Clinical trial NCT03813823: Biobehavioral Correlates of Acute Phobic Fear
Official title: Biobehavioral Correlates of Acute Phobic Fear: Proinflammatory, Autonomic, and Neurocognitive Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Phobia
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants exhibit high or low fear towards spiders.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Blood plasma concentration of IL-1 beta
timeFrame: 4 hours
measure: Blood plasma concentration of IL-6
timeFrame: 4 hours
measure: Blood plasma concentration of TNF-alpha
timeFrame: 4 hours
measure: Blood plasma concentration of CRP
timeFrame: 4 hours
Secondary outcomes:
measure: Autonomic marker: alpha amylase
timeFrame: 50 minutes
measure: Autonomic marker: galvanic skin response
timeFrame: 4 hours
measure: Autonomic marker: heart rate
timeFrame: 4 hours
measure: Threat sensitivity: neurocognitive task
timeFrame: 10 minutes
measure: Threat sensitivity: self-report
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Boulder
name: Alex Kirk, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Boulder
name: Joanna Arch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: