Psychological Trauma, HistoricalNCT05558527
The Social Regulation of Threat-related Vigilance and Arousal
A study testing social support in people with Psychological Trauma, Historical and Discrimination, Racial, run by University of Nevada, Reno at 1 site in United States.
Trial summary
This study will examine the effects of social support on threat vigilance and arousal using eye tracking. We will also test the moderating effects of trauma and discrimination history. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Trauma, Historical, Discrimination, Racial, Emotion Regulation
- What is being tested?
- social support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2025to Dec 2029
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In a stable romantic relationship for 6 months or more
- Normal vision or corrected-to-normal vision
- Fluent in English
Who cannot join
- If vision is corrected-to-normal, needs to use hard contact lenses, bifocal contact lenses, or glasses
- Experienced a traumatic event within the past 4 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nevada, Reno
Reno, Nevada, 89557
Cynthia L Lancaster, PhD
About this study
Official title: Effects of Trauma and Discrimination on the Social Regulation of Threat-related Vigilance and Arousal
This study will examine the effects of social support on threat vigilance and arousal using eye tracking. We will also test the moderating effects of trauma and discrimination history.
Read the detailed description
Both interpersonal trauma (IPT) and ethno-racial discrimination amplify risk for hyper-arousal symptoms of posttraumatic stress disorder (PTSD), but the mechanism of this effect is unclear. Prior research suggests that social support plays an important role in regulating emotional responses, a process called social emotion regulation. This study will test whether a history of IPT and/or ethno-racial discrimination influence the social regulation of arousal and vigilance. Social regulation will be tested by contrasting responses under conditions with and without social support.
- Conditions
- Psychological Trauma, Historical, Discrimination, Racial, Emotion Regulation, Social Interaction, Hypervigilance, Anxiety
- Being tested
- social support
- Keywords
- psychological trauma, ethnoracial discrimination, hypervigilance, anticipated threat, social emotion regulation, social touch
- Medical subject headings
- Historical Trauma, Racism, Emotional Regulation, Anxiety Disorders, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social supportBehavioural
social support is provided in the form of social touch (hand holding)
| Study group | Role | What they receive |
|---|---|---|
| Social support from a romantic partner | Experimental | Participants will hold the hand of their romantic partner Receives: Behavioral: social support |
| Social support from a stranger | Active comparator | Participants will hold the hand of a stranger Receives: Behavioral: social support |
| No social support | No intervention | Participants will hold a stress ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vigilance Related Eye Movements - Number of Eye Fixations
Participants will view 15 pictures of natural environmental scenes for 10 seconds per image. We will use an eye tracker to examine the number of eye fixations per scene. A greater number of fixations during the 10 second presentation of a scene would indicate greater vigilance.
Measured: Collected from minute 15 to minute 45 of study participation, approximately
Vigilance Related Eye Movements - Visual Scanning
Participants will view 15 pictures of natural environmental scenes for 10 seconds per image. We will use an eye tracker to examine the proportion of the scene that they look at (fixate on) out of approximately 80 possible sectors. A greater proportion of the scene they fixate on would indicate greater vigilance.
Measured: Collected from minute 15 to minute 45 of study participation, approximately
Threat-Related Physiological Arousal - Pupil Dilation
Participants will view a series of visual cues (either an 'X' or an 'O') where an 'X' signals a possible (20% probability) aversive auditory stimulus (human scream). We will examine pupil dilation during the task in order to measure arousal in response to uncertain threat. We will calculate average pupil dilation during the wait period after threat cues (X) and after safety cues (O). We will subtract average pupil dilation after safety cues from threat cues to create an index of threat-related arousal. Greater pupil dilation (for threat minus safety cues) would indicate greater threat-related arousal.
