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

February 13, 2024 updated by: Hôpital le Vinatier

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Clinical diagnosis of depressive episode or post traumatic stress disorder, confirmed
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.
No elements in clinical assessment for the diagnosis of a depressive episode or post traumatic stress disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between Day15 and Day30 after the death of one's loved one

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Edouard LEAUNE, Vinatier Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2023

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Traumatic Stress Disorder

Clinical Trials on Diagnosis of depressive episode or post traumatic stress disorder

3
Subscribe