Motivational Interviewing to Enhance Behavioral Change in Older Adults With Hoarding Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Motivational Interviewing to Enhance Behavioral Change in Older Adults With Hoarding Disorder (NCT05237466), a randomized na study. The primary outcome is Frequency of Sorting/Discarding Behavior.

2. Clinical Question

The study is a randomized, parallel-group comparison of two behavioral approaches. Its primary endpoint is not a direct measure of hoarding symptoms: it records participants’ reported sorting/discarding activity between treatment sessions. The posted summaries give group means and standard deviations, while the sponsor’s reported primary analysis uses a mixed-model slope. Those summaries address related aspects of behavior over the treatment period, but they are not the same statistical quantity.

The registry record identifies the primary outcome timeframe as four months and says the weekly reports were assessed at sessions 2-16. It does not report additional detail about participant eligibility, the recruitment setting, or the exact operational definition of a sorting day beyond the description of the outcome. These gaps limit how specifically the question can be generalized beyond the population and intervention descriptions in the record.

3. Trial Design

The registry describes a randomized, single-masked, parallel-group trial with behavioral interventions in both groups. The listed interventions are RECLAIM: Reducing Clutter and Increasing Meaning, which combines motivational interviewing and sorting practice, and Sorting Practice alone. The trial status is completed. The registry lists enrollment as 48, but the outcome summaries report 18 participants in each group for the primary measure. These figures describe different registry fields and should not be treated as interchangeable: the record does not explain the difference between the enrollment field and the analysis counts.

The primary outcome was assessed over four months. Participants were asked at weekly treatment sessions to report the frequency of sorting or discarding in the previous week, with data assessed at sessions 2-16. The registry says mixed-effects models included participants with at least one timepoint. It does not give the number of observations per participant, the distribution of missing timepoints, or a detailed account of how the model handled incomplete follow-up.

The trial’s listed condition is hoarding disorder, and the study description identifies older adults. The phase field is recorded as NA. The masking field is single, but the registry record does not identify who was masked or describe how masking was maintained. Additional details about the randomization procedure, allocation concealment, treatment delivery, adherence, or protocol deviations are not reported in the registry record.

The record lists the study start as 2022-06-01 and primary completion as 2025-12-10. It also lists seven outcome measures and seven analyses, while two secondary outcomes are posted in the available results. Those counts alone do not establish which outcomes or analyses were prespecified, whether all planned analyses were reported, or whether any analyses changed during the study.

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: 12 participants dropped from the study between enrollment and randomization.

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 Frequency of Sorting/Discarding Behavior, measured over Four months.

The primary endpoint is Frequency of Sorting/Discarding Behavior, expressed as the percent of days sorted between sessions over four months. Participants reported at weekly treatment sessions how often they had sorted or discarded items in the previous week. The registry describes this measure as a behavioral indicator of motivation to engage in sorting and discarding. It therefore captures reported activity rather than a direct clinical rating of hoarding symptoms or a broader measure of functioning.

Measuring behavior between sessions can describe whether participants are engaging in the activity targeted by treatment outside the session itself. It also creates repeated observations across the treatment period, rather than relying on a single report at the end. The registry says the measure was assessed at sessions 2-16 and analyzed with mixed-effects models, including participants with at least one timepoint. Mixed-effects models are generally useful for repeated measurements because they can represent the pattern across observations while accounting for the fact that measurements from the same person are related. That general explanation does not establish the exact model specification used in this trial.

The endpoint depends on participants’ reports of activity in the preceding week. The registry record does not report a method for verifying those reports or further detail about the coding of days with sorting or discarding. Interpretation should therefore stay close to the stated outcome: reported frequency of sorting/discarding behavior between sessions, not proof of symptom change or treatment benefit.

7. Results Posted in the Registry

• Sorting Practice: mean 29.10 versus 38.60 on control; difference -9.50 (95% CI -29.69 to 10.69), standardized effect d = -0.31; z-test p = 0.356.

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.

Treatment Acceptability/ Adherence Scale

• 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:
  • Sorting Practice: mean 55.00 versus 55.00 on control; difference 0.00 (95% CI -5.47 to 5.47), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sorting Practice and the control. The interval gives the range of effects that remain compatible with the data.

Saving Inventory-Revised

• 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:
  • Sorting Practice: mean 36.00 versus 33.00 on control; difference 3.00 (95% CI -4.39 to 10.39), standardized effect d = 0.27; z-test p = 0.426.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sorting Practice and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes provide additional context, but they do not form a uniform replication of the primary endpoint. One concerns treatment acceptability/adherence after session 1; the other is a measure of saving-related symptoms at four months. These outcomes differ in what they measure and when they are assessed. Their results therefore should not be treated as interchangeable with the primary measure of reported sorting/discarding behavior.

Across the posted secondary analyses, the results do not show a clear, consistent pattern of separation between the interventions. That broad pattern is compatible with the uncertainty in the primary comparison, but it does not establish that the interventions are the same. A secondary outcome can add useful information about a different aspect of treatment, while still leaving the primary question unresolved.

The registry lists seven outcome measures and seven analyses, but only two secondary outcomes are represented in the posted secondary results. The record does not explain whether the remaining listed measures were analyzed, whether all analyses were prespecified, or whether any results were not posted. It also does not report a multiplicity adjustment. When several outcomes or analyses are considered, unadjusted results carry less weight as confirmatory evidence because the chance of finding a seemingly notable result across many tests can increase. This is a general statistical concern, not evidence that a particular adjustment was required or performed.

Accordingly, the secondary findings are best read as supportive descriptive context rather than as independent proof of a treatment effect. Their different measurement timing and content, along with the unreported multiplicity plan, limit how strongly they can be combined with the primary analysis.

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

• Treatment Acceptability/ Adherence Scale
• Saving Inventory-Revised

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous: it is reported as a mean percentage of days sorted, with a standard deviation for each group. A mean describes the average outcome in a group, while a standard deviation describes how spread out individual measurements are around that mean. In the primary results, the group means are 38.6 and 29.1, and the standard deviations are 39.2 and 19.3. The large spread relative to the group means is a reminder that participants’ reported behavior varied; the group average does not describe every participant’s experience.

What does the simple mean difference represent?

The recalculated comparison subtracts the RECLAIM mean from the Sorting Practice mean, yielding -9.5. This is a simple, unadjusted contrast of the posted group means. It does not account for repeated observations, baseline values, or any covariates. The confidence interval for this contrast runs from -29.69 to 10.69, and the unadjusted p-value is 0.356. This re-calculation is useful as a transparent comparison of the posted summaries, but it is not a replacement for the trial’s own mixed-model analysis.

Why use a mixed-effects model?

In general, repeated observations from the same participant are correlated: a person’s reports across sessions are not independent observations. A mixed-effects model can represent this within-person structure and estimate a pattern across time while using observations from participants who have at least one measurement. The registry says this approach was used for the primary outcome and that participants with at least one timepoint were included. It reports an analysis of slope, rather than a single endpoint mean difference.

The record does not specify the exact fixed effects, random effects, covariance structure, time coding, or missing-data assumptions. Those choices matter to the interpretation of a longitudinal model and to whether a model-based result can be independently reproduced. The reported slope and confidence interval can be described as the sponsor’s analysis, but the registry does not give enough detail to explain exactly how the slope is scaled or how it should be translated into a change in reported sorting behavior.

How should the p-values be read?

A p-value describes how compatible the observed data are with a specified null model under the analysis assumptions. It is not the probability that the null hypothesis is true, and it does not measure the clinical importance of a difference. The unadjusted re-calculated p-value is 0.356; the sponsor’s reported primary p-value is .41. These belong to different analyses and should not be expected to match exactly. Neither p-value by itself indicates whether the estimate is sufficiently precise or whether a difference matters in practice.

A confidence interval describes a range of estimates compatible with the data and the specified statistical procedure. Here, the re-calculated interval for the mean difference includes values below and above no difference. The sponsor’s model interval also spans both directions. An interval that crosses no difference does not prove equivalence; it indicates that the analysis does not clearly distinguish a difference from no difference at its stated confidence level.

What is the role of standard deviations?

