Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension (NCT05387889), a randomized na study. The primary outcome is Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8..

2. Clinical Question

The central statistical question is whether the Week #8 depressive-symptom results differed between the group initially assigned to MMPH and the wait-listed group. The registry reports an ANCOVA comparison of final values. It also lists group means and standard deviations, but does not give confidence interval bounds for the ANCOVA estimate. The reported p-value is bounded by p < 0.054, which does not establish whether the actual value is below the conventional 0.05 threshold.

The within-group comparisons described in the outcome text ask a different question: whether scores changed from baseline to Week #8 among participants in each group who received the intervention. A change within a group does not, by itself, show that the intervention caused the change. The most direct randomized comparison is between groups at the stated endpoint, interpreted in light of the wait-list design, the pilot scale, and the incomplete reporting of analysis details.

3. Trial Design

This was a randomized, parallel-group pilot study with no masking. The registry lists the study as completed, with enrollment of 15. The study start date is 2022-06-17 and primary completion is 2022-11-30. The listed intervention was Mindfulness Meditation for Pulmonary Hypertension, a behavioral program designed for self-management support among underserved and racial minority adults with pulmonary hypertension.

The intervention ran over an eight-week study period. It included Zoom-delivered sessions at Weeks #1 and #4, video-recorded sessions at Weeks #2, #3, #5, #6, #7, and #8, and daily mindfulness meditation practice with a mobile app. Participants could use self-guided audio-video modules of differing durations according to preference and comfort. The intervention content included mindful breathing, movement, restorative poses, and body awareness meditation, with attention to health-management needs specific to pulmonary hypertension and cultural considerations related to stress and resiliency.

The initial treatment group received MMPH first. The comparison group waited while the treatment group completed the intervention, then was to receive the same program. This wait-list arrangement means the comparison was not a permanently untreated group. It can support an assessment of outcomes over the initial comparison period, but the registry record does not describe a comparison designed to separate the effects of mindfulness content from attention, participation, or other aspects of program delivery.

The primary outcome was change from baseline in PHQ-9 depressive-symptom scores to Week #8. The two listed secondary outcomes were change in pulmonary-hypertension-related quality of life on the EmPHasis-10 and change in mindfulness level on the CAMS-R, also to Week #8. The registry record does not report the rationale for the enrollment target or a detailed protocol for the statistical analyses.

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: For this analysis, 9 patients were analyzed for Arm 1, and 6 patients were analyzed for Arm 2.

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 Change From Baseline in Depressive Symptoms on the 27-point Patient Health Questionnaire-9 Scales (PHQ-9) to Week #8., measured over Baseline and at the end of the study intervention (Week #8).

The primary endpoint is change from baseline in depressive symptoms measured with the Patient Health Questionnaire-9 (PHQ-9) to Week #8. The PHQ-9 is described as a validated self-reported questionnaire assessing depressive symptoms over the past few weeks. Its possible score range is 0 to 27, with higher categories described in the registry as None or Minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), and Severe (20- 27).

A continuous score preserves information across the scale and can be compared between groups or over time. In this trial, the primary outcome is framed as a change from baseline, while the reported between-group analysis is described as a comparison of final values. Those are related but not identical estimands: a final-value comparison contrasts endpoint scores, whereas a change comparison contrasts the amount of within-participant change. The registry record does not provide enough model detail to determine precisely how baseline scores entered the reported ANCOVA.

Depressive symptoms are relevant to a program intended to support self-management and address stress-related needs. Using a validated self-report measure gives a structured way to assess this domain, but the numerical outcome remains a questionnaire score. The reported results should therefore be read as scores and a statistical comparison, not as a diagnosis or as evidence of a change in any individual participant's clinical status.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does an ANCOVA comparison do?

ANCOVA is a regression-based method for comparing an outcome between groups while accounting for one or more other variables. In trials with baseline and follow-up measurements, it is often used to compare final scores while adjusting for baseline scores. That general explanation does not establish which variables were included in this trial's model. The registry identifies ANCOVA and labels the result as a mean difference in final values, but the covariates, model specification, and handling of assumptions are not reported in the registry record.

The adjusted estimate and the raw group summaries answer different descriptive questions. The listed arm means and standard deviations summarize scores by group. An ANCOVA estimate may differ from a simple unadjusted contrast because adjustment can change the estimate and its uncertainty. Without model details, it is not possible to reproduce the sponsor's result or explain the reported estimate from the arm summaries alone.

How should the p-value be read?

A p-value describes how compatible the observed data are with a specified null model, under the assumptions of the statistical analysis. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. The registry reports p < 0.054. Since that bound does not locate the actual value in relation to 0.05, the record does not support a clear statement about whether the result crosses that threshold.

The registry also lists a 95% confidence level for the comparison, but the interval limits are not reported. In general, a confidence interval gives a range of estimates compatible with the data and model under a specified procedure. Its width helps convey precision, and its position can show which effect values remain plausible. Without the bounds, neither the estimated range nor the precision of this ANCOVA comparison can be evaluated from the record.

What do the mean and standard deviation describe?

For a continuous measure, the mean is the average score in the analyzed group, and the standard deviation describes the spread of individual scores around that mean. The registry lists a mean of 3.444 and standard deviation of 2.403 for the treatment arm, and a mean of 7.667 and standard deviation of 2.011 for the comparison arm. These summaries do not reveal the full distribution of scores, the baseline balance between groups, or the uncertainty around the adjusted ANCOVA estimate.

General statistical context: standard deviations describe variability among observations, whereas standard errors and confidence intervals describe uncertainty in an estimated quantity. They are not interchangeable. The reported arm-level standard deviations should not be read as confidence intervals for the between-group result.

Why can small pilot results be uncertain?

In general, estimates based on limited group sizes can vary substantially across samples. A confidence interval is particularly useful for showing how much uncertainty accompanies an estimate. Here, the registry reports the analyzed group sizes but does not give the ANCOVA interval bounds. The statistical precision of the adjusted result therefore cannot be judged directly from the reported comparison.

The registry record describes randomized allocation, a parallel model, and no masking. Randomization is intended to support comparability between groups on average, but in a pilot, baseline differences can still occur. The record does not report baseline PHQ-9 group summaries in the primary result information. The absence of masking can also be relevant when outcomes are self-reported, since participants know whether they are receiving the program during the initial comparison period.

What can be recalculated from the posted summaries?

The registry's posted analysis information does not include a recalculated two-arm result for the continuous endpoint; it identifies the values as missing or not estimable for that comparison. Accordingly, no unadjusted recalculation should be treated as a second estimate to compare with the sponsor's ANCOVA. The sponsor's reported analysis remains the available inferential comparison in the registry record, while its missing interval bounds and limited model detail constrain interpretation.

General statistical context: over-dispersion is a concern mainly for count outcomes when observed variability exceeds what a chosen count model allows. The primary PHQ-9 outcome is continuous, not a count measure, so count-model over-dispersion is not the central issue for this endpoint. The relevant considerations are the outcome's scale, model specification, baseline adjustment, uncertainty, and the small pilot analysis population.

What do the sample-size illustrations mean?

Any sample-size illustrations associated with this analysis are planning calculations based on the observed effect under stated assumptions, including two-sided significance level 0.05, equal allocation, and a normal approximation. They describe hypothetical planning requirements for detecting a fraction of an observed effect. They are not the trial's original design justification, not evidence that the study had a particular probability of detecting an effect, and not observed power. The registry record does not report the original sample-size justification.

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("Treatment Arm - Group 1", "Comparison Arm or Waited List Arm - Group 2")
n   <- c(9, 6)
m   <- c(3.44444, 7.6666)
sp  <- c(2.403, 2.011)
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  Treatment Arm - Group 1  9  3.444  2.403  1.597  5.292
CARM  Comparison Arm or Waited List Arm - Group 2  6  7.667  2.011  5.556  9.777

11. Analyses Reported by the Sponsor

The registry reports the sponsor's comparison as an ANCOVA of final values, with a mean difference of 0.05 and p < 0.054. A 95% confidence level is listed, but neither confidence interval bound is reported. The posted arm summaries give means and standard deviations, but the registry's analysis information does not provide a recalculated two-arm result for the continuous endpoint. There is therefore no posted unadjusted recalculation to set alongside the sponsor's ANCOVA estimate.

These results should not be conflated. The arm summaries are descriptive, while ANCOVA is a model-based comparison that may account for covariates. The registry does not report the model details needed to reconstruct the adjustment. In this record, the sponsor analysis is the available inferential result; the absence of a recalculation does not validate or invalidate that result.

The reported p-value bound is not sufficiently precise to establish whether the actual value is below 0.05. The missing interval bounds also limit assessment of estimate precision. The reported value should be quoted as recorded, without converting it into a definitive conclusion about statistical significance or clinical importance.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary PHQ-9 outcome and two secondary outcomes: pulmonary-hypertension-related quality of life on the EmPHasis-10 and mindfulness level on the CAMS-R. It also reports three analyses. The record does not state whether the analysis plan adjusted for multiple outcomes or comparisons, how any adjustment was made, or which outcome was designated as the principal basis for inference beyond the primary-outcome label.

Multiplicity matters because examining several outcomes or contrasts can increase the chance of at least one apparently notable result by chance. In general, a prespecified testing strategy can help control that issue. The registry does not report a multiplicity procedure, so the relationship between the primary and secondary analyses cannot be assessed fully. The secondary outcome descriptions do not include numerical results in the registry record reported for this analysis, and no conclusions about them can be drawn from the primary endpoint summary.

The primary outcome text describes both a between-group comparison at Week #8 and baseline-to-Week #8 comparisons within each group. The record does not specify how these contrasts were prioritized or whether they were adjusted for multiplicity. The within-group contrasts should not be substituted for the randomized between-group comparison.

The primary analysis population is described as 9 patients analyzed in Arm 1 and 6 patients analyzed in Arm 2. The registry does not explain whether these participants represent all randomized participants, whether any participants lacked endpoint data, or how missing observations were handled. It also does not report whether the analysis followed intention-to-treat principles, used imputation, or applied another missing-data method. The distinction between enrollment and analyzed populations therefore cannot be resolved from the record.

Details of allocation concealment, the statistical analysis plan, and interim analyses are not reported in the registry record. These gaps do not prove that such procedures were absent; they mean the registry entry does not provide a basis for assessing them.

13. 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 reports no serious adverse events and no other adverse events for the listed groups. The treatment arm has 9 participants at risk for both serious and other adverse events, with 0 affected in each category. The comparison or wait-list arm has 6 participants at risk for both categories, also with 0 affected. Deaths are reported as 0 in each arm, and no serious-event terms are listed.

These figures describe what was recorded for the listed at-risk participants. They do not show that the risk of an adverse event is zero, nor can they establish that the intervention is free of risk. In a pilot, no recorded events provide limited information about uncommon events or events that might occur in a larger or longer study. The registry record does not describe the duration or completeness of adverse-event surveillance, definitions used for event collection, or whether events were assessed as related to the intervention.

The safety counts should be read alongside the study's scope and follow-up period, not as a broad safety estimate. No medical conclusion follows from the absence of recorded events in these groups.

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

The results establish that this completed randomized pilot recorded PHQ-9 scores for an analyzed treatment group and a wait-listed comparison group, and that the registry reports an ANCOVA comparison of final values. The arm summaries and sponsor-reported estimate describe the posted statistical results. The record does not provide confidence interval bounds, detailed model specifications, or enough precision in the p-value bound to determine whether it is below 0.05.

The results do not establish the amount of change from baseline in either group. Although the primary outcome is titled as a change from baseline, the posted between-group analysis is labeled as a comparison of final values. The available result information does not report numerical within-group changes. It therefore cannot support a quantitative account of change over time or a clear comparison of changes between groups.

The results also do not establish that the program caused any observed difference, that the findings apply to all adults with pulmonary hypertension, or that the same pattern would occur under a different comparator or in a larger study. The trial used a wait-list comparison and no masking, and the primary endpoint was self-reported. The record does not provide enough information to evaluate baseline balance or all aspects of the analysis.

More generally, a p-value alone does not convey the magnitude, precision, or practical relevance of an effect. Confidence interval bounds and complete model details would help assess uncertainty. The registry's sample-size illustrations are planning exercises based on the observed effect, not evidence of observed power or a replacement for the trial's design rationale.

The proper interpretation is therefore limited: the registry records a pilot comparison and its reported analysis, but important information needed to judge the estimate's precision and robustness is not reported in the registry record. Neither a definitive positive nor a definitive negative conclusion is warranted from the available information.

15. Why This Trial Matters Statistically

This trial is statistically informative as a pilot because it tests the feasibility of studying a mobile mindfulness program in a population described as underserved and racially minoritized, while measuring outcomes relevant to the program's stated self-management aims. It also illustrates why the endpoint definition and the reported analysis need to be read together: the primary outcome is framed as change from baseline, while the sponsor's reported between-group analysis concerns final values.

The record highlights the importance of reporting effect estimates with their uncertainty. The ANCOVA estimate and p-value bound are present, but confidence interval limits are not. Without interval bounds, readers cannot evaluate the range of estimates compatible with the analysis. The inequality for the p-value also does not resolve whether the result is below 0.05. These are meaningful limitations even when a pilot's main purpose is exploratory.

The design has useful features for a randomized comparison, including allocation to parallel groups and a wait-list arrangement. At the same time, the wait-list design and lack of masking shape what the comparison can tell readers, particularly for self-reported outcomes. A wait-list comparison does not isolate the mindfulness content from the other experiences associated with taking part in a program.

The study also makes visible the distinction between descriptive arm summaries, adjusted inferential analyses, and within-group changes. Those quantities should not be treated as interchangeable. Clear reporting of baseline scores, analysis populations, missing-data handling, covariates, and multiplicity procedures would help readers understand how the primary comparison was constructed. The registry record does not report those details.

For biostatisticians and clinical researchers, the case underscores that a pilot result can be useful for understanding the reporting and measurement questions that a larger evaluation would need to address, without being treated as definitive evidence about an intervention's effects.

16. 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 registry record leaves several trial-specific uncertainties. It does not provide the ANCOVA model specification, including the covariates used, or the confidence interval bounds for the reported mean difference. The p-value is reported only as p < 0.054, which does not determine whether it is below 0.05. These omissions constrain interpretation of both precision and statistical evidence.

The endpoint is described as change from baseline, but the posted between-group analysis is labeled as a comparison of final values. The record does not report numerical results for the within-group baseline-to-Week #8 contrasts named in the outcome description. Baseline PHQ-9 summaries are also not included in the primary result information, so the initial group balance on this outcome cannot be assessed from these results.

The analyzed populations are stated, but the registry does not explain whether any randomized participants were excluded from the analysis, whether endpoint data were missing, or what methods were used to address missingness. The analysis population and missing-data approach are therefore not fully transparent. Multiplicity handling for the primary outcome, secondary outcomes, and described contrasts is also not reported.

The study was unmasked and used a wait-list comparison, while the primary outcome was self-reported. These features do not invalidate the observations, but they limit what can be separated from expectancy, participation, or other aspects of the intervention period. The registry does not describe the allocation concealment process or provide a detailed statistical analysis plan.

Finally, the study is a pilot with the reported analyzed group sizes of 9 and 6. The registry does not report the original sample-size justification. The sample-size illustrations based on the observed effect are planning calculations, not a substitute for that justification or for direct uncertainty estimates around the reported result.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Piloting Mindfulness Meditation Program for Underserved Racial Minority Adults With Pulmonary Hypertension — NCT05387889.
• Registry record last updated 2023-11-08; status last verified 2023-11.
• Results first posted 2023-11-08.
• 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.

20. Record Summary

NCT05387889 is a completed randomized, parallel-group pilot of Mindfulness Meditation for Pulmonary Hypertension in underserved and racial minority adults with pulmonary hypertension. The registry lists enrollment of 15, no masking, and an eight-week intervention that combined remote sessions, recorded material, and daily mobile-app practice. The wait-listed group was scheduled to receive the intervention after the initial treatment group completed it.

The primary outcome was change from baseline in PHQ-9 depressive-symptom scores to Week #8. Two secondary outcomes concerned pulmonary-hypertension-related quality of life and mindfulness. For the primary analysis, the record lists 9 patients in Arm 1 and 6 in Arm 2, with arm-level means and standard deviations. The sponsor reports an ANCOVA mean difference of 0.05, p < 0.054, and a 95% confidence level, but no interval bounds.

Important details—including the model specification, missing-data handling, multiplicity approach, and numerical within-group changes—are not reported in the registry record. The available results describe a pilot comparison but do not permit a complete assessment of its precision or robustness.