Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress (NCT06146218), a na na study. The primary outcome is Feasibility of Study.

2. Clinical Question

The broader study aims include gathering participant feedback and assessing psychological and biological outcomes, as well as exploring whether mindfulness may mediate effects. The listed psychological measures include race-based stress, depression, perceived stress, quality of life, social connectedness, sleep, and resilience. Biological measures include allostatic load, saliva cortisol, telomere length, and gene expression. However, estimates for changes in these outcomes and the proposed mediating role are not reported in the registry record. The available primary-endpoint information therefore addresses completion, not the intervention’s effect on those measures.

3. Trial Design

The registry describes a completed pilot study with a single-group, pretest-posttest design. Participants were assessed at baseline and at follow-up after a 10-week CBRT program. The program is described as addressing mindfulness, compassion, self-awareness, and stress-reduction techniques, with further details including social-emotional self-care, visualization, and deep breathing. The study is not registered as a randomized comparison: allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP.

There is a difference between the brief summary’s mention of a wait-list control group in its statement of the primary aim and its description of a 1-group pretest-posttest design. The registered design and the listed single-group model do not establish a control arm for the results presented. The record explicitly cautions that this is not a randomized comparison and that arms are not a like-for-like control comparison. Accordingly, the study’s stated aims should not be read as evidence that a controlled comparison was conducted.

The enrollment field lists 22 participants. The primary-endpoint description instead says 21 participants enrolled and started the intervention, and that 19 completed the intervention and outcome measurements. The registry does not explain the difference between the enrollment figures. It gives a start date of 2024-02-15, a primary completion date of 2024-08-09, and a status of COMPLETED. The phase is listed as NA. The sponsor is Rockefeller University.

The study’s title calls the intervention Compassion-Based Resiliency Training, while its intervention listing says Contemplative-Based Resilience Training. Both use the abbreviation CBRT in the record; the record does not explain the naming difference. The protocol’s sample-size justification, any interim analyses, and the detailed statistical analysis plan are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Of the 22 enrolled, 1 participant was lost to follow-up prior to beginning the intervention. Thus, 21 participants began CBRT.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 21 participants enrolled in the study and started the intervention. 19 participants completed the intervention and outcome measurements.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

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

6. Primary Endpoint

The registry lists the primary outcome as Feasibility of Study, measured over 10 weeks.

The primary endpoint is feasibility of the study, measured as the count of participants who complete the study. Its stated timeframe is 10 weeks, and the description defines completion as completing the intervention and outcome measurements. The registry reports that 19 participants completed these activities; it also describes 21 participants as having enrolled and started the intervention. The enrollment field separately lists 22, a difference the record does not explain.

A completion count is used in a feasibility study to describe whether participants reached the end of the study process. It is distinct from an outcome measuring change in stress or another psychological or biological measure. Completion can inform whether the planned intervention and assessments were carried through for participants, but the count alone does not establish why participants did or did not complete, how acceptable they found the program, or whether their health-related measures changed.

The registry lists psychological and biological measures as study objectives, but outcome estimates for those measures are not reported in the registry record. The primary endpoint therefore supports a narrow description of study completion. It cannot answer the broader question of preliminary effectiveness or identify a change attributable to the intervention.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registered design is a 1-group pretest-posttest study. Participants were assessed at baseline and follow-up after the 10-week program. The registry lists allocation as NA, masking as NONE, and the model as SINGLE GROUP. It also states that this is not a randomized comparison and that arms are not a like-for-like control comparison. These design details define what kinds of conclusions the available data can support.

What does a single-group pretest-posttest design estimate?

In general, a pretest-posttest design describes measurements in the same study group at different times. If the corresponding estimates are reported, the before-and-after pattern can show whether measured values changed over the study period. Such a pattern alone does not identify why they changed. Without a control comparison, changes may reflect intervention exposure, time, measurement variation, or other influences. This is a general limitation of the design, not a claim that any particular alternative explanation occurred in this study.

For this registry record, outcome estimates for the psychological and biological measures are not reported. The design description can therefore be explained, but no before-and-after effect size, confidence interval, or statistical test for those outcomes can be interpreted from the record. The primary endpoint is instead a count of participants who completed the study.

How should the completion count be read?

A count is a descriptive measure: it states how many participants met the endpoint definition. Here, the definition is the number who complete the study, and the timeframe is 10 weeks. The primary description says that 19 participants completed the intervention and outcome measurements and that 21 participants enrolled and started the intervention. The enrollment field gives 22. The record does not explain the difference, so no denominator should be selected or inferred for a completion rate.

General statistical explanation: a confidence interval expresses the uncertainty around an estimated quantity under a specified method. It does not correct a mismatch in recorded counts, replace a control group, or resolve missing outcome information. No confidence interval for the primary completion result is reported in the registry record.

What can be learned from the listed outcome domains?

The record names a broad set of outcomes. Psychological measures include race-based stress, depression, perceived stress, quality of life, social connectedness, sleep, and resilience. Biological measures include an allostatic load composite, cortisol awakening response, a composite CTRA gene expression score, and telomere length. The registry also gives descriptions of saliva cortisol and gene expression in its study summary. Naming a measure indicates what the study intended to assess; it is not itself a reported result. Numerical estimates and analytic details for these outcomes are not reported in the registry record.

The record lists 6 outcome measures and 3 analyses. It does not report how the analyses map to the outcomes, which analysis is primary for each outcome, or whether models adjust for baseline values or other variables. The statistical plan, handling of repeated measurements, and any assumptions about outcome distributions are not reported in the registry record.

Why do distribution and model choices matter?

General statistical explanation: statistical methods rely on assumptions about how outcome values vary and how observations relate to one another. A count, a continuous measurement, and a time-to-event outcome do not necessarily call for the same model. When variation is greater than a model expects, a condition often described as over-dispersion, standard errors from a model that ignores this feature may be too small. Analysts may need a method that accommodates the observed distribution. The registry does not report enough outcome data or modeling details to assess whether over-dispersion or any other distributional issue arose in this study.

For a single-group study with repeated measurements, methods may account for the relationship between measurements from the same participant. General explanation: treating related measurements as if they came from unrelated people can misstate uncertainty. The registry’s summary says that data were collected at baseline and 10 weeks, but it does not report the statistical method used to handle these repeated measurements.

How should planning illustrations be distinguished from results?

Any sample-size illustrations associated with posted results are planning calculations, not observed evidence from this pilot and not observed power. The registry description states that its own sample-size justification is not being reported as the basis for those illustrations. General explanation: a planning calculation asks how many participants per arm might be needed under specified assumptions to detect a chosen effect with a specified operating characteristic. It does not show that a study with a particular enrollment had that probability of finding an effect, and it cannot substitute for a reported estimate and its uncertainty. No numerical planning values are stated in the registry information, so no such values can be interpreted.

The detailed statistical methods, including any adjustment strategy, model diagnostics, confidence-interval method, and analysis population definitions, are not reported in the registry record. Those omissions limit reproducibility and prevent evaluation of whether the chosen analyses fit each outcome.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Contemplative-Based Resilience Training (CBRT)")
n      <- c(21)
events <- c(19)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Contemplative-Based Resilience Training (CBRT)  21  19  90.5  69.6  98.8  71.1  97.3  70.8  97.1

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 6 outcome measures and 3 analyses. The primary endpoint is study feasibility, defined as the count of participants who complete the study. Secondary outcomes include an allostatic load composite score, cortisol awakening response, a composite CTRA gene expression score, and telomere length. The study summary also describes psychological outcomes. The record does not explain how all listed measures relate to the analyses or identify a hierarchy among the non-primary outcomes.

When several outcomes or statistical tests are considered, the chance of at least one apparently notable result can increase. General statistical explanation: a prespecified testing strategy can clarify which results are confirmatory and how interpretation accounts for multiple comparisons. Whether any multiplicity adjustment or other strategy was used is not reported in the registry record. The absence of that information means the findings for multiple outcomes cannot be assessed for this issue; it does not establish that adjustment was or was not performed.

The primary-endpoint description reports 21 participants as enrolled and starting the intervention and 19 as completing it. The enrollment field lists 22, and the record does not explain the difference. It also does not state why participants did not complete, how missing measurements were handled, whether any imputation was used, or how many participants contributed data to each outcome analysis. Those details are not reported in the registry record.

The registry does not define an intention-to-treat, per-protocol, or other analysis population. It is therefore not possible to determine which participants were included in each analysis or whether analysis populations differed across outcomes. No assumptions about missingness or sensitivity analyses are reported. These gaps matter because incomplete measurements can affect both the number of observations analyzed and the interpretation of estimates, particularly in a study with repeated assessments.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: cervical surgery for pre-existing chronic pain condition (unrelated to intervention) (4.8%).

The safety record lists 21 participants at risk for the serious-event count, with 1 affected. It lists 21 participants at risk for other adverse events, with 0 affected, and reports 0 deaths. The record identifies “Cervical surgery for pre-existing chronic pain condition (unrelated to intervention)” as the top serious term and lists 4.8% alongside it. The registry describes that condition as unrelated to the intervention.

These are descriptive counts from the CBRT group, not a comparison of event frequency against a control group. The study is registered as single-group, so the safety figures cannot establish whether the intervention raised or lowered event risk. A zero count for other adverse events or deaths means none were recorded in the listed category; it does not establish that an event is impossible or that all possible harms were assessed.

The registry does not report further details about event timing, severity grading beyond the serious classification, adjudication, or the method used to determine relatedness. The serious-event count should therefore be read as a registry report, not as a complete causal assessment. The listed top term’s stated lack of relation to the intervention is part of the record, but the figures alone do not support broader safety conclusions.

13. What the Result Does, and Does Not, Mean

The result that can be stated directly is that 19 participants completed the intervention and outcome measurements, according to the primary-endpoint description. The same description says that 21 participants enrolled and started the intervention, while the enrollment field lists 22. Since the registry does not explain the difference, the counts should remain attributed to their respective entries rather than being combined or converted into a rate.

This information speaks to completion in a pilot study. It does not, by itself, show whether the intervention was acceptable to participants, whether recruitment was feasible against a prespecified target, or why some participants did not complete. No threshold for judging success on feasibility is reported in the registry record.

The study’s stated aims include preliminary assessment of psychological and biological outcomes and the possible mediating role of mindfulness. The record lists those domains but does not report numerical outcome estimates or statistical tests for them. Consequently, the registry information does not establish whether racism-based stress or any other listed measure changed, how large a change might have been, or how precisely an effect was estimated.

The single-group design also limits causal interpretation. General statistical explanation: observing change between baseline and follow-up in one group does not isolate the contribution of the intervention from other influences over the same period. A randomized control comparison is not described in the registered design, and the record explicitly cautions that this is not a randomized comparison.

The safety counts describe recorded events in the intervention group, including 1 serious event and 0 deaths. They should not be mistaken for a comparative estimate of risk. Taken together, the record supports a narrow account of completion and reported safety events, but not a conclusion about efficacy, causal effects, or comprehensive safety.

14. Why This Trial Matters Statistically

This pilot is statistically important to read in terms of what its design and primary endpoint actually measure. The central endpoint is a completion count, an operational measure of whether participants reached the end of the intervention and assessments. That is different from an estimate of change in racism-based stress and different again from a causal comparison between treatment options.

The record also illustrates why consistent participant accounting matters. The enrollment field lists 22, while the endpoint description identifies 21 participants as having enrolled and started and 19 as completing. The record does not reconcile the first two counts. Keeping each figure attached to its stated meaning avoids implying a rate or denominator that the registry does not establish.

A single-group pretest-posttest pilot can describe an intervention process and motivate further study, but a before-and-after pattern alone cannot distinguish intervention effects from other changes over time. Here, the registry does not report estimates for the psychological or biological outcomes, so even a descriptive account of their observed changes is unavailable from the record.

The broad set of named measures further emphasizes the value of a clear analysis plan. With multiple psychological and biological outcomes, readers need to know which analyses were prespecified, how missing measurements were handled, and how multiplicity was addressed. Those details are not reported in the registry record. Without them, readers cannot fully assess the precision, robustness, or relative priority of outcome findings.

The record’s safety counts also need design-aware interpretation. They identify events recorded within the study group but do not provide a controlled contrast. The statistical contribution of the study is therefore chiefly a description of completion and the registered study framework, rather than a comparative estimate of benefit or harm.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations are specific to the registry information for this study. The enrollment field lists 22 participants, but the primary-endpoint description says 21 participants enrolled and started the intervention. The record does not explain the difference. It reports 19 completions but does not give reasons for non-completion or identify the number contributing to each outcome analysis.

The design is registered as single-group and pretest-posttest, with allocation listed as NA and masking as NONE. Although the brief summary refers to a wait-list control in its description of the primary aim, the record also describes a 1-group design and cautions that there is no randomized, like-for-like control comparison. This means the registered information does not support a controlled effect estimate.

Outcome estimates for the psychological and biological measures are not reported in the registry record. The statistical methods, analysis population definitions, handling of missing data, multiplicity strategy, and any sensitivity analyses are also not reported. As a result, the precision and robustness of analyses for outcomes beyond the completion count cannot be assessed.

The record uses different expansions of CBRT in the study title and intervention listing: Compassion-Based Resiliency Training and Contemplative-Based Resilience Training. It does not explain this difference. In addition, its broad study aims and listed measures are not accompanied by reported outcome findings. These limitations call for a restrained reading focused on the stated completion and safety information, without filling gaps through assumptions.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress — NCT06146218.
• Registry record last updated 2026-04-09; status last verified 2026-03.
• Results first posted 2026-04-09.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT06146218 is a completed pilot study sponsored by Rockefeller University. Its official title is Effects of Compassion-Based Resiliency Training (CBRT) Intervention on Racism-based Stress Among African Americans: A Pilot Study. The registry describes a 10-week CBRT intervention and a single-group pretest-posttest design, with baseline and follow-up assessments.

The primary endpoint is the count of participants completing the study. The endpoint description reports 19 completers and says 21 participants enrolled and started the intervention; the enrollment field lists 22. The registry does not explain the discrepancy. Psychological and biological outcomes are listed, but their numerical results are not reported in the registry record.

The safety record reports 1 participant with a serious adverse event, 0 with other adverse events, and 0 deaths. A cervical surgery for a pre-existing chronic pain condition is listed as unrelated to the intervention. The registry does not describe a randomized control comparison or provide the detailed statistical plan, missing-data approach, or multiplicity strategy.