MASC: Reducing Stress for Caregivers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for MASC: Reducing Stress for Caregivers (NCT05847153), a na na study. The primary outcome is Feasibility of Recruitment.

2. Clinical Question

This distinction defines what the primary result can address. Recruitment feasibility is about whether eligible people enroll and whether the recruited group reflects a stated diversity goal. It is not a measure of whether MASC reduces caregiver stress, changes responses to challenging behaviors, or improves any health outcome. Those may motivate the program, but the primary endpoint described in the record is recruitment.

The record reports 13 enrolled participants and states that 4 of the 13 who chose to enroll were racial and ethnic minorities. It also gives a recruitment benchmark of at least 70% of eligible participants enrolling and a diversity benchmark of at least 38%. The registry record does not report calculated percentages or an inferential analysis of either benchmark. The counts can therefore be read as descriptive information, not as a statistical test of whether the benchmarks were achieved.

3. Trial Design

This is a completed, single-group behavioral intervention study sponsored by Massachusetts General Hospital. The registry lists the study phase as NA, allocation as NA, and masking as none. Enrollment is reported as 13. The record gives a start date of 2023-09-12 and a primary completion date of 2024-01-13, with status listed as completed.

The intervention is MASC, the Mindful and Self-Compassionate Care Program. Its stated content includes mindfulness skills, compassion and self-compassion skills, and behavioral management skills. The program also uses psychoeducation, group-based training, and practice intended to support integration of skills into caregivers’ experiences and tasks. The intervention description specifies six virtual group sessions and an opportunity for at-home practice after each group session.

Because the study is single-group and has no reported comparator, the design does not provide a concurrent control group for estimating how participants’ outcomes would have differed without MASC. It also is not a randomized comparison. Changes over time, if reported for other outcomes, could not by themselves separate an intervention effect from other explanations such as changes in participants’ circumstances, measurement variation, or time-related effects. The registry record lists no analyses.

The primary outcome is recruitment feasibility at baseline. The investigators describe examining the proportion of eligible participants who were eligible and chose to enroll, and exploring the representation of racial and ethnic minorities across the sample. The record reports the relevant counts, but does not state the calculated proportions or describe a statistical model for the primary endpoint.

Although the record marks the study completed, that status does not establish that all planned outcomes were collected or analyzed. The number of outcome measures is listed as 39, while the number of analyses is listed as 0. Further details about the conduct of follow-up, the analysis population, and whether all planned measurements were obtained are not reported in the registry record.

4. Participant Flow and Accounting

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

Overall Study

Analysis population for the primary outcome, as defined in the registry: 16 participants were eligible and 13 chose to enroll. Out of the 13 that chose to enroll, 4 were racial and ethnic minorities.

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 of Recruitment, measured over Baseline.

The primary endpoint is titled “Feasibility of Recruitment” and is measured in participants at baseline. It concerns the number of eligible people who chose to enroll, with an additional exploration of racial and ethnic representation in the enrolled sample. This kind of endpoint is used to assess whether recruitment procedures can attract participants from the intended population and whether enrollment is consistent with prespecified feasibility goals.

The record reports that 16 participants were eligible and 13 chose to enroll. It also reports that 4 of the 13 who enrolled were racial and ethnic minorities. The stated benchmarks are at least 70% enrollment among eligible participants and at least 38% racial and ethnic minorities. A calculated percentage for either measure, an uncertainty interval, and a formal benchmark comparison are not reported in the registry record. No conclusion about whether either benchmark was met should be inferred from a count alone in the absence of the registry’s reported calculation.

Recruitment feasibility is distinct from clinical effectiveness. It describes the process of enrolling participants; it does not quantify changes in stress or other caregiver outcomes. The record does not identify a stress measure as the primary endpoint, nor does it report a treatment-effect estimate for stress as the primary result. The endpoint is useful for judging recruitment and representation, but it cannot answer whether MASC changes caregiver outcomes.