Standard deviations describe variation among observations, whereas standard errors describe uncertainty in an estimated quantity. They are not interchangeable. The registry’s posted group summaries give standard deviations, and the re-calculation uses those summaries to estimate an unadjusted difference. The sponsor’s mixed-effects analysis uses repeated measurements and reports a slope. Its uncertainty depends on the model and the observed data structure, not only on the group standard deviations.

In general, over-dispersion means that the observed variability is greater than a model expects. For a continuous measure, substantial variability can make a mean difference harder to estimate precisely, especially when the analysis includes relatively few observations. That is a general statistical consideration, not a claim that a particular over-dispersion model was used in this trial. The registry record does not report a separate over-dispersion assessment.

Why are recalculations separate from the reported analysis?

The posted summary statistics allow a simple, unadjusted comparison, but they do not contain every detail needed to reproduce the mixed-effects model. The re-calculated result is therefore a descriptive check based on the group summaries, not the trial’s primary inferential model. The sponsor’s own analysis takes precedence for describing the trial’s reported primary analysis. The two results can be discussed side by side, while preserving their differences in method and estimand.

Finally, statistical significance is not the only consideration. The size and precision of an estimate, the quality and completeness of measurement, the relevance of the endpoint, and the analysis assumptions all affect interpretation. The registry record gives a useful outline of the outcome and analysis approach, but it does not report a full statistical analysis plan or enough technical detail to assess every modeling choice.

11. Confidence Intervals and Precision

The re-calculated primary mean difference is -9.5, with a 95% confidence interval from -29.69 to 10.69. This interval is broad relative to the point estimate and crosses zero. It is compatible with a range of possibilities, including a difference favoring either group and little or no difference. The data therefore do not provide a narrowly defined estimate of the difference in reported sorting behavior.

The sponsor’s reported mixed-model analysis gives a slope of .007 and a 95% confidence interval from -1.96 to 1.96. That interval also includes values on both sides of zero. Because the registry does not describe the slope scale or all model details, the interval should be interpreted as the model-based result as reported, not directly converted into the simple mean-difference scale.

In general, a confidence interval expresses sampling uncertainty under the assumptions of the analysis. It is not a range in which every individual outcome lies, nor does it account for every possible source of bias or measurement error. Wider intervals indicate less precision about the estimated contrast. The primary confidence interval leaves substantial uncertainty about the direction and size of the between-group difference.

The group standard deviations are 39.2 for RECLAIM and 19.3 for Sorting Practice. These describe variation in the posted summaries and help explain why a group mean alone is incomplete. The registry record does not report a clinically meaningful threshold for this endpoint, so the clinical importance of values within the interval cannot be judged from a threshold specified in the record. The interval’s inclusion of zero should not be interpreted as proof of equivalence.

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 sample-size figures are planning illustrations based on the observed effect, not a description of the trial’s original design. For the continuous-outcome comparisons shown, the values are participants per arm, not total events. The planning 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 the listed fraction of the observed effect. The registry record does not report the trial’s own original sample-size assumptions or justification.

The 80% power column gives the planned number of participants per arm for a hypothetical study designed to have an 80% chance of detecting the specified effect under those assumptions, if that effect were real. The 90% power column uses a higher target chance of detection for the same specified effect, and therefore requires more participants per arm. These are design illustrations, not observed power: they do not describe the probability that the completed trial detected an effect, and they do not validate the observed result.

Each planning row considers a different fraction of the observed effect. Planning for 100% of the observed effect gives 167 participants per arm for 80% power and 223 for 90% power. Planning for 75% of the observed effect gives 296 participants per arm for 80% power and 396 for 90% power. Planning for 50% of the observed effect gives 665 participants per arm for 80% power and 890 for 90% power. Smaller effects need more participants to detect under the same assumptions, which is why the required numbers increase as the assumed effect becomes smaller.

These illustrations rely on the observed estimate, which is itself uncertain, and on simplifying assumptions that may not match a future study’s design or analysis. They are not evidence that the observed difference is reliable or clinically important. The registry record does not report the assumptions used to set the trial’s original enrollment target.

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 = -9.500; pooled standard deviation σ = 30.896.
2. n = 2 × (1.96 + 0.842)² × 30.896² / -9.500² = 166.0, rounded up to 167 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 <- -9.5                      # observed difference in means
sigma <- 30.8960353443609                     # 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(5237466)
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 = 167 (80% power), 223 (90% power)
 75% of observed effect: n per arm = 296 (80% power), 396 (90% power)
 50% of observed effect: n per arm = 665 (80% power), 890 (90% power)
power.t.test: 167 
Simulated power at n = 167 per arm: 0.797 (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’s reported primary analysis is a mixed-model analysis of slope, with a value of .007, a 95% confidence interval from -1.96 to 1.96, and p = .41. The re-calculated comparison is a simple, unadjusted difference between the posted group means: -9.5, with a 95% confidence interval from -29.69 to 10.69 and an unadjusted p-value of 0.356.

These analyses use different methods and summarize the data differently. The re-calculation compares the posted means directly; the sponsor’s model analyzes slope across repeated observations. The registry does not provide enough model specification to reconstruct the sponsor’s estimate from the group summaries. Some difference between the results is therefore expected and does not, by itself, indicate an error.

The sponsor’s own analysis takes precedence as the trial’s reported primary analysis. The recalculation is an additional unadjusted reading of the posted summaries, not a substitute for that analysis. Both results leave uncertainty about the direction and size of the between-group pattern, and neither supports a conclusion of equivalence. The registry record does not report a discrepancy flag.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study assesses several outcomes, timepoints, subgroups, or statistical tests. In general, the more tests considered, the greater the chance that at least one result will appear notable by chance alone. Statistical approaches can address this issue, but the registry record does not report whether the investigators planned or used a multiplicity adjustment, or how the primary and secondary analyses were prioritized. The listed counts of outcome measures and analyses are not, by themselves, enough to determine the family of tests that should be considered together.

The primary endpoint is described as assessed at sessions 2-16 and analyzed using mixed-effects models. The record says participants with at least one timepoint were included. This gives some information about the analysis population, but does not report the number of missing observations, reasons for missingness, participant withdrawals, or the number of observations contributing to each model. It also does not report sensitivity analyses for missing data or the assumptions used to handle it. Consequently, the effect of incomplete follow-up on the result cannot be evaluated from the registry record.

Randomization is listed, but the record does not state whether the primary analysis followed an intention-to-treat principle, how participants were assigned to the analysis population, or how protocol deviations were handled. It does not report a per-protocol analysis or a detailed participant-flow account. The outcome group counts should therefore be understood as the numbers included in the posted summaries, not as a complete explanation of who was randomized, treated, or excluded.

The record also does not provide a full statistical analysis plan, details of prespecification, or a description of interim analyses. Those items are not reported in the registry record. Their absence limits assessment of whether the posted analyses follow a pre-established plan, but does not establish that the plan was changed or that unreported procedures occurred. These uncertainties are relevant to the strength of inference, especially for secondary findings and analyses across repeated measurements.

16. 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.

For the listed at-risk groups, the registry reports zero serious adverse events and zero other adverse events in the RECLAIM group, and zero serious adverse events and zero other adverse events in the Sorting Practice group. It also reports zero deaths in each listed group. No serious adverse event terms are listed.

These are registry-reported counts for the groups and at-risk numbers recorded with the safety results. They should be read as the events reported in this record, not as proof that no adverse experiences occurred. The record does not give additional detail about event definitions, monitoring procedures, reporting completeness, or the time period covered by the safety counts. The absence of listed events also does not establish that the interventions have no safety risks.

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

The primary results describe reported sorting/discarding behavior over four months in a randomized comparison of RECLAIM and Sorting Practice. The posted mean summaries and the sponsor’s mixed-model analysis do not provide a precise estimate of the difference between the groups. The confidence intervals include values in either direction, and the sponsor’s reported p-value does not establish a clear separation. This is an account of the posted data, not a medical recommendation.

The findings do not show that the interventions are equivalent. Demonstrating equivalence requires a prespecified margin and an analysis designed to test whether differences are contained within that margin. The registry record does not report such a margin or an equivalence analysis. A result that does not clearly distinguish groups can reflect uncertainty, including limited precision, rather than evidence that their effects are identical.

The endpoint is a behavioral measure based on participant reports of sorting or discarding in the preceding week. It is not itself a direct measure of hoarding symptoms, quality of life, or long-term outcomes. The posted secondary outcomes address other aspects of treatment and symptoms, but they do not remove the limitations of the primary comparison or establish a broad clinical conclusion.

The registry record describes a completed study and reports safety counts with no events listed in the analyzed groups. Those figures should be interpreted within the registry’s reporting detail and should not be generalized beyond it. Further information about eligibility, missing observations, measurement validation, the model specification, and the original design assumptions is not reported in the registry record. The result therefore supports a cautious description of what was measured and estimated, while leaving important questions about precision, generalizability, and the full analysis process unresolved.

18. Why This Trial Matters Statistically

This trial illustrates why a clinical result should not be reduced to a p-value. The primary outcome is repeated, participant-reported behavior, and the registry reports both group summaries and a mixed-model slope analysis. Those analyses answer related but distinct statistical questions. Keeping the methods separate helps prevent a simple comparison of means from being mistaken for a reproduction of the trial’s longitudinal model.

Precision is also central. The re-calculated interval is broad and crosses no difference, while the sponsor’s reported interval also spans values on both sides of zero. The estimates therefore leave uncertainty about the direction and size of the difference. This is different from showing that there is no meaningful difference, particularly when the record does not report a threshold for clinical importance or an equivalence margin.

The endpoint makes a useful statistical distinction visible: an outcome can reflect a behavior targeted by an intervention without being identical to symptom change or overall clinical benefit. Its interpretation depends on how the behavior was reported and on the repeated observations available for analysis. The registry gives an outline of these features but not enough detail to evaluate every measurement or model assumption.

Finally, the planning illustrations demonstrate how sample-size requirements depend on the effect a future study aims to detect. They do not retroactively establish what the completed trial could detect, and they are not evidence that the observed estimate is stable. Taken together, the trial matters statistically because it shows the importance of estimand, measurement, precision, missing-data information, and analysis transparency when reading a small two-group behavioral study.

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.

Several trial-specific limitations affect interpretation. The primary outcome is based on participants’ weekly reports of sorting or discarding in the previous week. The registry record does not report objective verification or further details about the measurement procedure. The outcome may capture activity relevant to the intervention, but it does not directly measure hoarding symptoms or broader functioning.

The group summaries include 18 participants per arm for the primary outcome, while the registry enrollment field lists 48. The record does not explain the difference between these counts or provide a participant-flow account. It says the mixed-effects analysis included participants with at least one timepoint, but does not report missingness by group, timepoint, or reason. This limits assessment of how representative the analyzed data are of the randomized participants.

The sponsor reports a mixed-model slope analysis, but the registry does not report the full model specification, the scale of the slope in relation to the outcome, or sensitivity analyses. A simple re-calculation from the posted means is available, but it cannot substitute for the model-based primary analysis. The single-masking field is not accompanied by information about who was masked. Randomization procedures and allocation concealment are also not described in the posted record.

The registry lists seven outcome measures and seven analyses, while the posted secondary results include two outcomes. It does not report the full prespecified analysis plan or a multiplicity strategy. The secondary findings therefore have limited confirmatory weight. The record also does not report a clinically meaningful threshold, an equivalence margin, or the original sample-size justification. Finally, safety counts are limited to the events recorded in the registry, without further detail about ascertainment or reporting procedures.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Motivational Interviewing to Enhance Behavioral Change in Older Adults With Hoarding Disorder — NCT05237466.
• Registry record last updated 2026-07-16; status last verified 2026-06.
• Results first posted 2026-07-16.
• 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

The registry describes a completed randomized, single-masked, parallel-group behavioral trial comparing RECLAIM, which combines motivational interviewing and sorting practice, with Sorting Practice alone in older adults with hoarding disorder. Enrollment is listed as 48. The primary outcome is the frequency of sorting/discarding behavior, measured as percent of days sorted between sessions over four months.

The posted primary summaries and the sponsor’s mixed-model analysis do not establish a clear between-group difference, and their intervals leave uncertainty about its direction and size. Two secondary outcomes are posted; multiplicity procedures and several details of the analysis population and model are not reported in the registry record. The listed safety results report no serious or other adverse events and no deaths in either group.