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

Overview

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.

Interventions

• Behavioral The virtual version of the Social stress task : V-TSST
  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 ex

Primary outcome measures

• Change in salivary cortisol [Time frame: Visit 2 : between 0 to 7 days after inclusion]

Secondary outcome measures (12)

• Changes in cardiovascular response (heart rate) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in cardiovascular response (Cardiac output) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in cardiovascular response (Total peripheral resistance) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in cardiovascular response (time between the two R peaks) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in cardiovascular response (pre-ejection period) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in cardiovascular response (Vascular contractibility) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in cardiovascular response (High frequency) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in cardiovascular response (Low frequency) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in cardiovascular response (Very low frequency) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in cardiovascular response (Root mean squared of successive R-R interval differences) [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Changes in salivary α-amylase [Time frame: Visit 2 : between 0 to 7 days after inclusion]
• Risk Taking decision making after V-TSST [Time frame: Visit 2 : between 0 to 7 days after inclusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Maude SENEQUE — Montpellier

Identifiers

NCT: NCT05227183 · RECMPL21_0405

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