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Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis (RECONEX)

Primary Purpose

Suicidal Behaviour Disorder

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The virtual version of the Social stress task : V-TSST
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Suicidal Behaviour Disorder focused on measuring suicide, social stress, suicide monitoring, cardiovascular, neuroendocrinology

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

For all subjects:

  • Patients benefiting from VigilanS monitoring at CHU Montpellier / Nîmes
  • aged between 18 and 55 years old;
  • able to understand experimental procedures
  • able to speak, read and understand French
  • able to give written informed consent

Specific inclusion criteria:

TS+: Had an actual suicide according to C-SSRS suicidal recurrence during the 6 months prior to VigilanS

TS-: Had not suffered a suicidal recurrence during the 6 months prior to VigilanS

Sites / Locations

  • Maude SENEQUE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with suicidal recurrence during VigilanS monitoring (Reattempters)

Patients without suicidal recurrence during VigilanS monitoring (No reattempters)

Arm Description

Patients with at least a past experience of suicidal attempt (SA), included after their last SA in the 6 months VigilanS monitoring protocol and who have presented a recurrence of SA during this monitoring

Patients with at least a past experience of suicidal attempt (SA), included after their last SA in the 6 months VigilanS monitoring protocol and who have not presented a recurrence of SA during this monitoring

Outcomes

Primary Outcome Measures

Change in salivary cortisol
study of the change in salivary cortisol, across all procedure (from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST)

Secondary Outcome Measures

Changes in cardiovascular response (heart rate)
study of the changes in heart rate (HR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in cardiovascular response (Cardiac output)
study of the changes in Cardiac output (CO) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in cardiovascular response (Total peripheral resistance)
study of the changes in Total peripheral resistance (TPR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in cardiovascular response (time between the two R peaks)
study of the changes in time between the two R peaks(time between the two R peaks) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in cardiovascular response (pre-ejection period)
study of the changes in pre-ejection period (PEP) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in cardiovascular response (Vascular contractibility)
study of the changes in vascular contractibility (VC) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in cardiovascular response (High frequency)
study of the changes in High frequency (HF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in cardiovascular response (Low frequency)
study of the changes in Low frequency (LF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in cardiovascular response (Very low frequency)
study of the changes in Very low frequency (VLF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in cardiovascular response (Root mean squared of successive R-R interval differences)
study of the changes in Root mean squared of successive R-R interval differences (RMSSD) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Changes in salivary α-amylase
Study of the changes in salivary α-amylase, after V-TSST, from -10 to +15, +30, +45 and +60 minutes following the completion fo V-TSST
Risk Taking decision making after V-TSST
risk-taking using Iowa Gambling (IG) index from Iowa Gambling Task (IGT)
Sense of fairness/unfairness after V-TSST
Using the total score of Ultimatum
Prissoner's Dilemma
Using the sum of A choice´s
Reading the mind in the eyes
Using the percentage of correct answer in the test
Changes in anxiety level induced by V-TSST
Changes in psychometric state measures : anxiety using the state anxiety inventory, after V-TSST, from -10 to + 15, + 60 and + 120 minutes post V-TSST
Changes in depression level induced by V-TSST
Changes in psychometric state measures : mood using the Positive and Negative Affect Schedule, after V-TSST, from baseline to + 15, + 60 and + 120 minutes post V-TSST
Changes in psychological pain level induced by V-TSST
Changes in psychometric state measures : psychological pain using a visual analogue scale, after V-TSST, from baseline to + 15, + 60 and + 120 post V-TSST. The score ranges from 0 to 10, a higher score indicates the most important psychological pain
Changes in suicidal ideation level induced by V-TSST
Changes in psychometric state measures : suicidal ideation using a visual analogue scale, after V-TSST, from baseline to + 15, + 60 and + 120 post V-TSST. SST. The score ranges from 0 to 10, a higher score indicates the most important suicidal ideation
Changes in social distress level induced by V-TSST
Changes in psychometric state measures : social distress using a visual analogue scale, after V-TSST, from -10 to + 15, + 60 and + 120 minutes post V-TSST. The score ranges from 0 to 10, a higher score indicates the most important social distress
Changes in C-Reactive Protein (CRP) induced by V-TSST
Study of the changes in CRP, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in Interleukin (IL) - 1b induced by V-TSST
Study of the changes in Interleukin (IL) - 1b after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in IL-6 induced by V-TSST
Study of the changes in IL-6 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in IL1β induced by V-TSST
Study of the changes in IL1β after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in IL4 induced by V-TSST
Study of the changes in IL4 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in IL8 induced by V-TSST
Study of the changes in IL8 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in IL10 induced by V-TSST
Study of the changes in IL10 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in IL13 induced by V-TSST
Study of the changes in IL13 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in IL27 induced by V-TSST
Study of the changes in IL27 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in NF-KB protein induced by V-TSST
Study of the changes in NF-KB protein after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in IKB protein induced by V-TSST
Study of the changes in IKB protein after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in Tumor necrosis factor (TNF) - α protein induced by V-TSST
Study of the changes in Tumor necrosis factor (TNF) - α protein after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in Interferon (IFN) - γ induced by V-TSST
Study of the changes in Interferon (IFN) - γ after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in Vascular endothelial growth factor (VEGF) induced by V-TSST
Study of the changes in Vascular endothelial growth factor (VEGF) after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in kyrunenine induced by V-TSST
Study of the changes in kyrunenine after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in sCD62P induced by V-TSST
Study of the changes in sCD62P after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in sCD40L induced by V-TSST
Study of the changes in sCD40L after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in Platelet factor (PF) 4 induced by V-TSST
Study of the changes in PF4 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in RANTES induced by V-TSST
Study of the changes in RANTES after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in Brain derived neurotrophic factor (BDNF) induced by V-TSST
Study of the changes in BDNF after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in sOx40L induced by V-TSST
Study of the changes in sOx40L after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in Microparticle induced by V-TSST
Study of the changes in Microparticle after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Changes in Mitochondrial DNA of platelet origin induced by V-TSST
Study of the changes in Mitochondrial deoxyribonucleic acid (DNA) of platelet origin after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
loneliness levels
Study of response to V-TSST depending on basal loneliness levels assed by UCLA Loneliness Scale. A higher score indicates high loneliness levels
Perceived social support
Study of response to V-TSST depending on basal perceived social support levels assed by the "Questionnaire de Soutien Social Perçu" . A higher score indicates high perception of social support
Availability of social support
Study of response to V-TSST depending on basal levels of social support assed by the Social Provisions Scale . A higher score indicates high availability of social support
Perceived online social support
Study of response to V-TSST depending on basal levels of online social support assed by the online social support scale . A higher score indicates high perception of online social support
Social isolation
Study of response to V-TSST depending on basal levels of social isolation assed by the Steptoe Social Isolation scale . A higher score indicates high perception of online social support
Suicidal recurrence
Occurrence of a suicidal event within 6 months of study follow up

