Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV (NCT04193605), a randomized na study. The primary outcome is Feasibility Intervention Measure.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, parallel-group behavioral pilot with two conditions: mindfulness-based stress reduction and standard of care. Allocation is listed as randomized, and masking is listed as none. The record identifies the study as completed and gives an enrollment of 48. It lists the start date as 2022-02-11 and primary completion as 2022-10-12. The phase is recorded as not applicable.

The study description sets out a broader development process: cultural adaptation of MBSR for Black women living with HIV, an open non-randomized pre-pilot to refine the adapted intervention, and a two-arm randomized pilot compared with standard of care. Its stated purpose for the randomized pilot is to assess feasibility and acceptability. The registry record does not report results from the adaptation or pre-pilot stages, or details that would establish how those stages contributed to the randomized study.

The MBSR arm description specifies an orientation, approximately eight intervention sessions, and an exit interview. The control description says participants continued usual care or standard of care. The primary measure was collected immediately after the intervention, within one week of completing the final session. The record does not report further operational details about session delivery, adherence, or how usual care varied across participants.

Although the record is randomized, the posted primary endpoint is not reported for both arms. Feasibility scores are reported for the MBSR group, while the endpoint description says the standard-of-care group did not receive the intervention and was not assessed on this measure. Thus the design includes a comparator, but the primary result is not a randomized comparison on the feasibility scale.

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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Participants in the standard of care did not receive the intervention. Therefore, data was not collected or analyzed on these participants

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.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility Intervention Measure, measured over Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session..

The primary endpoint is the Feasibility Intervention Measure, a continuous score based on four items. Each item uses a Likert-like response scale from “1” (completely disagree) to “5” (completely agree). The total score ranges from 4 to 20, with higher scores indicating greater perceived feasibility. The registry record reports the MBSR group’s mean as 18.0 units on the scale and its standard deviation as 2.4.

The measure is used to describe participants’ views about whether the intervention is feasible. This is relevant to a pilot whose stated purpose includes assessing feasibility and acceptability. It is not a direct measure of stress reduction, HIV self-care behavior, or viral load suppression. Those outcomes are mentioned as motivations in the study description, but they are not the posted primary outcome in this record.

The assessment was scheduled immediately after the intervention, with collection within one week of the final session. As the control participants did not receive MBSR, the record says their feasibility-measure data were not collected or analyzed. Consequently, the endpoint describes ratings among MBSR participants rather than a difference in feasibility scores between randomized groups. The registry record does not report a threshold defining acceptable feasibility or a separate decision rule for interpreting the score.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary result is a mean and standard deviation for a continuous measure. These are descriptive statistics: the mean gives the average scale score in the analyzed group, while the standard deviation describes how much scores varied around that average. The posted values are a mean of 18.0 and a standard deviation of 2.4 among 21 MBSR participants. These summaries do not reveal the exact score of any individual or the shape of the score distribution.

What does the scale represent?

The measure combines four item responses. Each item ranges from “1” (completely disagree) to “5” (completely agree), and the total ranges from 4 to 20. Higher totals indicate greater feasibility. Treating the total as a continuous measure allows a group average and standard deviation to be reported. That summary is useful for describing the assessed participants, but it compresses several individual responses into two numbers. It does not show whether participants agreed across all items or whether some items drew less favorable responses.

The timing matters to interpretation. The measure was collected immediately after the intervention, within one week after the final session. It therefore reflects participants’ feasibility ratings at the end of the intervention period. The registry record does not report repeated assessments, baseline ratings, or later follow-up for this endpoint, so changes over time and the persistence of ratings cannot be assessed from the posted result.

Why is there no group comparison?

A randomized comparison of a continuous endpoint ordinarily requires outcome information from each randomized group, along with a defined analysis comparing those groups. Here, the outcome description says that standard-of-care participants did not receive MBSR and that no feasibility data were collected or analyzed for them. A mean for the intervention arm alone cannot be subtracted from or otherwise contrasted with a control mean that is not available. The fact that allocation was randomized does not resolve this absence of an outcome value for the comparator.

For a group mean, a confidence interval would communicate the uncertainty around the estimated average, under the assumptions of the method used. The registry record does not post a confidence interval for the MBSR mean, and it does not report an inferential analysis for this endpoint. The standard deviation is not a confidence interval: it describes variation among participant scores, rather than the uncertainty in the estimated group mean. No inferential test or adjusted estimate is reported in the registry record.

What can randomization and masking tell readers?

Random allocation is intended to make treatment assignment independent of participants’ measured and unmeasured characteristics on average. In a sufficiently informative comparative analysis, that feature can support interpretation of between-group differences. It does not make descriptive findings from one group automatically comparable with another, and it does not compensate for an outcome that was not measured in the control group. The registry lists masking as none. It does not report additional steps to limit the influence of participants’ or assessors’ knowledge of assignment on this self-reported feasibility outcome.