General statistical context: a proportion is an estimate of the share of eligible people who enroll, while an uncertainty interval communicates how imprecise that estimate may be. Reporting the numerator and denominator is helpful, but an interval or other uncertainty assessment is needed to show how much the observed recruitment experience might vary across comparable recruitment efforts.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical information in this record is limited. The primary outcome is a count-based measure of recruitment feasibility, and the registry reports participant counts. It does not report a statistical analysis for that endpoint. Understanding what the counts can and cannot tell readers is therefore more important than interpreting a model or test that is not described.

What does a recruitment count represent?

The record states that 16 participants were eligible and 13 chose to enroll. These are the denominator and numerator relevant to the stated recruitment question. The record also gives the benchmark of at least 70% enrollment among eligible participants. A calculated proportion is not reported in the registry record, so the counts should not be converted into a new percentage or treated as a reported estimate. Nor does the record state that the benchmark was formally tested.

For a recruitment proportion, the enrolled count is evaluated in relation to the number eligible. The result describes a recruitment process in this study; it does not automatically predict what another clinic, community, or recruitment effort would achieve. Differences in setting, eligibility, outreach, and participant circumstances can affect recruitment. These are general considerations, not additional features reported for this study.

Why does uncertainty matter?

A count or proportion is an estimate based on the participants observed. An uncertainty interval can communicate how much imprecision accompanies that estimate. In general, an interval is more useful than a point estimate alone because it makes clear that the observed recruitment experience is not known with unlimited precision. No confidence interval or other uncertainty measure for recruitment is reported in the registry record.

General statistical explanation: a confidence interval is constructed using a method with assumptions about how observations arise. Its width reflects both the observed data and the method used. A narrow interval generally indicates greater precision than a wide interval, but an interval does not address every source of bias. For example, it cannot correct a recruitment process that systematically excludes people or a measure that does not represent the intended concept.

What does the single-group structure imply?

A single-group design observes participants receiving the intervention without a separate control group. It can describe feasibility and participant outcomes, but it does not directly estimate what would have happened to similar participants over the same period without the intervention. In general, a control group helps distinguish intervention-related changes from time trends, external events, and other influences. The registry lists allocation as NA and the model as single group; no like-for-like control comparison is reported.

The intervention is behavioral and includes group sessions and at-home practice. Masking is listed as none. In general, masking can reduce some forms of expectation or assessment influence, depending on who is masked and how outcomes are measured. The record does not report further masking details. It also does not report a statistical plan explaining how outcomes were to be analyzed.

How should planning assumptions be read?

A planning illustration is not an observed result. The recorded assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect expressed as a fraction of the observed effect. Those assumptions describe a hypothetical planning framework, not the single-group study design recorded for MASC. No resulting sample-size values are reported in the registry record.

General statistical explanation: sample-size calculations ask how much information a future study might need under chosen assumptions about the effect, variability, allocation, and decision threshold. They do not show that a completed study had a particular probability of detecting an effect, and they do not turn an unreported analysis into evidence. Sample-size estimates are sensitive to assumptions; if those assumptions do not match the eventual design or outcome, the planning calculation may not be informative for that study.

Here, the stated two-arm planning framework should not be mistaken for evidence that this trial had two arms. The record instead identifies a single-group model and no comparator. The planning assumptions also do not supply an effect estimate for caregiver outcomes, because no analysis results are listed. The registry record does not report a sample-size justification for the actual study design, interim analyses, or a statistical analysis plan.

What does the absence of listed analyses mean?

The record lists 0 analyses. That does not establish why analyses are absent or whether analyses were conducted outside the registry record. It does mean that effect estimates, standard errors, confidence intervals, test statistics, and p-values are not reported in the registry information. Without these, readers cannot assess statistical evidence or precision for clinical outcomes.

General statistical explanation: statistical significance and practical importance are different questions. A p-value, when reported, assesses compatibility of data with a specified null model under its assumptions; it is not the probability that a treatment works. An effect estimate describes the magnitude and direction of a result, while an interval conveys uncertainty. Neither a p-value nor an interval can remedy a design that lacks a comparator when the goal is causal attribution.

