Clinical trial NCT05574933: Racism-based and Biomarkers of Stress
Official title: Racism-based Stress Injury and Biomarkers of Stress: A Feasibility Study and Correlation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Racism
Stress, Psychological
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Self-identifying African Americans/Black 18-50 years of age

Brief 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). 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of study
timeFrame: 2 weeks
measure: Correlation analysis of race-based traumatic stress and allostatic load
timeFrame: 2 weeks
measure: Acceptability of planned 12 week intervention
timeFrame: 2 weeks
Secondary outcomes:
measure: Allostatic load composite score
timeFrame: 2 weeks
measure: Telomere Length
timeFrame: 2 weeks
measure: Salivary Cortisol-AUC
timeFrame: After baseline, 3 timepoints at waking, 30min after waking, and at bedtime. In a 24 hour period
measure: Concentrations of pro-inflammatory gene expression Response to Adversity (CTRA)
timeFrame: 2 weeks
measure: Qualitative evaluation of participants perspectives on racism based stress
timeFrame: 2 weeks
measure: Race-based traumatic stress symptoms
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University
state: New York
Study officials:
affiliation: Rockefeller University
name: Rachel W Kimani
role: PRINCIPAL_INVESTIGATOR
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