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

Post Traumatic Stress Disorder Clinical Trial

— PrEVENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874362
• Other study ID #: 2023-A00304-41
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Hôpital le Vinatier
• Contact: Laurene LESTIENNE
• Phone: 0033437915120
• Email: laurene.lestienne[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: December 31, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

• 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)

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Diagnosis of depressive episode or post traumatic stress disorder
Clinical diagnosis of depressive episode or post traumatic stress disorder, confirmed
• No 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

Locations

Country	Name	City	State
France	Hopital Vinatier	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Between Day15 and Day30 after the death of one's loved one
Secondary	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	Between Day15 and Day30 after the death of one's loved one
Secondary	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	Between Day15 and Day30 after the death of one's loved one
Secondary	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	Between Day15 and Day30 after the death of one's loved one