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NCT Number: NCT05227183

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

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).

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Key information

Conditions

Suicidal Behaviour Disorder Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maude SENEQUE

Montpellier, 34000, France

Location status: Recruiting

Location contact

Maude SENEQUE

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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 outcomes

  1. Change in salivary cortisol

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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 outcomes

  1. Changes in cardiovascular response (heart rate)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    study of the changes in heart rate (HR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.

  2. Changes in cardiovascular response (Cardiac output)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    study of the changes in Cardiac output (CO) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.

  3. Changes in cardiovascular response (Total peripheral resistance)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    study of the changes in Total peripheral resistance (TPR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.

  4. Changes in cardiovascular response (time between the two R peaks)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  5. Changes in cardiovascular response (pre-ejection period)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    study of the changes in pre-ejection period (PEP) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.

  6. Changes in cardiovascular response (Vascular contractibility)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    study of the changes in vascular contractibility (VC) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.

  7. Changes in cardiovascular response (High frequency)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    study of the changes in High frequency (HF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.

  8. Changes in cardiovascular response (Low frequency)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    study of the changes in Low frequency (LF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.

  9. Changes in cardiovascular response (Very low frequency)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    study of the changes in Very low frequency (VLF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.

  10. Changes in cardiovascular response (Root mean squared of successive R-R interval differences)

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  11. Changes in salivary α-amylase

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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

  12. Risk Taking decision making after V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    risk-taking using Iowa Gambling (IG) index from Iowa Gambling Task (IGT)

  13. Sense of fairness/unfairness after V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    Using the total score of Ultimatum

  14. Prissoner's Dilemma

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    Using the sum of A choice´s

  15. Reading the mind in the eyes

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    Using the percentage of correct answer in the test

  16. Changes in anxiety level induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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

  17. Changes in depression level induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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

  18. Changes in psychological pain level induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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

  19. Changes in suicidal ideation level induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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

  20. Changes in social distress level induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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

  21. Changes in C-Reactive Protein (CRP) induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  22. Changes in Interleukin (IL) - 1b induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  23. Changes in IL-6 induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  24. Changes in IL1β induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  25. Changes in IL4 induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  26. Changes in IL8 induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  27. Changes in IL10 induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  28. Changes in IL13 induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  29. Changes in IL27 induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  30. Changes in NF-KB protein induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  31. Changes in IKB protein induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  32. Changes in Tumor necrosis factor (TNF) - α protein induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  33. Changes in Interferon (IFN) - γ induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  34. Changes in Vascular endothelial growth factor (VEGF) induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  35. Changes in kyrunenine induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  36. Changes in sCD62P induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  37. Changes in sCD40L induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  38. Changes in Platelet factor (PF) 4 induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  39. Changes in RANTES induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  40. Changes in Brain derived neurotrophic factor (BDNF) induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  41. Changes in sOx40L induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  42. Changes in Microparticle induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  43. Changes in Mitochondrial DNA of platelet origin induced by V-TSST

    Time frame: Visit 2 : between 0 to 7 days after inclusion

    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.

  44. loneliness levels

    Time frame: inclusion Visit

    Study of response to V-TSST depending on basal loneliness levels assed by UCLA Loneliness Scale. A higher score indicates high loneliness levels

  45. Perceived social support

    Time frame: inclusion Visit

    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

  46. Availability of social support

    Time frame: inclusion Visit

    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

  47. Perceived online social support

    Time frame: inclusion Visit

    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

  48. Social isolation

    Time frame: inclusion Visit

    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

  49. Suicidal recurrence

    Time frame: 6months follow up Visit

    Occurrence of a suicidal event within 6 months of study follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Maude SENEQUE

CONTACT

[email protected]

Philippe Courtet, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: RECONEX

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2022
Registry last updated
Oct 2, 2025

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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