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The Social Regulation of Threat-related Vigilance and Arousal

Primary Purpose

Psychological Trauma, Historical, Discrimination, Racial, Emotion Regulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
social support
Sponsored by
University of Nevada, Reno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychological Trauma, Historical focused on measuring psychological trauma, ethnoracial discrimination, hypervigilance, anticipated threat, social emotion regulation, social touch

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Nevada, Reno

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Social support from a romantic partner

Social support from a stranger

No social support

Arm Description

Participants will hold the hand of their romantic partner

Participants will hold the hand of a stranger

Participants will hold a stress ball

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2022
Last Updated
June 16, 2023
Sponsor
University of Nevada, Reno
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1. Study Identification

Unique Protocol Identification Number
NCT05558527
Brief Title
The Social Regulation of Threat-related Vigilance and Arousal
Official Title
Effects of Trauma and Discrimination on the Social Regulation of Threat-related Vigilance and Arousal
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nevada, Reno

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Trauma, Historical, Discrimination, Racial, Emotion Regulation, Social Interaction, Hypervigilance, Anxiety
Keywords
psychological trauma, ethnoracial discrimination, hypervigilance, anticipated threat, social emotion regulation, social touch

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social support from a romantic partner
Arm Type
Experimental
Arm Description
Participants will hold the hand of their romantic partner
Arm Title
Social support from a stranger
Arm Type
Active Comparator
Arm Description
Participants will hold the hand of a stranger
Arm Title
No social support
Arm Type
No Intervention
Arm Description
Participants will hold a stress ball
Intervention Type
Behavioral
Intervention Name(s)
social support
Intervention Description
social support is provided in the form of social touch (hand holding)
Primary Outcome Measure Information:
Title
Vigilance Related Eye Movements - Number of Eye Fixations
Description
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.
Time Frame
Collected from minute 15 to minute 45 of study participation, approximately
Title
Vigilance Related Eye Movements - Visual Scanning
Description
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.
Time Frame
Collected from minute 15 to minute 45 of study participation, approximately
Title
Threat-Related Physiological Arousal - Pupil Dilation
Description
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.
Time Frame
Collected from minute 45 to minute 75 of study participation, approximately

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna C Cole, MA
Phone
(775) 682-8145
Email
accole@nevada.unr.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia L Lancaster, PhD
Phone
(775) 682-8145
Email
cynthialancaster@unr.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia L Lancaster, PhD
Organizational Affiliation
University of Nevada, Reno
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada, Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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)

Learn more about this trial

The Social Regulation of Threat-related Vigilance and Arousal

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