Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury (NCT00451282), a randomized phase 3 study. The primary outcome is PTSD Symptoms in Children 6 Weeks Post-injury.

2. Clinical Question

The study was intended to evaluate whether a brief psychosocial intervention could support psychological recovery and functional outcomes after injury, and to provide preliminary cost-effectiveness data. The primary posted outcome is a continuous symptom-severity measure, not a count of children diagnosed with PTSD. The registry record does not report a diagnostic-status result for the primary comparison.

3. Trial Design

The registry identifies this as a phase 3, randomized, single-masked, parallel-group study sponsored by Children's Hospital of Philadelphia. The listed enrollment is 290. The primary outcome description separately states that 85 children were randomly assigned to the usual-care or intervention groups. The record does not explain the relationship between the enrollment figure and the population described for the primary outcome, so they should not be treated as interchangeable counts.

The study began in 2007-04, had primary completion in 2009-06, and is listed as completed. The condition recorded is posttraumatic stress disorders. Participants were children or adolescents hospitalized for an unintentional injury. One group received stepped preventive care, while the comparison group received medical and psychosocial care according to usual hospital protocols.

The intervention was designed as a stepped approach rather than a uniform package of additional treatment: it included at least 2 brief assessments, with further intervention as needed and guided by a manual. Usual care could include social work support. The registry does not report the masking role, so the meaning of single masking cannot be specified further. The allocation method beyond its randomized designation, the detailed randomization procedure, and any stratification factors are not reported in the registry record.

For the primary outcome, the randomized groups included 39 usual-care subjects and 46 intervention subjects; five assigned to intervention did not go on to receive it. Six-week follow-up results are reported for 28 usual-care subjects and 36 intervention subjects. These are the outcome-specific analysis counts, not a description of all study follow-up or of an intention-to-treat analysis. The record does not state how participants with missing follow-up measurements were handled.

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.

Before assignment: 290 children were enrolled for risk screening, of these 85 (29%) scored positive on one or more screening measures for PTSD and were randomly assigned to receive usual care or the intervention (n=39 and n=46 respectively). 5 intervention subjects did not end up receiving the allocated intervention.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.

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 PTSD Symptoms in Children 6 Weeks Post-injury, measured over 6 weeks.

The primary endpoint is PTSD symptoms in children at 6 weeks after injury, measured in units on a scale and reported as a mean with standard deviation. The instrument is the Child PTSD Symptom Scale. Its 24 items yield a continuous severity score as well as a determination of likely PTSD diagnostic status based on symptom presence. The registry’s primary result is the continuous score comparison.

Seventeen symptom items correspond to DSM-IV symptom criteria and are described as yielding a severity-score range of 0-51; seven additional items assess impairment from symptoms. At baseline, before randomization, the 17 symptom items were administered. A score of 15 or greater was considered a positive screen for PTSD risk. The registry says higher values represent more significant severity of and impairment from PTSD symptoms.

The full 24-item scale was administered at 6 weeks and 6 months after injury to assess traumatic-stress symptom outcomes. A continuous score is useful for comparing average symptom burden across groups without reducing the result to a positive or negative screening category. However, a group mean does not show how individual children’s scores were distributed, how many crossed the screening threshold, or how many met diagnostic criteria. The record does not report those details for the primary outcome.

7. Results Posted in the Registry

• Intervention: mean 12.60 versus 13.60 on control; difference -1.00 (95% CI -6.18 to 4.18), standardized effect d = -0.10; z-test p = 0.705.

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.

Depression Symptoms in Children 6 Wks Post-injury

• 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:
  • Intervention: mean 15.00 versus 14.00 on control; difference 1.00 (95% CI -4.31 to 6.31), standardized effect d = 0.09; z-test p = 0.712.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Depression Symptoms in Children 6 Mos Post-injury

• 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:
  • Intervention: mean 15.60 versus 11.60 on control; difference 4.00 (95% CI -1.65 to 9.65), standardized effect d = 0.33; z-test p = 0.165.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary outcome areas that include depression symptoms, health-related quality of life, adherence to medical discharge instructions, and health-service use. Numerical summaries available for depression cover 6 weeks and 6 months after injury. At both time points, the intervention-group mean is higher than the usual-care mean, whereas the primary PTSD point estimate is lower in the intervention group. The direction of these descriptive differences is therefore not uniform across the outcomes with numerical results. The direction of the depression scale’s score interpretation is not stated, so a higher mean should not be labeled as better or worse.

