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临床试验/NCT03813823
NCT03813823Unknown不适用

Biobehavioral Correlates of Acute Phobic Fear: Proinflammatory, Autonomic, and Neurocognitive Outcomes

University of Colorado, Boulder0 个研究点目标入组 30 人开始时间: 2019年2月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Blood plasma concentration of IL-1 beta

研究概览

简要总结

This study seeks to measure the time course of circulating proinflammatory markers (interleukin-1 beta [IL-1β], interleukin-6 [IL-6], tumor necrosis factor alpha [TNF-α], and C-reactive protein [CRP]) and salivary alpha amylase (sAA) following laboratory fear arousal. Further, this study seeks to implement neurocognitive, physiological, and self-report measures to explore the role of threat sensitivity as a predictor of this response. The broad research question seeks to better understand the relationship between neurocognitive fear and subsequent stress responding elicited by both the immune system (i.e., proinflammatory markers) and autonomic nervous system (i.e., sAA). In light of these aims, the primary outcomes of the current study are the proinflammatory markers (IL-1β, IL-6, TNF-α, CRP), while secondary outcomes consist of sAA, neurocognitive measures (i.e., dot-probe task), physiological correlates (i.e., heart rate, galvanic skin response), and self-report measures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 - 40 years old
  • Phobic or nonphobic fear of spiders.
  • Willing to proceed through 5-stimulus fear hierarchy or maintain 7 or higher subjective units of distress through fear task (see Procedures section).

排除标准

  • Lifetime history of serious mental illness
  • Lifetime history of intellectual or developmental delays
  • Lifetime history of chronic physical or medical illness including blood clotting disorders
  • Lifetime history of allergies to latex
  • Lifetime history of hormonal replacement therapy
  • Lifetime history of blindness
  • Lifetime history of blood/injection phobia or aversion to needles/injection (based on IPS-Anx and MQ)
  • Substance abuse in the past 2 years
  • Cigarette/tobacco use in the past 2 years
  • Major depression within the past 12 months
  • Traumatic stress within the past 12 months
  • Pregnancy within the past 12 months
  • Anesthesia within the past 3 months
  • Night shift work within the past month
  • Use of medication within the past month (except for oral contraception)
  • Acute illness or infection within the past month
  • Average sleep outside of 6 - 10 hours per night within the past month
  • Average intake of 4 or more alcoholic beverages per week
  • Average intake of 6 or more cups caffeine per day
  • Use of marijuana within the week before the laboratory session
  • Use of alcohol within the week before the laboratory session
  • Body mass index outside of 18.5 - 24.9 range

结局指标

主要结局

Blood plasma concentration of IL-1 beta

时间窗: 4 hours

interleukin-1 beta (pg/mL) via blood draw

Blood plasma concentration of IL-6

时间窗: 4 hours

interleukin-6 (pg/mL) via blood draw

Blood plasma concentration of CRP

时间窗: 4 hours

C-reactive protein (mg/L) via blood draw

Blood plasma concentration of TNF-alpha

时间窗: 4 hours

Tumor necrosis factor-alpha (pg/mL) via blood draw

次要结局

  • Autonomic marker: heart rate(4 hours)
  • Threat sensitivity: self-report(10 minutes)
  • Autonomic marker: alpha amylase(50 minutes)
  • Autonomic marker: galvanic skin response(4 hours)
  • Threat sensitivity: neurocognitive task(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Kirk

Graduate Student

University of Colorado, Boulder

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