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

NCT ID: NCT05874362

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2026-12-31

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Diagnosis of depressive episode or post traumatic stress disorder

Intervention Type: OTHER

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

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.

Group Type: OTHER

No diagnosis of depressive episode or post traumatic stress disorder

Intervention Type: OTHER

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

Interventions

Diagnosis of depressive episode or post traumatic stress disorder

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edouard LEAUNE

Role: PRINCIPAL_INVESTIGATOR

Vinatier Hospital

Locations

Hopital Vinatier

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laurene LESTIENNE

Role: CONTACT

laurene.lestienne@ch-le-vinatier.fr

0033437915120

Véronique VIAL

Role: CONTACT

veronique.vial@ch-le-vinatier.fr

0033437915522

Facility Contacts

LEAUNE EDOUARD, Dr

Role: primary

edouard.leaune@ch-le-vinatier.fr

+33437915120

Other Identifiers

2023-A00304-41

Identifier Type: -

Identifier Source: org_study_id