Clinical trial NCT02490280: Examining Cortisol and Alpha Amylase in a Healthy Sample of Youth and Adults
Official title: Examining Biomarkers of Anxiety in a Healthy Sample of Youth and Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 11
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to investigate how healthy youth and adults' cortisol levels and other hormone levels relate to anxiety levels while they participate in a behavioral task called the Trier Social Stress Task.

Data from these healthy participants will also be compared to those of anxious youth and adults collected as part of the in the Principal Investigator's ongoing study titled, "Child/Adolescent Anxiety Multimodal Extended Long-term Study (NA00035687)."

Detailed description: The aim of this study is to investigate the independent and interactive associations linking salivary cortisol (a marker of hypothalamic-pituitary-adrenal activity or HPA activity) and alpha amylase (a marker of autonomic nervous system activity or ANS activity) in a sample of healthy controls. Data from these healthy controls will be compared in the future to clinically anxious youth. In this study, participants are asked to complete a one-time assessment consisting of interviews, questionnaires, and a behavioral task (called the Trier Social Stress Task) involving a short public speaking task and an arithmetic task in front of study staff. Throughout the behavioral task, study staff will collect four, small saliva samples using a straw-like tube from each participant. The assessment will take approximately 3 hours. Participants will be fully debriefed regarding the purposes of the stress procedure and assessed for any signs of residual distress. Since there is no treatment or randomization, blinding of study staff is not applicable. Participation in this study will not affect any current or future medical or psychiatric treatment.

AIMS: To examine whether a) salivary cortisol and alpha amylase response and recovery to the Trier Social Stress Task is associated with anxiety in non-psychiatrically ill participants.

Eligibility criteria: Inclusion Criteria:

* Participant has no current psychiatric disorder
* Participant has no past psychiatric disorder
* Participant has no major medical disorder
* Participant is not currently receiving psychological or psychopharmacological treatment (medication) for any psychological disorder
* Participant is between the ages 11 and 34

Exclusion Criteria:

* Participant has or has had psychiatric disorder or medical condition contraindicating study participation
* Participant is pregnant
* Participant is not an English speaker
* Participant has a visual, motor, or hearing problem that would affect participation

Primary outcomes:
measure: Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS), and Adult Versions (Client-ADIS)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Golda S Ginsburg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: