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

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05874362
Collaborator
(none)
61
2
43.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diagnosis of depressive episode or post traumatic stress disorder
  • Other: No diagnosis of depressive episode or post traumatic stress disorder
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
61 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
People Bereaved by Violent Death : a Negative Event Biases and Temporal Perception Study
Anticipated Study Start Date :
May 29, 2023
Anticipated Primary Completion Date :
Feb 28, 2026
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

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.

Other: Diagnosis of depressive episode or post traumatic stress disorder
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.

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

Outcome Measures

Primary Outcome Measures

  1. Amplitude of the Late Positive Potential (LPP) component in unpredictable event condition [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

Secondary Outcome Measures

  1. Amplitude of the Contingent Negative Variation (CNV ) component in unpredictable event condition [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

  2. Amplitude of the alpha and beta power in unpredictable event condition [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

  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. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hôpital le Vinatier

Investigators

  • Principal Investigator: Edouard LEAUNE, Vinatier Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT05874362
Other Study ID Numbers:
  • 2023-A00304-41
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2023