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The primary aim of this study is to explore the feasibility, acceptability, and preliminary effectiveness of CBRT intervention among African Americans compared to a wait-list control group. The specific objectives include assessing feasibility, gathering participant feedback, evaluating CBRT's impact on psychological and biological outcomes, and exploring the mediating role of mindfulness.
The study is a 1-group pretest-posttest design. 20 African American participants will be recruited from various sources and undergo baseline and follow-up assessments. The intervention involves a 10-week CBRT program focusing on mindfulness, compassion, self-awareness, and stress-reduction techniques. Measures include sociodemographics and psychological measures (race-based stress, depression, perceived stress, quality of life, social connectedness, sleep, and resilience) and biological measures ( allostatic load, saliva cortisol, telomere length, and gene expression. Data is collected at baseline and 10 weeks.
Racism and racial discrimination profoundly affect mental and physical health among historically disenfranchised ethnic groups, including Black, Indigenous, and People of Color (BIPOC). The negative health impacts are evident in elevated mortality rates, early disease onset, and increased comorbidity burden among BIPOC individuals. This study seeks to address these health disparities by investigating the potential of Contemplative-Based Resilience Training (CBRT) to mitigate the impact of racism-related stress. CBRT holds promise in countering the neurobiological changes attributed to chronic stress, aligning with the "weathering hypothesis" and Allostatic load theory.
The primary aim of this pilot study is to explore the feasibility, acceptability, and preliminary effectiveness of CBRT intervention among African Americans compared to a waitlist control group. The specific objectives include assessing feasibility, gathering participant feedback, evaluating CBRT's impact on psychological and biological outcomes, and exploring the mediating role of mindfulness.
The study utilizes a one-group pretest-posttest design, where participants are recruited from various sources and undergo baseline and follow-up assessments. The intervention involves a ten-week Cognitive-Based Resilience Training (CBRT) program focusing on developing mindfulness, compassion, self-awareness, and stress-reduction techniques. The study measures include socio-demographics and psychological measures such as race-based stress, depression, perceived stress, quality of life, social connectedness, sleep, and resilience, as well as biological measures including allostatic load, saliva cortisol, telomere length, and gene expression. Data is collected at baseline and after ten weeks of the program.
Feasibility will be assessed based on recruitment rates, retention, attendance, and qualitative feedback. The impact of CBRT will be evaluated through various statistical analyses, considering intention-to-treat principles and controlling for covariates. Preliminary findings from a pilot investigation with 20 African-American participants suggest associations between psychological measures, mindfulness, sleep, coping, resilience, and racism-induced stress. These results underscore the potential of CBRT in addressing complex relationships among these factors. By investigating the potential benefits of CBRT in alleviating racism-induced stress and associated health disparities, this research aims to contribute insights into mindfulness-based interventions to address racism-related stress and its broader implications for the well-being of BIPOC communities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contemplative-Based Resilience Training (CBRT) | Experimental | The intervention group will undergo a 10-week program addressing mindfulness, compassion, social-emotional self-care, exposing stress-reactive habits, self-awareness, visualization, and deep breathing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contemplative-Based Resilience Training (CBRT) | Behavioral | The intervention is a 10-week program that will address mindfulness, compassion, social-emotional self-care, exposing stress-reactive habits, self-awareness, visualization, and deep breathing. The rationale for applying this mindfulness intervention to promote psychological resilience following the development of race-based traumatic symptoms is based on the notion that mindfulness promotes acceptance of complex thoughts and feelings, reduces rumination, and improves psychological function, cognitive flexibility, and coping processes. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Study | number of participants who complete the study | 10 weeks |
| Acceptability of CBRT (Qualitative Interview Findings) | Acceptability was assessed using structured qualitative exit interviews conducted post-intervention. Interview transcripts were reviewed using structured thematic coding. Predefined themes reflecting participant experience were identified, including expectations alignment, perceived usefulness of meditation/emotional regulation tools, facilitator support, group dynamics, session structure, and behavioral impact. For reporting purposes, the number of participants who explicitly endorsed each theme during the interview was counted. Participants could endorse more than one theme; therefore, totals across themes do not sum to the overall sample size. Endorsement reflects a clear expression of agreement, perceived benefit, or experience related to the theme during qualitative analysis. | at the end of the 10 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Allostatic Load Composite Score (NHANES Clinically Relevant Scoring 0-11 ) | Allostatic load score is a composite score based on eleven biomarkers. Risk categories for the level of each biomarker are defined and points, high (Hi) (1 point), moderate (Mod) (0.5 points), or low (low) (0 points), are awarded based on established norms in clinical medicine. Allostatic Load is the sum of the points from the 11 biomarkers. High scores indicate a more significant risk. 1) SBP: Hi ≥ 150 mmHg, Mod 120 to 149 mmHg, Low < 120 mmHg; 2) DBP: Hi ≥ 90 mmHg, Mod 80 to 89 mmHg, Low < 80 mmHg; 3) Total cholesterol: Hi ≥ 240 mg/dL, Mod 200 to 239 mg/dL, Low < 200 mg/dL; 4) HDL cholesterol: Hi < 40 mg/dL, Mod 40 to 59 mg/dL, Low > 60 mg/dL; 5) Total/HDL cholesterol ratio: Hi ≥ 6, Mod 5 to < 6, Low < 5; 6) HgbA1C: Hi ≥ 6.5%, Mod 5.7 to < 6.5%, Low < 5.7%; 7) Waist-hip ratio (women): Hi ≥ 0.85, Mod > 0.80 to < 0.85, Low ≤ 0.80; Waist-hip ratio (men): Hi ≥ 1.0, Mod > 0.95 to < 1.0, Low ≤ 0.95; 8); BMI: Hi ≥ 30 kg/m2, Mod 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel W Kimani, DNP | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recrutment Office | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26398658 | Background | 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. | |
| 16380565 | Background | 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. |
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Of the 22 enrolled, 1 participant was lost to follow-up prior to beginning the intervention. Thus, 21 participants began CBRT.
