Clinical trial NCT05227183: Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis
Official title: Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicidal Behaviour Disorder
Keywords: suicide
social stress
suicide monitoring
cardiovascular
neuroendocrinology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 :

1. 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;
2. Demonstrate that social support, feelings of loneliness and isolation are associated with the prevention of suicidal relapse during VigilanS;
3. Demonstrate that social cognition performance is associated with the prevention of suicidal recidivism during VigilanS;
4. 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.

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

Primary outcomes:
measure: Change in salivary cortisol
timeFrame: Visit 2 : between 0 to 7 days after inclusion
Secondary outcomes:
measure: Changes in cardiovascular response (heart rate)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in cardiovascular response (Cardiac output)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in cardiovascular response (Total peripheral resistance)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in cardiovascular response (time between the two R peaks)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in cardiovascular response (pre-ejection period)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in cardiovascular response (Vascular contractibility)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in cardiovascular response (High frequency)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in cardiovascular response (Low frequency)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in cardiovascular response (Very low frequency)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in cardiovascular response (Root mean squared of successive R-R interval differences)
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in salivary α-amylase
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Risk Taking decision making after V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Sense of fairness/unfairness after V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Prissoner's Dilemma
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Reading the mind in the eyes
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in anxiety level induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in depression level induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in psychological pain level induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in suicidal ideation level induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in social distress level induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in C-Reactive Protein (CRP) induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in Interleukin (IL) - 1b induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in IL-6 induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in IL1β induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in IL4 induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in IL8 induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in IL10 induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in IL13 induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in IL27 induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in NF-KB protein induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in IKB protein induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in Tumor necrosis factor (TNF) - α protein induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in Interferon (IFN) - γ induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in Vascular endothelial growth factor (VEGF) induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in kyrunenine induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in sCD62P induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in sCD40L induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in Platelet factor (PF) 4 induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in RANTES induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in Brain derived neurotrophic factor (BDNF) induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in sOx40L induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in Microparticle induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: Changes in Mitochondrial DNA of platelet origin induced by V-TSST
timeFrame: Visit 2 : between 0 to 7 days after inclusion
measure: loneliness levels
timeFrame: inclusion Visit
measure: Perceived social support
timeFrame: inclusion Visit
measure: Availability of social support
timeFrame: inclusion Visit
measure: Perceived online social support
timeFrame: inclusion Visit
measure: Social isolation
timeFrame: inclusion Visit
measure: Suicidal recurrence
timeFrame: 6months follow up Visit
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Maude SENEQUE
Study officials:
References: