Mindfulness-based Cognitive Therapy for the Chronic Pain-depression Co-morbidity Among Older Black Adults in the Community; The Quiet Focus 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-depression Co-morbidity Among Older Black Adults in the Community; The Quiet Focus Open Pilot (NCT07336342), a na na study. The primary outcome is The Credibility and Expectancy Questionnaire.

2. Clinical Question

This distinction matters for interpretation. The pilot’s stated future aims concern whether the adapted program could improve quality of life and whether it could reduce pain interference more than a health enhancement program. The current design has no randomized comparison with that program, so those comparative questions are not tested by this pilot. The primary outcome listed for this study instead characterizes participants’ expectations and perceptions before intervention initiation. Results for that outcome are not reported in the registry record.

3. Trial Design

The registry identifies the study as the Quiet Focus Open Pilot, a completed, single-group behavioral intervention study sponsored by Massachusetts General Hospital. It lists the intervention as mindfulness-based cognitive therapy, adapted for older Black adults in the community with chronic pain and depression. Enrollment is recorded as 12. The study is marked open, with no masking, and allocation is listed as not applicable. These features mean that the registry does not describe a randomized, masked comparison between the intervention and a control condition.

The study began on 2024-11-15 and reached primary completion on 2025-07-22. Its status is completed. These record details describe the study timeline and status, but they do not establish that every enrolled participant received or completed the intervention. Participant flow, intervention attendance, follow-up completion, and reasons for withdrawal are not reported in the registry record. The study phase is listed as not applicable.

The registered primary outcome is the Credibility and Expectancy Questionnaire at baseline, before intervention initiation. The listed secondary outcomes include the Numerical Rating Scale; PROMIS measures of physical function, anxiety, depression, and emotional support; Measure of Current Status Part A; Cognitive and Affective Mindfulness Scale-Revised; and Chronic Pain Acceptance Questionnaire. The record lists 14 outcome measures overall. Further details about the timing and scoring of the secondary measures are not reported in the registry record.

The registry summary frames the pilot as preparation for a later fully powered randomized controlled trial. Its stated future questions concern quality of life and whether the adapted program reduces pain interference more than a traditional health enhancement program. That future comparison should not be mistaken for a comparison conducted in the current single-group study. The registry record lists zero analyses, and does not report an analysis plan or numerical outcome results.

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 Baseline (at enrollment, prior to intervention initiation)..

The primary endpoint is the Credibility and Expectancy Questionnaire (CEQ), assessed at baseline at enrollment and before intervention initiation. It is a self-report measure designed to capture how credible or logical a treatment seems and how much improvement a participant expects. The registry describes the CEQ as a 6-item measure, with items 1-3 assessing credibility and items 4-6 assessing expectancy.

Items 1-3 and 5 use response scales from 0 (not at all credible or logical) to 9 (extremely credible or logical). Items 4 and 6 use response scales from 0% to 100%. The credibility and expectancy subscale scores are standardized and summed; the registry describes a 3-27 raw equivalent for credibility and a similar range for expectancy. It gives a total score range of 6-54 after standardization. Higher scores indicate greater credibility and more positive outcome expectancy, described in the record as expectation of a better outcome.

Credibility and expectancy can be useful constructs in intervention research because they describe participants’ perceptions of the treatment and anticipated benefit. That general purpose does not make the CEQ a measure of clinical improvement. Because the registered assessment occurs before intervention initiation, it records baseline perceptions rather than change attributable to participation. The registry record does not state why this measure was selected as the primary endpoint, and does not report a CEQ mean, standard deviation, or other result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry lists a continuous primary outcome summarized as a mean, with standard deviation as its dispersion measure. These are descriptive statistics: a mean represents the average score in a group, while a standard deviation describes how spread out individual scores are around that average. They do not, on their own, establish that an intervention caused a change. No mean or standard deviation for the CEQ is reported in the registry record, and no statistical analyses are listed.

What does a mean and standard deviation convey?

For a continuous measure such as a questionnaire score, the mean offers a compact description of the group’s score level. The standard deviation adds information about variability between participants. A group mean can conceal differences among individuals, so the spread is relevant to understanding how representative the average may be. These summaries are most informative when the number of observations and the distribution of scores are also clear. The registry does not report the observed CEQ summary statistics, participant-level distribution, or analysis population.

The CEQ combines questions about credibility and expectancy, using the response formats and scoring approach described in the endpoint definition. Scores are standardized and summed according to the registry description. Standardization puts component scores onto a common scale for combining them; the resulting score is still a measure of reported perception and expectation, not a direct measure of clinical status. The registry does not report how the scoring procedure was implemented for participants with incomplete questionnaire responses, or whether any score transformation or distributional checks were used.

What would a confidence interval add?

In general, a confidence interval gives a range of values compatible with an estimated quantity under the assumptions of the analysis. It helps readers distinguish the estimated effect from its uncertainty. A narrow interval generally indicates greater precision than a wide interval, while an interval that includes values representing no difference may leave the direction or size of an effect uncertain. These are general interpretations, not conclusions about this study: no outcome estimate or confidence interval is reported in the registry record.

For a single-group pilot, estimates can describe the enrolled participants, but they do not supply a randomized comparison against an untreated or alternative-treatment group. If a study measured an outcome before and after an intervention, a within-group change would still not isolate the intervention’s contribution. Changes over time, expectations, measurement conditions, and other influences can also affect observed scores. This general limitation is particularly relevant to an open single-group design. The registry does not report an analysis of change for this study.

How should planning calculations be understood?

Planning illustrations based on an observed effect are not observed power. They show hypothetical sample sizes under stated assumptions, rather than describing the chance that the completed study detected an effect. The registry’s stated assumptions for such illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is described as a stated fraction of the observed effect. For continuous outcomes, the resulting quantities are participants per arm for a specified power target. These are planning concepts, not features of the current single-group design, which has no two-arm allocation.

Such illustrations depend on the effect used as their starting point and on their assumptions. A planning estimate based on an observed effect from a small pilot can be uncertain; more generally, planning outputs should be read as scenarios rather than as guarantees of future trial performance. No numerical planning outputs or observed effect estimate are reported in the registry record, so their magnitude cannot be evaluated from the available information. They do not replace an adequately described protocol or a reported analysis.

The record identifies a primary endpoint and secondary measures, but does not report the statistical plan, model specification, hypothesis tests, confidence intervals, or handling of repeated measurements. It also does not report an interim analysis plan or a sample-size justification for the pilot. These methods details cannot be inferred from the study being completed or from the names of the registered outcomes. Without them and without posted results, the statistical interpretation remains descriptive of the design rather than inferential about intervention effects.

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(12)
m   <- c(36.8)
sp  <- c(4.2)
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  12  36.800  4.200  34.131  39.469

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures and names a primary endpoint alongside secondary measures. When a study evaluates many outcomes, the chance of at least one apparently unusual result can increase if each outcome is tested separately without accounting for the number of tests. General approaches to multiplicity include identifying a primary outcome in advance, adjusting statistical thresholds, or treating secondary analyses as exploratory. The registry record does not report whether any multiplicity strategy was planned or used. Since it lists zero analyses and no outcome results, it is not possible to assess how multiple outcomes were interpreted.

The record identifies the CEQ as the primary outcome and lists the Numerical Rating Scale, several PROMIS measures, Measure of Current Status Part A, Cognitive and Affective Mindfulness Scale-Revised, and Chronic Pain Acceptance Questionnaire among the secondary outcomes. The registry does not report a hierarchy among secondary measures, planned contrasts, or which outcomes were included in any analysis. Names of registered outcomes alone do not establish that all were measured, analyzed, or reported.

Missing-data methods are not reported in the registry record. There is no reported account of incomplete questionnaires, missed assessments, participant withdrawals, or the assumptions used to handle missing values. Analysis populations are also not described: the record does not say whether analyses were intended to include everyone enrolled, only participants with a completed assessment, or another defined group. Participant flow and the number contributing data to each outcome are not reported.

These omissions affect interpretation because outcome estimates depend on which observations are included and how missingness is handled. If missingness is related to participants’ experiences or outcomes, an analysis of only observed data may not represent all enrolled participants. This is a general statistical concern, not a claim about missingness in this study. With no analysis details or results in the registry record, the extent of missing data and its influence cannot be assessed.

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 reports zero serious adverse events among the 12 participants listed as at risk in the mindfulness-based cognitive therapy group. It also reports zero other adverse events among the 12 participants listed as at risk, and zero deaths. No serious adverse event terms are listed. These are the safety figures recorded for the group; they should be read as registry-reported counts, not as proof that no adverse events occurred outside what was recorded.

Counts are useful for describing what the record reports, but they do not by themselves show how completely or for how long events were assessed. The registry record does not report event definitions, ascertainment procedures, follow-up duration for safety, or details of monitoring. It also does not provide an event-by-event account beyond the absence of listed serious-event terms and the reported counts.

With a single study group and no comparator, these figures cannot support a comparative estimate of adverse-event risk. Zero recorded events in this group should not be interpreted as evidence that the intervention has no risk or that a different group would have experienced more or fewer events. The information supports only the narrow statement that the registry lists no serious adverse events, no other adverse events, and no deaths for the recorded group.

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

The registry record establishes that the Quiet Focus Open Pilot was completed as an open, single-group study of an adapted mindfulness-based cognitive therapy intervention. Enrollment is recorded as 12, and the registered primary outcome is a baseline measure of credibility and expectancy. The record also identifies secondary measures related to pain, physical function, anxiety, depression, emotional support, mindfulness, current status, and pain acceptance. It does not report numerical results for these outcomes.

That absence sets a firm boundary on interpretation. There is no posted estimate of the primary CEQ score, no reported change in any outcome, and no analysis listed. The record therefore cannot establish whether participants’ scores improved, worsened, or remained stable. It cannot quantify the magnitude or precision of any change. Lack of reported results should not be recast as evidence of no effect; it means the registry record does not give outcome data from which to judge an effect.

