AnxietyNCT02490280
Examining Cortisol and Alpha Amylase in a Healthy Sample of Youth and Adults
A study testing Trier Social Stress Test in people with Anxiety, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Trier Social Stress Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 34 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Examining Biomarkers of Anxiety 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)."
Read the 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.
- Conditions
- Anxiety
- Being tested
- Trier Social Stress Test
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress TestBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Trier Social Stress Test | Experimental | Participants will be administered the Trier Social Stress Test (TSST). 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. Receives: Behavioral: Trier Social Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Golda S. Ginsburg, Ph.D., Johns Hopkins University
- Investigators
- Golda S Ginsburg, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490280
- Sponsor's protocol ID
- NA00083366
- Other IDs
- 1K24MH096760-01A1
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Biomarkers of Anxiety in a Healthy Sample of Youth and Adults
- ClinicalTrials.gov ID
- NCT02490280
- Acronym / sponsor ID
- NA00083366
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trier Social Stress Test | Experimental | Behavioral: Trier Social Stress TestParticipants will be administered the Trier Social Stress Test (TSST). 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. |
Who may qualify
- Ages
- 11 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trier Social Stress TestThe 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. | Behavioural | Trier Social Stress Test |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Golda S Ginsburg, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier Social Stress Test in people with Anxiety, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.