Results for the other listed secondary outcome areas, including quality of life, discharge-instruction adherence, and health-service utilization, are not reported in the registry record. Their inclusion as outcome areas does not establish that a difference was found. The secondary information therefore does not support a single overall account of how the intervention affected all dimensions of recovery.

Secondary findings generally carry less weight than a prespecified primary result when many outcomes or analyses are examined without adjustment. Each additional comparison creates more opportunity for an apparently notable result to arise by chance. The record reports unadjusted secondary p-values and does not describe a multiplicity correction or a hierarchy governing interpretation. These p-values should consequently be treated as exploratory rather than as independent confirmation of efficacy. The secondary outcomes can help identify questions for further study, but they do not replace the primary comparison or resolve its uncertainty.

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

• Depression Symptoms in Children 6 Wks Post-injury
• Depression Symptoms in Children 6 Mos Post-injury
• Health-related Quality of Life 6 Weeks and 6 Months Post-injury
• Adherence With Medical Discharge Instructions
• Health Service Utilization Over the 6 Months Post-injury

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, so the principal summary is a mean for each group, accompanied by a standard deviation. A mean describes the average scale score, while a standard deviation describes how spread out scores are around that average. These summaries do not reveal the full score distribution: groups with similar means can still differ in the shape or spread of their scores, and means do not identify individual outcomes.

What does the mean difference represent?

The comparison is expressed as intervention minus usual care. The recalculated estimate is -1.0, based on means of 12.6 and 13.6, respectively. The sign indicates direction: a negative value means the intervention-group mean is lower. Since higher CPSS values are described as more severe symptoms and impairment, the direction of the point estimate is toward a lower average score in the intervention group. The estimate is not an adjusted model result; it is an unadjusted comparison reconstructed from the posted group summaries.

What does the interval add?

An interval estimate communicates uncertainty around an estimated group difference. In general, a wider interval indicates less precision, while an interval spanning zero leaves open the possibility of no mean difference as well as differences in either direction. The recalculated bounds are -6.178 and 4.178. The confidence level associated with these bounds is not reported in the registry record, so it should not be assigned a level based on assumption. The interval is not a range containing every individual participant’s score; it concerns uncertainty about the group mean difference.

How should the p-values be read?

A p-value describes how compatible the observed data are with a specified null model, under the assumptions of the test. It is not the probability that the null hypothesis is true, nor is it a measure of clinical importance. The registry reports a two-sided t-test with p=.69. The unadjusted recalculation from posted summary statistics gives p=0.705. A two-sided test considers departures in either direction. The registry does not report the original trial’s prespecified significance threshold or a fuller statistical analysis plan, so the p-values should not be used to claim that a particular protocol-defined decision rule was met.

Why can summary-statistic recalculation differ?

A recalculation uses the reported group sizes, means, and standard deviations to form a simple unadjusted comparison. It does not reproduce any analysis that might have used participant-level data, covariate adjustment, a different missing-data method, or other details not included in the record. The registry’s discrepancy flag is false. That does not make the recalculation identical to the sponsor’s test: their reported p-values are .69 and 0.705. The sponsor-reported test remains the study’s own reported analysis, while the recalculation is a transparent summary-based check.

In general, over-dispersion matters when the variability in data is greater than a statistical model assumes. If variability is understated, standard errors can be too small and intervals too narrow; if it is modeled appropriately, uncertainty better reflects the observed spread. The primary outcome is a continuous scale score summarized with standard deviations, and no over-dispersion model is reported for this endpoint. The concept is therefore general context, not a claim that over-dispersion was detected or addressed in this trial.

What does randomization contribute?

