Domestic ViolenceSOI-MEMNCT03906487
Self Defining Memories in Women Victims of Intimate Partner Violence.
A study testing Assessment measures MINI, PCL5 and BDI-II and definition of 5 SDM and Assessment measures MINI and definition of 5 SDM in people with Domestic Violence, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Assessment measures MINI, PCL5 and BDI-II and definition of 5 SDM and Assessment measures MINI and definition of 5 SDM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Sophie BILLOUX contact
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse
Damien PIERRE, MD, pierre.d@chu-toulouse.fr
About this study
Official title: Self Defining Memories in Women Victims of Intimate Partner Violence: a Pilot Study.
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.
Read the detailed description
Intimate partner violence among women is associated to identity problems. Indeed, the victims have a poor self esteem and difficulties to express their own wishes. In this study investigators suggest an analysis of a type of memory, that is known to be essential, to profile an identity functioning: self-defining memories. To date, no study has explored SDM in women with IPV. The characteristics of the SDM in women victims of IPV will be compared to a group of women who has never been diagnosed in this situation. Those memories could be used in therapy. A French adaptation of the questionnaire proposed by Singer \& Moffitt (1992) will be used (Berna et al., 2011a, 2011b) for the assessment of SDM.
Four elements will be study: specificity, meaning, content, affect.
The two groups will have two visits:
- the first to verify inclusion criteria and assessed psychotraumatic and depressive symptoms;
- the last to characterize the SDM.
- Conditions
- Domestic Violence
- Being tested
- Assessment measures MINI, PCL5 and BDI-II and definition of 5 SDM, Assessment measures MINI and definition of 5 SDM
- Keywords
- Intimate partner violence, Self defining memories
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment measures MINI, PCL5 and BDI-II and definition of 5 SDMBehavioural
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
Assessment measures MINI and definition of 5 SDMBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Assessment measures MINI and definition of 5 SDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 7 to 10 days after inclusion visit
Relationships between the 4 dimensions of SDM and psychotraumatic symptoms in IPV victims.
These symptoms will be measured via the Posttraumatic Stress Disorder Checklist (PCL-5 scale).This is a self-questionnaire to assess the main symptoms of Post traumatic stress disorder. It has 20 items that evaluate the intensity and frequency of symptoms in the previous month using scores from 1 to 4.The higher the score, the more important the trauma.
Measured: 7 to 10 days after inclusion visit
Relationships between the 4 dimensions of SDM and depressive symptoms in IPV victims.
These symptoms will be measured via the Beck Depressin Inventory (BDI) scale: this is a self-questionnaire to assess the severity of depressive symptoms using 21 items. Once the test is completed, a score is made by decounting, then compared according to the score, thus determining the severity of the depression:
0 - 9: indicates a minor depression 10 - 18: indicates slight depression 19 - 29: indicates moderate depression 30 - 63: indicates severe depression
Measured: 7 to 10 days after inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start6 Feb 2020
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien PIERRE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906487
- Sponsor's protocol ID
- RC31/19/0051
- Acronym
- SOI-MEM
- Status last verified
- Jul 2020
- First submitted
- 4 Apr 2019
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Defining Memories in Women Victims of Intimate Partner Violence: a Pilot Study.
- ClinicalTrials.gov ID
- NCT03906487
- Acronym / sponsor ID
- SOI-MEM / RC31/19/0051
- Conditions
- Domestic Violence
- Keywords
- Intimate partner violence, Self defining memories
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intimate partner violence among women is associated to identity problems. Indeed, the victims have a poor self esteem and difficulties to express their own wishes. In this study investigators suggest an analysis of a type of memory, that is known to be essential, to profile an identity functioning: self-defining memories. To date, no study has explored SDM in women with IPV. The characteristics of the SDM in women victims of IPV will be compared to a group of women who has never been diagnosed in this situation. Those memories could be used in therapy. A French adaptation of the questionnaire proposed by Singer \& Moffitt (1992) will be used (Berna et al., 2011a, 2011b) for the assessment of SDM.
Four elements will be study: specificity, meaning, content, affect.
The two groups will have two visits:
- the first to verify inclusion criteria and assessed psychotraumatic and depressive symptoms;
- the last to characterize the SDM.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intimate partner violence | Experimental | Behavioral: Assessment measures MINI, PCL5 and BDI-II and definition of 5 SDMThe 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 comparator | Behavioral: Assessment measures MINI and definition of 5 SDMThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- French mother tongue.
- Informed consent.
- Affiliated to social security
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment measures MINI, PCL5 and BDI-II and definition of 5 SDMThis 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 | Behavioural | Intimate partner violence |
| Assessment measures MINI and definition of 5 SDMThis 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 | Behavioural | Control group |
Primary outcome
Description of five Self Defining Memories.
Time frame: 7 to 10 days after inclusion visit
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.
4 secondary outcomes
Proportions of SDM whose content is associated with discomfort in IPV victims compared to those of control.
Time frame: 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.
Time frame: 7 to 10 days after inclusion visit
Relationships between the 4 dimensions of SDM and psychotraumatic symptoms in IPV victims.
Time frame: 7 to 10 days after inclusion visit
Relationships between the 4 dimensions of SDM and depressive symptoms in IPV victims.
Time frame: 7 to 10 days after inclusion visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie BILLOUX contact
Damien PIERRE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment measures MINI, PCL5 and BDI-II and definition of 5 SDM and Assessment measures MINI and definition of 5 SDM in people with Domestic Violence, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien PIERRE, MD ((0)5 34 55 75 68 ext. +33, pierre.dam@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of five Self Defining Memories. (time frame: 7 to 10 days after inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.