<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813823</url>
  </required_header>
  <id_info>
    <org_study_id>18-0284</org_study_id>
    <nct_id>NCT03813823</nct_id>
  </id_info>
  <brief_title>Biobehavioral Correlates of Acute Phobic Fear</brief_title>
  <official_title>Biobehavioral Correlates of Acute Phobic Fear: Proinflammatory, Autonomic, and Neurocognitive Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Boulder</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Boulder</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to measure the time course of circulating proinflammatory markers&#xD;
      (interleukin-1 beta [IL-1β], interleukin-6 [IL-6], tumor necrosis factor alpha [TNF-α], and&#xD;
      C-reactive protein [CRP]) and salivary alpha amylase (sAA) following laboratory fear arousal.&#xD;
      Further, this study seeks to implement neurocognitive, physiological, and self-report&#xD;
      measures to explore the role of threat sensitivity as a predictor of this response. The broad&#xD;
      research question seeks to better understand the relationship between neurocognitive fear and&#xD;
      subsequent stress responding elicited by both the immune system (i.e., proinflammatory&#xD;
      markers) and autonomic nervous system (i.e., sAA). In light of these aims, the primary&#xD;
      outcomes of the current study are the proinflammatory markers (IL-1β, IL-6, TNF-α, CRP),&#xD;
      while secondary outcomes consist of sAA, neurocognitive measures (i.e., dot-probe task),&#xD;
      physiological correlates (i.e., heart rate, galvanic skin response), and self-report&#xD;
      measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 4, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood plasma concentration of IL-1 beta</measure>
    <time_frame>4 hours</time_frame>
    <description>interleukin-1 beta (pg/mL) via blood draw</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood plasma concentration of IL-6</measure>
    <time_frame>4 hours</time_frame>
    <description>interleukin-6 (pg/mL) via blood draw</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood plasma concentration of TNF-alpha</measure>
    <time_frame>4 hours</time_frame>
    <description>Tumor necrosis factor-alpha (pg/mL) via blood draw</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood plasma concentration of CRP</measure>
    <time_frame>4 hours</time_frame>
    <description>C-reactive protein (mg/L) via blood draw</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Autonomic marker: alpha amylase</measure>
    <time_frame>50 minutes</time_frame>
    <description>salivary alpha amylase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic marker: galvanic skin response</measure>
    <time_frame>4 hours</time_frame>
    <description>galvanic skin response (GSR) via Empatica E4 wristband</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic marker: heart rate</measure>
    <time_frame>4 hours</time_frame>
    <description>heart rate variability (HRV) via Empatica E4 wristband</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Threat sensitivity: neurocognitive task</measure>
    <time_frame>10 minutes</time_frame>
    <description>exogenous cueing task via PsychoPy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Threat sensitivity: self-report</measure>
    <time_frame>10 minutes</time_frame>
    <description>Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); 6 items (B4, B5, D4, D5, C1, C2) reworded for spider phobia</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Phobia</condition>
  <arm_group>
    <arm_group_label>Phobic</arm_group_label>
    <description>Adults aged 18-40 exhibiting high levels of self-reported phobic symptoms to spiders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nonphobic</arm_group_label>
    <description>Adults aged 18-40 exhibiting low levels of self-reported phobic symptoms to spiders</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fear tasks</intervention_name>
    <description>All participants will be exposed to 5 fear tasks involving spiders, with increasing fear intensity.</description>
    <arm_group_label>Nonphobic</arm_group_label>
    <arm_group_label>Phobic</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood plasma; saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy participants exhibit high or low fear towards spiders.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 - 40 years old&#xD;
&#xD;
          -  Phobic or nonphobic fear of spiders.&#xD;
&#xD;
          -  Willing to proceed through 5-stimulus fear hierarchy or maintain 7 or higher&#xD;
