Biobehavioral Correlates of Acute Phobic Fear

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

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.

Study Overview

• Status: Unknown
• Conditions: Phobia
• Intervention / Treatment: Behavioral: Fear tasks

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy participants exhibit high or low fear towards spiders.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phobic; Adults aged 18-40 exhibiting high levels of self-reported phobic symptoms to spiders	Behavioral: Fear tasks; All participants will be exposed to 5 fear tasks involving spiders, with increasing fear intensity.
Nonphobic; Adults aged 18-40 exhibiting low levels of self-reported phobic symptoms to spiders	Behavioral: Fear tasks; All participants will be exposed to 5 fear tasks involving spiders, with increasing fear intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomic marker: alpha amylase	salivary alpha amylase	50 minutes
Autonomic marker: galvanic skin response	galvanic skin response (GSR) via Empatica E4 wristband	4 hours
Autonomic marker: heart rate	heart rate variability (HRV) via Empatica E4 wristband	4 hours
Threat sensitivity: neurocognitive task	exogenous cueing task via PsychoPy	10 minutes
Threat sensitivity: self-report	Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); 6 items (B4, B5, D4, D5, C1, C2) reworded for spider phobia	10 minutes

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Investigators: Principal Investigator: Alex Kirk, M.A., University of Colorado, Boulder; Principal Investigator: Joanna Arch, Ph.D., University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start (Anticipated): February 4, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 18-0284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No