Exploratory Study for Toivoa-001 on Human Factors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Exploratory Study for Toivoa-001 on Human Factors (NCT06477913), a na na study. The primary outcome is Completion Rates as a Percentage of Enrolled Participants.

2. Clinical Question

3. Trial Design

This is a completed, single-group study of Rauha. The registry record lists enrollment as 13, the intervention as a device, and the sole arm as Active Rauha Therapy. Its description refers to a qualified intent-to-treat population evaluating Rauha and access to mental health coaches. There is no separate comparator arm, and the record lists allocation as NA and masking as none. Accordingly, the study is not a randomized comparison and cannot isolate changes associated with Rauha from changes that might occur over time or for other reasons.

The study is titled an exploratory study for human factors. Its stated purpose was to evaluate Rauha for people with disabilities experiencing anxiety and/or depression, assess program completion, and survey the user experience upon completion. Changes in anxiety and depression scores were also to be monitored. The primary endpoint concerns engagement during an 8-week period. Secondary outcomes list changes in Hamilton Anxiety Rating Scale scores and Hamilton Depression Rating Scale scores following therapy and 4 weeks post-therapy.

The study status is completed. The recorded start date is 2024-07-11 and the primary completion date is 2024-12-27. The phase is listed as NA. The registry record does not report a randomized allocation method, a control condition, or masking beyond the listed value of none. It also does not report how many of the enrolled participants began or completed the intervention, or how many contributed data to each endpoint.

Completion of the study does not, by itself, establish that outcome data or an analysis have been posted. The registry record lists 8 outcome measures and 0 analyses. Numeric results for the primary endpoint and the listed anxiety and depression outcomes are not reported in the registry record. Therefore, the design and planned measurements can be described, but a treatment-effect estimate cannot be assessed from these entries.

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: No one enrolled in the study dropped from participating prior to initiating (and completing) the intervention.

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 Completion Rates as a Percentage of Enrolled Participants, measured over 8 weeks.

The primary endpoint is completion rates as a percentage of enrolled participants. The description focuses on the proportion of the intent-to-treat population who remain active users at the end of the 8-week primary study period. It also says completion will be reported as the percentage of enrolled users who continue to engage with digital therapy per week. The listed unit is participants, while the endpoint title emphasizes a percentage; no endpoint result or detailed calculation rule is reported in the registry record.

Engagement is relevant to an exploratory digital intervention because an intervention cannot be meaningfully evaluated among intended users if participation is not sustained. A completion measure can describe whether users continue to interact with a program over its planned period. It is distinct from a measure of anxiety or depression: staying active does not establish symptom change, and symptom change does not establish sustained use.

In general, a percentage endpoint needs a clearly specified numerator and denominator, including rules for incomplete follow-up and missing engagement data. The record refers to enrolled users and an intent-to-treat population but does not explain how these populations relate, how weekly engagement is classified, or how missing observations are handled. The posted completion result is not reported in the registry record, so the endpoint’s observed frequency and its precision cannot be evaluated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary measure count?

The primary outcome concerns participants who continue to engage with Rauha during the 8-week primary study period. A count describes the number of participants meeting a definition; a percentage expresses that count relative to a denominator. The registry record gives the endpoint title as a percentage of enrolled participants, lists participants as the unit, and describes both end-of-period active use and engagement per week. It does not give a detailed rule for classifying completion or specify the exact numerator and denominator used for a reported estimate. Since no result is reported, neither the count nor percentage can be interpreted.

How should a single-group result be understood?

The study has one intervention group and no comparator. If a within-participant change were reported, it would describe how measured outcomes differed across time in the observed participants. In general, that is not the same as estimating what would have happened to those same participants without the intervention. Changes over time can reflect multiple influences, including natural variation, concurrent services, or changes in how participants respond to a measure. A controlled comparison can help separate treatment differences from these influences, but this design does not provide one.

The record lists no masking. In general, lack of masking can matter when outcomes depend on participant reports, study staff assessments, or judgments about engagement, because knowledge of the intervention may influence reporting or assessment. The record does not describe the administration of the Hamilton scales or the completion measure in enough detail to assess this concern further.

What would an uncertainty interval tell a reader?

In general, a confidence interval describes the range of estimates reasonably compatible with the observed data under the statistical model and its assumptions. A narrow interval indicates greater precision than a wide interval, while neither interval alone resolves bias or confounding. The registry record does not report confidence intervals or other uncertainty estimates for the outcomes. Without outcome estimates and uncertainty, the magnitude and precision of any observed pattern cannot be assessed.

What does over-dispersion mean for count data?

In general, over-dispersion occurs when count outcomes vary more than a chosen statistical model expects. If it is ignored, standard errors may be too small and uncertainty may be understated. The primary measure is described as a count or percentage of participants, but the record does not report a statistical model or a count distribution. It is therefore not possible to determine whether over-dispersion was assessed or relevant to an analysis.

What can the planning illustration establish?

The recorded planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustration is described as based on a fraction of an observed effect. In general, a sample-size calculation estimates how much information may be needed under specified assumptions; it is not an observed outcome and is not a measure of the probability that a completed study detected an effect. The illustration’s numeric results are not reported in the registry record.

Those assumptions also differ from the recorded study structure: this trial has a single group and no randomized comparator. The illustration should therefore not be treated as a description of the actual design or as proof that the study was adequately powered. The registry record does not report a trial-specific sample-size justification, a target enrollment rationale, or a statistical analysis plan. It does not report interim analyses. These items are not reported in the registry record.

What role do the symptom measures have?

The secondary outcomes list Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale score changes following therapy, with additional assessments 4 weeks post-therapy. In general, a change score compares measurements taken at different times, but interpretation depends on the scale administration, timing, analysis population, and handling of missing measurements. The record does not supply numerical values, a change-score method, or an analysis model. No conclusions about symptom trajectories or follow-up persistence can be drawn from the outcome descriptions alone.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Active Rauha Therapy")
n      <- c(13)
events <- c(13)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Active Rauha Therapy  13  13  100.0  75.3  100.0  77.2  100.0  76.8  99.8

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists multiple outcomes: the primary completion measure, four named secondary anxiety and depression outcomes, and 8 outcome measures in total. When several outcomes or time points are examined, the chance of finding at least one apparently noteworthy result can increase. In general, a prespecified multiplicity strategy can address this issue by defining which outcomes are confirmatory and how inference across them is controlled. A multiplicity strategy is not reported in the registry record. Because numerical outcome results are also not reported, it is not possible to assess how multiplicity affected any reported inference.

The record describes an intent-to-treat population for the primary outcome, but it does not define the population or explain whether every enrolled participant is included in each analysis. It does not report the number contributing data at each time point or how withdrawals, incomplete program use, or missing scale responses were handled. Missing-data assumptions and methods are not reported in the registry record.

In general, missingness can affect both the denominator of an engagement percentage and estimates of symptom change. If participants with less engagement or different symptom experiences are more likely to have missing observations, analyses restricted to complete records may not represent all enrolled participants. This is a general concern, not a finding about this study; the record does not describe its missingness pattern.

The registry record lists 0 analyses. It does not report a statistical analysis plan, the analysis population for each secondary endpoint, or any method for handling multiple comparisons or missing data. These absences limit assessment of how the planned outcomes would be analyzed and how robust any estimate might be.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry adverse-event figures list 13 participants at risk in the Active Rauha Therapy group, 0 serious adverse events, and 0 deaths. The other adverse-event count is also recorded as 0 among 13 at risk. These are the posted counts; they do not provide detailed event descriptions, timing, severity beyond the serious-event classification, or information about how events were collected.

A zero count in a group of this size means that no event in the listed category was recorded among those at risk in the registry entry. It does not establish that the risk is absent or that an event could not occur in a larger or different population. In general, the precision of safety estimates depends on the amount of observation and on complete, consistent event ascertainment. The registry record does not report exposure time, surveillance methods, or confidence intervals for the event counts.

No serious event terms are listed. The figures should be read as registry-reported counts rather than as a comprehensive account of all possible harms. They do not establish the safety profile of Rauha beyond the information recorded for this study.

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

The record establishes that a completed, single-group study evaluated Rauha and access to mental health coaches, with enrollment listed as 13. It identifies program completion during an 8-week period as the primary outcome and lists anxiety and depression score changes after therapy and 4 weeks post-therapy as secondary outcomes. It also records zero serious adverse events and zero deaths among 13 participants at risk.

