Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in salivary cortisol
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
non applicable
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Patients with suicidal recurrence during VigilanS monitoring (Reattempters)
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
干预措施: The virtual version of the Social stress task : V-TSST (Behavioral)
Patients without suicidal recurrence during VigilanS monitoring (No reattempters)
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
干预措施: The virtual version of the Social stress task : V-TSST (Behavioral)
结局指标
主要结局
Change in salivary cortisol
时间窗: 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)
次要结局
- Changes in cardiovascular response (Vascular contractibility)(Visit 2 : between 0 to 7 days after inclusion)
- Changes in cardiovascular response (Very low frequency)(Visit 2 : between 0 to 7 days after inclusion)
- Sense of fairness/unfairness after V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Reading the mind in the eyes(Visit 2 : between 0 to 7 days after inclusion)
- Changes in suicidal ideation level induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in IL10 induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in IL13 induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in IL27 induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in NF-KB protein induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in cardiovascular response (pre-ejection period)(Visit 2 : between 0 to 7 days after inclusion)
- Changes in cardiovascular response (Total peripheral resistance)(Visit 2 : between 0 to 7 days after inclusion)
- Changes in cardiovascular response (Root mean squared of successive R-R interval differences)(Visit 2 : between 0 to 7 days after inclusion)
- Changes in cardiovascular response (Cardiac output)(Visit 2 : between 0 to 7 days after inclusion)
- Changes in cardiovascular response (Low frequency)(Visit 2 : between 0 to 7 days after inclusion)
- Changes in salivary α-amylase(Visit 2 : between 0 to 7 days after inclusion)
- Changes in depression level induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in kyrunenine induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in cardiovascular response (heart rate)(Visit 2 : between 0 to 7 days after inclusion)
- Changes in cardiovascular response (time between the two R peaks)(Visit 2 : between 0 to 7 days after inclusion)
- Changes in cardiovascular response (High frequency)(Visit 2 : between 0 to 7 days after inclusion)
- Risk Taking decision making after V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Prissoner's Dilemma(Visit 2 : between 0 to 7 days after inclusion)
- Changes in psychological pain level induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in Interleukin (IL) - 1b induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in IL-6 induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in IL8 induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in Tumor necrosis factor (TNF) - α protein induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in sCD62P induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in Vascular endothelial growth factor (VEGF) induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in anxiety level induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in IL1β induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in IL4 induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in Platelet factor (PF) 4 induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in IKB protein induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in Interferon (IFN) - γ induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in sCD40L induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in Mitochondrial DNA of platelet origin induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Availability of social support(inclusion Visit)
- Changes in social distress level induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in C-Reactive Protein (CRP) induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in RANTES induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in Brain derived neurotrophic factor (BDNF) induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Changes in Microparticle induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- loneliness levels(inclusion Visit)
- Perceived social support(inclusion Visit)
- Suicidal recurrence(6months follow up Visit)
- Changes in sOx40L induced by V-TSST(Visit 2 : between 0 to 7 days after inclusion)
- Perceived online social support(inclusion Visit)
- Social isolation(inclusion Visit)