ASPIRE Cognitive Enhancement Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for ASPIRE Cognitive Enhancement Study (NCT02657954), a randomized na study. The primary outcome is Change in Global Deficit Score From Expanded MATRICS Consensus Cognitive Battery (MCCB).

2. Clinical Question

The primary outcome combines cognitive test information from the MATRICS Consensus Cognitive Battery, D-KEFS subtests, and Trail Making Test, Part B. Its score range is 0-5, with lower scores indicating less deficit at a given assessment; for change, however, a higher value is better. The comparison therefore concerns the difference in change, not simply which group had the lower score at one time point.

The registry’s stated rationale is that cognitive impairment may affect functioning and reintegration for homeless Veterans. It describes anticipated effects on cognition, functional skills, disability, and community reintegration, but these are expectations in the study description, not findings. The posted primary result gives mean change for each group and a between-group mean difference. It does not by itself establish what produced any observed difference or whether changes persisted beyond the measured follow-up.

3. Trial Design

The registry identifies NCT02657954 as the ASPIRE Cognitive Enhancement Study, with the official title Cognitive Rehabilitation for Homeless OEF/OIF/OND Veterans. It records the study as randomized, single-masked, and parallel-group. The study status is completed. Enrollment was 79, and the registry lists the VA Office of Research and Development as sponsor. The phase is recorded as NA.

The two behavioral interventions were Compensatory Cognitive Training (CCT) and Holistic Cognitive Education (HCE). The brief description characterizes the planned study as a 15-week randomized controlled trial, with a 10-week CCT intervention compared with an education control. The registry gives the primary outcome timeframe as baseline to 15 weeks. It does not give further details about what the single masking covered or how allocation was generated or concealed; those details are not reported in the registry record.

The primary outcome population is described as all participants who completed a baseline assessment, identified in the registry as the intent-to-treat sample. The posted primary outcome includes 39 participants in the CCT group and 40 in the HCE group. These are the numbers associated with the posted outcome summaries; the record does not give a separate flow of participants through randomization, follow-up, or analysis.

The record lists three outcome measures and one posted secondary outcome, change in WHODAS 2.0 from baseline to 15 weeks. The posted results include group means and standard deviations for the primary and secondary measures. The registry does not report the original sample-size justification, the detailed statistical analysis plan, or whether interim analyses were planned or conducted.

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: All participants who completed a baseline assessment (i.e., intent to treat sample)

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.

Population: 79 participants enrolled and baseline tested; 10 did not receive intervention

6. Primary Endpoint

The registry lists the primary outcome as Change in Global Deficit Score From Expanded MATRICS Consensus Cognitive Battery (MCCB), measured over baseline to 15 weeks.

The primary endpoint is change in Global Deficit Score from baseline to 15 weeks. The score is a composite based on the MATRICS Consensus Cognitive Battery, D-KEFS Verbal Fluency and Color-Word Interference subtests, and Trail Making Test, Part B. The registry gives a score range of 0-5: lower scores are better at a particular assessment, while a higher change score is better over time. This distinction matters because the comparison is about change between assessments rather than the absolute score at one assessment.

A composite can represent performance across several cognitive tests in one summary measure. In general, combining measures can help characterize a broad domain, while an individual composite may not reveal which component contributed most to a change. The registry does not give component-level results or additional information on how the composite was constructed, so the posted overall score cannot identify effects on particular cognitive skills.

The endpoint addresses the study’s central cognitive-rehabilitation question: whether the average change in measured cognitive deficit differed between CCT and HCE during the stated follow-up. It is a continuous outcome, summarized by group means and standard deviations. It does not directly measure homelessness, community reintegration, or long-term disability; those are separate concepts in the study rationale or outcomes.

7. Results Posted in the Registry

• Holistic Cognitive Education (HCE): mean 0.14 versus 0.26 on control; difference -0.12 (95% CI -0.27 to 0.03), standardized effect d = -0.35; z-test p = 0.122.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Holistic Cognitive Education (HCE): mean -4.50 versus -5.60 on control; difference 1.10 (95% CI -3.79 to 5.99), standardized effect d = 0.10; z-test p = 0.659.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Holistic Cognitive Education (HCE) and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary evidence concerns change in WHODAS 2.0, a disability measure, over the same baseline-to-15-week timeframe. Its estimated contrast has an interval that includes zero and an unadjusted p-value of 0.659. At a broad level, that pattern does not provide a clear secondary signal that separates the groups. It is consistent with the uncertainty in the primary comparison rather than resolving it.

The primary measure concerns cognitive deficit change, while WHODAS 2.0 concerns disability. They address related but distinct parts of the study rationale. Cognitive test performance and disability are not interchangeable outcomes: a change in one does not automatically establish a change in the other. The two posted summaries therefore offer different kinds of information, and the secondary measure does not independently validate or overturn the primary finding.

Secondary outcomes generally carry less weight than a designated primary endpoint because they may be exploratory, may be numerous, and can raise the chance of an apparently noteworthy finding when many comparisons are examined. General statistical context: multiplicity refers to making several statistical comparisons, where evaluating each at the same threshold can increase the overall chance of a false-positive result. An adjustment or a prespecified hierarchy can address this concern, but the registry record does not report a multiplicity plan.

The record lists three outcome measures but posts one secondary outcome; it reports no secondary analyses. The absence of a reported analysis plan makes it difficult to determine how the secondary measure was selected or whether other planned comparisons were considered. The secondary result should accordingly be regarded as supporting context, not as a stand-alone confirmatory conclusion. A fuller assessment would require the protocol or analysis plan, details of outcome selection, and complete reporting of all planned outcomes.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant has a numerical change score, and the registry summarizes each group using a mean and standard deviation. A mean gives the average score in a group. A standard deviation describes how dispersed individual scores are around that group mean. These summaries answer different questions: the mean describes the group’s center, while the standard deviation describes variation among participants.

What does the mean difference represent?

The comparison is a difference between the group means. The registry reports the HCE mean as 0.14 and the CCT mean as 0.26, with the contrast expressed as HCE relative to CCT. Accordingly, the posted estimate is -0.12. The direction depends on the stated subtraction order. Since higher change is better for the primary endpoint, a negative HCE-minus-CCT estimate means the observed mean change was lower in HCE than in CCT. This is a description of the point estimate, not a causal explanation or a conclusion about individual participants.

A confidence interval describes a range of values that are reasonably compatible with the data under the statistical procedure used to construct it. A wider interval indicates less precision; an interval containing zero means that no difference is among the values compatible with the data. It does not mean that zero has been proven, nor does it rule out differences in either direction. The primary interval crosses zero, so the estimate does not sharply distinguish a between-group difference from no difference.

What does the p-value tell us?

The unadjusted p-value for the primary comparison is 0.122. In general, a p-value measures how unusual data at least as inconsistent with a null hypothesis would be if that null model and the test’s assumptions were correct. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. The posted value is unadjusted, and the record does not report the test procedure or a multiplicity adjustment. It should be interpreted alongside the estimate and confidence interval, rather than alone.

The primary group standard deviations are 0.47 for CCT and 0.12 for HCE. Unequal spreads can matter because some methods assume similar variability across groups, while other methods allow for it. The registry does not identify the method used to calculate the comparison or whether the analysis addressed unequal variance. No specific test or model should therefore be inferred from the posted summaries.

How should a standardized effect be read?

A standardized mean difference expresses a contrast in standard-deviation units, making effects measured on different scales easier to compare in general. The registry’s derived standardized effect for the primary outcome is -0.352, using the HCE-minus-CCT direction. That quantity is not in the original score units and does not replace the raw mean difference. Standardization depends on the variability used in its denominator; the registry gives a pooled standard deviation of 0.341 for this comparison. The record does not identify a clinical threshold for interpreting this standardized value.

Some summary-statistic calculations can be reconstructed from group means, standard deviations, and sample sizes, but such calculations are unadjusted and cannot reproduce an analysis that accounts for design features or covariates. The registry does not report covariate-adjusted results, a model specification, or a detailed analysis plan. The posted comparison should therefore be read as the available summary-level result, not as evidence of a particular regression or repeated-measures approach.

Why does over-dispersion matter?

General statistical context: over-dispersion occurs when the observed variability is greater than a model assumes. If a method assumes less variation than is present, its uncertainty estimates can be too small and its confidence intervals too narrow. For continuous outcomes, attention to the observed spread and to the method’s variance assumptions is important. The record does not label these data as over-dispersed, and the posted means and standard deviations alone do not establish that over-dispersion occurred. This is a general consideration, not a finding about this trial.

The secondary WHODAS 2.0 endpoint is also continuous and is summarized by group mean change and standard deviation. Its comparison is likewise a difference in group means. The result is unadjusted, and no separate inferential procedure is reported. The same general cautions apply: the estimate describes the observed contrast, the interval describes uncertainty, and the p-value does not indicate the probability that a treatment effect exists.

In general, sound interpretation combines the scale’s direction, the estimate’s sign, the interval’s width and relation to zero, the variability of the observations, and the design and analysis details. In this record, the outcome direction and summary statistics are described, but important analytic details are not reported. That limits evaluation of assumptions and means that the numerical summaries should not be taken as a full account of the trial’s statistical analysis.

11. Confidence Intervals and Precision

The primary mean difference is -0.12, comparing HCE with CCT. Its confidence interval extends across zero. This means the posted estimate is not highly precise in the sense of locating the contrast entirely on one side of no difference: values compatible with the data include no difference and possible differences in either direction. The interval is the key complement to the point estimate because it conveys uncertainty that a single number cannot.

The group means are 0.26 for CCT and 0.14 for HCE, with standard deviations of 0.47 and 0.12, respectively. The spread of individual observations is relevant to precision: greater variability generally makes a group mean less precisely estimated when sample size is held constant. General statistical context: a confidence interval’s width reflects both the amount of information and the variability assumed or observed under the method. The registry does not state the interval-construction method, so its precise assumptions cannot be evaluated from the record alone.

The primary unadjusted p-value is 0.122. It does not summarize precision as fully as the confidence interval and should not be used as a substitute for the range of plausible contrasts. In particular, an interval containing zero does not prove the absence of a difference. The posted comparison leaves uncertainty about both the size and direction of the underlying contrast.

The WHODAS 2.0 comparison also has a confidence interval that includes zero. Its estimate and p-value likewise should be read with the interval rather than as a definitive answer. For both outcomes, the record does not report a minimum clinically important difference or another threshold that would determine whether a particular contrast is meaningful to participants. Statistical compatibility with a range of effects is not the same as evidence that all those effects would be important in practice.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations based on the observed effect, not the trial’s original design assumptions. For this continuous-outcome comparison, the figures are participants per arm, not a total number of events. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The scenarios use the full observed effect and smaller fractions of that effect. The registry’s original sample-size rationale and assumptions are not reported.

Each 80% power entry is the planned number of participants per arm under the stated assumptions for an 80% chance of detecting the specified effect if that effect were truly present. Each 90% power entry is the corresponding number per arm for a 90% chance. These are design targets for hypothetical future studies, not probabilities that the result of this completed trial is correct. They also do not show the probability that this trial found an effect.

The rows for 100%, 75%, and 50% of the observed effect ask how many participants per arm would be needed to detect effects of those relative sizes under the same assumptions. Smaller effects require more participants because they are harder to distinguish from random variation. For example, the primary endpoint’s planning figures rise as the assumed effect is reduced from the full observed estimate to smaller fractions. The secondary endpoint has its own planning figures based on its observed contrast; those estimates are especially large relative to the observed study groups.

These calculations are not observed power. Observed power is not a useful replacement for reading the estimate and its uncertainty after a trial is complete. The planning numbers are sensitive to the effect chosen as the target, and the observed effect itself is uncertain. They should be treated as illustrations of how assumptions affect sample-size requirements, not as a recommendation or a reconstruction of the completed study’s design process.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.120; pooled standard deviation σ = 0.341.
2. n = 2 × (1.96 + 0.842)² × 0.341² / -0.120² = 126.8, rounded up to 127 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.12                      # observed difference in means
sigma <- 0.341041186528975                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2657954)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 127 (80% power), 170 (90% power)
 75% of observed effect: n per arm = 226 (80% power), 302 (90% power)
 50% of observed effect: n per arm = 508 (80% power), 679 (90% power)
power.t.test: 127.8 
Simulated power at n = 127 per arm: 0.796 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when researchers examine several outcomes, time points, subgroups, or statistical comparisons. In general, the more opportunities there are to identify an unusual result, the greater the chance that at least one result may appear noteworthy by chance. Researchers may control this through prespecified primary outcomes, ordered testing, or statistical adjustments. The registry record does not report whether such a plan was set out or used. The posted p-values are unadjusted, so they should not be interpreted as multiplicity-controlled evidence across the study’s outcomes.

The registry lists three outcome measures, while one secondary outcome is posted. The number of analyses is recorded as zero, and the secondary outcome has no reported analyses. The record does include descriptive summaries and comparisons for the primary and posted secondary results, but it does not explain the relationship between those summaries and a formal trial analysis plan. Details of any additional outcomes or analyses are not reported in the registry record.

The primary population is described as participants who completed a baseline assessment and is labeled the intent-to-treat sample. The group summaries include 39 participants for CCT and 40 for HCE. The record does not provide a participant-flow diagram or an account of how many randomized participants lacked baseline or follow-up measurements. It also does not state whether missing values occurred, how they were handled, whether imputation was used, or whether sensitivity analyses were conducted. Those details are not reported in the registry record.

Intent-to-treat commonly refers, as a general principle, to analyzing participants according to their randomized assignment, regardless of adherence. Here, the registry’s own description specifies participants who completed a baseline assessment. Without further information, it is not possible to determine whether all randomized participants were included in the posted summaries or how the stated population definition was implemented. No assumptions about attrition or missingness should be made from the available group counts alone.

The record also does not report the prespecified analysis method, covariates, handling of repeated measurements, or any interim-analysis plan. These omissions do not erase the descriptive results, but they restrict assessment of selection, assumptions, and the degree to which the posted comparisons follow a prospectively defined analysis. Access to the study protocol, analysis plan, and participant-flow details would be needed to address these questions.

15. 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 lists serious adverse events, other adverse events, and deaths separately for the two groups. For CCT, 39 participants were listed as at risk for serious adverse events and none were recorded as affected; 39 were at risk for other adverse events and none were recorded as affected. For HCE, 40 were listed as at risk for serious adverse events and none were recorded as affected; 40 were at risk for other adverse events and none were recorded as affected. Deaths were recorded as zero in both groups.

These figures describe the adverse-event entries in the registry. They do not establish that no untoward events of any kind occurred: the record may reflect the specific event definitions, collection methods, reporting period, and reporting completeness used in the trial. The registry lists no top serious-event terms. Further details about event definitions, ascertainment procedures, timing, severity, or causal assessment are not reported in the registry record.

Zero recorded events in these groups should therefore be read as a report of the posted counts, not as proof of absence of risk or a comparison demonstrating that one intervention is safer. The group counts are also limited in size, and no inferential safety analysis is reported.

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

The result does show a numerical difference in the posted mean changes: the primary outcome mean was 0.26 for CCT and 0.14 for HCE, and the HCE-minus-CCT contrast was -0.12. Since higher change is better for this measure, the direction of the point estimate is toward a higher average change in CCT. The confidence interval includes zero, however, and the unadjusted p-value is 0.122. The estimate is uncertain and does not establish a clear difference between groups.

This does not mean the groups have been shown to be identical. A result with an interval that includes zero can still be compatible with differences on either side of zero. Nor does the numerical direction alone establish a clinically important effect. The registry does not give a threshold for a meaningful difference on the primary score, and the record does not provide a detailed analysis plan with which to evaluate all assumptions.

The findings also do not establish whether cognitive change led to changes in disability, homelessness, reintegration, or quality of life. The registry describes those as broader interests or anticipated outcomes, while the posted secondary result concerns WHODAS 2.0 change. Outcomes are related conceptually but cannot be substituted for one another. The reported follow-up is baseline to 15 weeks; longer-term effects are not reported in the registry record.

Similarly, the adverse-event counts are a summary of recorded events, not a guarantee of safety. They do not support a safety comparison beyond the counts reported. The record’s limited event details and sample size mean that uncommon events or longer-term safety cannot be assessed from these figures alone.

The most defensible reading is therefore narrow: the registry posts a modestly higher average primary change for CCT than for HCE, but the comparative estimate remains imprecise and compatible with no difference. The secondary comparison does not resolve that uncertainty. The data do not justify a broad conclusion about effectiveness, clinical importance, long-term benefit, or overall safety.

17. Why This Trial Matters Statistically

This study raises a statistical question that is important in rehabilitation research: how to distinguish a potentially meaningful change in a complex cognitive measure from variability in individual performance. A randomized comparison helps organize that question by setting the intervention against an active education control. The parallel-group design and posted group summaries make the main contrast interpretable in terms of average change, while the confidence interval makes its uncertainty visible.

The endpoint’s direction requires careful attention. Lower Global Deficit Scores indicate better status at a single assessment, but higher change scores are better. Confusing the level with the change direction could reverse the interpretation of the mean difference. The sign convention also depends on the comparison order, which is HCE relative to CCT. A clear account of scale direction and contrast direction is essential for reading the result correctly.

The record also illustrates why a point estimate, p-value, and confidence interval answer different questions. The mean difference describes the estimated contrast; the p-value summarizes compatibility with a null model under a specified test; and the interval conveys a range of plausible contrasts under the method used. Considered together, they show a numerical direction but considerable uncertainty. A threshold-based reading of the p-value alone would miss that distinction.

Finally, planning illustrations derived from an observed effect demonstrate how assumptions about effect size and target power can affect hypothetical sample requirements. They are not a substitute for a prospectively justified sample size, and they are not observed power. Since the original sample-size rationale and analysis plan are not reported, the registry supports a careful reading of posted outcomes but not a complete audit of design decisions.

18. 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 are specific to what is reported for this trial. Enrollment was 79, with posted outcome summaries based on 39 CCT participants and 40 HCE participants. These group sizes limit the precision available for estimating differences, particularly when outcomes vary among participants. The primary standard deviations are notably different in size, while the registry does not describe the analytic method or its assumptions about variance.

The target population is narrow: homeless, treatment-seeking OEF/OIF/OND Veterans. Findings from this group cannot automatically be generalized to other Veterans, people experiencing homelessness in other circumstances, or populations with different service and treatment contexts. The registry’s rationale specifically emphasizes this group’s circumstances, which also makes population definition important to interpretation.

The outcome timeframe is baseline to 15 weeks. The record does not post longer-term results, so persistence of any measured change cannot be evaluated. The primary composite draws on several cognitive tests, but component-level results and details of score construction are not reported. It is therefore not possible to identify which test domains may have contributed to the group averages.

The record describes the trial as single-masked but does not state who was masked. It also does not report allocation procedures, adherence, treatment exposure, participant flow, missing-data handling, or the original sample-size justification. These missing details limit assessment of potential bias and the relationship between the stated intent-to-treat population and the posted outcome counts. The number and status of other planned outcomes or analyses are also not fully explained.

Finally, the disability outcome is secondary, and the record does not give a multiplicity strategy or clinically meaningful thresholds for either measure. The unadjusted comparisons should be interpreted with these constraints in mind. These are reporting limitations; they do not, by themselves, demonstrate that the trial was conducted improperly.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: ASPIRE Cognitive Enhancement Study — NCT02657954.
• Registry record last updated 2024-01-09; status last verified 2023-02.
• Results first posted 2023-12-12.
• 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.

22. Record Summary

NCT02657954 is the completed ASPIRE Cognitive Enhancement Study, titled Cognitive Rehabilitation for Homeless OEF/OIF/OND Veterans in the registry. It was a randomized, single-masked, parallel-group study sponsored by the VA Office of Research and Development, with enrollment of 79. CCT was compared with HCE.

The primary outcome was change in Global Deficit Score from baseline to 15 weeks. The posted mean changes were 0.26 for CCT and 0.14 for HCE; the HCE-minus-CCT mean difference was -0.12, with an unadjusted p-value of 0.122 and a confidence interval that includes zero. The secondary posted outcome was WHODAS 2.0 change, also with an interval including zero.

The registry does not report the detailed statistical plan, missing-data methods, multiplicity approach, or original sample-size justification. The posted results support a cautious description of the observed contrasts, not a definitive claim about benefit, equivalence, long-term outcomes, or safety.