Stress PhysiologyNCT04317482
The Human Stress Response in a Simulated ED Setting
A study testing Standard social stress task and Stressful experience in the ED in people with Stress Physiology and Stress Reaction, run by University of Arkansas at 1 site in United States.
Trial summary
Stress is important for health. As emergency departments (EDs) are often stressful places, a better understanding of the human stress response is important for understanding how and why patients respond as they do when they come to the ED. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Physiology, Stress Reaction, Substance Use Disorders
- What is being tested?
- Standard social stress task and Stressful experience in the ED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult
- 21-55 years of age
- Self-reported recent history of meth use that meets DSM-5 criteria for current meth use disorder
- Have been previously inside an ED as either a patient or visitor
- Able to construct a stressful mental script of ED experiences
- Body mass index (BMI) < 30
- Ability to read and understand English
- If matched control, no lifetime history of any recreational or non-prescribed drug use.
Who cannot join
- Eating/drinking/taking drugs or alcohol the morning before the experiment
- If smoker, not smoking the morning before the experiment
- Subjective or objective signs of intoxication or withdrawal from any substance
- History of any serious medical condition such as cardiovascular, endocrine, neurologic (seizures), or hepatic disease
- Pregnancy
- History of any mental illness
Show all 12Show fewer
- Hypertensive (>150/90) or abnormal EKG at screening
- Use of any daily medication
- Any recent night shift work in the last 4 weeks
- Any travel across time zones in the last 14 weeks
- Participation in a similar study in the past year
- Refusal to allow videotaping
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Stress is important for health. As emergency departments (EDs) are often stressful places, a better understanding of the human stress response is important for understanding how and why patients respond as they do when they come to the ED. Since the investigators cannot take up space in the ED for research, the investigators will instead recruit 20 methamphetamine-using participants who are not currently in treatment and 10 healthy adult matched participants to a simulated ED room in the University of Arkansas for Medical Sciences (UAMS) Simulation Center. The investigators will have participants perform a stressor task involving public speaking and a simple arithmetic task. The investigators will see if this experiment can be made to be like being in an actual ED by varying what participants speak about in the task. By doing this, the investigators hope to find out several important things: 1) Is a stressor task feasible and acceptable to participants? 2) What does the stress response -- as measured by cortisol and alpha-amylase -- look like in these participants? 3) Does varying what participants talk about make the experiment seem more like an actual ED? 4) Do participants under stress show even mild symptoms of agitation as measured by clinical scales? If so, how often?
Read the detailed description
Aim 1: Determine the feasibility and acceptability of an ED-relevant stressor task as compared to a standard social stressor task. The investigators hypothesize that an ED-relevant stressor task will be feasible, as measured by the ability to recruit/randomize/retain participants, and as acceptable to participants as a standard social stressor task.
Aim 2: Measure the stress response (alpha-amylase, cortisol, vital signs) in participants who undergo an ED-relevant stress task compared to a standard social stress task. The investigators hypothesize that norepinephrine release will be adequately assessed by salivary alpha-amylase and that an ED-relevant stressor task will elicit similar or greater physiological responses as a standard social stress task.
Aim 3: Evaluate the ED-representativeness of an ED-relevant stressor task compared to a standard social stressor task. Although both tasks will be performed in a simulated ED room in the UAMS Simulation Center, the investigators hypothesize that an ED-relevant task will be rated as more representative of an actual ED visit.
Aim 4: Evaluate ethological ratings of non-verbal behavior thought to indicate assertion and ratings of agitation using rating scales commonly employed in the clinical environment for this purpose. Participants undergoing stress sometimes display symptoms of assertion or agitation, but it is unknown when or how often this occurs. The investigators hypothesize that ethological ratings will be correlated with agitation scale scores and physiological changes.
- Conditions
- Stress Physiology, Stress Reaction, Substance Use Disorders, Methamphetamine-dependence, Stress, Emotional
- Being tested
- Standard social stress task, Stressful experience in the ED
- Keywords
- Stress Response
- Medical subject headings
- Fractures, Stress, Substance-Related Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard social stress taskBehavioural
Participants will be asked to respond in detail to three scenarios. This is a standard social stressor task. Participants may be prompted by an experimenter. However, the participant will receive no verbal nor nonverbal feedback.
