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Disentangling Anxiety Sensitivity and Anxiety-induced Physiological Stress Response

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ClinicalTrials.gov Identifier: NCT02372110
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Robert Josephs, University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Anxiety Drug: HPA, ANS stimulation Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Disentangling Anxiety Sensitivity and Anxiety-induced Physiological Stress Response
Study Start Date : March 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Caffeine

Arm Intervention/treatment
Experimental: HPA, ANS stimulation
Oral administration of 400mg caffeine and 20mg hydrocortisone will stimulate HPA axis and ANS activity, respectively
Drug: HPA, ANS stimulation
Oral administration of Hydrocortisone will increase HPA axis activity. Oral administration of Caffeine will boost ANS activity
Other Name: vivarin, cortef

Placebo Comparator: Two cellulose placebo capsules
two cellulose capsule filled with acidophilus powder will be administered orally
Drug: Placebo
Two cellulose placebo capsules filled with acidophilus powder will be administered to subjects who are randomly assigned to the placebo condition
Other Name: fake pill




Primary Outcome Measures :
  1. Heart Rate [ Time Frame: 180 minutes ]
    continuous heart rate monitoring



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372110


Locations
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United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Robert A Josephs, Ph.D University of Texas at Austin
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Responsible Party: Robert Josephs, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02372110    
Other Study ID Numbers: 2015010023
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents