The Social Regulation of Threat-related Vigilance and Arousal

Anxiety Clinical Trial

Official title:

Effects of Trauma and Discrimination on the Social Regulation of Threat-related Vigilance and Arousal

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05558527
• Other study ID #: 1883993-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: University of Nevada, Reno
• Contact: Anna C Cole, MA
• Phone: (775) 682-8145
• Email: accole[@]nevada.unr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• In a stable romantic relationship for 6 months or more
• Normal vision or corrected-to-normal vision
• Fluent in English

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety
• Discrimination, Racial
• Emotion Regulation
• Hypervigilance
• Psychological Trauma
• Social Interaction
• Wounds and Injuries

Intervention

Behavioral:
• social support
social support is provided in the form of social touch (hand holding)

Locations

Country	Name	City	State
United States	University of Nevada, Reno	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Reno

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Collected from minute 15 to minute 45 of study participation, approximately
Primary	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.	Collected from minute 15 to minute 45 of study participation, approximately
Primary	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.	Collected from minute 45 to minute 75 of study participation, approximately