Full Information

First Posted
January 26, 2022
Last Updated
January 26, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05227183
Brief Title
Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis
Acronym
RECONEX
Official Title
Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

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
The World Health Organization (WHO) estimates, with 800,000 annual deaths, that suicide is the second leading cause of death in people aged 10 to 44 and thus recognizes suicide prevention as a public health priority. The psychological impact of the COVID-19 pandemic, the social isolation and the economic consequences engendered by the confinement, as well as the direct effects of this viral infection increase suicidal mortality. Sensitivity to social rejection in suicide : Epidemiological and clinical studies indicate that social isolation and loneliness are very strongly associated with suicide. Our works suggests that suicide vulnerability is associated with specific processing of social information related to brain regions playing a role in psychological pain and inflammation. In fact, social stresses are powerful inducers of inflammation, also associated with suicide. Thus, we hypothesize that patients at risk of suicide could be particularly sensitive to social adversity (social stress / lack of social support), via the activation of specific brain regions regulating social cognitions, psychological pain and 'inflammation. The VigilanS device: a monitoring tool in suicide prevention. VigilanS is a national telephone recontact system initiated in 2015, which has already shown its effectiveness in preventing suicidal recurrence. Patients admitted to the Emergency Department of the Montpellier and Nimes CHUs for SA benefit from VigilanS monitoring for 6 months (period of major risk). These organized calls aim to assess the patient's condition, manage a possible suicidal crisis and ensure the compromise for discharge from the emergency room. It is important to determine the factors explaining the effectiveness of this device. Thus, we formulate the hypothesis that VigilanS prevents suicidal recurrence by acting on the restoration of the social bond in subjects vulnerable to suicide and isolated. We will test the hypothesis that the preventive effect of the VigilanS device on suicidal recurrence during the 6 months of the day before depends on the sensitivity to social stress of the suicidal patients (measured by the response to an experimental task of social stress).
Detailed Description
Main Objective : To compare the cortisol response to an experimental social stress task, the virtual trier social stress test (V-TSST), between patients who performed a relapse in suicide attempt (TS+) vs. did not relapsed (TS-) during the VigilanS monitoring . Secondary Objectives : To compare the biological (alpha amylase and inflammatory markers), cardiac (heart rate variability), and emotional response to an experimental social stress task (V-TSST), between patients who reattempted suicide (TS+) vs. those that did not (TS-) during the VigilanS monitoring; Demonstrate that social support, feelings of loneliness and isolation are associated with the prevention of suicidal relapse during VigilanS; Demonstrate that social cognition performance is associated with the prevention of suicidal recidivism during VigilanS; To assess the predictive value of the experimental social stress response regarding suicidal relapse during an additional 6 months of follow-up (without VigilanS monitoring) It is an interventional research, multicentric, which involves only minimal risks and constraints. We will recruit 120 patients who had performed a suicide attempt according to the Columbia-suicide severity rating scale (C-SSRS) and were included in VigilanS. 60 patients who had a suicidal recurrence during the 6 months of the VigilanS monitoring protocol (TS+) according to the Columbia-suicide severity rating scale (C-SSRS). 60 patients who had not suffered a suicidal recurrence during the 6 months of the VigilanS monitoring protocol (TS-). Patient participation includes 3 visits : inclusion visit (clinical ans psychological assessment), experimental Visit (V-TSST with cardiovascular, neuroendocrine, inflammatory measures), 6months follow up visit to assess suicidal recurrence Perspectives : This study will contribute to a better understanding of the pathophysiological mechanisms of suicidal behavior in a social stress environment. The results could help us to prevent suicidal behavior in the most vulnerable individuals and, potentially, to develop a therapeutic approach complementary to VigilanS such as biofeedback and mindfulness interventions in difficult situations so that patients can better adapt to social stressors in real life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Behaviour Disorder
Keywords
suicide, social stress, suicide monitoring, cardiovascular, neuroendocrinology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
non applicable
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with suicidal recurrence during VigilanS monitoring (Reattempters)
Arm Type
Experimental
Arm Description
Patients with at least a past experience of suicidal attempt (SA), included after their last SA in the 6 months VigilanS monitoring protocol and who have presented a recurrence of SA during this monitoring
Arm Title
Patients without suicidal recurrence during VigilanS monitoring (No reattempters)
Arm Type
Experimental
Arm Description
Patients with at least a past experience of suicidal attempt (SA), included after their last SA in the 6 months VigilanS monitoring protocol and who have not presented a recurrence of SA during this monitoring
Intervention Type
Behavioral
Intervention Name(s)
The virtual version of the Social stress task : V-TSST
Intervention Description
The task consists in a brief presentation about the abilities of participants followed by an arithmetic task in front of a virtual 3D audience projected and one researcher in a room.First, participants have 5 minutes to prepare an exhibition about their qualities, their strengths and defects, and, why they identify with them. During this period virtual reality shows a closed curtain, and sounds from the audience can be heard. In the second phase, the curtain is raised and the participant must expose his speech during 5 minutes. Audience will remain attentive during 2 minutes, then audience will change to a restless attitude. The third phase consists of subtracting back a two-digit number from a four-digit number, as quickly as possible, starting again if participant makes a mistake. A debriefing of the test is scheduled at the end of the protocol, to remind patients of the purely fictional nature of this test. The visit will only end after a return to the baseline emotional state
Primary Outcome Measure Information:
Title
Change in salivary cortisol
Description
study of the change in salivary cortisol, across all procedure (from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST)
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Secondary Outcome Measure Information:
Title
Changes in cardiovascular response (heart rate)
Description
study of the changes in heart rate (HR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in cardiovascular response (Cardiac output)
Description
study of the changes in Cardiac output (CO) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in cardiovascular response (Total peripheral resistance)
Description
study of the changes in Total peripheral resistance (TPR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in cardiovascular response (time between the two R peaks)
Description
study of the changes in time between the two R peaks(time between the two R peaks) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in cardiovascular response (pre-ejection period)
Description
study of the changes in pre-ejection period (PEP) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in cardiovascular response (Vascular contractibility)
Description
study of the changes in vascular contractibility (VC) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in cardiovascular response (High frequency)
Description
study of the changes in High frequency (HF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in cardiovascular response (Low frequency)
Description
study of the changes in Low frequency (LF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in cardiovascular response (Very low frequency)
Description
study of the changes in Very low frequency (VLF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in cardiovascular response (Root mean squared of successive R-R interval differences)
Description
study of the changes in Root mean squared of successive R-R interval differences (RMSSD) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in salivary α-amylase
Description
Study of the changes in salivary α-amylase, after V-TSST, from -10 to +15, +30, +45 and +60 minutes following the completion fo V-TSST
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Risk Taking decision making after V-TSST
Description
risk-taking using Iowa Gambling (IG) index from Iowa Gambling Task (IGT)
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Sense of fairness/unfairness after V-TSST
Description
Using the total score of Ultimatum
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Prissoner's Dilemma
Description
Using the sum of A choice´s
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Reading the mind in the eyes
Description
Using the percentage of correct answer in the test
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in anxiety level induced by V-TSST
Description
Changes in psychometric state measures : anxiety using the state anxiety inventory, after V-TSST, from -10 to + 15, + 60 and + 120 minutes post V-TSST
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in depression level induced by V-TSST
Description
Changes in psychometric state measures : mood using the Positive and Negative Affect Schedule, after V-TSST, from baseline to + 15, + 60 and + 120 minutes post V-TSST
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in psychological pain level induced by V-TSST
Description
Changes in psychometric state measures : psychological pain using a visual analogue scale, after V-TSST, from baseline to + 15, + 60 and + 120 post V-TSST. The score ranges from 0 to 10, a higher score indicates the most important psychological pain
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in suicidal ideation level induced by V-TSST
Description
Changes in psychometric state measures : suicidal ideation using a visual analogue scale, after V-TSST, from baseline to + 15, + 60 and + 120 post V-TSST. SST. The score ranges from 0 to 10, a higher score indicates the most important suicidal ideation
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in social distress level induced by V-TSST
Description
