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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

10 weeks

Results posted on

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

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

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.
Overall Study
Two (2) participants did not provide the biological sample for the outcome measure.
2

Baseline Characteristics

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

Baseline characteristics by cohort

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.
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 weeks

Population: 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

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 intervention

Population: 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

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.
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
12 Participants

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

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
Allostatic Load Composite Score (NHANES Clinically Relevant Scoring 0-11 )
Post-CBRT Allostatic Load
2 points
Standard Deviation 0.97

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

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
Cortisol Awakening Response (CAR)
Post-CBRT CAR
-0.025 µg/dL
Standard Deviation 0.336

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

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.
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

SECONDARY outcome

Timeframe: 10 weeks

Population: 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 events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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.
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.

Other adverse events

Adverse event data not reported

Additional Information

Rachel W. Kimani

Rockefeller University

Phone: 212-327-8432

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place