Post Traumatic Stress DisorderPrEVENTNCT05874362
People Bereaved by Violent Death : Negative Event Biases and Temporal Perception
A study testing Diagnosis of depressive episode or post traumatic stress disorder and No diagnosis of depressive episode or post traumatic stress disorder in people with Post Traumatic Stress Disorder, run by Hôpital le Vinatier at 1 site in France.
Trial summary
A violent death is defined by its brutality, unexpectedness and is secondary to an external cause (suicide, homicide, accident). Bereavement following a violent death constitutes a particular clinical situation, at risk of complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Diagnosis of depressive episode or post traumatic stress disorder and No diagnosis of depressive episode or post traumatic stress disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2023to 19 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An age between 18 and 65 years old
- Recent bereavement by violent death of a relative in first and second degree
Who cannot join
- Protected adults
- Lack of mastering French language
- History of neurodegenerative disorder
- History of psychiatric disorder treated pharmacologically with modification of the basic treatment in the month preceding the death
- The take of an benzodiazepine treatment in the 24th hours before the first visit (T0)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Vinatier
Bron, 69678
LEAUNE EDOUARD, Dr, +33437915120, edouard.leaune@ch-le-vinatier.fr
About this study
Official title: People Bereaved by Violent Death : a Negative Event Biases and Temporal Perception Study
A violent death is defined by its brutality, unexpectedness and is secondary to an external cause (suicide, homicide, accident). Bereavement following a violent death constitutes a particular clinical situation, at risk of complications. Research on bereavement after a violent death shows higher risks of psychiatric and somatic complications than in bereavement by non-violent death. These complications, sometimes comorbid, take the form of depressive episodes, post-traumatic stress disorders, suicidal behavior and prolonged grief disorders after 12 months, precociously mediated by ruminations.
Processes responsible for this increased risk of complications are poorly documented. Current literature relates mainly to socio-demographic and epidemiological factors which, alone, do not explain this difference in risks. Further research is needed exploring other kinds of data and processes. To our knowledge, there is no description of early neurocognitive functioning in people bereaved after violent death. This study aims at exploring early neurocognitive processes which can lead to complications in people bereaved by violent death.
Read the detailed description
This work is based on cognitive models of post-traumatic stress disorder involving cognitive biases as factors of development and maintenance of symptomatology. Indeed, in people exposed to a potentially traumatic event, it has been found that an early deterioration in cognitive functioning is a risk factor for developing post-traumatic stress disorders . Among these cognitive alterations, attentional biases toward threat are the most explored and research shows both facilitated engagement and difficulties in disengagement in front of threatening stimuli. In addition, while expecting for a negative event, there is changes in the perception of time . These processes can be explored on a behavioral level and in electroencephalography , in particular through the evoked related potentials following a stimulus. Among these evoked related potentials , the Late Positive Potential component reflects the attentional process, while the Contingent Negative Variation component and the α and β power reflects temporal perception.
As exposure to violent death can have a traumatic impact, our hypothesis is that people bereaved by violent death could present attentional biases, and that these biases would be prodromal of the onset of a psychiatric disorder (Post-traumatic stress disorders , depression afterwards). The objective of this study is to describe the presence of these biases through electrophysiological and behavioral measures in a sample of subjects bereaved by violent death.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Diagnosis of depressive episode or post traumatic stress disorder, No diagnosis of depressive episode or post traumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of depressive episode or post traumatic stress disorderOther
Clinical diagnosis of depressive episode or post traumatic stress disorder, confirmed
No diagnosis of depressive episode or post traumatic stress disorderOther
No elements in clinical assessment for the diagnosis of a depressive episode or post traumatic stress disorder
| Study group | Role | What they receive |
|---|---|---|
| Group with complications at 3 month | Other | Group composed with participants who develop a psychiatric complication (depressive episode or post traumatic stress disorder) 3 month after the death of their loved one. Receives: Other: Diagnosis of depressive episode or post traumatic stress disorder |
| Group without complication at 3 month | Other | Group composed with participants who do not develop a psychiatric complication (depressive episode or post traumatic stress disorder) 3 month after the death of their loved one. Receives: Other: No diagnosis of depressive episode or post traumatic stress disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of the Late Positive Potential (LPP) component in unpredictable event condition
Measure in Electroencephalography (EEG) of the Late Positive Potential (LPP), an Event Related Potential (ERP) relating to attention biases
Measured: Between Day15 and Day30 after the death of one's loved one
Secondary outcomes (3)
Amplitude of the Contingent Negative Variation (CNV ) component in unpredictable event condition
Measure in Electroencephalography (EEG) of the Contingent Negative Variation (CNV), EEG measures relating to temporal perception
Measured: Between Day15 and Day30 after the death of one's loved one
Amplitude of the alpha and beta power in unpredictable event condition
Measure in Electroencephalography (EEG) of the alpha and beta power, EEG measures relating to temporal perception
Measured: Between Day15 and Day30 after the death of one's loved one
Comparison of Constant Errors (CE) relative to time estimates in the unpredictability condition (D15-J30) in people developing a psychiatric complication at 3 months and in people not developing these complications.
Proportion of overestimation of the duration preceding an unpredictable event, and calculation of the point of subjective equality, for measurements of constant errors (CEs) corresponding to the difference between the effective time and the point of subjective equality for each subject
Measured: Between Day15 and Day30 after the death of one's loved one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start19 Sep 2023
- Primary completion19 Sep 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be separated into two groups at the end of the study to conduct analyses, depending on the development of a psychiatric complication or not.
