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Completed

NCT Number: NCT02490280

Examining Cortisol and Alpha Amylase in a Healthy Sample of Youth and Adults

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)."

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

11 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trier Social Stress Test

Behavioral

The TSST is the gold standard social stress test and involves speaking in front of confederate judges and completing arithmetic tasks. The task takes 10-15 minutes.

Primary outcomes

  1. 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)

    Time frame: 1 day

    The C/P and Client-ADIS' are semi-structured diagnostic interviews used to assess symptoms of anxiety, depression, and behavioral issues.

    This interview will be administered by a trained staff member and will utilize information from both parents and children (if child is under 18 years of age) or from the adult participant (if the participant is 18 years of age or older).

    This interview will be used to determine the presence or absence of an anxiety disorder for participants in this study.

    The ADIS is administered one time because each participant only completes a single study visit.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Examining Biomarkers of Anxiety in a Healthy Sample of Youth and Adults

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2015
Registry last updated
Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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