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Suicidal Behaviour DisorderRECONEXNCT05227183

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

A study testing The virtual version of the Social stress task : V-TSST in people with Suicidal Behaviour Disorder, run by University Hospital, Montpellier at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Suicidal Behaviour Disorder
What is being tested?
The virtual version of the Social stress task : V-TSST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteFrance
Study dates
12 Sep 2024to 13 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Philippe Courtet, PhD contact

p-courtet@chu-montpellier.fr

Maude SENEQUE contact

m-senequehaize@chu-montpellier.fr

France1 site, 1 recruiting

  • Maude SENEQUE

    Montpellier, 34000

    Maude SENEQUE, m-senequehaize@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

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.

Read more

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).

Read the 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.

Being tested
The virtual version of the Social stress task : V-TSST
Keywords
suicide, social stress, suicide monitoring, cardiovascular, neuroendocrinology
Medical subject headings
Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The virtual version of the Social stress task : V-TSSTBehavioural

    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

Study groups in NCT05227183
Study groupRoleWhat they receive
Patients with suicidal recurrence during VigilanS monitoring (Reattempters)ExperimentalPatients 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
Receives: Behavioral: The virtual version of the Social stress task : V-TSST
Patients without suicidal recurrence during VigilanS monitoring (No reattempters)ExperimentalPatients 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
Receives: Behavioral: The virtual version of the Social stress task : V-TSST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Visit 2 : between 0 to 7 days after inclusion

Secondary outcomes (49)

  1. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  2. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  3. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  4. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  5. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  6. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  7. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  8. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  9. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  10. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  11. 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

    Measured: Visit 2 : between 0 to 7 days after inclusion

  12. Risk Taking decision making after V-TSST

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

    Measured: Visit 2 : between 0 to 7 days after inclusion

  13. Sense of fairness/unfairness after V-TSST

    Using the total score of Ultimatum

    Measured: Visit 2 : between 0 to 7 days after inclusion

  14. Prissoner's Dilemma

    Using the sum of A choice´s

    Measured: Visit 2 : between 0 to 7 days after inclusion

  15. Reading the mind in the eyes

    Using the percentage of correct answer in the test

    Measured: Visit 2 : between 0 to 7 days after inclusion

  16. 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

    Measured: Visit 2 : between 0 to 7 days after inclusion

  17. 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

    Measured: Visit 2 : between 0 to 7 days after inclusion

  18. 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

    Measured: Visit 2 : between 0 to 7 days after inclusion

  19. 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

    Measured: Visit 2 : between 0 to 7 days after inclusion

  20. 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

    Measured: Visit 2 : between 0 to 7 days after inclusion

  21. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  22. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  23. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  24. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  25. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  26. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  27. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  28. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  29. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  30. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  31. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  32. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  33. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  34. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  35. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  36. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  37. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  38. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  39. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  40. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  41. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  42. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  43. 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.

    Measured: Visit 2 : between 0 to 7 days after inclusion

  44. 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

    Measured: inclusion Visit

  45. 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

    Measured: inclusion Visit

  46. 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

    Measured: inclusion Visit

  47. 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

    Measured: inclusion Visit

  48. 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

    Measured: inclusion Visit

  49. Suicidal recurrence

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

    Measured: 6months follow up Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start12 Sep 2024
  3. Primary completion13 Mar 2027 (estimated)
  4. Study completion13 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05227183
Sponsor's protocol ID
RECMPL21_0405
Acronym
RECONEX
Status last verified
Sep 2025
First submitted
26 Jan 2022
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing The virtual version of the Social stress task : V-TSST in people with Suicidal Behaviour Disorder, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philippe Courtet, PhD (p-courtet@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in salivary cortisol (time frame: Visit 2 : between 0 to 7 days after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05227183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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