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

University Hospital Center (CHU)

Status: Enrolling

Conditions: Suicidal Behaviour Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05227183

RECMPL21_0405

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Patients with suicidal recurrence during VigilanS monitoring (Reattempters)

Experimental group

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

Treatment:

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

Patients without suicidal recurrence during VigilanS monitoring (No reattempters)

Experimental group

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

Treatment:

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