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

NCT05874362 | Recruiting

• 1 other identifier: 2023-A00304-41
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

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

  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

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

• Amplitude of the alpha and beta power in unpredictable event condition

  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.

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

Study Arms (2)

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.

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.

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

Interventions

Diagnosis of depressive episode or post traumatic stress disorder OTHER

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

Group with complications at 3 month

No diagnosis of depressive episode or post traumatic stress disorder OTHER

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

Group without complication at 3 month

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Hopital Vinatier

Bron, 69678, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Edouard LEAUNE

  Vinatier Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurene LESTIENNE

CONTACT

0033437915120; laurene.lestienne@ch-le-vinatier.fr

Véronique VIAL

CONTACT

0033437915522; veronique.vial@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 24, 2023
• Study Start: September 19, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)