- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05874362
People Bereaved by Violent Death : Negative Event Biases and Temporal Perception (PrEVENT)
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
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: VERONIQUE VIAL
- Phone Number: 0033437915522
- Email: veronique.vial@ch-le-vinatier.fr
Study Contact Backup
- Name: Laurene LESTIENNE
- Phone Number: 0033437915120
- Email: laurene.lestienne@ch-le-vinatier.fr
Study Locations
-
-
-
Bron, France, 69678
- Recruiting
- Hopital Vinatier
-
Contact:
- LEAUNE EDOUARD, Dr
- Phone Number: +33437915120
- Email: edouard.leaune@ch-le-vinatier.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Edouard LEAUNE, Vinatier Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A00304-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
University of California, Los AngelesRecruitingPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder in ChildrenUnited States
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingPost-Traumatic Stress Disorder in Children | Post-Traumatic Stress Disorder in AdolescenceUnited States
-
University of ZurichCompletedPost Traumatic Stress Disorder (PTSD) | Complex Post-Traumatic Stress Disorder (CPTSD)Switzerland
-
University of NottinghamNottinghamshire Healthcare NHS Trust; Lincolnshire Partnership NHS Foundation...CompletedDomestic Violence | Trauma, Psychological | Post-Traumatic Stress Disorder in Children | Narrative Exposure Therapy | Post-Traumatic Stress Disorder in Adolescence | Post-Traumatic Stress Disorder ComplexUnited Kingdom
-
University Hospital, LilleNot yet recruiting
-
Steinn SteingrimssonRecruiting
-
Direction Centrale du Service de Santé des ArméesRecruitingPost-traumatic Stress DisorderFrance
-
VA Greater Los Angeles Healthcare SystemUniversity of California, Los AngelesRecruitingPost-Traumatic Stress DisorderUnited States
Clinical Trials on Diagnosis of depressive episode or post traumatic stress disorder
-
Hospices Civils de LyonCompletedPregnancy Related | Cytomegalovirus Infections | MothersFrance
-
Centre Hospitalier de NiortCompletedPost-Traumatic Stress Disorder in Old AgeFrance
-
University Hospital, ToulouseCompletedPost-traumatic StressFrance
-
Ryerson UniversityNational Institute of Mental Health (NIMH)CompletedPost-traumatic Stress DisorderCanada, United States
-
Melek InceRecruiting
-
National Taiwan University HospitalRecruiting
-
National University Hospital, SingaporeNational Healthcare Group, SingaporeCompleted
-
National Taiwan University HospitalRecruitingCKD | PAD - Peripheral Arterial DiseaseTaiwan
-
Fondation LenvalCompletedPsychiatric DisorderFrance
-
Micelle BioPharma IncUnknownSickle Cell DiseaseUnited States