Potency and Precision Investigation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Potency and Precision Investigation (NCT06240091), a na na study. The primary outcome is Working Alliance Inventory-Short Revised (WAI-SR), Total Scale.

2. Clinical Question

In practical terms, the study sought to characterize working alliance between participants and Woebot while they had access to DISC-MA. The registry describes alliance in terms of agreement on therapy tasks and goals, together with development of an affective bond. It also notes that “therapist” was replaced with “Woebot” in the measure. Because outcome estimates and analysis results are not reported in the registry record, the clinical question cannot be answered from the posted results: they do not show the measured level of alliance or how it changed between assessments.

3. Trial Design

This completed study is titled “Potency and Precision Investigation” and is described in the registry as an exploratory, open-label investigation of a relational agent intervention. It is a single-group study, with allocation listed as NA and masking listed as NONE. The registry reports enrollment of 203 and identifies depression and anxiety as the conditions of interest. The study is listed as phase NA.

All participants were asked to download and use the DISC-MA study application. The app was available throughout the 4 week study. The registry lists the study start as 2024-03-13 and primary completion as 2024-05-09; its status is COMPLETED. These record details establish the study’s planned setting and timing, but they do not establish how many participants completed each outcome assessment.

The primary measure was the WAI-SR Total Scale, with assessments described at 1 week and post-treatment at 4 weeks. The registry lists one outcome measure and no posted analyses. It does not report a separate control group, so the design cannot distinguish changes associated with using the app from changes that might occur over time or for other reasons. The detailed protocol, recruitment procedures, adherence information, and reasons for noncompletion are not reported in the registry record. Nor is a statistical analysis plan reported in the registry record. The record supports describing this as an exploratory, open-label, single-group investigation, but not as a randomized comparison or a controlled test of intervention effects.

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: Data missing

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 Working Alliance Inventory-Short Revised (WAI-SR), Total Scale, measured over 1 week and Post-treatment at 4 weeks.

The primary endpoint is the Working Alliance Inventory-Short Revised (WAI-SR), Total Scale. The registry describes it as a 12-item measure of working alliance. It assesses agreement on the tasks of therapy, agreement on therapy goals, and the development of an affective bond. In this study, the wording “therapist” was replaced with “Woebot,” adapting the measure’s referent to the relational agent.

The total mean score ranges from 1-5, with higher scores indicating greater alliance between the participant and Woebot. A measure of alliance is relevant to a study focused on relational interaction because it describes participants’ reported relationship with the agent, rather than a clinical symptom outcome. The registry identifies assessments at 1 week and post-treatment at 4 weeks. However, it does not report the endpoint means, standard deviations, participant counts at each assessment, or a comparison between the assessment times. The population field for this outcome is marked “Data missing.” Consequently, the measure’s definition and intended interpretation are available, but the observed level of working alliance and its precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical information in the registry record is limited. It identifies a continuous primary outcome summarized as a mean and standard deviation, but lists no analyses. The explanations below describe general statistical concepts and clarify what can and cannot be inferred from the recorded design; they do not assert that a particular method was used.

What do a mean and standard deviation describe?

For a continuous outcome, the mean is the arithmetic average of the recorded scores in the analyzed group. It provides a measure of the group’s central score, but does not show how scores are distributed or whether individual participants had similar experiences. The standard deviation describes the dispersion of scores around the mean. A smaller spread indicates that values are more clustered around the average, while a larger spread indicates greater variation. These are general interpretations of the statistics named in the registry, not reported findings for this study: the WAI-SR means and standard deviations are not reported in the registry record.

A mean and standard deviation also depend on which observations are included. If some participants lack an assessment, the analyzed group may differ from the enrolled group. The registry does not report the number contributing WAI-SR data at either assessment, or how missing observations were handled. The outcome’s population field is marked “Data missing,” so the analysis population is not reported in the registry record.

What would a confidence interval add?

In general, a confidence interval conveys the uncertainty around an estimate under the assumptions of the method used. A narrower interval indicates greater statistical precision than a wider interval, but an interval is not a guarantee that the underlying value falls within it. Intervals can be useful for interpreting a mean or a difference in means because they show a range of estimates compatible with the data and method. No confidence interval for the WAI-SR outcome is reported in the registry record. Without an estimate and interval, the result’s precision cannot be assessed.

How does the design affect interpretation?

In general, a single-group study can describe outcomes among participants who received the intervention, but it does not provide a concurrent control group for estimating a between-group contrast. An open-label design means masking is not listed; participants and study personnel may know the intervention being used. The registry lists masking as NONE. This description does not establish whether expectations affected any particular response, but it is relevant context for a self-reported alliance measure.

The registry specifies assessments at 1 week and post-treatment at 4 weeks. A comparison across assessment times would be a within-group comparison, not a randomized treatment-control contrast. The record does not report whether such a comparison was performed, how repeated observations were modeled, or whether any adjustment was made. Those analysis details are not reported in the registry record.

What does over-dispersion mean in general?

Over-dispersion is a general issue for some count-data models: the observed variation in counts is greater than the model’s assumptions allow. It can affect standard errors and statistical tests if not accounted for. The WAI-SR is described as a continuous scale summarized by a mean and standard deviation, rather than a count endpoint. The registry does not report an over-dispersion assessment or a count model, and there is no basis to say that over-dispersion was relevant to the primary analysis.

How should the planning illustrations be read?

The registry describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are hypothetical planning quantities, not observed power and not the study’s actual design: this trial is a single-group study, not a two-arm randomized comparison. The record does not report the effect value used for those illustrations or a sample-size justification for the trial itself. The illustrations therefore cannot establish that the enrolled group was adequate for a specific analysis or precision target. Any interpretation of the observed effect as a planning basis would also require the outcome estimates, which are not reported in the registry record.

More broadly, a statistical method’s assumptions and the data available for analysis determine what an estimate means. The registry record does not report the detailed model, test, uncertainty interval, or analysis population for the primary endpoint. These absences prevent evaluation of the analysis choices, their assumptions, or the robustness of any result.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure, the WAI-SR Total Scale, and no analyses. It does not report a statistical analysis plan, a hierarchy of outcomes, or any adjustment for multiple testing. Because no analysis results are posted, it is not possible to determine whether multiple time points, subscales, or other outcomes were tested or whether multiplicity was a concern in the actual analysis. The registry’s count of one outcome measure does not by itself establish that only one statistical test was conducted.

Missing outcome information is a central limitation. The population field for the WAI-SR is marked “Data missing,” and assessment-specific participant counts are not reported in the registry record. The record does not describe how missing scores were handled, whether participants with incomplete assessments were excluded, or whether any imputation method was used. It also does not report reasons for missing assessments or provide a comparison of participants with and without outcome data. These details matter because missing observations can affect both the estimated mean and the group to which it applies.

The enrolled group is reported as 203, but that enrollment figure should not be treated as the number contributing data at every outcome time. The registry separately records 203 participants at risk in the safety group; that safety denominator does not establish the primary endpoint analysis population. Without outcome-specific denominators and a missing-data description, the completeness and representativeness of the WAI-SR results cannot be evaluated. The posted record therefore does not support a judgment about attrition bias, the handling of incomplete responses, or the consequences of missing data.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: eating disorders and disturbances (0.5%), active suicidal ideation (0.5%).

The registry reports serious adverse events for the DISC-MA group among 203 participants at risk. It lists 2 participants affected by serious adverse events and 56 participants affected by other adverse events. The recorded number of deaths is 0. The record also lists “Eating disorders and disturbances” and “Active suicidal ideation” among the top serious-event terms, each with a reported value of 0.5%.

These figures are descriptive safety counts in this single-group study. They are not a comparison with an untreated or control group, and they do not establish whether an event was caused by the intervention. The registry does not report event-level details, timing, severity beyond the serious-event classification, or whether participants could appear in both the serious and other adverse-event counts. The listed terms should be read as registry event categories, not as evidence that the categories were mutually exclusive or that they represent distinct participants.

The count of participants affected is not interchangeable with the count of event episodes: one participant can potentially experience more than one event. The record’s safety information should therefore be interpreted as reported participant counts and listed terms, not as a complete account of individual event histories or a comparative risk estimate.

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

The registry record documents a completed exploratory investigation of an app-based relational agent intervention, with a single group of participants and a primary measure focused on working alliance. It gives the WAI-SR measure’s content, score direction, and assessment times. It also reports enrollment and descriptive adverse-event counts. These are useful details about the study’s scope and recorded outcomes, but they do not establish the observed level of alliance.

The primary endpoint results are not reported in the registry record. There are no posted WAI-SR means, standard deviations, assessment-specific participant counts, or analyses. The record therefore cannot show whether average alliance was high or low, whether it changed over the study, or how precisely it was estimated. The absence of posted results is not evidence that the outcome was favorable, unfavorable, or unchanged; it means that the registry entry does not provide the information needed to assess that outcome.

