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临床试验/NCT05268965
NCT05268965已完成不适用

Autonomic and Subjective Correlates of Affective Forecasting Skills in Post-traumatic Stress Disorder

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2022年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
97
试验地点
1
主要终点
difference of arousal assessments measured using the Self-Assessment Manikin between the prediction and emotional experience phases

研究概览

简要总结

Post-traumatic stress disorder (PTSD) is associated with a marked tendency to have exaggerated and persistent negative beliefs and expectations about oneself or the world . Although posttraumatic stress symptoms have been shown to be associated with a tendency to negatively anticipate the future, affective forecasting skills (i.e., the ability to predict one's own emotional reactions in response to a future event) have never been explored in PTSD . The hypothesis that the PTSD is associated with a negative affective forecasting bias, characterized by a tendency to predict more intense emotional responses to future negative events.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Understanding and being able to express themselves in French
  • Understanding of informed consent and signature of the study participation form
  • Giving informed, dated and signed consent
  • Benefiting from health insurance coverage
  • Normal or corrected visual and auditory acuity to achieve normality
  • Group 1 : DSM-5 PTSD criteria, assessed using CAPS and PTSD Checklist for DSM-5 (PCL-5, Weathers & al., 2013)
  • Group 2: PTSD Criteria A only

排除标准

  • Refusal of participation after clear and fair information on the study.
  • Visual or auditory sensory disability to participate in the study.
  • Personal history of neurological disease or current neurological disease.
  • Personal history of current psychiatric disorder or psychiatric disorder (excluding PTSD in patients in the experimental group), assessed via the MINI.
  • Pregnant or breastfeeding women
  • Consumption of toxic substances other than tobacco and alcohol.
  • Minors or adults under guardianship, under judicial protection, persons deprived of liberty.
  • Groups 2 and 3: personal history of psychiatric disorder or current psychiatric disorder and taking psychotropic drugs
  • Group 1: personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, trauma and stress-related disorders and treatment with psychotropic drugs not stabilized

结局指标

主要结局

difference of arousal assessments measured using the Self-Assessment Manikin between the prediction and emotional experience phases

时间窗: During the experimental task (2 hours)

To compare the subjective affective forecasting bias between the PTSD group and the two control groups

次要结局

  • link and correlation coefficients between affective forecasting bias and emotion regulation skills within each group(During the experimental task (2 hours))
  • subjective correlates of the affective forecasting bias associated with PTSD changes in: valence scores.(During the experimental task (2 hours))
  • link and correlation coefficients between biases measured at the neurovegetative (changes in heart rate and skin conductance) and subjective levels (arousal and valence ratings from the Self-Assessment Manikin) in PTSD(During the experimental task (2 hours))
  • autonomic correlates of the affective prediction bias associated with PTSD: changes in the skin conductance response and heart rate.(During the experimental task (2 hours))
  • link between PTSD symptomatology and affective forecasting bias(During the experimental task (2 hours))
  • link and correlation coefficients between affective forecasting bias and anxiety and depression(During the experimental task (2 hours))

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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