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard LEAUNE, Principal investigator, Vinatier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874362
- Sponsor's protocol ID
- 2023-A00304-41
- Acronym
- PrEVENT
- Status last verified
- Jun 2026
- First submitted
- 12 May 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- People Bereaved by Violent Death : a Negative Event Biases and Temporal Perception Study
- ClinicalTrials.gov ID
- NCT05874362
- Acronym / sponsor ID
- PrEVENT / 2023-A00304-41
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 19 Sep 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 24 May 2023 (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 violent death is defined by its brutality, unexpectedness and is secondary to an external cause (suicide, homicide, accident). Bereavement following a violent death constitutes a particular clinical situation, at risk of complications. Research on bereavement after a violent death shows higher risks of psychiatric and somatic complications than in bereavement by non-violent death. These complications, sometimes comorbid, take the form of depressive episodes, post-traumatic stress disorders, suicidal behavior and prolonged grief disorders after 12 months, precociously mediated by ruminations.
Processes responsible for this increased risk of complications are poorly documented. Current literature relates mainly to socio-demographic and epidemiological factors which, alone, do not explain this difference in risks. Further research is needed exploring other kinds of data and processes. To our knowledge, there is no description of early neurocognitive functioning in people bereaved after violent death. This study aims at exploring early neurocognitive processes which can lead to complications in people bereaved by violent death.
Detailed description
This work is based on cognitive models of post-traumatic stress disorder involving cognitive biases as factors of development and maintenance of symptomatology. Indeed, in people exposed to a potentially traumatic event, it has been found that an early deterioration in cognitive functioning is a risk factor for developing post-traumatic stress disorders . Among these cognitive alterations, attentional biases toward threat are the most explored and research shows both facilitated engagement and difficulties in disengagement in front of threatening stimuli. In addition, while expecting for a negative event, there is changes in the perception of time . These processes can be explored on a behavioral level and in electroencephalography , in particular through the evoked related potentials following a stimulus. Among these evoked related potentials , the Late Positive Potential component reflects the attentional process, while the Contingent Negative Variation component and the α and β power reflects temporal perception.
As exposure to violent death can have a traumatic impact, our hypothesis is that people bereaved by violent death could present attentional biases, and that these biases would be prodromal of the onset of a psychiatric disorder (Post-traumatic stress disorders , depression afterwards). The objective of this study is to describe the presence of these biases through electrophysiological and behavioral measures in a sample of subjects bereaved by violent death.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be separated into two groups at the end of the study to conduct analyses, depending on the development of a psychiatric complication or not.
| Arm | Type | Receives |
|---|---|---|
| Group with complications at 3 month | Other | Other: Diagnosis of depressive episode or post traumatic stress disorderGroup composed with participants who develop a psychiatric complication (depressive episode or post traumatic stress disorder) 3 month after the death of their loved one. |
| Group without complication at 3 month | Other | Other: No diagnosis of depressive episode or post traumatic stress disorderGroup composed with participants who do not develop a psychiatric complication (depressive episode or post traumatic stress disorder) 3 month after the death of their loved one. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- An age between 18 and 65 years old
- Recent bereavement by violent death of a relative in first and second degree
Key exclusion criteria (5 listed)
- Protected adults
- Lack of mastering French language
- History of neurodegenerative disorder
- History of psychiatric disorder treated pharmacologically with modification of the basic treatment in the month preceding the death
- The take of an benzodiazepine treatment in the 24th hours before the first visit (T0)
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 |
|---|---|---|
| Diagnosis of depressive episode or post traumatic stress disorderClinical diagnosis of depressive episode or post traumatic stress disorder, confirmed | Other | Group with complications at 3 month |
| No diagnosis of depressive episode or post traumatic stress disorderNo elements in clinical assessment for the diagnosis of a depressive episode or post traumatic stress disorder | Other | Group without complication at 3 month |
Primary outcome
Amplitude of the Late Positive Potential (LPP) component in unpredictable event condition
Time frame: Between Day15 and Day30 after the death of one's loved one
Measure in Electroencephalography (EEG) of the Late Positive Potential (LPP), an Event Related Potential (ERP) relating to attention biases
3 secondary outcomes
Amplitude of the Contingent Negative Variation (CNV ) component in unpredictable event condition
Time frame: Between Day15 and Day30 after the death of one's loved one
Amplitude of the alpha and beta power in unpredictable event condition
Time frame: Between Day15 and Day30 after the death of one's loved one
Comparison of Constant Errors (CE) relative to time estimates in the unpredictability condition (D15-J30) in people developing a psychiatric complication at 3 months and in people not developing these complications.
Time frame: Between Day15 and Day30 after the death of one's loved one
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Edouard LEAUNE principal investigator
Vinatier Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis of depressive episode or post traumatic stress disorder and No diagnosis of depressive episode or post traumatic stress disorder in people with Post Traumatic Stress Disorder, run by Hôpital le Vinatier 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurene LESTIENNE (0033437915120, laurene.lestienne@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of the Late Positive Potential (LPP) component in unpredictable event condition (time frame: Between Day15 and Day30 after the death of one's loved one). 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 12 Jun 2026.