The design also limits what could be concluded from a change over time. A single-group study has no separate control group to provide a concurrent comparison. General statistical reasoning therefore cautions against treating an uncontrolled pattern as proof that the intervention caused that pattern. The open-label design and self-reported measure are additional context for interpreting any eventual estimates, though the record does not report data that would quantify their influence.

The safety counts describe reports in the study group. They do not establish comparative safety or causation, and the listed event terms do not explain the circumstances of the events. The record reports no deaths, but that fact alone is not a comprehensive safety assessment.

In summary, the posted information supports a description of the trial’s design, intended outcome, timing, enrollment, and adverse-event counts. It does not support a conclusion about the primary outcome’s observed value, change, precision, or causal interpretation. Further outcome and analysis details are not reported in the registry record.

13. Why This Trial Matters Statistically

This study is statistically notable for the contrast between its stated exploratory aim and the limited outcome information in the registry record. The registry frames the work as an initial investigation of precision interventions in an adult population, and it identifies working alliance as its sole listed outcome measure. That focus makes clear what construct the study intended to assess: participants’ reported agreement on therapeutic tasks and goals, and their affective bond with the relational agent.

The design also makes the distinction between description and comparison especially important. A single-group, open-label study can describe scores among participants using the application, but it does not provide a randomized control group for estimating a comparative effect. If outcome estimates were available, they would need to be interpreted in that design context. Since the record does not report the endpoint estimates or analyses, even a descriptive account of measured alliance is unavailable.

The entry further illustrates why enrollment and endpoint information should not be treated as interchangeable. Although enrollment is listed as 203, the outcome population is marked “Data missing,” and the number of participants with scores at each assessment is not reported in the registry record. Without those details, readers cannot judge outcome completeness or the precision of any endpoint estimate.

The statistical importance of the record is therefore mainly methodological: it identifies a measure and a study structure, while leaving the result needed to answer the primary question unreported. The safety counts add a separate descriptive dimension, but do not substitute for efficacy or outcome reporting. Clear reporting of endpoint estimates, uncertainty, analysis populations, and missing-data handling would be needed to support a fuller statistical interpretation.

14. Limitations

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

The primary limitation for interpreting this trial is that the registry does not report the WAI-SR outcome results or analyses. Without means, standard deviations, uncertainty intervals, or assessment-specific denominators, readers cannot evaluate the observed alliance scores or their precision. The outcome population is marked “Data missing,” leaving unclear which participants contributed to the endpoint.

The study is single-group and open-label, with no like-for-like control comparison. This limits the interpretation of any within-group pattern: it cannot, by itself, identify what would have happened over the same period without the intervention. The registry does not report whether the planned assessment-time comparison was analyzed or what methods were used.

Further details needed to evaluate the endpoint are not reported in the registry record, including the handling of missing scores, the analysis population, adherence to app use, and the statistical analysis plan. The record does not provide participant characteristics or explain how the enrolled group relates to the adult population described in the study aim. The planning illustrations are based on an observed effect under a hypothetical two-arm setup, while the trial itself is single-group; the record does not report the trial’s own sample-size justification.

Safety interpretation is also limited to aggregate counts and listed terms. Event timing, detailed descriptions, attribution, and overlap between the serious and other adverse-event counts are not reported in the registry record. These limitations are specific to the design and reporting available for this study and prevent a comprehensive assessment of either the primary outcome or the safety experience.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Potency and Precision Investigation — NCT06240091.
• Registry record last updated 2025-02-19; status last verified 2025-01.
• Results first posted 2025-02-19.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT06240091, “Potency and Precision Investigation,” is listed as COMPLETED. The registry describes it as an exploratory, open-label, single-group study of the DISC-MA relational agent application, with enrollment of 203 and a 4 week period of app access. The study start is recorded as 2024-03-13 and primary completion as 2024-05-09.

The primary outcome is the WAI-SR Total Scale, assessed at 1 week and post-treatment at 4 weeks. The outcome is described as a mean score on a scale ranging from 1-5, with higher scores indicating greater alliance. The registry lists one outcome measure and no analyses, and marks the outcome population as “Data missing.” Primary endpoint estimates and analysis details are not reported in the registry record.

For safety, the record lists 2 participants with serious adverse events, 56 with other adverse events, and 0 deaths among 203 participants at risk. These are descriptive figures for the study group, not comparisons with a control group.