PhobiaNCT03813823
Biobehavioral Correlates of Acute Phobic Fear
An observational study of Phobia, run by University of Colorado, Boulder.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Phobia
- What is being tested?
- Fear tasks
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2019to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy participants exhibit high or low fear towards spiders.
Who may be able to join
- 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).
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Phobia
- Being tested
- Fear tasks
- Medical subject headings
- Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear tasksBehavioural
All participants will be exposed to 5 fear tasks involving spiders, with increasing fear intensity.
| Study group | Role | What they receive |
|---|---|---|
| Phobic | Adults aged 18-40 exhibiting high levels of self-reported phobic symptoms to spiders Receives: Behavioral: Fear tasks | |
| Nonphobic | Adults aged 18-40 exhibiting low levels of self-reported phobic symptoms to spiders Receives: Behavioral: Fear tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood plasma concentration of IL-1 beta
interleukin-1 beta (pg/mL) via blood draw
Measured: 4 hours
Blood plasma concentration of IL-6
interleukin-6 (pg/mL) via blood draw
Measured: 4 hours
Blood plasma concentration of TNF-alpha
Tumor necrosis factor-alpha (pg/mL) via blood draw
Measured: 4 hours
Blood plasma concentration of CRP
C-reactive protein (mg/L) via blood draw
Measured: 4 hours
Secondary outcomes (5)
Autonomic marker: alpha amylase
salivary alpha amylase
Measured: 50 minutes
Autonomic marker: galvanic skin response
galvanic skin response (GSR) via Empatica E4 wristband
Measured: 4 hours
Autonomic marker: heart rate
heart rate variability (HRV) via Empatica E4 wristband
Measured: 4 hours
Threat sensitivity: neurocognitive task
exogenous cueing task via PsychoPy
Measured: 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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start4 Feb 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Kirk, University of Colorado, Boulder
- Investigators
- Alex Kirk, M.A., Principal investigator, University of Colorado, BoulderJoanna Arch, Ph.D., Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813823
- Sponsor's protocol ID
- 18-0284
- Status last verified
- Jan 2019
- First submitted
- 17 Dec 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Correlates of Acute Phobic Fear: Proinflammatory, Autonomic, and Neurocognitive Outcomes
- ClinicalTrials.gov ID
- NCT03813823
- Acronym / sponsor ID
- 18-0284
- Conditions
- Phobia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 4 Feb 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phobic | – | Behavioral: Fear tasksAdults aged 18-40 exhibiting high levels of self-reported phobic symptoms to spiders |
| Nonphobic | – | Behavioral: Fear tasksAdults aged 18-40 exhibiting low levels of self-reported phobic symptoms to spiders |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy participants exhibit high or low fear towards spiders.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fear tasksAll participants will be exposed to 5 fear tasks involving spiders, with increasing fear intensity. | Behavioural | Nonphobic, Phobic |
Primary outcome
Blood plasma concentration of IL-1 beta
Time frame: 4 hours
interleukin-1 beta (pg/mL) via blood draw
Blood plasma concentration of IL-6
Time frame: 4 hours
interleukin-6 (pg/mL) via blood draw
Blood plasma concentration of TNF-alpha
Time frame: 4 hours
Tumor necrosis factor-alpha (pg/mL) via blood draw
Blood plasma concentration of CRP
Time frame: 4 hours
C-reactive protein (mg/L) via blood draw
5 secondary outcomes
Autonomic marker: alpha amylase
Time frame: 50 minutes
Autonomic marker: galvanic skin response
Time frame: 4 hours
Autonomic marker: heart rate
Time frame: 4 hours
Threat sensitivity: neurocognitive task
Time frame: 10 minutes
Threat sensitivity: self-report
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Phobia
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of Transcranial Direct Current Stimulation and Manual Therapy on Musculoskeletal Pain in Adolescent Dancers
Musculoskeletal Pain, Chronic Pain
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Kirk, M.A. principal investigator
University of Colorado, Boulder
Joanna Arch, Ph.D. principal investigator
University of Colorado, Boulder
Questions about this trial
What is this clinical trial studying?
An observational study of Phobia, run by University of Colorado, Boulder.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Kirk, M.A. (303-210-8106, alex.kirk@colorado.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood plasma concentration of IL-1 beta (time frame: 4 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.