Trial Outcomes & Findings for Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress (NCT NCT06146218)
NCT ID: NCT06146218
Last Updated: 2026-04-09
Results Overview
number of participants who complete the study
COMPLETED
NA
22 participants
10 weeks
2026-04-09
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.
Of the 22 enrolled, 1 participant was lost to follow-up prior to beginning the intervention. Thus, 21 participants began CBRT.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
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Overall Study
Two (2) participants did not provide the biological sample for the outcome measure.
|
2
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Baseline Characteristics
Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress
Baseline characteristics by cohort
| Measure |
Contemplative-Based Resilience Training (CBRT)
n=19 Participants
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.
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|---|---|
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Age, Customized
Age
|
36.1 years
STANDARD_DEVIATION 8 • n=36 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: 21 participants enrolled in the study and started the intervention. 19 participants completed the intervention and outcome measurements.
number of participants who complete the study
Outcome measures
| Measure |
Contemplative-Based Resilience Training (CBRT)
n=21 Participants
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.
|
|---|---|
|
Feasibility of Study
|
19 Participants
|
PRIMARY outcome
Timeframe: at the end of the 10 week interventionPopulation: Participants who completed the 10-week intervention and post-intervention qualitative interview (N=19).
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.
Outcome measures
| Measure |
Contemplative-Based Resilience Training (CBRT)
n=19 Participants
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.
|
|---|---|
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Acceptability of CBRT (Qualitative Interview Findings)
Intervention Met Expectations
|
6 Participants
|
|
Acceptability of CBRT (Qualitative Interview Findings)
Meditation and Tools Were Useful
|
17 Participants
|
|
Acceptability of CBRT (Qualitative Interview Findings)
Group Dynamics Were Helpful
|
11 Participants
|
|
Acceptability of CBRT (Qualitative Interview Findings)
Session Structure Was Appropriate
|
5 Participants
|
|
Acceptability of CBRT (Qualitative Interview Findings)
Intervention Changed Behaviors
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12 Participants
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SECONDARY outcome
Timeframe: Baseline (pre-CBT) to 10 weeks (post-CBT)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
Outcome measures
| Measure |
Contemplative-Based Resilience Training (CBRT)
n=19 Participants
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.
|
|---|---|
|
Allostatic Load Composite Score (NHANES Clinically Relevant Scoring 0-11 )
Baseline Allostatic Load
|
2.11 points
Standard Deviation 0.94
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|
Allostatic Load Composite Score (NHANES Clinically Relevant Scoring 0-11 )
Post-CBRT Allostatic Load
|
2 points
Standard Deviation 0.97
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SECONDARY outcome
Timeframe: Baseline (Pre-CBRT) and 10 weeks (Post-CBRT)Population: Participants with complete pre- and post-intervention morning cortisol samples (N = 19).
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.
Outcome measures
| Measure |
Contemplative-Based Resilience Training (CBRT)
n=19 Participants
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.
|
|---|---|
|
Cortisol Awakening Response (CAR)
Baseline CAR
|
.100 µg/dL
Standard Deviation .355
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|
Cortisol Awakening Response (CAR)
Post-CBRT CAR
|
-0.025 µg/dL
Standard Deviation 0.336
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SECONDARY outcome
Timeframe: comparison from baseline (pre-CBT) to 10 weeks (post-CBT)Population: Participants who completed both baseline and post-intervention assessments and had analyzable gene expression data were included in the analysis.
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.
Outcome measures
| Measure |
Contemplative-Based Resilience Training (CBRT)
n=19 Participants
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.
|
|---|---|
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Composite CTRA Gene Expression Score
10 weeks Post CBRT
|
6.19 log2 mRNA expression (composite score)
Standard Error 0.17
|
|
Composite CTRA Gene Expression Score
Baseline
|
6.20 log2 mRNA expression (composite score)
Standard Error 0.17
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SECONDARY outcome
Timeframe: 10 weeksPopulation: 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.
Quantitative Polymerase Chain Reaction (PCR )will determine average telomere length.
Outcome measures
Outcome data not reported
Adverse Events
Contemplative-Based Resilience Training (CBRT)
Serious adverse events
| Measure |
Contemplative-Based Resilience Training (CBRT)
n=21 participants at risk
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.
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|---|---|
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Musculoskeletal and connective tissue disorders
Cervical surgery for pre-existing chronic pain condition (unrelated to intervention)
|
4.8%
1/21 • Number of events 1 • 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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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place