Stressful experience in the EDBehavioural
Participants will be asked to imagine and then describe both feelings and bodily sensations experienced at their most stressful ED visit, in order to help them more fully re-experience the situation. In this regard, the second condition is more similar to stress imagery employed by Sinha et al, which elevated cortisol to a greater degree than a social stressor task. Participants may be prompted by an experimenter. However, the participant will receive no verbal nor nonverbal feedback.
| Study group | Role | What they receive |
|---|---|---|
| Standard social stress task | Other | Participants will be given 4.5 minutes to prepare a 4.5-minute public speech on three standard scenarios presented in counterbalanced order. This will involve approximately 30 minutes of public speaking stress given expected transitions. The public speeches will be presented in front of 1-2 individuals who are evaluating their presentations. Immediately after the public speaking task, participants will be asked to complete a mental arithmetic task for 15 minutes. Receives: Behavioral: Standard social stress task |
| Stressful experience in the ED | Other | Participants will be given 4.5 minutes to prepare a 4.5-minute public speech on three experiences surrounding their most stressful ED visit. These experiences are presented in counterbalanced order. This will involve approximately 30 of public speaking stress given expected transitions. The public speeches will be presented in front of 1-2 individuals who are evaluating their presentations. Immediately after the public speaking task, participants will be asked to complete a mental arithmetic task for 15 minutes. Receives: Behavioral: Stressful experience in the ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility and acceptability of an ED-relevant stressor task as compared to a standard social stressor task.
Measure feasibility and acceptability in the following ways: participant recruitment; the number of participants completing the experiment; and the acceptability ratings of the task after completion. The 9-point acceptability responses will be analyzed by calculating the mean and 95% confidence intervals for each question, then calculating a chi-square goodness of fit test across the 3 ranges of the scores.
Answers to open-ended questions about participant experiences will be coded using conventional content analysis, as per Hsieh and Shannon. In this analysis, two research associates separately read through all the participants' qualitative responses and highlight key words which reflect the overall idea of the patient's response. After multiple reviews, 3-5 main categories will be identified which reflect responses of a similar nature. After categorization, a third research associate will make final decisions on the placement of individual responses.
Measured: Up to 12 hours
Measure the stress response (alpha-amylase) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Compare alpha-amylase in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Measured: Up to 12 hours
Measure the stress response (cortisol) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Compare cortisol levels in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Measured: Up to 12 hours
Measure the stress response (systolic blood pressure) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Compare systolic blood pressure in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Measured: Up to 12 hours
Measure the stress response (diastolic blood pressure) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Compare diastolic blood pressure in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Measured: Up to 12 hours
Measure the stress response (heart rate) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Compare heart rate in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Measured: Up to 12 hours
Evaluate the ED-representativeness of an ED-relevant stressor task compared to a standard social stressor task.
Measure ED-representativeness in the following way: the ED-representativeness ratings of the task after completion. Investigators will compare representative ratings on a 9-point scale. The 9-point acceptability responses will be analyzed by calculating the mean and 95% confidence intervals for each question, then calculating a chi-square goodness of fit test.
Measured: Up to 12 hours
Measure agitation scale ratings (Behavioral Activity Rating Scale) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Use the videotaped recordings to compare agitation scale ratings (Behavioral Activity Rating Scale) in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with three stressful ED experiences). Agitation will be rated on a 7-point scale (from "1 - difficult or unable to rouse" to "7 - violent, requires restraint").
Measured: Up to 12 hours
Measure agitation scale ratings (Positive and Negative Syndrome Scale - Excited Component) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Use the videotaped recordings to compare agitation scale ratings (Positive and Negative Syndrome Scale - Excited Component) in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with three stressful ED experiences). Agitation will be rated on a 7-point scale (from "1 - absent" to "7 - extreme") on each of five items: poor impulse control, tension, hostility, uncooperativeness, and excitement.
Measured: Up to 12 hours
Evaluate ethological ratings of non-verbal behaviors thought to indicate assertion using a rating scale (Ethological Coding System for Interviews) commonly employed in the clinical environment for this purpose.
Divide the videotaped recordings of the task into 15-second intervals and code for the presence or absence of non-verbal behaviors. These behaviors will then be calculated as a percentage (i.e., the number of time intervals with a behavior divided by the total number of time intervals). These will be compared participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with three stressful ED experiences).