The design also does not answer the comparative question posed for a future trial. The summary’s proposed comparison with a traditional health enhancement program is not a control arm in this study. Without a comparator, outcomes in the intervention group cannot be contrasted with outcomes under another program. More generally, changes over time in a single group do not by themselves show that an intervention caused those changes.

The primary measure has a narrower meaning than a clinical endpoint such as pain interference or quality of life. It records participants’ perceptions of credibility and expected benefit before intervention initiation. Even if reported, such a baseline score would not show whether the intervention later changed symptoms or functioning. Those distinctions keep the study’s registered measurement question separate from the later trial questions described in the summary.

Overall, the record describes a pilot and its measurement framework, but offers no posted outcome analysis on which to base claims about clinical benefit, comparative performance, or precision. The appropriate conclusion is about what the record documents, not about treatment effectiveness.

14. Why This Trial Matters Statistically

This study is statistically relevant because pilot studies and definitive comparative trials answer different kinds of questions. A pilot can help establish whether an adapted intervention and its measures are suitable for further study, but this record does not report findings on feasibility, acceptability, or participant experience beyond naming the registered measures. Those outcomes should not be assumed from the pilot label alone.

The population and intervention specified in the registry give the study a focused context: older Black adults in the community with chronic pain and depression, and an adaptation of mindfulness-based cognitive therapy. The summary explicitly places questions about quality of life and comparative reduction in pain interference in a later fully powered randomized controlled trial. That distinction is statistically important: a pilot’s single-group observations, even if reported, would not replace the randomized comparison needed to estimate differences between programs.

The primary outcome also illustrates why endpoint selection and timing matter. The CEQ is a measure of credibility and expectancy, and it is scheduled at baseline before intervention initiation. It can characterize initial perceptions, but it does not directly quantify a later clinical response. Readers should therefore avoid treating the primary endpoint as if it were a measure of symptom improvement.

Finally, the record shows how reporting completeness shapes what can be learned. It identifies a study design, enrollment, outcomes, and safety counts, while listing no analyses or outcome results. Without estimates, uncertainty measures, missing-data information, and an analysis description, readers cannot assess the direction, size, precision, or robustness of outcomes. That limitation is not a statistical result in favor of or against the intervention; it is a limit on the conclusions supported by the posted record.

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 follow directly from the registered design and the information reported. The study is single-group, open, and has no randomized comparator. As a result, it does not estimate how outcomes differ between the intervention and another program. The absence of masking also means participants and study personnel were not masked according to the record; the registry does not describe any steps to limit potential influence on assessments.

Enrollment is recorded as 12. The record does not report the number who completed the intervention or contributed data to each outcome, so the amount of information available for any endpoint cannot be determined. It also does not report participant characteristics beyond the target population description. The enrolled group’s representativeness and the degree to which findings might apply beyond it therefore cannot be assessed from this record.

The primary measure is collected at baseline before intervention initiation. It can describe initial credibility and expectancy but cannot directly evaluate post-intervention change. Although secondary measures are listed, their assessment timing and numerical results are not reported. The registry lists zero analyses, leaving no estimates, precision measures, or analysis details for interpretation.

Further limitations are the absence of reported information about missing data, participant flow, intervention delivery, adherence, and statistical planning. The record does not describe how incomplete questionnaires would be scored, which participants would enter analyses, or whether multiple outcomes would be handled using a specified strategy. These details are not reported in the registry record and should not be inferred from the study’s completion status.

Finally, the pilot’s stated future questions include a comparison with a traditional health enhancement program, but such a comparator is not part of the current study. The record can therefore neither estimate that comparative effect nor address whether any observed changes would be attributable to the intervention.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Mindfulness-based Cognitive Therapy for the Chronic Pain-depression Co-morbidity Among Older Black Adults in the Community; The Quiet Focus Open Pilot — NCT07336342.
• Registry record last updated 2026-08-19; status last verified 2026-08.
• Results first posted 2026-08-19.
• 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 describes the Quiet Focus Open Pilot as a completed, open, single-group behavioral study sponsored by Massachusetts General Hospital. It concerns an adaptation of mindfulness-based cognitive therapy for older Black adults in the community with chronic pain and depression. Enrollment is recorded as 12; the study began on 2024-11-15 and reached primary completion on 2025-07-22.

The primary outcome is the Credibility and Expectancy Questionnaire at baseline, before intervention initiation. The registry lists 14 outcome measures and zero analyses. It does not report numerical results for the primary or secondary outcomes, statistical methods for outcome analysis, or missing-data and analysis-population details. The record reports zero serious adverse events, zero other adverse events, and zero deaths in the study group.

The summary identifies quality of life and comparative pain interference as questions for a later fully powered randomized controlled trial. Those are not comparative findings from this single-group pilot. The registry record documents the design and planned measurements, but does not report outcome analyses that answer the clinical questions.