Random allocation is intended to create groups that are comparable on average at the start of a trial, including for characteristics not measured by investigators. It does not guarantee identical groups, particularly in a small outcome sample. The record does not provide baseline group summaries for this endpoint or describe the randomization sequence and allocation concealment. The randomized assignment counts and the counts with six-week outcome data are reported, but the analysis population and missing-data procedures are not specified.

Assignment to the intervention and receipt of the intervention are distinct. The primary outcome description says five people assigned to intervention did not go on to receive it. The record does not report whether the primary analysis followed assigned groups regardless of receipt, included only those who received intervention, or used another approach. This distinction can affect what a group comparison estimates. Without the analysis-population definition, the result should not be labeled an intention-to-treat or per-protocol estimate.

The registry also reports multiple outcome areas and more than one analysis, but a complete account of model specifications, covariate adjustment, missing-data handling, and multiplicity control is not reported in the registry record. General statistical principles can explain why these details matter, but they cannot fill in the trial’s unreported methods.

11. Confidence Intervals and Precision

The recalculated mean difference is -1.0 scale units, with bounds from -6.178 to 4.178. The interval spans zero, so the data are compatible with no mean difference as well as with a lower or higher mean in the intervention group. The point estimate alone should not be read as a precise measurement of the intervention’s effect.

Precision depends in part on the amount of information available and the variability of the outcome. For the six-week comparison, the reported standard deviations are 10.2 in the intervention group and 10.7 in usual care, while the outcome counts are 36 and 28. The relatively broad interval reflects that the estimated difference is uncertain in relation to the observed spread. It does not mean that individual scores fall within the interval; the interval concerns the group-level difference.

The registry does not state the confidence level associated with the posted bounds. The recalculated interval should therefore be read by its stated endpoints, without adding an unreported confidence percentage. The same caution applies to interpretation of precision more generally: an interval describes sampling uncertainty under its method and assumptions, not all sources of uncertainty in a trial. Missing follow-up outcomes, unreported analysis choices, and limits in the registry description are additional considerations that the interval does not account for unless incorporated in its method.

Because the interval includes differences in both directions, the results do not establish that the groups are equivalent. Equivalence requires a prespecified range of differences considered acceptably small and an analysis designed to assess that question. Neither is reported in the registry record. The interval is best understood as showing substantial uncertainty about the size and direction of the mean difference.

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 for this continuous outcome are participants per arm, not total events. Their assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to a stated fraction of the observed effect. These are planning illustrations based on the observed effect, not a description of the trial’s original design assumptions; those original assumptions are not reported in the registry record.

The 80% power column represents the planned number of participants per arm under which a study would have an 80% chance of detecting the specified effect, if the planning assumptions and effect were correct. The 90% column represents a higher target probability of detecting that effect, under the same assumptions. These are design concepts, not guarantees about what a future study will find. In this case, the observed mean difference is modest relative to the spread of scores, so the planning figures are sensitive to the effect size chosen.

Rows for planning for 100%, 75%, or 50% of the observed effect illustrate how the assumed effect changes the required sample. A smaller effect is harder to distinguish from random variation and therefore requires more participants per arm to attain the same target power. The figures are not observed power, and they do not explain the enrollment or sample-size decisions in the completed trial. They are conditional illustrations using the listed assumptions, not evidence that the study had a particular probability of success after its results were observed.

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 = -1.000; pooled standard deviation σ = 10.421.
2. n = 2 × (1.96 + 0.842)² × 10.421² / -1.000² = 1,704.6, rounded up to 1,705 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 <- -1                      # observed difference in means
sigma <- 10.4206912655357                     # 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(451282)
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 = 1,705 (80% power), 2,283 (90% power)
 75% of observed effect: n per arm = 3,031 (80% power), 4,057 (90% power)
 50% of observed effect: n per arm = 6,819 (80% power), 9,129 (90% power)
power.t.test: 1705.6 
Simulated power at n = 1,705 per arm: 0.801 (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. Analyses Reported by the Sponsor

The registry reports the sponsor’s own primary comparison as a two-sided t-test with p=.69. The recalculation from the posted group means, standard deviations, and outcome counts gives an unadjusted mean difference of -1.0 and p=0.705. The interval from the recalculation runs from -6.178 to 4.178. The recalculation is a simple summary-statistic analysis and should not be mistaken for a reconstruction of any analysis that used participant-level data or additional adjustments.

The registry’s discrepancy flag is false. The reported p-values are not identical, but both describe little evidence of a clear group difference in this comparison; the recalculated interval also includes zero. The record does not explain why the rounded sponsor-reported p-value differs from the recalculation. No adjustment or alternative analysis can be attributed to the sponsor without further details.

Where a genuine discrepancy is identified, the sponsor’s own analysis takes precedence as the trial-reported analysis. Here, the record does not flag a discrepancy, and the two results have a similar broad interpretation. Both should be kept distinct: the sponsor result is the analysis reported by the registry, while the recalculated result is an unadjusted check based on the posted summary statistics.

15. Multiplicity, Missing Data and Analysis Populations

The registry describes a primary PTSD-symptom outcome and several secondary outcome areas. It also records multiple analyses. When investigators assess more than one outcome or conduct multiple analyses, the chance of observing at least one apparently unusual result can increase. Statistical procedures such as a prespecified testing hierarchy or multiplicity adjustment can address that issue, but the registry record does not report whether either was used.

The study’s original statistical analysis plan, including the intended handling of multiple outcomes and analyses, is not reported in the registry record. The available descriptions do not establish which secondary analyses were prespecified, whether any were exploratory, or whether the sponsor adjusted p-values for multiple comparisons. Accordingly, the secondary p-values should be read individually and cautiously, not as a collection of independently confirmatory tests.

Missing outcome data also affect interpretation. For the primary six-week result, the endpoint description reports 28 usual-care subjects and 36 intervention subjects with follow-up, while the randomized groups are described as 39 and 46, respectively. The record does not state why follow-up data were absent, whether missingness differed by participant characteristics, or how missing values were handled. It does not report imputation, weighting, sensitivity analyses, or a comparison of participants with and without follow-up data. The extent to which missingness could influence the group comparison therefore cannot be assessed from this description.

The record also does not define the primary analysis population. It notes that five assigned to intervention did not go on to receive the intervention, but does not say how those participants were treated in the primary analysis. An analysis based on assignment, an analysis based on treatment received, and other approaches answer different questions. It would be inappropriate to assume that the reported results follow an intention-to-treat approach or any other specific population rule.

These omissions do not show that a particular method was absent from the conduct of the study; they mean the method is not reported in the registry record. They limit the ability to assess robustness, reproduce the sponsor’s analysis, and distinguish confirmatory findings from exploratory ones.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

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 0 serious adverse events in the intervention group, with 46 at risk, and 0 in usual care, with 39 at risk. It also lists 0 other adverse events in each group, using the same respective at-risk counts. No serious adverse-event terms are listed.

These figures describe what is recorded in the registry, not proof that no adverse events occurred or that no safety concerns are possible. The record does not provide event definitions, a narrative of event ascertainment, or further details about the observation period for these summaries. Death counts are not reported in the registry record. The figures should therefore be read as registry-reported event counts, not as a complete evaluation of safety or as a basis for comparing risk beyond the information recorded.

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

The posted primary result describes average CPSS scores among participants with six-week outcome data. The intervention-group mean was 12.6 and the usual-care mean was 13.6. The unadjusted recalculation estimates a difference of -1.0 scale units, with an interval from -6.178 to 4.178. This is a modest point estimate accompanied by considerable uncertainty about the direction and size of the group difference.

The result does not establish that stepped preventive care reduced PTSD symptoms, and it does not establish that it had no effect. The interval includes zero and allows values on either side. The result also does not demonstrate equivalence between the groups, because no equivalence margin or equivalence analysis is reported. A non-significant or uncertain comparison is not the same as evidence that two approaches produce identical outcomes.

The mean comparison does not indicate how many children screened positive, met criteria for likely PTSD diagnostic status, improved, worsened, or experienced a meaningful change. Although the CPSS description refers to screening and diagnostic-status information, the primary posted result is a mean score. Results for those other interpretations are not reported in the registry record.

The comparison also does not answer whether the intervention changed depression, quality of life, adherence, follow-up attendance, emergency department use, rehospitalization, or costs. These were part of the study’s stated questions, but the relevant numerical results are not all reported in the outcome information. Nor does a group average specify what any individual participant should expect. The study result is not medical advice and should not be used alone to make decisions about care.

In short, the record provides a randomized comparison with a small observed difference in the primary outcome mean, but limited precision and incomplete reporting of analysis details. The finding is best treated as an uncertain estimate for this specific six-week scale outcome, rather than a definitive statement about the intervention’s overall effects.

18. Why This Trial Matters Statistically

This trial illustrates why effect estimates and their uncertainty matter more than a binary reading of a p-value. The observed difference in mean symptom scores is modest, while the interval spans zero and differences in either direction. Reporting only a test result could obscure how much uncertainty remains about the magnitude of the group contrast.

It also demonstrates the importance of keeping outcome populations distinct. The record reports 85 randomized children in the primary outcome description, but fewer completed the six-week assessment. Enrollment is listed as 290. Those figures refer to different descriptions in the record, and the available information does not explain their relationship. Clear reporting of participant flow and analysis populations is essential for understanding who contributes to an outcome estimate.

The distinction between assignment and treatment receipt is relevant as well. Five assigned to the intervention did not go on to receive it, while the analysis population definition is not stated. That detail matters because a randomized assignment comparison and a comparison among those who received treatment can answer different questions.

Finally, the record lists multiple outcomes, while several outcome results and analysis details are not reported. The example underscores why multiplicity, missing data, and prespecified analysis methods matter when interpreting clinical trials. Statistical conclusions depend not only on the point estimate but also on precision, who was analyzed, how outcomes were selected, and how many comparisons were made. Transparent reporting allows readers to distinguish what the data show from what remains uncertain.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry description leaves important trial details unavailable. Although the study is labeled single-masked, the masked party or parties are not identified. The randomization sequence, allocation concealment, stratification, and baseline comparability for the primary outcome are not reported in the registry record. The detailed original statistical plan, including a prespecified significance threshold and model specifications, is also not reported.

The relationship between the listed enrollment of 290 and the 85 randomized children described for the primary outcome is not explained. The primary outcome follow-up counts are smaller than the randomized group counts, but reasons for missing outcomes and methods for handling missing data are not reported. The record notes that five assigned to intervention did not receive it, without defining how this was handled in the primary analysis. These gaps constrain assessment of attrition and analysis-population bias.

The primary result is a group mean and standard deviation. The registry does not provide individual score distributions, a group comparison for likely PTSD diagnostic status, or a measure of clinically meaningful change. The confidence level for the recalculated interval is not stated in the outcome details. The result therefore supports a summary comparison but not a detailed assessment of individual response or diagnostic outcomes.

Only some secondary outcome results have numerical summaries in the information analyzed. Results for quality of life, adherence, and health-service utilization are not reported in the registry record, and the approach to multiplicity is not specified. Adverse-event entries list no events but do not provide details of ascertainment or event definitions. These reporting limitations do not establish that the study lacked such procedures; they limit what can be concluded from the registry record.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury — NCT00451282.
• Registry record last updated 2015-04-20; status last verified 2015-04.
• Results first posted 2015-04-20.
• 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.

23. Record Summary

NCT00451282 is a completed, phase 3, randomized, single-masked, parallel-group study sponsored by Children's Hospital of Philadelphia. It compared stepped preventive care with usual care for children or adolescents hospitalized after unintentional injury. The listed enrollment is 290, while the primary outcome description reports 85 children randomly assigned and six-week follow-up results for 28 usual-care and 36 intervention subjects.

The primary outcome was mean CPSS symptom severity at 6 weeks. The intervention mean was 12.6 and the usual-care mean was 13.6. The unadjusted recalculated mean difference was -1.0, with interval bounds of -6.178 and 4.178; the sponsor-reported two-sided t-test p-value was .69. The record lists secondary outcomes in depression, quality of life, adherence, and health-service use, but numerical results are not reported for all listed areas. Serious and other adverse-event counts are recorded as 0 in each group; deaths are not reported in the registry record.