ClinicalTrials.gg
CompletedNCT06146218Updated Apr 9, 2026Results posted

Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress

An interventional study of Contemplative-Based Resilience Training (CBRT) in Racism and Stress, Psychological, sponsored by Rockefeller University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Rockefeller University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Racism
  • Stress, Psychological
03

In context

Racism

47 studies on the registry are indexed under Racism; 8 are open to participants now.

This study's enrollment of 22 is below the median of 106 across 34 interventional studies indexed under Racism.

Browse Racism studies →

Lead sponsor

Rockefeller University is the lead sponsor of 123 studies on the registry; 3 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Self Identity as African American or Black
  • 18-50 years old
  • Fluent in English

Exclusion criteria

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 more than 30 minutes, 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 are known impacts on brain function) e.g. antipsychotics, antianxiety
  • Severe/chronic medical illness (e.g., reported + 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Contemplative-Based Resilience Training (CBRT)

Interventions

  • BehavioralContemplative-Based Resilience Training (CBRT)

    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.

06

What researchers measure

Primary outcomes

  1. Feasibility of Study

    number of participants who complete the study

    Time frame: 10 weeks

  2. 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.

    Time frame: at the end of the 10 week intervention

Secondary outcomes

  1. 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

    Time frame: Baseline (pre-CBT) to 10 weeks (post-CBT)

  2. 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.

    Time frame: Baseline (Pre-CBRT) and 10 weeks (Post-CBRT)

  3. 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.

    Time frame: comparison from baseline (pre-CBT) to 10 weeks (post-CBT)

  4. Telomere Length

    Quantitative Polymerase Chain Reaction (PCR )will determine average telomere length.

    Time frame: 10 weeks

07

Results

Posted Apr 9, 2026
Limitations and caveats
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.

Participant flow

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.

Participant flow — Overall Study
MilestoneContemplative-Based Resilience Training (CBRT)
Started21
Completed19
Not completed2
Withdrew: Two (2) participants did not provide the biological sample for the outcome measure.2

Outcome measures

PrimaryFeasibility of Study

number of participants who complete the study

Time frame:
10 weeks
Reported as:
Count of participants · Participants
Feasibility of Study
ParticipantsContemplative-Based Resilience Training (CBRT)
Feasibility of Study19
PrimaryAcceptability 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.

Time frame:
at the end of the 10 week intervention
Reported as:
Count of participants · Participants
Acceptability of CBRT (Qualitative Interview Findings)
ParticipantsContemplative-Based Resilience Training (CBRT)
Intervention Met Expectations6
Meditation and Tools Were Useful17
Group Dynamics Were Helpful11
Session Structure Was Appropriate5
Intervention Changed Behaviors12
SecondaryAllostatic 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

Time frame:
Baseline (pre-CBT) to 10 weeks (post-CBT)
Reported as:
Mean · points
Allostatic Load Composite Score (NHANES Clinically Relevant Scoring 0-11 )
pointsContemplative-Based Resilience Training (CBRT)
Baseline Allostatic Load2.11 ± 0.94
Post-CBRT Allostatic Load2 ± 0.97
Statistical analysis
  • Contemplative-Based Resilience Training (CBRT) · Wilcoxon signed-rank test (paired) · p = 0.135A two-sided Wilcoxon signed-rank test was used to compare baseline and post-intervention allostatic load scores in paired participants (N=19).
SecondaryCortisol 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.

Time frame:
Baseline (Pre-CBRT) and 10 weeks (Post-CBRT)
Reported as:
Mean · µg/dL
Cortisol Awakening Response (CAR)
µg/dLContemplative-Based Resilience Training (CBRT)
Baseline CAR.100 ± .355
Post-CBRT CAR-0.025 ± 0.336
Statistical analysis
  • Contemplative-Based Resilience Training (CBRT) · Wilcoxon signed-rank test (paired) · p = 0.395 (Two-sided Wilcoxon signed-rank test comparing pre- and post-intervention CAR values in paired participants (N=19).)
SecondaryComposite 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.

Time frame:
comparison from baseline (pre-CBT) to 10 weeks (post-CBT)
Reported as:
Mean · log2 mRNA expression (composite score)
Composite CTRA Gene Expression Score
log2 mRNA expression (composite score)Contemplative-Based Resilience Training (CBRT)
Baseline6.20 ± 0.17
10 weeks Post CBRT6.19 ± 0.17
Statistical analysis
  • Contemplative-Based Resilience Training (CBRT) · Mixed Models Analysis · p = 0.93 (Linear mixed-effects model with time (baseline vs 10 weeks) as a fixed effect and subject as a random intercept.)
SecondaryTelomere Length

Quantitative Polymerase Chain Reaction (PCR )will determine average telomere length.

Time frame:
10 weeks

No measurements were reported for this outcome.

Adverse events

Collected over From enrollment through completion of the 10-week intervention period. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Contemplative-Based Resilience Training (CBRT)0/21 (0%)1/21 (4.8%)0/21 (0%)
Most frequent serious events
Most frequent serious events
EventContemplative-Based Resilience Training (CBRT)
Cervical surgery for pre-existing chronic pain condition (unrelated to intervention)Musculoskeletal and connective tissue disorders1/21

Baseline characteristics

Only participants who completed the intervention and all assessments (N=19) are included in the baseline analysis population.

Age, Customized
Age, Customized(years)Contemplative-Based Resilience Training (CBRT)
Age36.1 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)Contemplative-Based Resilience Training (CBRT)
Female11
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Contemplative-Based Resilience Training (CBRT)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American19
White0
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Recrutment Office
    New York, New York 10065, United States
09

References and documents

Publications

  • 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. PubMed 26398658 ↗
  • 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. PubMed 16380565 ↗
  • 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. PubMed 29628069 ↗
  • 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. PubMed 24673162 ↗
  • 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. PubMed 15712783 ↗
  • 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. PubMed 28165267 ↗
  • 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. PubMed 21133583 ↗
  • 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. PubMed 9629234 ↗
  • 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. PubMed 22013026 ↗
  • 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. PubMed 30854146 ↗
  • 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. PubMed 33727090 ↗
  • 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. PubMed 31592179 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2024 to primary completion in Aug 2024, 5 months.

Results were first posted in Apr 2026, 1 year 8 months after primary completion.

Of 29 non-industry interventional studies with no phase under Racism, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 5 months is below that.

Counting every sponsor, half of 29 studies reached it within 32 months; a quarter within 14 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2023
First posted
Nov 24, 2023
StartActual
Feb 15, 2024
Primary completionActual
Aug 9, 2024
CompletionActual
Aug 9, 2024
Results first posted
Apr 9, 2026
Last update
Apr 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06146218
Responsible party
Sponsor
First posted
Nov 24, 2023
Start date
Feb 15, 2024
Primary completion
Aug 9, 2024
Completion
Aug 9, 2024
Results posted
Apr 9, 2026
Last update
Apr 9, 2026

Study contacts

Rachel W Kimani, DNP
principal investigator · Rockefeller University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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