Measured: Collected from minute 45 to minute 75 of study participation, approximately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start18 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Trauma, HistoricalStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Lancaster, University of Nevada, Reno
- Investigators
- Cynthia L Lancaster, PhD, Principal investigator, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558527
- Sponsor's protocol ID
- 1883993-2
- Status last verified
- Feb 2026
- First submitted
- 12 Aug 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data including primary and secondary outcomes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trauma and Discrimination on the Social Regulation of Threat-related Vigilance and Arousal
- ClinicalTrials.gov ID
- NCT05558527
- Acronym / sponsor ID
- 1883993-2
- Conditions
- Psychological Trauma, Historical, Discrimination, Racial, Emotion Regulation, Social Interaction, Hypervigilance, Anxiety
- Keywords
- psychological trauma, ethnoracial discrimination, hypervigilance, anticipated threat, social emotion regulation, social touch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 28 Sep 2022 (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.
This study will examine the effects of social support on threat vigilance and arousal using eye tracking. We will also test the moderating effects of trauma and discrimination history.
Detailed description
Both interpersonal trauma (IPT) and ethno-racial discrimination amplify risk for hyper-arousal symptoms of posttraumatic stress disorder (PTSD), but the mechanism of this effect is unclear. Prior research suggests that social support plays an important role in regulating emotional responses, a process called social emotion regulation. This study will test whether a history of IPT and/or ethno-racial discrimination influence the social regulation of arousal and vigilance. Social regulation will be tested by contrasting responses under conditions with and without social support.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social support from a romantic partner | Experimental | Behavioral: social supportParticipants will hold the hand of their romantic partner |
| Social support from a stranger | Active comparator | Behavioral: social supportParticipants will hold the hand of a stranger |
| No social support | No intervention | –Participants will hold a stress ball |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- In a stable romantic relationship for 6 months or more
- Normal vision or corrected-to-normal vision
- Fluent in English
Key exclusion criteria (2 listed)
- If vision is corrected-to-normal, needs to use hard contact lenses, bifocal contact lenses, or glasses
- Experienced a traumatic event within the past 4 weeks
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 |
|---|---|---|
| social supportsocial support is provided in the form of social touch (hand holding) | Behavioural | Social support from a romantic partner, Social support from a stranger |
Primary outcome
Vigilance Related Eye Movements - Number of Eye Fixations
Time frame: Collected from minute 15 to minute 45 of study participation, approximately
Participants will view 15 pictures of natural environmental scenes for 10 seconds per image. We will use an eye tracker to examine the number of eye fixations per scene. A greater number of fixations during the 10 second presentation of a scene would indicate greater vigilance.
Vigilance Related Eye Movements - Visual Scanning
Time frame: Collected from minute 15 to minute 45 of study participation, approximately
Participants will view 15 pictures of natural environmental scenes for 10 seconds per image. We will use an eye tracker to examine the proportion of the scene that they look at (fixate on) out of approximately 80 possible sectors. A greater proportion of the scene they fixate on would indicate greater vigilance.
Threat-Related Physiological Arousal - Pupil Dilation
Time frame: Collected from minute 45 to minute 75 of study participation, approximately
Participants will view a series of visual cues (either an 'X' or an 'O') where an 'X' signals a possible (20% probability) aversive auditory stimulus (human scream). We will examine pupil dilation during the task in order to measure arousal in response to uncertain threat. We will calculate average pupil dilation during the wait period after threat cues (X) and after safety cues (O). We will subtract average pupil dilation after safety cues from threat cues to create an index of threat-related arousal. Greater pupil dilation (for threat minus safety cues) would indicate greater threat-related arousal.
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes. de-identified data including primary and secondary outcomes
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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.
Cynthia L Lancaster, PhD principal investigator
University of Nevada, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social support in people with Psychological Trauma, Historical and Discrimination, Racial, run by University of Nevada, Reno 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Apr 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?
Contact Kylie Baer, MS ((775) 682-8145, kyliebaer@unr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vigilance Related Eye Movements - Number of Eye Fixations (time frame: Collected from minute 15 to minute 45 of study participation, approximately). The study lists 3 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 13 Apr 2026.