Back to resultsDisentangling Anxiety Sensitivity and Anxiety-induced Physiological Stress Response
Primary Purpose
Anxiety
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
HPA, ANS stimulation
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Both male and female participants will be required to pass the telephone-screening questionnaire. All eligible participants will be 18 years and older.
Exclusion Criteria:
- Full physiological exclusions include: abnormal electrocardiogram (i.e., arrhythmias), allergy to hydrocortisone or caffeine, anemia, cancer, chronic pain, compromised immune system (e.g., HIV), congestive heart failure, diabetes, diverticulitis, epilepsy, gastroesophageal reflux disease, gastrointestinal disease (e.g., bleeding), heart disease, hepatic impairment, herpes virus, high blood pressure or low blood pressure, high cholesterol, history of stroke, hypothyroidism, infection/fever in the last 7 days, kidney disease, liver disease (e.g., hepatitis), migraines/chronic headaches, myasthenia gravis, ocular herpes simplex virus, osteoporosis, peptic ulcer disease, renal impairment, respiratory disease (e.g., asthma), seizure disorder, skeletal muscle disease, spastic colon, strongyloides infection, surgeries within the last 6 weeks, systemic fungal infection, thyroid disease, tuberculosis/history of positive tuberculosis test, and ulcerative colitis.
Full medication exclusions include: ADHD medication, antibiotics in the last 7 days, antidepressants, antiplatelet drugs, anxiolytics, bipolar disorder medication, blood pressure medication, blood thinners, bronchodilators, drugs for allergies, drugs to treat hormonal disorders, estrogen, insulin, live vaccinations in the last 7 days, long-lasting decongestants, pain killers (i.e., NSAIDS: aspirin or ibuprofen), sleeping pills, statins (i.e., to lower cholesterol), steroids.
Full psychological exclusions include current or previous diagnosis of major depression, posttraumatic stress disorder, specific phobia, anxiety disorders, or any other psychiatric condition.
Sites / Locations
- University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HPA, ANS stimulation
Two cellulose placebo capsules
Arm Description
Oral administration of 400mg caffeine and 20mg hydrocortisone will stimulate HPA axis and ANS activity, respectively
two cellulose capsule filled with acidophilus powder will be administered orally
Outcomes
Primary Outcome Measures
Heart Rate
continuous heart rate monitoring
Secondary Outcome Measures
Full Information
NCT ID
NCT02372110
First Posted
February 12, 2015
Last Updated
April 26, 2021
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT02372110
Brief Title
Disentangling Anxiety Sensitivity and Anxiety-induced Physiological Stress Response
Official Title
Disentangling Anxiety Sensitivity and Anxiety-induced Physiological Stress Response
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed study aims to investigate experimentally anxiety sensitivity and physiologic sensations associated with anxiety using a paradigm combining hydrocortisone, caffeine, and a set of social stress challenges. Following informed consent, participants will be instructed to ingest either 400 milligrams of caffeine (an amount of caffeine roughly equivalent to that in two 8 oz. cups of brewed coffee from Starbucks), and 20 milligrams of hydrocortisone or two placebo capsules via stratified, random assignment. Physiologic and self-reported measures of stress and anxiety will be taken.
Detailed Description
Given the debilitating nature of anxiety disorders, a greater understanding of its etiology and the development of appropriate early interventions are critical. However, due to the mutually reinforcing nature of anxiety sensitivity (a key component of anxiety disorders) and physiological sensations associated with anxiety, no previous studies have examined these two variables separately in response to an acute stressor. The proposed study aims to investigate these two variables independently using a paradigm combining hydrocortisone, caffeine, and TSST.
It is hypothesized that when an individual's physiological stress responses (SNS and HPA axis) are enhanced, he or she will experience greater subjective stress and a lesser sense of mastery in response to an acute stressor (e.g., the TSST). In addition, anxiety sensitivity will moderate subjective ratings of stress and mastery, such that individuals high on anxiety sensitivity will rate the TSST as more subjectively stressful and their performance as less effectual compared to individuals low on anxiety sensitivity, due to greater vigilance of interoceptive responses and internal stimuli.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPA, ANS stimulation
Arm Type
Experimental
Arm Description
Oral administration of 400mg caffeine and 20mg hydrocortisone will stimulate HPA axis and ANS activity, respectively
Arm Title
Two cellulose placebo capsules
Arm Type
Placebo Comparator
Arm Description
two cellulose capsule filled with acidophilus powder will be administered orally
Intervention Type
Drug
Intervention Name(s)
HPA, ANS stimulation
Other Intervention Name(s)
vivarin, cortef
Intervention Description
Oral administration of Hydrocortisone will increase HPA axis activity. Oral administration of Caffeine will boost ANS activity
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
fake pill
Intervention Description
Two cellulose placebo capsules filled with acidophilus powder will be administered to subjects who are randomly assigned to the placebo condition
Primary Outcome Measure Information:
Title
Heart Rate
Description
continuous heart rate monitoring
Time Frame
180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Both male and female participants will be required to pass the telephone-screening questionnaire. All eligible participants will be 18 years and older.
Exclusion Criteria:
Full physiological exclusions include: abnormal electrocardiogram (i.e., arrhythmias), allergy to hydrocortisone or caffeine, anemia, cancer, chronic pain, compromised immune system (e.g., HIV), congestive heart failure, diabetes, diverticulitis, epilepsy, gastroesophageal reflux disease, gastrointestinal disease (e.g., bleeding), heart disease, hepatic impairment, herpes virus, high blood pressure or low blood pressure, high cholesterol, history of stroke, hypothyroidism, infection/fever in the last 7 days, kidney disease, liver disease (e.g., hepatitis), migraines/chronic headaches, myasthenia gravis, ocular herpes simplex virus, osteoporosis, peptic ulcer disease, renal impairment, respiratory disease (e.g., asthma), seizure disorder, skeletal muscle disease, spastic colon, strongyloides infection, surgeries within the last 6 weeks, systemic fungal infection, thyroid disease, tuberculosis/history of positive tuberculosis test, and ulcerative colitis.
Full medication exclusions include: ADHD medication, antibiotics in the last 7 days, antidepressants, antiplatelet drugs, anxiolytics, bipolar disorder medication, blood pressure medication, blood thinners, bronchodilators, drugs for allergies, drugs to treat hormonal disorders, estrogen, insulin, live vaccinations in the last 7 days, long-lasting decongestants, pain killers (i.e., NSAIDS: aspirin or ibuprofen), sleeping pills, statins (i.e., to lower cholesterol), steroids.
Full psychological exclusions include current or previous diagnosis of major depression, posttraumatic stress disorder, specific phobia, anxiety disorders, or any other psychiatric condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Josephs, Ph.D
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
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Disentangling Anxiety Sensitivity and Anxiety-induced Physiological Stress Response
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