Changes in psychometric state measures : social distress using a visual analogue scale, after V-TSST, from -10 to + 15, + 60 and + 120 minutes post V-TSST. The score ranges from 0 to 10, a higher score indicates the most important social distress
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in C-Reactive Protein (CRP) induced by V-TSST
Description
Study of the changes in CRP, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in Interleukin (IL) - 1b induced by V-TSST
Description
Study of the changes in Interleukin (IL) - 1b after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in IL-6 induced by V-TSST
Description
Study of the changes in IL-6 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in IL1β induced by V-TSST
Description
Study of the changes in IL1β after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in IL4 induced by V-TSST
Description
Study of the changes in IL4 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in IL8 induced by V-TSST
Description
Study of the changes in IL8 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in IL10 induced by V-TSST
Description
Study of the changes in IL10 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in IL13 induced by V-TSST
Description
Study of the changes in IL13 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in IL27 induced by V-TSST
Description
Study of the changes in IL27 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in NF-KB protein induced by V-TSST
Description
Study of the changes in NF-KB protein after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in IKB protein induced by V-TSST
Description
Study of the changes in IKB protein after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in Tumor necrosis factor (TNF) - α protein induced by V-TSST
Description
Study of the changes in Tumor necrosis factor (TNF) - α protein after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in Interferon (IFN) - γ induced by V-TSST
Description
Study of the changes in Interferon (IFN) - γ after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in Vascular endothelial growth factor (VEGF) induced by V-TSST
Description
Study of the changes in Vascular endothelial growth factor (VEGF) after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in kyrunenine induced by V-TSST
Description
Study of the changes in kyrunenine after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in sCD62P induced by V-TSST
Description
Study of the changes in sCD62P after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in sCD40L induced by V-TSST
Description
Study of the changes in sCD40L after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in Platelet factor (PF) 4 induced by V-TSST
Description
Study of the changes in PF4 after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in RANTES induced by V-TSST
Description
Study of the changes in RANTES after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in Brain derived neurotrophic factor (BDNF) induced by V-TSST
Description
Study of the changes in BDNF after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in sOx40L induced by V-TSST
Description
Study of the changes in sOx40L after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in Microparticle induced by V-TSST
Description
Study of the changes in Microparticle after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
Changes in Mitochondrial DNA of platelet origin induced by V-TSST
Description
Study of the changes in Mitochondrial deoxyribonucleic acid (DNA) of platelet origin after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Time Frame
Visit 2 : between 0 to 7 days after inclusion
Title
loneliness levels
Description
Study of response to V-TSST depending on basal loneliness levels assed by UCLA Loneliness Scale. A higher score indicates high loneliness levels
Time Frame
inclusion Visit
Title
Perceived social support
Description
Study of response to V-TSST depending on basal perceived social support levels assed by the "Questionnaire de Soutien Social Perçu" . A higher score indicates high perception of social support
Time Frame
inclusion Visit
Title
Availability of social support
Description
Study of response to V-TSST depending on basal levels of social support assed by the Social Provisions Scale . A higher score indicates high availability of social support
Time Frame
inclusion Visit
Title
Perceived online social support
Description
Study of response to V-TSST depending on basal levels of online social support assed by the online social support scale . A higher score indicates high perception of online social support
Time Frame
inclusion Visit
Title
Social isolation
Description
Study of response to V-TSST depending on basal levels of social isolation assed by the Steptoe Social Isolation scale . A higher score indicates high perception of online social support
Time Frame
inclusion Visit
Title
Suicidal recurrence
Description
Occurrence of a suicidal event within 6 months of study follow up
Time Frame
6months follow up Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For all subjects: Patients benefiting from VigilanS monitoring at CHU Montpellier / Nîmes aged between 18 and 55 years old; able to understand experimental procedures able to speak, read and understand French able to give written informed consent Specific inclusion criteria: TS+: Had an actual suicide according to C-SSRS suicidal recurrence during the 6 months prior to VigilanS TS-: Had not suffered a suicidal recurrence during the 6 months prior to VigilanS
Facility Information:
Facility Name
Maude SENEQUE
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis

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