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

Primary Purpose

Post Traumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diagnosis of depressive episode or post traumatic stress disorder
No diagnosis of depressive episode or post traumatic stress disorder
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Group with complications at 3 month

    Group without complication at 3 month

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    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

    Full Information

    First Posted
    May 12, 2023
    Last Updated
    May 23, 2023
    Sponsor
    Hôpital le Vinatier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05874362
    Brief Title
    People Bereaved by Violent Death : Negative Event Biases and Temporal Perception
    Acronym
    PrEVENT
    Official Title
    People Bereaved by Violent Death : a Negative Event Biases and Temporal Perception Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 29, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2026 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hôpital le Vinatier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Traumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    61 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group with complications at 3 month
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Group without complication at 3 month
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Diagnosis of depressive episode or post traumatic stress disorder
    Intervention Description
    Clinical diagnosis of depressive episode or post traumatic stress disorder, confirmed
    Intervention Type
    Other
    Intervention Name(s)
    No diagnosis of depressive episode or post traumatic stress disorder
    Intervention Description
    No elements in clinical assessment for the diagnosis of a depressive episode or post traumatic stress disorder
    Primary Outcome Measure Information:
    Title
    Amplitude of the Late Positive Potential (LPP) component in unpredictable event condition
    Description
    Measure in Electroencephalography (EEG) of the Late Positive Potential (LPP), an Event Related Potential (ERP) relating to attention biases
    Time Frame
    Between Day15 and Day30 after the death of one's loved one
    Secondary Outcome Measure Information:
    Title
    Amplitude of the Contingent Negative Variation (CNV ) component in unpredictable event condition
    Description
    Measure in Electroencephalography (EEG) of the Contingent Negative Variation (CNV), EEG measures relating to temporal perception
    Time Frame
    Between Day15 and Day30 after the death of one's loved one
    Title
    Amplitude of the alpha and beta power in unpredictable event condition
    Description
    Measure in Electroencephalography (EEG) of the alpha and beta power, EEG measures relating to temporal perception
    Time Frame
    Between Day15 and Day30 after the death of one's loved one
    Title
    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.
    Description
    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
    Time Frame
    Between Day15 and Day30 after the death of one's loved one

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laurene LESTIENNE
    Phone
    0033437915120
    Email
    llaurene.lestienne@ch-le-vinatier.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Véronique VIAL
    Phone
    0033437915522
    Email
    veronique.vial@ch-le-vinatier.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edouard LEAUNE
    Organizational Affiliation
    Vinatier Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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