Racism-based and Biomarkers of Stress

May 9, 2023 updated by: Rockefeller University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Rockefeller University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of study
Time Frame: 2 weeks
percentage of participants who complete the study
2 weeks
Correlation analysis of race-based traumatic stress and allostatic load
Time Frame: 2 weeks
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.
2 weeks
Acceptability of planned 12 week intervention
Time Frame: 2 weeks
Percentage of participants willing to participate in a future planned Intervention
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allostatic load composite score
Time Frame: 2 weeks
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)
2 weeks
Telomere Length
Time Frame: 2 weeks
Quantitative RT-PCR will be used to determine average telomere length
2 weeks
Salivary Cortisol-AUC
Time Frame: After baseline, 3 timepoints at waking, 30min after waking, and at bedtime. In a 24 hour period
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)
After baseline, 3 timepoints at waking, 30min after waking, and at bedtime. In a 24 hour period
Concentrations of pro-inflammatory gene expression Response to Adversity (CTRA)
Time Frame: 2 weeks
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
2 weeks
Qualitative evaluation of participants perspectives on racism based stress
Time Frame: 2 weeks
Qualitative interviews using semistructured questions will be conducted to understand participants' perspectives on racism and how they cope with racism
2 weeks
Race-based traumatic stress symptoms
Time Frame: 2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockefeller University

Investigators

  • Principal Investigator: Rachel W Kimani, Rockefeller University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2022

Primary Completion (Actual)

April 6, 2023

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RKI-1036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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