scale, feeling of security and well-being using five-point Likert scales.

Questionnaire on daily and occasional smoking, alcohol consumption using the Alcohol Use Disorders Identification Test-Concise (AUDIT-C), cannabis dependence using the Cannabis Abuse Screening Test (CAST) and use of other psychoactive substances.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women who have not objected to taking part in the trial
* Adult women (≥18 years),
* Victim of domestic and/or sexual violence, consulting at one of our study centres. Exposure to violence, whatever the initial reason for consultation, will be determined by a positive response to at least one question on the French version of the Abuse Assessment Screen, a standardised screening tool which has the advantage of not being limited to domestic violence.
* Ability to understand the objectives of the study and to answer the questionnaires

Exclusion Criteria

* Not affiliated to the national health insurance system
* Person under legal protection (curatorship, guardianship)
* Person under court order
* Adult who is unable to express his/her non-opposition
* Minor
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marc DOMMERGUES

Role: CONTACT

01 42 17 77 01 ext. +33

Facility Contacts

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Marc DOMMERGUES

Role: primary

01 42 17 77 01 ext. +33

References

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El-Khoury F, Ben Ghezala I, Hatem G, Jaffal Z, Soares A, Yacini L, Duchesne S, Dommergues M, Bretelle F, Eudeline S, Hoffmann P, Masse-Navette C, Layachi F, Maurice O, de Foucher de Careil T, Bardou M. IROND-L: study protocol for a French prospective, quasi-experimental, multicentre trial to examine the impact of a coordinated multidisciplinary approach for women victims of violence. BMJ Open. 2024 Nov 19;14(11):e086143. doi: 10.1136/bmjopen-2024-086143.

Reference Type DERIVED
PMID: 39566954 (View on PubMed)

Other Identifiers

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BARDOU PREPS 2022

Identifier Type: -

Identifier Source: org_study_id

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