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RacismNCT05574933

Racism-based and Biomarkers of Stress

An observational study of Racism and Stress, Psychological, run by Rockefeller University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This feasibility study aims to explore how racism-induced stress impacts the brain and body and how a culturally responsive intervention can reduce the mental and physical effects of this stress among African Americans (AA). Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Racism, Stress, Psychological
How many people
20 participants
Where
1 siteUnited States
Study dates
31 Oct 2022to 6 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Self-identifying African Americans/Black 18-50 years of age

Who may be able to join

  • Self Identity as African American or Black
  • 18-50 years old
  • Fluent in English
  • Born and or raised in the United States

Who cannot join

  • History of significant pre-existing brain disease or injury (e.g., dementia, stroke, seizure disorder, and head injury with cognitive sequelae or loss of consciousness >30 min.ute, seizure disorder)
  • Reported history of learning disability/mental retardation
  • Current Attention Deficit Hyperactive Disorder (ADHD), depression, bipolar disorder, post-traumatic stress disorder (PTSD), or psychotic disorder diagnosis
  • Current psychotropic medication (as these medications have known impacts on brain function) eg. antipsychotics, antianxiety
  • Severe/chronic medical illness (e.g., reported HIV+ status, cardiovascular disease, liver disease/cirrhosis, chronic kidney disease, current/past cancer with radiation/chemotherapy treatment, etc.)
  • Current methadone/suboxone/buprenorphine (or similar) maintenance
Show all 9Show fewer
  • Use of illicit substances other than cannabis within the past 90 days
  • Pregnant
  • Major life events in the last 30 days (hospitalization, marriage, death in the family of friends, disaster)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rockefeller University

    New York, New York, 10065

Other trials in United States

About this study

Official title: Racism-based Stress Injury and Biomarkers of Stress: A Feasibility Study and Correlation Study

This feasibility study aims to explore how racism-induced stress impacts the brain and body and how a culturally responsive intervention can reduce the mental and physical effects of this stress among African Americans (AA). We aim to acquire methodological and protocol insights for a subsequent study by assessing 1) the feasibility of recruiting AA for a race-related study and collecting psychological and biomarkers of stress, 2) determining the association between racism-based stress surveys and biomarkers of stress, and 3) explore participants feedback on the impact of racism in their life and their willingness to participate in a 12-week mindfulness intervention with additional assessments, such as functional MRI testing.

Read the detailed description

Racism is a chronic stressor affecting minority groups, particularly Black, Indigenous, and People of Color (BIPOC), which increases their vulnerability to disease and adverse outcomes. Several studies have associated racism with psychosocial distress, elevated inflammation, and accumulation of toxic radicals in the body, leading to diabetes and heart disease. Moreover, studies investigating biological structural changes suggest that racism is associated with alterations in activation and connectivity of brain regions controlling emotional behavior. Race-based encounters can lead to high levels of stress that can cause a traumatic reaction raising chronic vigilance by creating anticipatory distress and concerns, which could drive the output of allostatic mediators. Allostatic load represents the cumulative physiological burden exacted on the body throughout a lifetime in the effort to adapt to stressors. Therefore, in addition to broader structural and institutional changes, there is a critical need for interventions to mitigate race-related injury and promote enhanced physical and mental health.

Contemplative-Based Resilience Training (CBRT) is a potential non-invasive intervention that may moderate the effects of racism on health outcomes. CBRT is a contemplative self-healing program that integrates mindfulness with cognitive education, affect modulation, motivational imagery, breath control, and self-massage. Research demonstrates that compassion-based meditative therapies support the development of pro-social attributes and social connections. Individuals with higher mindfulness traits are thought to have a greater ability to regulate their emotions and are less emotionally reactive. In addition, mindfulness interventions can also lead to the development of individual resilience and by focusing on the present moment, negative feelings are less likely to persist leading to psychological well-being and consequently physiological health. Mindfulness-based interventions are efficacious in reducing anxiety, depression, substance abuse, eating disorders, and chronic pain and improving general well-being and quality of life. Although there is some evidence of the buffering effect of mindfulness on psychological outcomes from discrimination, few studies have focused on race-based stress and are limited to examining psychological outcomes.

This feasibility study aims to acquire methodological and protocol insights and build the infrastructure for a subsequent CBRT interventional study to reduce the effects of race-based trauma and stress. The study will be a mixed-methods study with an embedded qualitative study. First, we will determine if it is feasible to recruit a sample of 20 African American/Black participants to measure behavioral and physiological measures of race-based stress. Second, we will validate and further test additional physiological variables of racism as a stressor on allostatic load, gene expression, and telomere length. Third, we will conduct interviews to obtain participants' perspectives and feedback on a planned 12-week mindfulness intervention study to reduce the effects of race-based stress among African Americans, as well as to assess their willingness to undergo additional assessments, such as functional MRI scans. The deliverables of this study are to build a community-based research infrastructure, to determine with greater clarity some of the relationships between physiological variables and racism-induced stress, and how to adapt an existing CBRT intervention to address the experience of race-based stress in a more culturally responsive manner.

Medical subject headings
Racism, Stress, Psychological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of study

    percentage of participants who complete the study

    Measured: 2 weeks

  2. Correlation analysis of race-based traumatic stress and allostatic load

    Correlate levels of race-based traumatic stress calculated from a questionnaire (Race-based Traumatic stress symptoms-RBTSSS) with allostatic load and stress biomarkers (salivary cortisol). The RBTSS is 52 items self-report instrument that assesses reactions resulting from negative racial experiences. Participants identify the most memorable negative racial encounter and complete emotional symptom reaction items. Items are rated along a 5-point Likert scale. RBTSSS comprises of 7 symptom scales: Depression (10 items), Intrusion (8 items), Anger (8 items), hypervigilance (8 items), physical reactions (8 items), Low self-esteem (6 items), and avoidance (4 items). Higher scores indicate a greater presence of reaction symptoms. The Allostatic score is calculated as a composite of 10 biomarkers focused on the metabolic, renal, and immune physiologic systems.

    Measured: 2 weeks

  3. Acceptability of planned 12 week intervention

    Percentage of participants willing to participate in a future planned Intervention

    Measured: 2 weeks

Secondary outcomes (6)
  1. Allostatic load composite score

    The Allostatic score was calculated as a composite of these 10 biomarkers focused on the metabolic, renal, and immune physiologic systems. A Biomarkers from the metabolic system included body mass index (BMI) (kg/m2), albumin, and alkaline phosphatase. The renal system biomarkers were creatinine and creatinine clearance, and immune system biomarkers were C-reactive protein (CRP) and white blood cell count (WBC). The cut points are determined by pre-established values in clinical medicine and generate three categories: high-risk (1 point), moderate-risk (0.5 point), and low-risk (0 points)

    Measured: 2 weeks

  2. Telomere Length

    Quantitative RT-PCR will be used to determine average telomere length

    Measured: 2 weeks

  3. Salivary Cortisol-AUC

    Samples will be collected using the passive drool technique using a . Participants will be instructed to gather saliva samples 3 times in one day: at waking, 30min after waking, and at bedtime. Participants will be instructed not to eat, drink or brush their teeth during the 30 min prior to sample collection times. Salivary cortisol will be analyzed using area-under-the-curve (AUC)

    Measured: After baseline, 3 timepoints at waking, 30min after waking, and at bedtime. In a 24 hour period

  4. Concentrations of pro-inflammatory gene expression Response to Adversity (CTRA)

    Gene expression measures of immune system function will be collected via Paxegene tubes. Analyses will focus on a priori-specified gene regulation pattern involving increased expression of inflammation-related genes and decreased expression of antiviral genes - a pattern called the conserved transcriptional response to adversity

    Measured: 2 weeks

  5. Qualitative evaluation of participants perspectives on racism based stress

    Qualitative interviews using semistructured questions will be conducted to understand participants' perspectives on racism and how they cope with racism

    Measured: 2 weeks

  6. Race-based traumatic stress symptoms

    Race-based Traumatic stress symptoms (RBTSSS) is a 52-item self-report instrument that assesses reactions resulting from negative racial experiences. Participants identify the most memorable negative racial encounter and complete emotional symptom reaction items. Items are rated along a 5-point Likert scale. RBTSSS comprises of 7 symptom scales: Depression (10 items), Intrusion (8 items), Anger (8 items), hypervigilance (8 items), physical reactions (8 items), Low self-esteem (6 items), and avoidance (4 items). Higher scores indicate a greater presence of reaction symptoms.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2022
  2. Study start31 Oct 2022
  3. Primary completion6 Apr 2023
  4. Study completion6 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05574933
Sponsor's protocol ID
RKI-1036
Status last verified
May 2023
First submitted
6 Oct 2022
Last updated
11 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • American Public Health Association. Analysis: Declarations of Racism as a Public Health Crisis.2021. https://www.apha.org/-/media/Files/PDF/topics/racism/Racism_Declarations_Analysis. ashx

  • Williams DR, Mohammed SA. Racism and Health I: Pathways and Scientific Evidence. Am Behav Sci. 2013 Aug 1;57(8):10.1177/0002764213487340. doi: 10.1177/0002764213487340.

    PubMed 24347666
  • Bailey ZD, Krieger N, Agenor M, Graves J, Linos N, Bassett MT. Structural racism and health inequities in the USA: evidence and interventions. Lancet. 2017 Apr 8;389(10077):1453-1463. doi: 10.1016/S0140-6736(17)30569-X.

    PubMed 28402827
  • Becares L, Nazroo J, Kelly Y. A longitudinal examination of maternal, family, and area-level experiences of racism on children's socioemotional development: Patterns and possible explanations. Soc Sci Med. 2015 Oct;142:128-35. doi: 10.1016/j.socscimed.2015.08.025. Epub 2015 Aug 15.

    PubMed 26301485
  • Paradies Y, Ben J, Denson N, Elias A, Priest N, Pieterse A, Gupta A, Kelaher M, Gee G. Racism as a Determinant of Health: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 23;10(9):e0138511. doi: 10.1371/journal.pone.0138511. eCollection 2015.

    PubMed 26398658
  • Geronimus AT, Hicken M, Keene D, Bound J. "Weathering" and age patterns of allostatic load scores among blacks and whites in the United States. Am J Public Health. 2006 May;96(5):826-33. doi: 10.2105/AJPH.2004.060749. Epub 2005 Dec 27.

    PubMed 16380565
  • Clark US, Miller ER, Hegde RR. Experiences of Discrimination Are Associated With Greater Resting Amygdala Activity and Functional Connectivity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Apr;3(4):367-378. doi: 10.1016/j.bpsc.2017.11.011. Epub 2017 Dec 8.

    PubMed 29628069
  • Akdeniz C, Tost H, Streit F, Haddad L, Wust S, Schafer A, Schneider M, Rietschel M, Kirsch P, Meyer-Lindenberg A. Neuroimaging evidence for a role of neural social stress processing in ethnic minority-associated environmental risk. JAMA Psychiatry. 2014 Jun;71(6):672-80. doi: 10.1001/jamapsychiatry.2014.35.

    PubMed 24740491
  • Brody GH, Lei MK, Chae DH, Yu T, Kogan SM, Beach SRH. Perceived discrimination among African American adolescents and allostatic load: a longitudinal analysis with buffering effects. Child Dev. 2014 May-Jun;85(3):989-1002. doi: 10.1111/cdev.12213. Epub 2014 Feb 5.

    PubMed 24673162
  • Epel ES, Blackburn EH, Lin J, Dhabhar FS, Adler NE, Morrow JD, Cawthon RM. Accelerated telomere shortening in response to life stress. Proc Natl Acad Sci U S A. 2004 Dec 7;101(49):17312-5. doi: 10.1073/pnas.0407162101. Epub 2004 Dec 1.

    PubMed 15574496
  • Thomas MD, Sohail S, Mendez RM, Marquez-Magana L, Allen AM. Racial Discrimination and Telomere Length in Midlife African American Women: Interactions of Educational Attainment and Employment Status. Ann Behav Med. 2021 Jun 28;55(7):601-611. doi: 10.1093/abm/kaaa104.

    PubMed 33289498
  • Tull ES, Sheu YT, Butler C, Cornelious K. Relationships between perceived stress, coping behavior and cortisol secretion in women with high and low levels of internalized racism. J Natl Med Assoc. 2005 Feb;97(2):206-12.

    PubMed 15712783
  • Miller HN, LaFave S, Marineau L, Stephens J, Thorpe RJ Jr. The impact of discrimination on allostatic load in adults: An integrative review of literature. J Psychosom Res. 2021 Jul;146:110434. doi: 10.1016/j.jpsychores.2021.110434. Epub 2021 Mar 24.

    PubMed 33810863
  • Watson-Singleton NN, Pennefather J, Trusty T. Can a culturally-responsive Mobile health (mHealth) application reduce African Americans' stress?: A pilot feasibility study. Current Psychology. 2021 /03/02 2021;doi:10.1007/s12144-021-01534-9

  • Carter RT, Muchow C. Construct validity of the Race-Based Traumatic Stress Symptom Scale and tests of measurement equivalence. Psychol Trauma. 2017 Nov;9(6):688-695. doi: 10.1037/tra0000256. Epub 2017 Feb 6.

    PubMed 28165267

Questions about this trial

What is this clinical trial studying?

An observational study of Racism and Stress, Psychological, run by Rockefeller University 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 11 May 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of study (time frame: 2 weeks). 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?

On the ClinicalTrials.gov record for NCT05574933, which also lists 18 linked publications.

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 11 May 2023.

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