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start26 Aug 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress PhysiologyStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Oliveto, Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317482
- Sponsor's protocol ID
- 260721
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Human Stress Response in a Simulated ED Setting
- ClinicalTrials.gov ID
- NCT04317482
- Acronym / sponsor ID
- 260721
- Conditions
- Stress Physiology, Stress Reaction, Substance Use Disorders, Methamphetamine-dependence, Stress, Emotional
- Keywords
- Stress Response
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Mar 2020 (actual)
- 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.
Stress is important for health. As emergency departments (EDs) are often stressful places, a better understanding of the human stress response is important for understanding how and why patients respond as they do when they come to the ED. Since the investigators cannot take up space in the ED for research, the investigators will instead recruit 20 methamphetamine-using participants who are not currently in treatment and 10 healthy adult matched participants to a simulated ED room in the University of Arkansas for Medical Sciences (UAMS) Simulation Center. The investigators will have participants perform a stressor task involving public speaking and a simple arithmetic task. The investigators will see if this experiment can be made to be like being in an actual ED by varying what participants speak about in the task. By doing this, the investigators hope to find out several important things: 1) Is a stressor task feasible and acceptable to participants? 2) What does the stress response -- as measured by cortisol and alpha-amylase -- look like in these participants? 3) Does varying what participants talk about make the experiment seem more like an actual ED? 4) Do participants under stress show even mild symptoms of agitation as measured by clinical scales? If so, how often?
Detailed description
Aim 1: Determine the feasibility and acceptability of an ED-relevant stressor task as compared to a standard social stressor task. The investigators hypothesize that an ED-relevant stressor task will be feasible, as measured by the ability to recruit/randomize/retain participants, and as acceptable to participants as a standard social stressor task.
Aim 2: Measure the stress response (alpha-amylase, cortisol, vital signs) in participants who undergo an ED-relevant stress task compared to a standard social stress task. The investigators hypothesize that norepinephrine release will be adequately assessed by salivary alpha-amylase and that an ED-relevant stressor task will elicit similar or greater physiological responses as a standard social stress task.
Aim 3: Evaluate the ED-representativeness of an ED-relevant stressor task compared to a standard social stressor task. Although both tasks will be performed in a simulated ED room in the UAMS Simulation Center, the investigators hypothesize that an ED-relevant task will be rated as more representative of an actual ED visit.
Aim 4: Evaluate ethological ratings of non-verbal behavior thought to indicate assertion and ratings of agitation using rating scales commonly employed in the clinical environment for this purpose. Participants undergoing stress sometimes display symptoms of assertion or agitation, but it is unknown when or how often this occurs. The investigators hypothesize that ethological ratings will be correlated with agitation scale scores and physiological changes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard social stress task | Other | Behavioral: Standard social stress taskParticipants will be given 4.5 minutes to prepare a 4.5-minute public speech on three standard scenarios presented in counterbalanced order. This will involve approximately 30 minutes of public speaking stress given expected transitions. The public speeches will be presented in front of 1-2 individuals who are evaluating their presentations. Immediately after the public speaking task, participants will be asked to complete a mental arithmetic task for 15 minutes. |
| Stressful experience in the ED | Other | Behavioral: Stressful experience in the EDParticipants will be given 4.5 minutes to prepare a 4.5-minute public speech on three experiences surrounding their most stressful ED visit. These experiences are presented in counterbalanced order. This will involve approximately 30 of public speaking stress given expected transitions. The public speeches will be presented in front of 1-2 individuals who are evaluating their presentations. Immediately after the public speaking task, participants will be asked to complete a mental arithmetic task for 15 minutes. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult
- 21-55 years of age
- Self-reported recent history of meth use that meets DSM-5 criteria for current meth use disorder
- Have been previously inside an ED as either a patient or visitor
- Able to construct a stressful mental script of ED experiences
Key exclusion criteria (12 listed)
- Eating/drinking/taking drugs or alcohol the morning before the experiment
- If smoker, not smoking the morning before the experiment
- Subjective or objective signs of intoxication or withdrawal from any substance
- History of any serious medical condition such as cardiovascular, endocrine, neurologic (seizures), or hepatic disease
- Pregnancy
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 |
|---|---|---|
| Standard social stress taskParticipants will be asked to respond in detail to three scenarios. This is a standard social stressor task. Participants may be prompted by an experimenter. However, the participant will receive no verbal nor nonverbal feedback. | Behavioural | Standard social stress task |
| Stressful experience in the EDParticipants will be asked to imagine and then describe both feelings and bodily sensations experienced at their most stressful ED visit, in order to help them more fully re-experience the situation. In this regard, the second condition is more similar to stress imagery employed by Sinha et al, which elevated cortisol to a greater degree than a social stressor task. Participants may be prompted by an experimenter. However, the participant will receive no verbal nor nonverbal feedback. | Behavioural | Stressful experience in the ED |
Primary outcome
Determine the feasibility and acceptability of an ED-relevant stressor task as compared to a standard social stressor task.
