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RecruitingNCT05874362PrEVENTUpdated Jun 12, 2026

People Bereaved by Violent Death : Negative Event Biases and Temporal Perception

An interventional study of Diagnosis of depressive episode or post traumatic stress disorder and No diagnosis of depressive episode or post traumatic stress disorder in Post Traumatic Stress Disorder, sponsored by Hôpital le Vinatier. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Post Traumatic Stress Disorder
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 61 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • An age between 18 and 65 years old
  • Recent bereavement by violent death of a relative in first and second degree

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (estimated)

Study arms

  • Other
    Group with complications at 3 month

    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.

    Other: Diagnosis of depressive episode or post traumatic stress disorder

  • Other
    Group without complication at 3 month

    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.

    Other: No diagnosis of depressive episode or post traumatic stress disorder

Interventions

  • OtherDiagnosis of depressive episode or post traumatic stress disorder

    Clinical diagnosis of depressive episode or post traumatic stress disorder, confirmed

  • OtherNo diagnosis of depressive episode or post traumatic stress disorder

    No elements in clinical assessment for the diagnosis of a depressive episode or post traumatic stress disorder

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Between Day15 and Day30 after the death of one's loved one

Secondary outcomes

  1. 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

    Time frame: Between Day15 and Day30 after the death of one's loved one

  2. 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

    Time frame: Between Day15 and Day30 after the death of one's loved one

  3. 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

    Time frame: Between Day15 and Day30 after the death of one's loved one

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05874362
Responsible party
Sponsor
First posted
May 24, 2023
Start date
Sep 19, 2023
Primary completion
Sep 19, 2026 (estimated)
Completion
Dec 19, 2026 (estimated)
Last update
Jun 12, 2026

Study contacts

Laurene LESTIENNE
Contact
laurene.lestienne@ch-le-vinatier.fr
0033437915120
Véronique VIAL
Contact
veronique.vial@ch-le-vinatier.fr
0033437915522
Edouard LEAUNE
principal investigator · Vinatier Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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