Status:
COMPLETED
Biological Response to Brief Psychological Challenge
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Acute Inflammatory Response to Psychological Stress
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
The investigators plan to conduct a crossover experimental trial examining physiological responses to a socio-evaluative speech task under laboratory conditions. Participants will attend two laborator...
Detailed Description
The proposed study will examine physiologic responses to acute psychological challenge in the laboratory among healthy adults. It is widely accepted that there is an increase in circulating markers of...
Eligibility Criteria
Inclusion
- Generally healthy
- Non-smokers/illicit drug users
- Blood pressure below 140/90
- Weight \> 110 lbs
- BMI \< 30
- Fluent in English
- Women -- regular menstrual cycles over the past 12 months (defined as 21- 35 days in length)
- Able and willing to give informed consent
- Willing to abstain from alcohol and vigorous exercise for 24 hours, from food and drinks (other than water) for 3 hours and from non-prescription medications (other than oral contraception) for 2 days before testing.
- Willing to attend two laboratory stress testing sessions, give blood though an intravenous catheter, undergo medical evaluation and complete psychosocial questionnaires.
Exclusion
- Reported history of chronic systemic immune, metabolic or mitochondrial diseases, or chronic diseases that influence the central nervous, autonomic nervous or neuroendocrine systems, e.g., autoimmune disease, chronic infections, cardiovascular disease, diabetes, chronic kidney or liver disease, cancer treatment.
- Reported psychiatric history of schizophrenia or other psychotic illness, or mood disorder.
- Resting blood pressure \> 140/90 mmHg at baseline testing.
- Weight \< 110 lbs
- BMI equal to or greater than 30
- Report currently taking glucocorticoid, anti-inflammatory, anti-retroviral, immunosuppressant, insulin, antiarrhythmic, antihypertensive, oral hypoglycemic, antidepressant, benzodiazepine or prescription weight loss medications or other medications known to influence the immune, autonomic or neuroendocrine systems.
- For women - Post-menopausal or irregular menstrual cycles over the past 12 months. Report current pregnancy or lactation.
- Current smokers (defined as having smoked a cigarette in the previous 3 months).
- Current illicit drug use (defined as reported use of illicit drugs such as marijuana, cocaine or heroin in the previous 3 months).
- Not fluent in English (have used English in everyday speaking and reading for at least 10 years)
- Unable or unwilling to give informed consent
- Unwilling to abstain from alcohol and vigorous exercise for 24 hours, from food and drinks (other than water) for 3 hours and from non-prescription medications (other than oral contraception) for 2 days prior to testing.
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04078035
Start Date
July 23 2020
End Date
January 31 2022
Last Update
March 1 2024
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213