The Social Regulation of Threat-related Vigilance and Arousal

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Emotion Regulation; Discrimination, Racial; Social Interaction; Psychological Trauma, Historical; Hypervigilance
• Intervention / Treatment: Behavioral: social support

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna C Cole, MA; Phone Number: (775) 682-8145; Email: accole@nevada.unr.edu
• Study Contact Backup: Name: Cynthia L Lancaster, PhD; Phone Number: (775) 682-8145; Email: cynthialancaster@unr.edu

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89557
      • University of Nevada, Reno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social support from a romantic partner; Participants will hold the hand of their romantic partner	Behavioral: social support; social support is provided in the form of social touch (hand holding)
Active Comparator: Social support from a stranger; Participants will hold the hand of a stranger	Behavioral: social support; social support is provided in the form of social touch (hand holding)
No Intervention: No social support; Participants will hold a stress ball

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Nevada, Reno
• Investigators: Principal Investigator: Cynthia L Lancaster, PhD, University of Nevada, Reno

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: psychological trauma; ethnoracial discrimination; hypervigilance; anticipated threat; social emotion regulation; social touch
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Psychological Trauma; Historical Trauma
• Other Study ID Numbers: 1883993-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified data including primary and secondary outcomes
• IPD Sharing Time Frame: within 6 months after publication
• IPD Sharing Access Criteria: email request to the study PI (cynthialancaster@unr.edu)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No