Over-dispersion is relevant to some count outcomes when observed variation exceeds what a simple count model assumes. General methods may use models that accommodate extra variation when the data and endpoint call for them. The primary endpoint is presented as recruitment counts, and the registry does not report an over-dispersion analysis or a model for those counts. No claim about over-dispersion or a model choice can therefore be made for this trial.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 39 outcome measures and 0 analyses. It does not report which outcomes were analyzed, how any outcomes were prioritized beyond the stated primary recruitment endpoint, or whether adjustments for multiple testing were planned or used. A multiplicity procedure is not reported in the registry record.

General statistical context: when many outcomes or comparisons are tested, the chance of obtaining at least one apparently unusual result can increase if each is considered separately. Methods for handling multiplicity can control or describe that issue, but the appropriate approach depends on the prespecified questions and analysis plan. The number of listed outcomes alone does not show that multiple tests were performed. Since no analyses are listed, the record does not support a claim about the presence or absence of false-positive findings.

Information about missing data is not reported in the registry record. The record does not state whether participants missed sessions, whether outcome measurements were incomplete, how missing observations were handled, or whether missingness differed across measures. Completion status does not answer these questions.

The analysis population is also not reported in the registry record. The enrolled count is 13, but the record does not specify an analysis set for outcomes or explain whether all enrolled participants contributed data to each planned measure. No intention-to-treat, per-protocol, or other analysis-population definition is given. These gaps limit assessment of how representative any future reported estimates would be of all enrolled participants.

For the recruitment endpoint, the record gives the eligible and enrolled counts and the count of racial and ethnic minority participants. It does not provide an uncertainty analysis, a missing-data account, or a description of how eligibility and enrollment information was verified. Those details would help readers judge the completeness and reproducibility of the feasibility assessment.

11. 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 adverse-event record lists 13 participants at risk for serious adverse events and 0 participants affected. It also lists 13 at risk for other adverse events and 0 affected. The reported number of deaths is 0. These are the recorded event figures for the intervention group.

These counts describe what is entered in the registry; they do not establish that an event could not occur or that the intervention has no safety risks. With no separate comparison group, the figures do not estimate whether event occurrence differs from what would have happened without MASC. The record does not report serious adverse-event terms, and it does not provide event-level details, severity descriptions, timing, or an account of how adverse events were monitored.

General statistical context: a zero count is an observed result, not proof that the underlying risk is zero. Precision depends on the amount of observation and the event definitions and ascertainment procedures. The registry does not provide enough information to calculate or interpret an uncertainty interval for these safety counts. The figures should therefore be read as descriptive reports, not as a comparative safety analysis or a guarantee about risk.

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

The result establishes that recruitment occurred and gives the counts recorded for eligibility, enrollment, and racial and ethnic representation: 16 participants were eligible, 13 chose to enroll, and 4 of those who enrolled were racial and ethnic minorities. The record also states recruitment and diversity benchmarks. It does not report calculated percentages or a formal comparison with those benchmarks, so it does not state whether they were achieved.

The result does not establish that MASC reduces stress, improves caregiver well-being, or changes management of challenging behaviors. Those topics appear in the program rationale and content, but the registry record lists no analyses. It therefore provides no reported treatment-effect estimate, uncertainty interval, or statistical test for those outcomes.

The single-group design also limits causal interpretation. Without a separate control group, participant changes cannot be attributed to the program on the basis of the design information alone. A comparison with participants who did not receive MASC is not reported, and random allocation is not part of the recorded design. The record cannot establish how outcomes would have differed in the absence of the program.

General statistical context: an observed result is not automatically a reliable forecast. Recruitment counts from one study can inform planning, but their applicability to a different setting depends on whether eligibility, outreach, and the population are sufficiently comparable. An uncertainty estimate and fuller description of recruitment procedures would support a more precise assessment; neither is reported for the primary recruitment outcome.

The record’s completed status and reported safety counts add descriptive context, but neither is evidence of clinical effectiveness. The appropriate reading is narrow: the registry documents enrollment and representation counts for a completed MASC study and describes a recruitment-feasibility objective. Broader conclusions about effectiveness, generalizability, or comparative safety are not supported by the analyses reported in the registry record.

