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.

NCT06226818 | Recruiting

• 1 other identifier: BARDOU PREPS 2022
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Domestic and/or Sexual Violence

Outcome Measures

Primary Outcomes (2)

• Change in mean PCL-5 score

  measured using the validated French version of the Post-traumatic Stress Disorder Checklist for DSM-V (score from 0 to 80).

  Through study completion, an average of 6 months

• Change in the proportion of women with a PCL-5 score < 33 (validated threshold for absence of overt PTSD)

  measured using the validated French version of the Post-traumatic Stress Disorder Checklist for DSM-V (score from 0 to 80).

  Through study completion, an average of 6 months

Study Arms (2)

experimental group

Women cared for in a women's centre

Other: completion of scales and questionnaires

comparator group

Women in a health centre or family planning centre.

Other: completion of scales and questionnaires

Interventions

completion of scales and questionnaires 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; experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be identified by a doctor at one of the participating centres, on the basis of their response to the AAS questionnaire during the initial consultation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 39566954 DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Marc DOMMERGUES

CONTACT

01 42 17 77 01; marc.dommergues@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 26, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

FR (1)