NCT03813823

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

December 17, 2018

Last Update Submit

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

Behavioral: Fear tasks

Nonphobic

Adults aged 18-40 exhibiting low levels of self-reported phobic symptoms to spiders

Behavioral: Fear tasks

Interventions

Fear tasksBEHAVIORAL

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

NonphobicPhobic

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Retention: SAMPLES WITHOUT DNA

Blood plasma; saliva

MeSH Terms

Conditions

Phobic Disorders

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Alex Kirk, M.A.

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR
  • Joanna Arch, Ph.D.

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

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