             subjective units of distress through fear task (see Procedures section).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime history of serious mental illness&#xD;
&#xD;
          -  Lifetime history of intellectual or developmental delays&#xD;
&#xD;
          -  Lifetime history of chronic physical or medical illness including blood clotting&#xD;
             disorders&#xD;
&#xD;
          -  Lifetime history of allergies to latex&#xD;
&#xD;
          -  Lifetime history of hormonal replacement therapy&#xD;
&#xD;
          -  Lifetime history of blindness&#xD;
&#xD;
          -  Lifetime history of blood/injection phobia or aversion to needles/injection (based on&#xD;
             IPS-Anx and MQ)&#xD;
&#xD;
          -  Substance abuse in the past 2 years&#xD;
&#xD;
          -  Cigarette/tobacco use in the past 2 years&#xD;
&#xD;
          -  Major depression within the past 12 months&#xD;
&#xD;
          -  Traumatic stress within the past 12 months&#xD;
&#xD;
          -  Pregnancy within the past 12 months&#xD;
&#xD;
          -  Anesthesia within the past 3 months&#xD;
&#xD;
          -  Night shift work within the past month&#xD;
&#xD;
          -  Use of medication within the past month (except for oral contraception)&#xD;
&#xD;
          -  Acute illness or infection within the past month&#xD;
&#xD;
          -  Average sleep outside of 6 - 10 hours per night within the past month&#xD;
&#xD;
          -  Average intake of 4 or more alcoholic beverages per week&#xD;
&#xD;
          -  Average intake of 6 or more cups caffeine per day&#xD;
&#xD;
          -  Use of marijuana within the week before the laboratory session&#xD;
&#xD;
          -  Use of alcohol within the week before the laboratory session&#xD;
&#xD;
          -  Body mass index outside of 18.5 - 24.9 range&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alex Kirk, M.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joanna Arch, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alex Kirk, M.A.</last_name>
    <phone>303-210-8106</phone>
    <email>alex.kirk@colorado.edu</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Colorado, Boulder</investigator_affiliation>
    <investigator_full_name>Alex Kirk</investigator_full_name>
    <investigator_title>Graduate Student</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813823
org study id: 18-0284
nct id: NCT03813823
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Blood plasma concentration of IL-1 beta
time frame: 4 hours
description: interleukin-1 beta (pg/mL) via blood draw
measure: Blood plasma concentration of IL-6
time frame: 4 hours
description: interleukin-6 (pg/mL) via blood draw
measure: Blood plasma concentration of TNF-alpha
time frame: 4 hours
description: Tumor necrosis factor-alpha (pg/mL) via blood draw
measure: Blood plasma concentration of CRP
time frame: 4 hours
description: C-reactive protein (mg/L) via blood draw
measure: Autonomic marker: alpha amylase
time frame: 50 minutes
description: salivary alpha amylase
measure: Autonomic marker: galvanic skin response
time frame: 4 hours
description: galvanic skin response (GSR) via Empatica E4 wristband
measure: Autonomic marker: heart rate
time frame: 4 hours
description: heart rate variability (HRV) via Empatica E4 wristband
measure: Threat sensitivity: neurocognitive task
time frame: 10 minutes
description: exogenous cueing task via PsychoPy
measure: Threat sensitivity: self-report
time frame: 10 minutes
description: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); 6 items (B4, B5, D4, D5, C1, C2) reworded for spider phobia
arm group label: Phobic
description: Adults aged 18-40 exhibiting high levels of self-reported phobic symptoms to spiders
arm group label: Nonphobic
description: Adults aged 18-40 exhibiting low levels of self-reported phobic symptoms to spiders
intervention type: Behavioral
intervention name: Fear tasks
description: All participants will be exposed to 5 fear tasks involving spiders, with increasing fear intensity.
arm group label: Nonphobic
arm group label: Phobic
Blood plasma; saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alex Kirk, M.A.
role: Principal Investigator
affiliation: University of Colorado, Boulder
last name: Joanna Arch, Ph.D.
role: Principal Investigator
affiliation: University of Colorado, Boulder
last name: Alex Kirk, M.A.
phone: 303-210-8106
email: alex.kirk@colorado.edu
responsible party type: Principal Investigator
investigator affiliation: University of Colorado, Boulder
investigator full name: Alex Kirk
investigator title: Graduate Student
sharing ipd: Undecided