Social Experiences and Demographic Factors in the Regulation of Immune Cells

NCT ID: NCT06519487

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2029-02-28

Brief Summary

Immune-mediated inflammatory diseases are a health burden for approximately seven percent of the population of Western nations. Preliminary data suggest variations in ethnic identity and/or geography influence discrimination experiences and inflammatory response trends. This study investigates how geography, ethnicity, and laboratory manipulation of discrimination experiences affect immune cell function and genomic regulation. Flow cytometry and immune cell stimulation will test monocytes collected from peripheral blood for functional effects. Next-generation transcriptomics and epigenomics will assess genomic and epigenetic mechanisms. The hypothesis is that geography, self-identified race, and ethnicity, interacting with laboratory discrimination conditions during the virtual ballgame Cyberball™, significantly affect immune cell function through genomic and epigenetic mechanisms, with perceived discrimination as a moderating factor on the immune outcomes. The transdisciplinary nature of the proposed study aims to provide valuable insights into differential susceptibility to immune-mediated inflammatory diseases across diverse populations. Uncovering these insights will better inform population-relevant interventions for immune-mediated inflammatory diseases.

Detailed Description

More than a third of the residents of the United States suffer from a chronic disease, with almost half involving dysregulated immune processes. Immune-mediated inflammatory diseases pose a public health burden in the United States. Preliminary data from previous work suggest that variations in ethnic identity and geography might influence discrimination experiences and inflammatory response trends. To investigate the functional implications of these findings, a multi-institutional study is proposed, examining how social experiences and demographic factors predict the regulation and activity of immune cells. Specifically, the hypothesis is that geography, self-identified race, and ethnicity, interacting with laboratory discrimination conditions, significantly affect immune cell function through genomic and epigenetic mechanisms, with perceived discrimination moderating the immune outcomes. Participants will provide saliva samples, complete psychosocial and demographic questionnaires, and play the virtual social exclusion game Cyberball™ in a randomly assigned block order. Acute discrimination experiences are manipulated by conditions during Cyberball. Virtual players, who appear to be of a different race from the participant, exclude them by not passing the participant the ball in the race-based exclusion condition. In the inclusion condition, the participant receives the ball regardless of participant and virtual player race. In the general social exclusion (not race-based), the players and participant races are similar to the inclusion condition, except that the participant does not receive the ball. The block of Cyberball and blood draws randomly assigned are either: 1) race-based social exclusion and inclusion first, a blood draw, then non-race-based social exclusion, inclusion, and blood draw, or 2) non-race-based social exclusion and inclusion, a blood draw and then the race-based social exclusion and inclusion and a blood draw. Baseline and post-first block inflammatory responses in saliva will be measured using enzyme-linked immunosorbent assays (ELISAs) to determine the concentration of cytokines like C-reactive protein, interleukin-6, and tumor necrosis factor-alpha. Flow cytometry and immune cell stimulation with toxin will test monocytes purified and sorted from the participant's blood for functional effects. Next-generation transcriptomics and epigenomics will assess differentially expressed RNA and methylation enrichment, emphasizing genes involved in inflammation signaling pathways. The data will be statistically analyzed using regression analysis and structural equation modeling to determine the relationship between discrimination, geography, immune cell function, and regulation while controlling for other socio-demographic factors. The findings could inform public health initiatives and interventions to reduce health disparities and improve outcomes for marginalized communities.

Conditions

Perceived Discrimination; RNA; Inflammatory Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Mid-Atlantic: Non-Hispanic Black Order 1

Participants play Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times.