13. Why This Trial Matters Statistically

Recruitment feasibility is an important statistical question because intervention studies depend on reaching and enrolling the population they intend to study. Reporting both the number eligible and the number who enroll makes the recruitment process more interpretable than reporting enrollment alone. The racial and ethnic representation count also connects the feasibility question to who was reached and included.

This study’s record makes the distinction between feasibility and effectiveness especially important. MASC is described as a program for caregivers of people with Alzheimer Disease and Related Dementias, with mindfulness, self-compassion, behavioral management, psychoeducation, group training, and practice. But the stated primary endpoint is recruitment, and the record lists no analyses. The study rationale should not be mistaken for a demonstrated clinical effect.

Statistically, the reported counts are useful starting information for understanding enrollment in this study. At the same time, the absence of calculated percentages and uncertainty intervals means the precision of the recruitment and representation estimates is not reported. The benchmarks provide reference goals, but without a reported comparison they do not establish whether the goals were reached.

The single-group design is also relevant for future interpretation. It can contribute information about whether a program can be delivered and participants recruited, but it does not furnish a control-based estimate of effectiveness. Keeping those questions separate helps avoid overreading a feasibility result as a treatment-effect result.

General context: early work on an intervention can address whether recruitment and delivery are workable before a study is designed to estimate comparative effects. Such feasibility information may help frame later research questions, but it is not a substitute for outcome analyses or a controlled comparison. In this registry record, the most defensible statistical contribution is descriptive information about recruitment and representation, alongside clear limits on what can be concluded about clinical outcomes.

14. 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 primary endpoint information is limited to counts. The record gives 16 eligible participants, 13 who chose to enroll, and 4 racial and ethnic minorities among those enrolled, but it does not report the calculated proportions, uncertainty intervals, or a formal comparison against the stated benchmarks. Readers therefore cannot assess precision or determine from the registry’s own analysis whether the benchmarks were met.

The single-group design has no separate comparator, and allocation is listed as NA. As a result, the design information does not support a controlled estimate of the effect of MASC. Masking is listed as none; further details about outcome assessment and potential sources of measurement influence are not reported in the registry record.

The record lists 39 outcome measures but 0 analyses. Specific results for caregiver stress or other clinical outcomes are not reported in the registry record. The statistical analysis plan, interim analyses, missing-data approach, and analysis populations are also not reported. These omissions make it impossible to assess the methods and completeness of outcome analyses from the registry information.

The intervention description identifies six virtual group sessions and an opportunity for at-home practice after each session, but additional details about implementation, adherence, or actual participation are not reported in the registry record. The record also does not provide enough detail to judge how broadly the recruitment counts might apply beyond the study’s setting and eligibility process.

The safety figures are descriptive and lack reported event terms or comparative analysis. The study’s completed status does not resolve the limits created by absent analysis results. Together, these features mean that the registry supports a narrow account of recruitment and recorded events, but not conclusions about intervention effectiveness, precision of clinical effects, or comparative safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: MASC: Reducing Stress for Caregivers — NCT05847153.
• Registry record last updated 2026-03-19; status last verified 2025-06.
• Results first posted 2025-05-22.
• 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.

18. Record Summary

NCT05847153, “MASC: Reducing Stress for Caregivers,” is a completed, single-group behavioral study sponsored by Massachusetts General Hospital. The intervention is the Mindful and Self-Compassionate Care Program, described as teaching mindfulness, self-compassion, and behavioral management skills through six virtual group sessions and at-home practice opportunities.

The primary endpoint is recruitment feasibility at baseline. The record reports that 16 participants were eligible, 13 chose to enroll, and 4 of those who enrolled were racial and ethnic minorities. It lists benchmarks of at least 70% enrollment among eligible participants and at least 38% racial and ethnic minorities, but does not report calculated proportions or a formal benchmark comparison.

The record lists 39 outcome measures and 0 analyses. No comparator is reported, and the registry does not provide analysis results for clinical outcomes. Adverse-event figures list 0 serious events, 0 other events, and 0 deaths. These counts are descriptive and do not establish comparative safety or clinical effectiveness.