Stress, Psychological Clinical Trial
Official title:
Racism-based Stress Injury and Biomarkers of Stress: A Feasibility Study and Correlation Study
NCT number | NCT05574933 |
Other study ID # | RKI-1036 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 31, 2022 |
Est. completion date | April 6, 2023 |
Verified date | May 2023 |
Source | Rockefeller University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 6, 2023 |
Est. primary completion date | April 6, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Rockefeller University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Rockefeller University |
United States,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of study | percentage of participants who complete the study | 2 weeks | |
Primary | 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. | 2 weeks | |
Primary | Acceptability of planned 12 week intervention | Percentage of participants willing to participate in a future planned Intervention | 2 weeks | |
Secondary | 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) | 2 weeks | |
Secondary | Telomere Length | Quantitative RT-PCR will be used to determine average telomere length | 2 weeks | |
Secondary | 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) | After baseline, 3 timepoints at waking, 30min after waking, and at bedtime. In a 24 hour period | |
Secondary | 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 | 2 weeks | |
Secondary | 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 | 2 weeks | |
Secondary | 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. | 2 weeks |
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