After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play cyberball with virtual players who do not have any obvious ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth with each other a number of times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Group Type: EXPERIMENTAL

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Mid-Atlantic: Non-Hispanic Black Order 2

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Group Type: ACTIVE_COMPARATOR

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Mid-Atlantic: Non-Hispanic White Order 1

Participants play Cyberball™ with virtual players who appear non-Hispanic Black, or Hispanic. The participant receives the ball once during the game, while all the non-Hispanic Black or Hispanic avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Group Type: EXPERIMENTAL

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Mid-Atlantic: Non-Hispanic White Order 2

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball with virtual players who appear to be non-Hispanic Black or Hispanic. The participant receives the ball once during the game, while all the non-Hispanic Black or Hispanic avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Group Type: ACTIVE_COMPARATOR

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Mid-Atlantic Hispanic Order 1

Participants play Cyberball™ with virtual players who appear to be non-Hispanic White. The participant receives the ball once during the game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Group Type: EXPERIMENTAL

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Mid-Atlantic Hispanic Order 2

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Group Type: ACTIVE_COMPARATOR

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Southwest Non-Hispanic Black Order 1

Participants play Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Group Type: EXPERIMENTAL

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Southwest Non-Hispanic Black Order 2

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Group Type: ACTIVE_COMPARATOR

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Southwest Non-Hispanic White Order 1

Participants play Cyberball™ with virtual players who appear non-Hispanic Black or Hispanic. The participant receives the ball once during the game, while all the non-Hispanic Black or Hispanic avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the different avatars, regardless of ethnicity.

Group Type: EXPERIMENTAL

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Southwest Non-Hispanic White Order 2

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. Participants play another session of Cyberball with virtual players who appear to be non-Hispanic Black or Hispanic. The participant only receives the ball once during the entire game, while all the non-white avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Group Type: ACTIVE_COMPARATOR

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Southwest Hispanic Order 1

Participants play Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Group Type: EXPERIMENTAL

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Southwest Hispanic White Order 2

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball™ with virtual players who appear to be non-Hispanic White. The participant receives the ball once during the game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Group Type: EXPERIMENTAL

Cyberball

Intervention Type: BEHAVIORAL

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Interventions

Cyberball

Cyberball™ is a virtual social exclusion game that simulates social interactions and acute discrimination experiences in a controlled laboratory setting. The game involves passing a virtual ball between players represented by images. In this study, only the participant is a real player, while the other "players" are pre-programmed virtual avatars controlled by the experimenter using Cyberball software. The ethnicity of these virtual players can be manipulated by changing the stock photos used to represent them. Participants in the Race-Based Social Exclusion condition play Cyberball with virtual players who appear to be of a different ethnicity from the participant. In the Non-Race-Based Social Exclusion, the participant plays with virtual players who do not have any obvious ethnic differences from the participant, and social inclusion is a washout condition where the participant receives the ball from the virtual players, regardless of the ethnicity of the avatars.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Non-Hispanic Black, Non-Hispanic White, or Hispanic
• At least 18 years of age
• Lives within 25 miles of, works, or attends Morgan State University, The University of Baltimore or Texas Christian University

Exclusion Criteria

• Anyone not identifying as either non-Hispanic Black, non-Hispanic White, or Hispanic,
• Under 18 years old
• Does not live within 25 miles of, works, or attends Morgan State University, the University of Baltimore or Texas Christian University

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Christian University

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: collaborator

University of Baltimore

UNKNOWN

Sponsor Role: collaborator

Morgan State University

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Tulloch

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Morgan State University

Baltimore, Maryland, United States

Site Status: RECRUITING

Texas Christian University

Fort Worth, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ingrid Tulloch K tulloch, PhD

Role: CONTACT

ingrid.tulloch@morgan.edu

4438852276

Sarah E Hill, PhD

Role: CONTACT

s.e.hill@tcu.edu

817-257-6424

Facility Contacts

Ingrid Tulloch, PhD

Role: primary

ingrid.tulloch@morgan.edu

443-885-2276

Arnold Nicole, PhD

Role: backup

nicole.arnold@morgan.edu

4433342276 ext. tulloch

Sarah Hill, PhD

Role: primary

s.e.hill@tcu.edu

817-257-6424

Talia Chachkes, MS

Role: backup

T.CHACHKES@tcu.edu

817-257-6424

Other Identifiers

2407001

Identifier Type: -

Identifier Source: org_study_id