The record does not report the primary completion result, anxiety or depression scores, user-experience findings, or estimates of uncertainty. Therefore, it does not show how many participants completed the program, whether symptom scores changed, or how precisely any outcome was measured. The absence of reported outcome results is not evidence that no change occurred; it means the registry record does not provide results for these questions.

Even if before-and-after outcome values were available, the single-group design would support a description of observed change rather than a direct estimate of the difference attributable to the intervention. There is no control group in the record to distinguish intervention-associated changes from other influences over time. The study’s exploratory framing and human-factors focus are consistent with examining feasibility and user experience, but the registry record does not provide the underlying results needed to characterize either.

The safety counts are limited to the events recorded in the entry. They do not prove that no other events occurred or establish safety in other populations or settings. Overall, the record describes the question and design, but does not supply the outcome evidence required to judge completion, symptom change, user experience, or comparative effects.

14. Why This Trial Matters Statistically

This study illustrates the distinction between an intervention’s usability or engagement and its clinical outcome measures. Continued use of a digital program is a meaningful implementation question, but it is not interchangeable with a measured change in anxiety or depression. Keeping these outcomes separate helps avoid treating engagement as evidence of symptom benefit or symptom measures as evidence of sustained use.

It also illustrates the limits of a single-group design. In general, repeated measurements can document how participants’ scores change over time, but without a comparator they do not establish what the same participants would have experienced under a different condition. That distinction matters when interpreting any future results from a small exploratory study.

The registry record gives a defined 8-week primary period and lists post-therapy and 4-week follow-up symptom measures, while leaving important analysis details and outcome results unreported. This makes transparent registration details valuable: readers can identify the intended outcomes and see what remains unavailable for evaluation. Here, the record lists 8 outcome measures and 0 analyses, so the listed plans cannot be compared with reported estimates or methods.

The sample-size assumptions also illustrate why planning calculations need to be interpreted in the context of the actual design. An illustration framed around two equally allocated arms does not describe a single-group study. Planning numbers, even when available, are not observed evidence and cannot compensate for an absent comparator or missing outcome estimates.

The statistical value of this record is therefore primarily in clarifying the study’s structure and measurement aims. It highlights why completion definitions, analysis populations, missing-data handling, and outcome reporting are essential for evaluating digital interventions, without allowing conclusions about the study’s unreported outcomes.

15. Limitations

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

The most direct limitation for interpreting the study is that numerical results for the primary endpoint and listed secondary outcomes are not reported in the registry record. The study status is completed, but completion status does not provide the missing outcome estimates. The record also lists 0 analyses, so no analytical result or uncertainty estimate is available for review.

The single-group design has no control condition and is not a randomized comparison. It can describe outcomes among participants receiving the intervention, but it cannot by itself separate changes associated with the intervention from changes due to other factors. The listed masking value is none, and the record does not give further information about outcome assessment or safeguards against measurement bias.

The primary endpoint description does not fully define completion. It refers to remaining an active user at the end of the 8-week study period and to engagement per week, but does not report the engagement threshold, numerator and denominator rules, or approach to missing usage information. The record refers to an intent-to-treat population without defining its membership or explaining how it relates to enrolled participants.

Other design and analysis details are not reported in the registry record, including a trial-specific sample-size justification, a statistical analysis plan, missing-data methods, and a multiplicity strategy. User-experience findings and details of the survey are also not reported. These limitations prevent assessment of the magnitude, precision, completeness, and robustness of the planned outcomes.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Exploratory Study for Toivoa-001 on Human Factors — NCT06477913.
• Registry record last updated 2026-08-21; status last verified 2024-07.
• Results first posted 2026-08-21.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT06477913 is a completed, single-group exploratory study of Rauha for people with disabilities and anxiety and/or depression. Enrollment is listed as 13. The intervention is described as digital-based cognitive behavioral therapy with access to mental health coaches, and the primary endpoint concerns program completion and engagement during an 8-week period.

Secondary outcomes list changes in Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale scores following therapy and 4 weeks post-therapy. The registry record lists 8 outcome measures and 0 analyses. Numeric outcome results, user-experience findings, and detailed analysis methods are not reported in the registry record. Adverse-event figures list 0 serious adverse events and 0 deaths among 13 at risk.