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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03813823
Other study ID # 18-0284
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 4, 2019
Est. completion date August 1, 2019

Study information

Verified date January 2019
Source University of Colorado, Boulder
Contact Alex Kirk, M.A.
Phone 303-210-8106
Email alex.kirk@colorado.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 1, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Fear tasks
All participants will be exposed to 5 fear tasks involving spiders, with increasing fear intensity.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Boulder

Outcome

Type Measure Description Time frame Safety issue
Primary Blood plasma concentration of IL-1 beta interleukin-1 beta (pg/mL) via blood draw 4 hours
Primary Blood plasma concentration of IL-6 interleukin-6 (pg/mL) via blood draw 4 hours
Primary Blood plasma concentration of TNF-alpha Tumor necrosis factor-alpha (pg/mL) via blood draw 4 hours
Primary Blood plasma concentration of CRP C-reactive protein (mg/L) via blood draw 4 hours
Secondary Autonomic marker: alpha amylase salivary alpha amylase 50 minutes
Secondary Autonomic marker: galvanic skin response galvanic skin response (GSR) via Empatica E4 wristband 4 hours
Secondary Autonomic marker: heart rate heart rate variability (HRV) via Empatica E4 wristband 4 hours
Secondary Threat sensitivity: neurocognitive task exogenous cueing task via PsychoPy 10 minutes
Secondary 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
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