NCT05574933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

October 6, 2022

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Feasibility of study

    percentage of participants who complete the study

    2 weeks

  • 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

  • Acceptability of planned 12 week intervention

    Percentage of participants willing to participate in a future planned Intervention

    2 weeks

Secondary Outcomes (6)

  • Allostatic load composite score

    2 weeks

  • Telomere Length

    2 weeks

  • Salivary Cortisol-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)

    2 weeks

  • Qualitative evaluation of participants perspectives on racism based stress

    2 weeks

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (18)

  • 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

    BACKGROUND
  • 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.

    PMID: 24347666BACKGROUND
  • 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.

    PMID: 28402827BACKGROUND
  • 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.

    PMID: 26301485BACKGROUND
  • 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.

    PMID: 26398658BACKGROUND
  • 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.

    PMID: 16380565BACKGROUND
  • 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.

    PMID: 29628069BACKGROUND
  • 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.

    PMID: 24740491BACKGROUND
  • 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.

    PMID: 24673162BACKGROUND
  • 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.

    PMID: 15574496BACKGROUND
  • 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.

    PMID: 33289498BACKGROUND
  • 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.

    PMID: 15712783BACKGROUND
  • 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.

    PMID: 33810863BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 28165267BACKGROUND
  • Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

    PMID: 16004657BACKGROUND
  • Wei M, Alvarez AN, Ku TY, Russell DW, Bonett DG. Development and validation of a Coping with Discrimination Scale: factor structure, reliability, and validity. J Couns Psychol. 2010 Jul;57(3):328-44. doi: 10.1037/a0019969.

    PMID: 21133583BACKGROUND
  • Tedeschi RG, Calhoun LG. The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress. 1996 Jul;9(3):455-71. doi: 10.1007/BF02103658.

    PMID: 8827649BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for a complete blood count, gene expression analysis, and telomere length testing

MeSH Terms

Conditions

RacismStress, Psychological

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial DiscriminationBehavioral Symptoms

Study Officials

  • Rachel W Kimani

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 12, 2022

Study Start

October 31, 2022

Primary Completion

April 6, 2023

Study Completion

April 6, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations