Mindfulness-based Cognitive Therapy for the Chronic Pain-early Cognitive Decline Co-morbidity Among Older Black Individuals in the Community; The Feeling of Being Open Pilot: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mindfulness-based Cognitive Therapy for the Chronic Pain-early Cognitive Decline Co-morbidity Among Older Black Individuals in the Community; The Feeling of Being Open Pilot (NCT07210398), a na na study. The primary outcome is The Credibility and Expectancy Questionnaire.

2. Clinical Question

The study’s stated aim is to pilot an adaptation of mindfulness-based cognitive therapy, with questions intended to inform a later, fully powered randomized controlled trial. The summary identifies two questions for that future trial: whether an adaptation can improve quality of life, and whether it can reduce pain interference more than a traditional health enhancement program. These are proposed future research questions, not findings from the present single-group study.

The distinction between the pilot’s registered primary outcome and those future questions is important. The primary outcome is a measure of participants’ credibility judgments and expectations at enrollment. It is not a registered treatment-versus-control contrast, and a score recorded at enrollment does not by itself establish a change after therapy. The record lists additional measures, including pain, physical function, anxiety, emotional support, mindfulness, pain acceptance, and pain self-efficacy, but does not provide their results in the information available for this analysis.

3. Trial Design

This is a completed, single-group behavioral pilot sponsored by Massachusetts General Hospital. The registry record lists an enrollment of 9 and identifies chronic pain and early cognitive decline as the conditions under study. The trial is titled as an adaptation of mindfulness-based cognitive therapy for older Black individuals in the community. The record gives a start date of 2024-12-05 and a primary completion date of 2025-07-22, with status listed as completed.

The design has no randomized allocation and no concurrent control arm. Masking is listed as none. Consequently, the study does not provide a randomized comparison between the adapted therapy and another program. Its design can describe observations in the single group, but cannot separate changes associated with the intervention from changes that might arise over time or for other reasons. The registry record does not report a protocol, detailed intervention schedule, or a rationale for the enrollment target.

The registered primary measure is the Credibility and Expectancy Questionnaire total score at enrollment. The record also lists 16 outcome measures and 26 analyses, and names secondary measures covering several patient-reported domains and physical function. The number of listed outcomes and analyses does not establish which were included in any particular analysis or whether all were reported. Specific analysis populations and methods are not reported in the registry record.

The registry summary frames the pilot as preparation for later research and states questions about quality of life and pain interference in a future fully powered randomized controlled trial. Those future aims should not be treated as comparisons performed in this study. The trial has one listed intervention group, so the interpretation must remain focused on what the registry reports for that group. In particular, neither the title nor the planned future questions can substitute for outcome estimates that are not reported.

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

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 The Credibility and Expectancy Questionnaire, measured over At enrollment.

The primary outcome is the total score on the Credibility and Expectancy Questionnaire (CEQ), recorded at enrollment. The CEQ is described as a 6-item self-report measure. Items 1-3 address treatment credibility, while items 4-6 address expectancy. The record explains that responses use different formats: some are rated from 0 (not at all credible/logical) to 9 (extremely credible/logical), and others from 0% to 100%. Subscale scores are standardized and summed. The total score ranges from 6-54 after standardization, with higher scores indicating greater credibility and positive outcome expectancy.

Credibility and expectancy are relevant to understanding how participants view a treatment and the prospect of its outcomes. A score on this measure is not itself a measure of pain relief, cognitive change, quality of life, or treatment effectiveness. Its use as the registered primary outcome means it describes participants’ credibility and expectations at the specified time, enrollment. The registry record does not state a later CEQ assessment or a planned change-from-baseline contrast.

No mean, standard deviation, confidence interval, or other numerical CEQ result is reported in the registry record. Without a reported estimate, it is not possible to characterize the participants’ average score or the precision of that average from the registry information. The score description clarifies the construct and direction of the measure, but does not supply the observed score.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation begins by distinguishing the design from the outcomes. This trial is listed as a single-group study, with no allocation to a comparison group and no masking. The only intervention group is mindfulness-based cognitive therapy. In a randomized comparative trial, an analysis can estimate a contrast between assigned groups, subject to its assumptions. This pilot has no such concurrent contrast. Its design therefore cannot directly estimate how outcomes under the intervention compare with outcomes under a control program.

The primary outcome is a continuous measure summarized, according to the record, as a mean and standard deviation. A mean describes the arithmetic average of observed scores; a standard deviation describes how dispersed individual scores are around that average. These answer different questions. The mean gives a central summary, while the standard deviation characterizes variability among observations. Neither is reported for the primary outcome in the registry record. Without those values, the average CEQ score and the spread of participant scores cannot be described numerically.

A confidence interval is a range of values compatible with an estimate under a specified statistical procedure. Its width conveys precision: narrower intervals indicate greater precision, while wider intervals indicate more uncertainty. A confidence interval is not reported for the primary outcome in the registry record. General statistical interpretation cannot recover one without the relevant estimate, variability, sample information, and analysis details. The enrollment count alone is not enough to reconstruct the interval.

Because the primary outcome is measured at enrollment, it is a score at a specified time rather than, as registered in the information available, a change between two times. A change analysis would require measurements at multiple times and a defined way to compare them. The record does not report a later primary-outcome time point or a change estimate. It would therefore be inaccurate to describe the CEQ result as an improvement or decline.

What does the single-group design permit?

In general, a single-group study can describe the participants who were observed and the values recorded for them. If repeated outcomes are reported, their changes can also be summarized, but change alone does not show what would have happened without the intervention. External influences, natural variation, and other changes over time remain possible explanations. A concurrent comparison group helps address that question, especially when assignment is randomized. No comparison group is listed for this pilot, so a causal comparison with a traditional health enhancement program is not available.

That limitation is especially important when interpreting the study summary. The summary asks whether the adapted therapy can reduce pain interference more than a traditional health enhancement program, but it identifies this as a question for a later fully powered randomized controlled trial. It is not the contrast analyzed by the present design. The same care is needed for the future quality-of-life question: describing a research aim does not establish an observed effect.

What do planning calculations mean?

In general, a sample-size planning calculation uses assumptions about a target effect, variability, significance level, allocation, and statistical model to illustrate how many participants might be needed for a future study. The registry record describes an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes planning for a stated fraction of that effect. The record does not report the numerical planning results in the information, and it does not identify those calculations as the trial’s own design justification.

Such a calculation is a planning aid, not a measure of the probability that the completed pilot detected an effect. “Observed power” is not a substitute for reporting an effect estimate and its uncertainty. Nor does a hypothetical two-arm planning scenario change the actual single-group design. A future comparison would need its own design assumptions, including the selected outcome, target effect, variability, allocation, and analysis approach. The registry record does not report a protocol-based sample-size justification, so the enrollment of 9 should be treated as the recorded enrollment rather than evidence of a particular design target or inferential capability.

Why can over-dispersion matter?

As a general statistical concept, over-dispersion occurs when the variability in observed data is greater than a model assumes. If a method assumes less variability than the data contain, uncertainty can be understated and intervals or tests may be poorly calibrated. The appropriate response depends on the outcome type and analysis model. The primary outcome is described as continuous and summarized by a mean and standard deviation; the registry record does not report an over-dispersion assessment or identify a model that would allow such an assessment. It would not be appropriate to claim that over-dispersion was present or handled.

More broadly, the registry record does not specify the tests, model terms, covariate adjustments, confidence level, or missing-data procedure used for the outcome analyses. The count of 26 analyses does not identify their statistical methods. Any detailed account of those procedures would therefore go beyond what is reported. The relevant reading is to separate the documented design and outcome definitions from analysis choices that are not described.

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 Cognitive Therapy")
n   <- c(9)
m   <- c(35.07)
sp  <- c(5.94)
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 Cognitive Therapy  9  35.070  5.940  30.504  39.636

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 16 outcome measures and 26 analyses. When a study examines multiple outcomes or performs multiple analyses, the chance of finding at least one apparently notable result can rise if each test is interpreted without regard to the others. General approaches to multiplicity include prespecifying a primary outcome, adjusting some inferences, or treating secondary analyses as exploratory. The record identifies a primary outcome, but does not report whether any multiplicity adjustment was planned or used. The number of listed measures and analyses alone does not establish which comparisons were tested or how their results should be interpreted.

The available information does not report missing-data counts, reasons for missingness, or methods for handling missing observations. It also does not describe an analysis population, such as whether results were based on all enrolled participants, participants who began the intervention, or participants with an available measurement. These details are important because different analysis populations and missing-data methods can produce different summaries. They are not reported in the registry record, so no claim about completeness or the handling of absent measurements can be made.

There is no randomized allocation or control arm listed. Therefore, questions about an intention-to-treat comparison between assigned groups do not apply as a description of this design. The registry record does not specify a replacement analysis population or explain how participants were included in each of the 26 analyses. The enrollment count should not be taken as proof that every participant contributed data to every measure.

For the primary CEQ measure, the registry specifies assessment at enrollment, but does not report the number of completed questionnaires or a result. Thus even basic completeness for this outcome cannot be determined from the information available. Interpretation should remain limited to what is documented: the endpoint definition and timing are given, while multiplicity procedures, missing-data handling, and analysis populations are not reported in the registry record.

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 record lists one group, mindfulness-based cognitive therapy, with 9 participants at risk for serious adverse events and 0 serious adverse events. It also lists 9 at risk for other adverse events and 0 other adverse events. The deaths count is 0. These are the counts recorded for the group; the registry information does not list any serious adverse event terms.

Zero recorded events is not the same as proof that an intervention has no risks. In general, event counts from a small group provide limited information about uncommon events, and a count is not a complete description of how safety was monitored or how events were defined. The registry record does not report further details about monitoring, event ascertainment, or the observation period for these safety summaries. It is therefore not possible to evaluate those aspects from the counts alone.

The figures should also be read within the study design. There is one intervention group and no concurrent control group, so the counts do not compare event rates between treatment conditions. They describe the registry’s reported counts in this group and should not be used to infer a comparative safety effect. The reported zero counts are relevant descriptive information, but the small enrollment and lack of a comparator limit what they can establish.

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

The registry record documents a completed pilot of an adapted mindfulness-based cognitive therapy intervention in a population described as older Black individuals in the community with chronic pain and early cognitive decline. It records an enrollment of 9, identifies a single intervention group, and specifies the CEQ total score at enrollment as the primary outcome. This describes the focus and structure of the study; it does not establish an effect on pain, cognition, quality of life, or any other clinical outcome.

The primary outcome is a measure of credibility and positive outcome expectancy. The registry record explains how the questionnaire is scored and what higher scores mean, but does not report the observed score. No primary outcome mean, standard deviation, confidence interval, or statistical test result is available in the registry information. Consequently, the participants’ average credibility and expectancy and the precision of that average cannot be assessed from this record.

The absence of a concurrent comparator also matters. The trial does not test whether the adapted therapy performs better than a traditional health enhancement program. That comparison appears in the summary as a question for later research. The summary’s question about quality of life is likewise an intended future research question rather than a reported finding from this pilot. Outcome lists and study aims should not be confused with results.

The record lists 16 outcome measures and 26 analyses, but does not report their numerical findings in the information available for this analysis. Without estimates and uncertainty, it is not possible to describe the direction or magnitude of results for the secondary measures. The completed status and the presence of safety counts do not fill that gap.

