Self Defining Memories in Women Victims of Intimate Partner Violence.
SOI-MEM
1 other identifier
interventional
80
1 country
1
Brief Summary
A recent report by the World Health Organization demonstrated that 30 % of women worldwide have been victims of intimate-partner violence (IPV). IPV is a public health problem thus it seems important to propose relevant care. It is difficult to carry out an effective therapy. Psychological care is based on cognitive abilities but these women have cognitive impairment. Few studies investigated their cognitive dysfunction. Investigators suggest in this study an exploration of the Self Defining Memories (SDM) which can highlight the loss of identity of these women and a new target of therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 8, 2019
CompletedStudy Start
First participant enrolled
February 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 31, 2020
July 1, 2020
1.7 years
April 4, 2019
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Description of five Self Defining Memories.
These memories are declined in four dimensions: specificity, content, meaning and emotional valence. Investigator will get a proportion of memories which are specific, which are negative, positive or neutral, which have an integrative meaning and which are associated to violence for IPV victims. The results of Self Defining Memories will be compared between a group of IPV victims and a control group.
7 to 10 days after inclusion visit
Secondary Outcomes (4)
Proportions of SDM whose content is associated with discomfort in IPV victims compared to those of control.
7 to 10 days after inclusion visit
Proportions of SDM whose emotional valence is associated with a feeling of redemption or contamination in IPV victims compared to those of control.
7 to 10 days after inclusion visit
Relationships between the 4 dimensions of SDM and psychotraumatic symptoms in IPV victims.
7 to 10 days after inclusion visit
Relationships between the 4 dimensions of SDM and depressive symptoms in IPV victims.
7 to 10 days after inclusion visit
Study Arms (2)
Intimate partner violence
EXPERIMENTALThe women in this arm must have suffered at least two physical aggressions. They will be recruited in the study as part of their coming to the consultation of intentional injury of the medico-legal unit of the University Hospital Toulouse.
Control group
ACTIVE COMPARATORThe women in this group are women who have never experienced domestic violence or have experienced a potentially traumatic event. These women will be recruited by a call for volunteers.
Interventions
This group will have two visits: * the first to verify inclusion criteria and assessed psychotraumatic and depressive symptoms by completing assessment measures called MINI, PCL-5, BDI-II ; * the last to characterize the SDM by defining 5 personal memories
This group will have two visits: * the first to verify inclusion criteria and assessed psychotraumatic and depressive symptoms by completing MINI questionary; * the last to characterize the SDM by and defining 5 personal memories
Eligibility Criteria
You may qualify if:
- For all participants:
- French mother tongue.
- Informed consent.
- Affiliated to social security
- For women who are victims of IPV only:
- Having at least two physical aggressions
- To meet criterion A of the diagnosis of PTSD according to the Diagnostic and Statistical Manual of Mental Disorders DSM (DSM-5) (evaluated using the Mini International Neuropsychiatric Interview, MINI)
- For women of the control group only:
- \- None a victim of IPV
You may not qualify if:
- For all participants:
- Neurological pathology, brain damage.
- History of head trauma with loss of consciousness.
- Severe, progressive somatic pathology
- Psychotherapy in progress
- Taking psychotropic drugs or beta-blockers (because of their potential impact on memory capacity)
- Pregnant or lactating women
- Under a legal regime for the protection of adults
- For women who are victims of IPV only:
- Antecedent or presence of PTSD other than that related to IPV
- History or presence of progressive mental disorders (Axis I DSM-5 - evaluated using Mini International Neuropsychiatric Interview, MINI)
- For women of the control group only:
- History or presence of progressive mental disorders including PTSD (Axis I DSM-5 - evaluated using Mini International Neuropsychiatric Interview, MINI)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Toulouse
Toulouse, France
Study Officials
- PRINCIPAL INVESTIGATOR
Damien PIERRE, MD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 8, 2019
Study Start
February 6, 2020
Primary Completion
November 1, 2021
Study Completion
December 1, 2021
Last Updated
July 31, 2020
Record last verified: 2020-07