Biobehavioral Correlates of Acute Phobic Fear
1 other identifier
observational
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2019
CompletedStudy Start
First participant enrolled
February 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedJanuary 23, 2019
January 1, 2019
6 months
December 17, 2018
January 22, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Blood plasma concentration of IL-1 beta
interleukin-1 beta (pg/mL) via blood draw
4 hours
Blood plasma concentration of IL-6
interleukin-6 (pg/mL) via blood draw
4 hours
Blood plasma concentration of TNF-alpha
Tumor necrosis factor-alpha (pg/mL) via blood draw
4 hours
Blood plasma concentration of CRP
C-reactive protein (mg/L) via blood draw
4 hours
Secondary Outcomes (5)
Autonomic marker: alpha amylase
50 minutes
Autonomic marker: galvanic skin response
4 hours
Autonomic marker: heart rate
4 hours
Threat sensitivity: neurocognitive task
10 minutes
Threat sensitivity: self-report
10 minutes
Study Arms (2)
Phobic
Adults aged 18-40 exhibiting high levels of self-reported phobic symptoms to spiders
Nonphobic
Adults aged 18-40 exhibiting low levels of self-reported phobic symptoms to spiders
Interventions
All participants will be exposed to 5 fear tasks involving spiders, with increasing fear intensity.
Eligibility Criteria
Healthy participants exhibit high or low fear towards spiders.
You may qualify if:
- 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).
You may not qualify if:
- 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)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Blood plasma; saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Kirk, M.A.
University of Colorado, Boulder
- PRINCIPAL INVESTIGATOR
Joanna Arch, Ph.D.
University of Colorado, Boulder
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Graduate Student
Study Record Dates
First Submitted
December 17, 2018
First Posted
January 23, 2019
Study Start
February 4, 2019
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
January 23, 2019
Record last verified: 2019-01