Accordingly, the record supports a description of a small, single-group pilot and its registered measurement plan. It does not support a conclusion about treatment benefit, lack of benefit, comparative performance, or the size and precision of any clinical change. The next research questions identified in the registry require outcome reporting and, for comparative claims, a design capable of making the relevant comparison.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of why a pilot’s design and a later trial’s research questions must be kept separate. The registry describes a single-group intervention study with an enrollment of 9, while its summary points toward a later, fully powered randomized controlled trial. A single group can describe the participants and measurements recorded, but it does not provide the concurrent comparison required to answer whether the therapy reduces pain interference more than another program.

The registered primary outcome also deserves attention. It is a CEQ total score at enrollment, measuring credibility and expectancy rather than a treatment effect on pain or quality of life. The registry record does not report its numerical result. This highlights a basic statistical principle: an endpoint definition specifies what a study intends to measure, but readers need the observed estimate and its uncertainty to understand the data. Naming the measure and explaining its scale do not substitute for reporting results.

The record’s lists of 16 outcomes and 26 analyses make transparent reporting especially important. Multiple measures can address different aspects of a pilot, but readers need to know which outcomes were analyzed, what methods were used, how missing measurements were handled, and whether analyses were exploratory or confirmatory. Those details are not reported in the registry record. Without them, the list of planned or registered measures cannot be interpreted as evidence that all outcomes were completed or analyzed in a particular way.

Finally, the reported safety counts belong in their design context. Zero recorded events among the listed group is a descriptive finding, not a comparative safety estimate. The small enrollment and absence of a control group constrain what safety conclusions can be drawn. Overall, the statistical value of this record lies in clarifying the study’s scope and the information still needed for a more complete evaluation.

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 arise from the trial design and from the information reported in the registry. First, this is a single-group study with no randomized allocation and no concurrent control group. It cannot estimate a treatment-versus-control contrast, including the comparison with a traditional health enhancement program described as a future research question. Changes in any measured outcome, if reported elsewhere, would not by themselves establish that the intervention caused them.

Second, the registry lists an enrollment of 9. Estimates from a group of this size may be imprecise, but the actual precision depends on each outcome’s variability and the analysis used. The primary outcome mean and standard deviation are not reported, so its precision cannot be quantified from the record. The record also does not report a sample-size justification based on a protocol. Planning illustrations are not evidence that the pilot was designed to detect a particular effect.

Third, the primary outcome is a credibility and expectancy measure assessed at enrollment, not a reported comparison of clinical outcomes over time. The registry does not provide the observed score or a later CEQ assessment. Although it lists measures relevant to pain, function, emotional support, mindfulness, acceptance, and self-efficacy, their numerical results are not reported in the information available for this analysis.

Additional limitations concern reporting. Statistical tests, model specifications, confidence intervals, multiplicity procedures, missing-data methods, and analysis populations are not reported in the registry record. The record lists 16 outcome measures and 26 analyses, but does not clarify which contributed to each reported analysis. The participant characteristics and detailed eligibility criteria are also not given in the information. These gaps restrict assessment of the results, data completeness, and applicability beyond the population described in the title and summary.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Mindfulness-based Cognitive Therapy for the Chronic Pain-early Cognitive Decline Co-morbidity Among Older Black Individuals in the Community; The Feeling of Being Open Pilot — NCT07210398.
• Registry record last updated 2026-09-09; status last verified 2026-08.
• Results first posted 2026-04-17.
• 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, single-group behavioral pilot sponsored by Massachusetts General Hospital. The study focuses on adapting mindfulness-based cognitive therapy for older Black individuals in the community with chronic pain and early cognitive decline. Enrollment is listed as 9; allocation is listed as NA, and masking as none.

The primary outcome is the Credibility and Expectancy Questionnaire total score at enrollment. The record lists 16 outcome measures and 26 analyses, along with 0 serious adverse events, 0 other adverse events, and 0 deaths in the intervention group. It identifies future research questions about quality of life and pain interference, including a comparison with a traditional health enhancement program in a later randomized trial.

The primary outcome result and secondary outcome estimates are not reported in the registry information available for this analysis. The record therefore supports a description of the study design and registered measures, but not a conclusion about intervention effects or comparative performance.