The parallel design means the conditions are assigned to separate groups rather than being described as sequential exposure of the same participants to both conditions. The record does not provide further information about randomization procedures, concealment, stratification, or the handling of any departures from assigned treatment. Those details are not reported in the registry record.

How should planning calculations be understood?

Planning illustrations based on an observed effect are distinct from the analysis of trial outcomes. In general, such illustrations can describe the number of participants per arm that a hypothetical future study might require to detect a specified fraction of an observed between-arm effect, under stated assumptions. The assumptions listed for the illustration in this record include a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such planning figures, when available, are not observed power and do not show the probability that this pilot detected a true effect.

For the posted feasibility endpoint, a between-arm effect cannot be estimated from the reported values because the control outcome was not collected. The registry record also indicates that values are missing or not estimable for a two-arm comparison of this continuous endpoint. Therefore, planning calculations tied to a fraction of an observed arm-to-arm effect cannot be interpreted as being grounded in an observed comparison for this outcome. The record does not report a sample-size justification for the trial, and the planning assumptions should not be mistaken for the trial’s original design rationale.

What is and is not reported about analysis?

The record lists one outcome measure and no analyses. It does not describe a statistical analysis plan for the primary endpoint, an analysis population, a missing-data method, or adjustment for baseline variables. It also does not report a pre-specified feasibility threshold or an inferential framework. These absences limit the ability to assess how the posted descriptive result relates to a planned decision process. They do not imply that an unreported method was or was not used; the relevant details are not reported in the registry record.

In general, pilot studies can use descriptive summaries to characterize implementation and participant feedback, rather than being designed to establish comparative clinical effects. The registry’s stated feasibility aim is consistent with a descriptive focus, but the record does not specify the intended role of each analysis or the criteria for deciding whether to proceed to a larger study. The reported mean and standard deviation can be interpreted as descriptive evidence about ratings among assessed MBSR participants, with the limitations of a one-group endpoint result.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Mindfulness Based Stress Reduction")
n   <- c(21)
m   <- c(18)
sp  <- c(2.4)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Mindfulness Based Stress Reduction  21  18.000  2.400  16.908  19.092

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure, the Feasibility Intervention Measure, and no secondary outcomes. It lists no analyses. A multiplicity adjustment is not reported in the registry record. With no posted set of multiple outcome tests or arm-to-arm analyses, there is no reported family of comparisons for which an adjustment can be evaluated. The record does not describe whether any outcomes or analyses were planned outside the registry listing.

For the primary endpoint, the control group is not simply a group with an unreported score of uncertain status: the endpoint description says standard-of-care participants did not receive the intervention and were not assessed on the measure. This is a design-related absence for the feasibility scale. It precludes a direct randomized comparison on that endpoint, but it should not be treated as evidence that control scores were zero or that the groups had equal feasibility ratings.

The MBSR endpoint summary includes 21 participants, while total enrollment is 48. The registry record does not report why the outcome count differs from enrollment, how many participants were eligible for the assessment, whether any MBSR participants lacked scores, or how incomplete item responses were handled. It does not report a missing-data method or sensitivity analysis. The reasons for and consequences of any unavailable observations therefore cannot be assessed.

The record also does not identify an analysis population, such as all randomized participants or participants who completed the intervention. The 21 participants are the number attached to the posted MBSR outcome result; further population definitions are not reported in the registry record. Without those details, readers should not assume that the result represents every participant assigned to MBSR or every participant enrolled. No inference about attrition, adherence, or treatment exposure can be made from the endpoint count alone.

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.

The registry safety summaries list 24 participants at risk in each group. For serious adverse events, the reported number affected is 0 in the MBSR group and 0 in the standard-of-care group. For other adverse events, the reported number affected is also 0 in each group. These are event summaries in the registry record; they do not establish that no event of any kind occurred outside the categories or reporting process represented by those entries.

The record reports 1 death in the MBSR group and 0 in the standard-of-care group. It does not report the cause, timing, circumstances, or relationship of the death to the intervention. The death count should therefore be reported as a safety observation, not interpreted as evidence that the intervention caused or did not cause the death. The registry record does not provide event-level descriptions or additional details that would support a causal assessment.

These safety counts are separate from the feasibility outcome. The safety groups each list 24 participants at risk, whereas the primary feasibility result is reported for 21 MBSR participants and is not reported for the control group. The different summaries should not be conflated. The safety figures do not provide a comparative estimate of feasibility, and the feasibility score does not determine how adverse events should be classified.

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

The result does show that the registry record contains a feasibility-scale summary for MBSR participants: a mean score of 18.0 and a standard deviation of 2.4 among 21 participants. On this scale, higher scores indicate greater feasibility, and the possible total score ranges from 4 to 20. The summary is consistent with relatively high ratings among those assessed, while the standard deviation indicates variation between participants.

The result does not show whether MBSR produced a higher feasibility rating than standard of care. No control-group score was collected or analyzed for this measure. It also does not show that every MBSR participant found the intervention feasible, because a group mean does not describe the response of each participant. The registry record does not state a threshold for what would count as acceptable feasibility or provide a count meeting such a threshold.

The score is not evidence of improvement in stress, HIV self-care behavior, or viral load suppression. These are aims described in the study background, not results reported for the primary outcome. The record does not post secondary outcome results. It also does not establish that the intervention is clinically effective or that the observed ratings would generalize beyond the participants whose data contributed to the summary.

Precision is difficult to judge because the registry does not report a confidence interval for the mean, individual scores, or an explanation for the endpoint sample count relative to the overall enrollment of 48. The mean and standard deviation are informative descriptive statistics, but they do not substitute for a comparative analysis or an assessment of uncertainty around the mean. No claim about treatment benefit, equivalence, or absence of an effect follows from the missing control score.

The appropriate interpretation is narrow: the posted data characterize feasibility ratings in the assessed MBSR group at the end of the intervention. They do not provide a randomized comparison on feasibility, establish clinical outcomes, or resolve how representative the assessed participants are of all enrolled participants.

14. Why This Trial Matters Statistically

This trial is statistically notable because its randomized design and its posted primary endpoint answer different kinds of questions. Randomization creates a framework for comparing assigned groups, but the primary feasibility measure was collected only from the MBSR group. The resulting mean is useful as a description of participants’ ratings, yet it is not a between-group treatment estimate. Recognizing that distinction prevents a descriptive pilot finding from being interpreted as comparative evidence.

The endpoint also illustrates why a pilot’s purpose matters. The study description emphasizes feasibility and acceptability, while its broader motivation refers to stress, self-care behavior, and viral load. The posted primary result concerns the feasibility measure only. A favorable rating can inform discussion of participant experience, but it does not answer whether the intervention changes the other outcomes named in the study description.

Statistical interpretation depends not only on the reported point estimate but also on its uncertainty and the data contributing to it. The registry reports a mean, standard deviation, and group count, but no confidence interval, individual score distribution, or explanation of the difference between enrollment and the endpoint count. Those omissions limit assessment of precision and representativeness. The lack of a control score further prevents estimation of an arm-to-arm contrast.

The record is also a reminder that planning assumptions are not results. Illustrative calculations based on an observed between-group effect require a usable comparison; this endpoint has no reported control value. Even when planning numbers are available, they concern possible future-study design under stated assumptions rather than observed power in the pilot. Keeping those concepts separate is important when interpreting small feasibility studies.

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.

The main endpoint limitation is the absence of a standard-of-care feasibility score. Because the control group did not receive MBSR and was not assessed with this measure, the result is limited to a single-arm description within a randomized trial. It cannot estimate a comparative difference or show whether the score would have differed under standard care.

The MBSR result is reported for 21 participants, while the total enrollment is 48. The record does not explain this endpoint count, define the analysis population, or report the reasons for any unavailable outcome data. It therefore cannot establish the extent or causes of missing endpoint information, or how the observed participants compare with those not represented in the score summary.

The mean and standard deviation do not reveal the distribution of individual responses. No confidence interval, item-level results, or participant-level feasibility proportions are reported. The registry also does not report a decision threshold for acceptable feasibility, a separate acceptability outcome, or implementation measures such as attendance or completion. These omissions limit how fully the mean can characterize feasibility.

The record lists no analyses and no secondary outcomes. A statistical analysis plan, missing-data approach, and analysis population are not reported. Masking is listed as none, and the endpoint is based on participant ratings; the registry does not describe measures to address potential influence from awareness of intervention assignment. Details of allocation procedures and intervention fidelity are also not reported.

Finally, the posted primary endpoint is feasibility rather than a clinical outcome. The record does not provide results for stress, HIV self-care behavior, or viral load suppression, which are mentioned as aims in the study description. The safety record includes one death in the MBSR group, but does not report its cause or relationship to the intervention. These limitations constrain interpretation to the descriptive feasibility ratings and reported safety counts.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV — NCT04193605.
• Registry record last updated 2024-04-18; status last verified 2024-04.
• Results first posted 2024-04-17.
• 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

The registry record describes a completed, randomized, parallel-group behavioral pilot of mindfulness-based stress reduction versus standard of care, with enrollment of 48 and no masking. The stated study purpose includes assessing feasibility and acceptability of an intervention adapted for Black women living with HIV.

The primary outcome is a four-item feasibility score, ranging from 4 to 20, with higher scores indicating greater feasibility. Among 21 MBSR participants, the reported mean is 18.0 and the standard deviation is 2.4. The record says the standard-of-care group was not assessed on this measure, so no randomized comparison is available for the primary endpoint. One outcome measure and no secondary outcomes are listed; no analyses are listed.

Safety summaries report 0 participants affected by serious adverse events and 0 affected by other adverse events in each group, with 24 at risk in each. The record reports 1 death in the MBSR group and 0 in standard care, without details about cause or relationship to the intervention. The posted evidence is descriptive and does not establish comparative feasibility or clinical effects.