Response to Social Rejection in Suicidal Behavior
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale
研究概览
简要总结
Suicide is a major health problem that causes annually a million death worldwild. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. We hypothesized that the sensitivity to social exclusion may represent a core component of the suicidal vulnerability Recent evidence also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social stressors are particulary strong and specific triggers of inflammatory response.
To sum up, patients carrying a suicidal vulnerability are expected to present greater responses to social rejection in terms of inflammatory activity and psychological pain.
The aim of the study is to evaluate the psychological and inflammatory responses to a social stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the moderating effect of childhood abuse, attachment, trait rejection sensitivity and social isolation.
In the second part of the study, we will also investigate the prospective association between inflammatory responses induces by laboratory paradigms of social rejection and the occurrence of social distress, suicidal ideation and psychological pain in response to social exclusion events in real life (using ecological momentary assessment).
详细描述
Over one year, we will recruit 140 female outpatients suffering from a major depressive episode with (n=70) and without any history of suicide attempt (n=70) from a specialized clinic for mood disorders and SB.
First visit: clinical, biological and neuropsychological assessment Second visit: The TSST is a standardized laboratory psychosocial stress protocol that involves public speaking, role play, and mental arithmetic tasks in front of a panel of confederate judges. Blood samples will be obtained before the introduction to the TSST and immediately after and at + 30, + 60, + 90, and + 120 min. Self-ratings of emotional states, anxiety, anger and psychological pain will be completed at the same times.
Third visit: Participants will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non specifics
- •Between 18 and 65 years
- •Main diagnosis of unipolar major depressive episode (DSM-IV criteria)
- •Having signed informed consent
- •Able to understand nature, aims, and methodology oh the study
- •Specifics :
- •Having a personal history of suicidal behavior (group : depressed patient with history of SB) OR
- •Not Having personal history of suicidal behavior (group : depressed patient without history of SB)
- •Exclusion criteria:
- •Inflammatory or intercurrent pathology
- •Lifetime history of schizophrenia, or schizoaffective or bipolar disorder, according to DSM-IV criteria;
- •Current diagnosis of substance abuse or dependence in the last year (excluding tobacco)
- •Current organic mental disorder or mental retardation, or severe comorbid medical condition
- •Participation in another clinical trial
- •Pregnancy
- •Not able to speak, read and understand French
- •Patient on protective measures (guardianship or trusteeship)
排除标准
- 未提供
结局指标
主要结局
Psychological pain response to Trier Social Stress Test (TSST) assessed by visual analogic sale
时间窗: up to one week
comparaison of psychological pain response between group with personal history of suicid attempt and group without personal history of suicid attempt
次要结局
- Social rejection assessed by likert scale in real life condition with a smartphone(7 days after the TSST)
- Impact of loneliness and childhood abuse on inflammatory markers(up to one week)
- Inflammatory response to TTST(up to one week)
- impact of neuropschychological function on psychological pain(up to one week)