Time frame: Up to 12 hours
Measure feasibility and acceptability in the following ways: participant recruitment; the number of participants completing the experiment; and the acceptability ratings of the task after completion. The 9-point acceptability responses will be analyzed by calculating the mean and 95% confidence intervals for each question, then calculating a chi-square goodness of fit test across the 3 ranges of the scores. Answers to open-ended questions about participant experiences will be coded using conventional content analysis, as per Hsieh and Shannon. In this analysis, two research associates separately read through all the participants' qualitative responses and highlight key words which reflect the overall idea of the patient's response. After multiple reviews, 3-5 main categories will be identified which reflect responses of a similar nature. After categorization, a third research associate will make final decisions on the placement of individual responses.
Measure the stress response (alpha-amylase) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Time frame: Up to 12 hours
Compare alpha-amylase in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Measure the stress response (cortisol) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Time frame: Up to 12 hours
Compare cortisol levels in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Measure the stress response (systolic blood pressure) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Time frame: Up to 12 hours
Compare systolic blood pressure in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Measure the stress response (diastolic blood pressure) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Time frame: Up to 12 hours
Compare diastolic blood pressure in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Measure the stress response (heart rate) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Time frame: Up to 12 hours
Compare heart rate in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with stressful imagery).
Evaluate the ED-representativeness of an ED-relevant stressor task compared to a standard social stressor task.
Time frame: Up to 12 hours
Measure ED-representativeness in the following way: the ED-representativeness ratings of the task after completion. Investigators will compare representative ratings on a 9-point scale. The 9-point acceptability responses will be analyzed by calculating the mean and 95% confidence intervals for each question, then calculating a chi-square goodness of fit test.
Measure agitation scale ratings (Behavioral Activity Rating Scale) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Time frame: Up to 12 hours
Use the videotaped recordings to compare agitation scale ratings (Behavioral Activity Rating Scale) in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with three stressful ED experiences). Agitation will be rated on a 7-point scale (from "1 - difficult or unable to rouse" to "7 - violent, requires restraint").
Measure agitation scale ratings (Positive and Negative Syndrome Scale - Excited Component) in participants who undergo an ED-relevant stress task compared to a standard social stress task.
Time frame: Up to 12 hours
Use the videotaped recordings to compare agitation scale ratings (Positive and Negative Syndrome Scale - Excited Component) in participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with three stressful ED experiences). Agitation will be rated on a 7-point scale (from "1 - absent" to "7 - extreme") on each of five items: poor impulse control, tension, hostility, uncooperativeness, and excitement.
Evaluate ethological ratings of non-verbal behaviors thought to indicate assertion using a rating scale (Ethological Coding System for Interviews) commonly employed in the clinical environment for this purpose.
Time frame: Up to 12 hours
Divide the videotaped recordings of the task into 15-second intervals and code for the presence or absence of non-verbal behaviors. These behaviors will then be calculated as a percentage (i.e., the number of time intervals with a behavior divided by the total number of time intervals). These will be compared participants randomized to a standard stressor task (i.e., with three standard scenarios) versus an ED-relevant stressor task (i.e., with three stressful ED experiences).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Alison Oliveto, Ph.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard social stress task and Stressful experience in the ED in people with Stress Physiology and Stress Reaction, run by University of Arkansas 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Determine the feasibility and acceptability of an ED-relevant stressor task as compared to a standard social stressor task. (time frame: Up to 12 hours). The study lists 10 primary outcomes in all. 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 16 Oct 2026.