- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07578194
Coercive Control and Intimate Partner Violence (CCVCS)
Coercive Control and Intimate Partner Violence: Examining the Relationships Between Exposure to Violence and Victims' Physical and Mental Health Outcomes
Coercive control (CC) is increasingly recognized as a central component of intimate partner violence (IPV) and a major determinant of victims' health outcomes. While widely integrated into policy and legal frameworks in several countries, CC remains insufficiently explored in the French research context, particularly regarding its clinical and psychopathological dimensions. This gap may limit the identification of victims and the provision of appropriate care.
The present study aims to investigate the association between exposure to coercive control and physical and mental health outcomes among victims of intimate partner violence. By improving the understanding of CC-related health impacts, this research seeks to support better identification of high-risk situations and inform clinical and public health interventions.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Fatima F LE GRIGUER, Principal Investigator
- Telefonnummer: 00 33 1 49 36 72 38
- E-Mail: fatima.le-griguer@ght-gpne.fr
Studienorte
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Île-de-France Region
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Aulnay-sous-Bois, Île-de-France Region, Frankreich, 93600
- CHI Robert Ballanger
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Kontakt:
- Nour BEKOUCHE, Head manager
- Telefonnummer: 0033141708631
- E-Mail: nour.bekouche@ght-gpne.fr
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Hauptermittler:
- Fatima Le Griguer, psychologist
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Women aged 18 years and older, who have experienced an intimate partner relationship involving violence for at least three months (currently in the relationship or separated).
- Women identified as victims of intimate partner violence.
- Sufficient proficiency in French to complete self-administered questionnaires and participate in interviews.
- No objection to participation in the study (non-opposition).
- Affiliation with a French social security scheme or eligibility for universal health coverage (Couverture Maladie Universelle, CMU).
Exclusion Criteria:
- Individuals under legal protection in accordance with the French Public Health Code (Articles L.1121-5 to L.1121-8 and L.1122-1-2), with the exception of pregnant or breastfeeding women.
- Cognitive impairment or severe intellectual disability preventing comprehension of the questionnaires.
- Severe and unstable psychiatric disorders (e.g., schizophrenia, delusional disorders, acute bipolar disorder).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Questionnaire arm
Participants will complete online questionnaires via the Qualtrics platform
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Participants will complete online questionnaires via the Qualtrics platform at baseline and at 6 months post-enrollment
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Coercive Control Screening Scale
Zeitfenster: Measure of CCSS between inlusion and month 6
|
Measure of Coercive Control Screening Scale (CCSS).
Minimal scale = 0, maximal scale = 44.
Higher score means worse outcome
|
Measure of CCSS between inlusion and month 6
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Measure of Hospital Anxiety and Depression scale (HAD scale)
Zeitfenster: Measure of HHAD scale between inclusion and month 6
|
correlation between HAD scale and CCSS scale.
Minimal scale = 0, maximal scale = 42.
Higher score means worse outcome
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Measure of HHAD scale between inclusion and month 6
|
|
Severity of post-traumatic stress disorder symptoms
Zeitfenster: at inclusion and month 6
|
Severity of post-traumatic stress disorder (PTSD) symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5), based on total score and DSM-5 clinical thresholds.
Minimal scale = 0, maximal scale = 80.
Higher score means worse outcome
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at inclusion and month 6
|
|
International Trauma Questionnaire (ITQ).
Zeitfenster: Inclusion and month 6
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International Trauma Questionnaire (ITQ), according to ICD-11 criteria.
Minimal scale = 0, maximal scale = 72.
Higher score means worse outcome
|
Inclusion and month 6
|
|
Severity of emotional dysregulation
Zeitfenster: inclusion and month 6
|
Severity of emotional dysregulation assessed using the Difficulties in Emotion Regulation Scale - French version (DERS-F).
Minimal scale = 36, maximal scale = 180.
Higher score means worse outcome
|
inclusion and month 6
|
|
Short Form Health Survey (SF-12)
Zeitfenster: inclusion and month 6
|
Health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12), including physical and mental component summary scores.
optimal scale more than 40.
scale < 40 means worse outcome
|
inclusion and month 6
|
|
Brief Pain Inventory
Zeitfenster: at inclusion and month 6
|
Pain intensity and functional impact assessed using the Brief Pain Inventory (BPI).
mninimal scale = 0, maximal scale = 10.
Higher score means worse outcome
|
at inclusion and month 6
|
|
Coercive Control Scale (CCSS)
Zeitfenster: inclusion and month 6
|
Analysis of score distribution on the Coercive Control Scale (CCSS) to determine a clinically relevant threshold for coercive control.
Minimal scale = 0, maximal scale = 44.
Higher score means worse outcome
|
inclusion and month 6
|
|
Woman Abuse Screening Tool (WAST)
Zeitfenster: inclusion and month 6
|
Intimate partner violence assessed using the Woman Abuse Screening Tool (WAST).
minimal scale = 0, maximal scale = 16.
Higher score means worse outcome
|
inclusion and month 6
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: fatima F Le Griguer, psychologist, CHI Robert Balanger of GHT GPNE
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GHT GPNE
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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