Participants were recruited through community outreach, flyers, and word of mouth in New York City. Eligibility: self-identified African American adults between 18 and 50 years of age. A total of 35 individuals were screened, and 22 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Contemplative-Based Resilience Training (CBRT) | The intervention group will undergo a 10-week program addressing mindfulness, compassion, social-emotional self-care, exposing stress-reactive habits, self-awareness, visualization, and deep breathing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only participants who completed the intervention and all assessments (N=19) are included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Contemplative-Based Resilience Training (CBRT) | The intervention group will undergo a 10-week program addressing mindfulness, compassion, social-emotional self-care, exposing stress-reactive habits, self-awareness, visualization, and deep breathing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Participant age at baseline, recorded in years at the time of enrollment. Eligible participants were between 18 and 50 years old. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Study | number of participants who complete the study | 21 participants enrolled in the study and started the intervention. 19 participants completed the intervention and outcome measurements. | Posted | Count of Participants | Participants | 10 weeks |
|
|
From enrollment through completion of the 10-week intervention period
One participant underwent cervical surgery for a pre-existing condition during the study period. The event was deemed unrelated to the CBRT intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contemplative-Based Resilience Training (CBRT) | The intervention group will undergo a 10-week program addressing mindfulness, compassion, social-emotional self-care, exposing stress-reactive habits, self-awareness, visualization, and deep breathing. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervical surgery for pre-existing chronic pain condition (unrelated to intervention) | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
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Telomere length assays were not performed due to funding constraints. As a result, no telomere data are available for analysis or reporting in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel W. Kimani | Rockefeller University | 212-327-8432 | rkimani@rockefeller.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2025 | Nov 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063505 | Racism |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D011287 | Prejudice |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D063508 | Social Discrimination |
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|
| Baseline (pre-CBT) to 10 weeks (post-CBT) |
| Cortisol Awakening Response (CAR) | Cortisol Awakening Response (CAR) was calculated as the difference between salivary cortisol concentration measured 30 minutes after awakening and at waking (µg/dL). Positive values reflect a physiologic increase in cortisol following awakening. | Baseline (Pre-CBRT) and 10 weeks (Post-CBRT) |
| Composite CTRA Gene Expression Score | CTRA gene expression was assessed using genome-wide transcriptional profiling of peripheral blood samples. Expression levels of 45 pre-specified CTRA indicator genes were quantified as log2-transformed mRNA abundance values. Gene expression values were mean-centered and weighted using established contrast scores reflecting pro-inflammatory and antiviral gene contributions. A composite CTRA score was calculated by averaging the weighted expression values across all genes, with higher scores indicating greater pro-inflammatory and lower antiviral gene expression activity. | comparison from baseline (pre-CBT) to 10 weeks (post-CBT) |
| Telomere Length | Quantitative Polymerase Chain Reaction (PCR )will determine average telomere length. | 10 weeks |
| 29628069 | Background | 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. |
| 24673162 | Background | 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. |
| 15712783 | Background | 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. |
| 28165267 | 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. |
| 21133583 | Background | 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. |
| 9629234 | Background | McEwen BS. Stress, adaptation, and disease. Allostasis and allostatic load. Ann N Y Acad Sci. 1998 May 1;840:33-44. doi: 10.1111/j.1749-6632.1998.tb09546.x. |
| 22013026 | Background | Williams DR, Yan Yu, Jackson JS, Anderson NB. Racial Differences in Physical and Mental Health: Socio-economic Status, Stress and Discrimination. J Health Psychol. 1997 Jul;2(3):335-51. doi: 10.1177/135910539700200305. |
| 30854146 | Background | Zapolski TCB, Faidley MT, Beutlich M. The Experience of Racism on Behavioral Health Outcomes: The Moderating Impact of Mindfulness. Mindfulness (N Y). 2019 Jan;10(1):168-178. doi: 10.1007/s12671-018-0963-7. Epub 2018 Jun 4. |
| 33727090 | Background | Saban KL, Motley D, Shawahin L, Mathews HL, Tell D, De La Pena P, Janusek LW. Preliminary evidence for a race-based stress reduction intervention for Black women at risk for cardiovascular disease. Complement Ther Med. 2021 May;58:102710. doi: 10.1016/j.ctim.2021.102710. Epub 2021 Mar 13. |
| 31592179 | Background | Cole SW. The Conserved Transcriptional Response to Adversity. Curr Opin Behav Sci. 2019 Aug;28:31-37. doi: 10.1016/j.cobeha.2019.01.008. Epub 2019 Feb 25. |
| Mean |
| Standard Deviation |
| years |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
|
|
| Primary | Acceptability of CBRT (Qualitative Interview Findings) | Acceptability was assessed using structured qualitative exit interviews conducted post-intervention. Interview transcripts were reviewed using structured thematic coding. Predefined themes reflecting participant experience were identified, including expectations alignment, perceived usefulness of meditation/emotional regulation tools, facilitator support, group dynamics, session structure, and behavioral impact. For reporting purposes, the number of participants who explicitly endorsed each theme during the interview was counted. Participants could endorse more than one theme; therefore, totals across themes do not sum to the overall sample size. Endorsement reflects a clear expression of agreement, perceived benefit, or experience related to the theme during qualitative analysis. | Participants who completed the 10-week intervention and post-intervention qualitative interview (N=19). | Posted | Count of Participants | Participants | at the end of the 10 week intervention |
|
|
|
| Secondary | Allostatic Load Composite Score (NHANES Clinically Relevant Scoring 0-11 ) | Allostatic load score is a composite score based on eleven biomarkers. Risk categories for the level of each biomarker are defined and points, high (Hi) (1 point), moderate (Mod) (0.5 points), or low (low) (0 points), are awarded based on established norms in clinical medicine. Allostatic Load is the sum of the points from the 11 biomarkers. High scores indicate a more significant risk. 1) SBP: Hi ≥ 150 mmHg, Mod 120 to 149 mmHg, Low < 120 mmHg; 2) DBP: Hi ≥ 90 mmHg, Mod 80 to 89 mmHg, Low < 80 mmHg; 3) Total cholesterol: Hi ≥ 240 mg/dL, Mod 200 to 239 mg/dL, Low < 200 mg/dL; 4) HDL cholesterol: Hi < 40 mg/dL, Mod 40 to 59 mg/dL, Low > 60 mg/dL; 5) Total/HDL cholesterol ratio: Hi ≥ 6, Mod 5 to < 6, Low < 5; 6) HgbA1C: Hi ≥ 6.5%, Mod 5.7 to < 6.5%, Low < 5.7%; 7) Waist-hip ratio (women): Hi ≥ 0.85, Mod > 0.80 to < 0.85, Low ≤ 0.80; Waist-hip ratio (men): Hi ≥ 1.0, Mod > 0.95 to < 1.0, Low ≤ 0.95; 8); BMI: Hi ≥ 30 kg/m2, Mod 25 | Posted | Mean | Standard Deviation | points | Baseline (pre-CBT) to 10 weeks (post-CBT) |
|
|
|
|
| Secondary | Cortisol Awakening Response (CAR) | Cortisol Awakening Response (CAR) was calculated as the difference between salivary cortisol concentration measured 30 minutes after awakening and at waking (µg/dL). Positive values reflect a physiologic increase in cortisol following awakening. | Participants with complete pre- and post-intervention morning cortisol samples (N = 19). | Posted | Mean | Standard Deviation | µg/dL | Baseline (Pre-CBRT) and 10 weeks (Post-CBRT) |
|
|
|
|
| Secondary | Composite CTRA Gene Expression Score | CTRA gene expression was assessed using genome-wide transcriptional profiling of peripheral blood samples. Expression levels of 45 pre-specified CTRA indicator genes were quantified as log2-transformed mRNA abundance values. Gene expression values were mean-centered and weighted using established contrast scores reflecting pro-inflammatory and antiviral gene contributions. A composite CTRA score was calculated by averaging the weighted expression values across all genes, with higher scores indicating greater pro-inflammatory and lower antiviral gene expression activity. | Participants who completed both baseline and post-intervention assessments and had analyzable gene expression data were included in the analysis. | Posted | Mean | Standard Error | log2 mRNA expression (composite score) | comparison from baseline (pre-CBT) to 10 weeks (post-CBT) |
|
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|
|
| Secondary | Telomere Length | Quantitative Polymerase Chain Reaction (PCR )will determine average telomere length. | Telomere length assays were not performed. Samples were collected but assays were not completed and therefore teleomere length data were not collected. Assays were not completed due to funding restraints and will not be completed in the future. | Posted | 10 weeks |
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| 0 |
| 21 |
One participant underwent cervical surgery for a chronic pain condition unrelated to the CBRT intervention. No other serious or study-related adverse events occurred.
|
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| D001526 |
| Behavioral Symptoms |
| Title | Measurements |
|---|---|
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| Session Structure Was Appropriate |
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| Intervention Changed Behaviors |
|