NCT03906487

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

April 4, 2019

Last Update Submit

July 29, 2020

Conditions

Keywords

Intimate partner violenceSelf defining memories

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

EXPERIMENTAL

The 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.

Behavioral: Assessment measures MINI, PCL5 and BDI-II and definition of 5 SDM

Control group

ACTIVE COMPARATOR

The 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.

Behavioral: Assessment measures MINI and definition of 5 SDM

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

Intimate partner violence

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

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

Study Officials

  • Damien PIERRE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie BILLOUX

CONTACT

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

Locations