Technology Enabled Services to Enhance Depression Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Technology Enabled Services to Enhance Depression Care (NCT05406791), a randomized na study. The primary outcome is Patient Health Questionaire-9 (PHQ-9).

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. In a parallel design, participants are assigned to one of the study conditions and remain in that assigned condition for the comparison; the registry does not describe further details about assignment procedures, allocation concealment, or follow-up beyond the listed primary endpoint timeframe.

The two conditions are a sensor-enabled digital mental health intervention using the Vira platform with study-coach support, and a control treatment using a Mood Education App. The registry identifies both interventions as “other” and lists the study phase as NA. The study is marked completed. Its listed enrollment is 130, and Northwestern University is identified as the sponsor.

The registry lists a start date of 2022-06-10 and a primary completion date of 2023-09-30. These record details establish the study’s design and administrative status, but they do not by themselves establish how many participants completed follow-up or contributed to the primary analysis. The number analyzed and the handling of participants who discontinued or missed assessments are not reported in the registry record.

No masking means the registry does not describe the study as blinded. It does not specify whether outcome collection or analysis was conducted by people unaware of treatment assignment. The populations and care settings described in the summary provide context, but participant characteristics and any results by subgroup are not reported in the registry record.

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: Of 258 individuals assessed for eligibility, 130 met inclusion criteria and were randomized to treatment groups.

Overall Study

Reasons for not completing this period:

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 Patient Health Questionaire-9 (PHQ-9), measured over 12 weeks.

The primary endpoint is the Patient Health Questionnaire-9 (PHQ-9) score at 12 weeks. The registry describes the PHQ-9 as a scale from 0-27, with higher scores indicating greater depression symptom severity. It is a continuous measure, so results are ordinarily expressed as scores or as a difference in scores rather than as a count of events.

The PHQ-9 is used to quantify symptom severity in a consistent way at an assessment point. For a randomized comparison, a group-level summary can describe the average score in each condition, while a contrast between groups can describe how those averages differ. The registry specifies a least-squares mean and a 95% confidence interval as the endpoint’s statistical format. In general, least-squares means are model-based group averages; the model and any covariate adjustments used for this study are not reported in the registry record.

The 12-week timeframe identifies when the primary measure is intended to be assessed. It does not establish that all participants completed the assessment. The registry does not provide PHQ-9 estimates, a treatment contrast, or its confidence interval, so the endpoint’s observed results and their precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The trial is described as randomized and parallel-group. In general, random assignment is intended to make treatment groups comparable at the start of a study, on average, so that a later comparison can be interpreted in relation to assignment. Randomization does not guarantee identical groups in every characteristic, and the registry does not report the sequence-generation or allocation-concealment procedures. A parallel-group design compares conditions assigned to separate groups rather than having each participant receive both interventions.

What does a least-squares mean represent?

For a continuous endpoint such as PHQ-9 score, a mean is a summary of participant scores. In general, a least-squares mean is an estimate from a statistical model, and can represent a model-adjusted group average. The registry names least-squares means as the endpoint parameter, but does not report the fitted model, its covariates, or the precise contrast used. It is not possible to infer which factors, if any, were included in an adjustment.

How should a confidence interval be read?

The registry specifies a 95% confidence interval. In general, a confidence interval expresses the uncertainty associated with an estimate under the method used to calculate it. Its width conveys precision, and its endpoints describe values compatible with the data and method. It is not a guarantee that a particular range contains the true value, nor does it communicate the clinical importance of an effect on its own. Since neither the estimate nor the interval is reported for the primary comparison, those features cannot be assessed for this trial.

What does the randomized comparison estimate?

In general, a comparison between randomized groups estimates a contrast between the outcomes observed under their assigned conditions, subject to how adherence, missing observations, and analysis populations are handled. Here, the conditions are not identical except for one isolated feature: the Vira condition includes a mobile therapy platform and study-coach support, while the comparator provides psychoeducational content through a Mood Education App. A group contrast would therefore concern the assigned intervention packages, not the separate contribution of the app, coaching, or messaging. The registry does not report adherence or exposure details.

What can be learned from the stated planning assumptions?

The sample-size assumptions describe a planning illustration using a two-sided significance level of 0.05, equal allocation, and a normal approximation. They specify that the effect to detect is a stated fraction of the observed effect. In general, such an illustration asks how many participants per arm would be needed under those assumptions to detect a chosen effect with a target power. It is not the trial’s own sample-size justification, and it is not observed power. The registry does not report the trial’s sample-size justification or a protocol-level statistical plan. The assumptions do not establish that the trial used these methods for its actual analysis.

Sample-size calculations depend on the assumed effect and on the statistical model and error rates used in the calculation. A planning estimate should therefore be interpreted as conditional on its assumptions, not as a summary of the results. The registry does not report a primary-outcome estimate from which to evaluate the observed effect or its uncertainty.

Why does the absence of a single comparison matter?

The registry indicates that the primary outcome has several categories or time points and was not reduced to one comparison. A single, prespecified contrast can make the target question clear, while multiple possible comparisons can complicate interpretation. In general, multiplicity refers to the increased chance of a false-positive result when many hypotheses are tested without accounting for the number of tests. The registry does not report how the categories or time points were handled, whether a particular comparison was prespecified, or whether any multiplicity procedure was used. It would be inappropriate to infer an analysis strategy from the endpoint description alone.

The record lists two outcome measures and no analyses. A complete statistical interpretation would require the reported estimates, their uncertainty, the analysis population, and enough information about the model and missing-data handling to understand how the comparison was produced. Those analysis details are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and identifies PHQ-9 as the primary measure. It also states that the primary outcome has several categories or time points and was not reduced to one comparison. The record does not explain which categories or time points were analyzed, which comparison was intended as the primary contrast, or whether adjustment for multiple testing was planned or used. Those details are not reported in the registry record.

In general, multiplicity arises when several hypotheses or comparisons are examined. If each is treated as a separate opportunity to declare a finding without an appropriate strategy, the chance of at least one false-positive result can increase. This is a general statistical concern, not a claim that any particular error occurred in this trial. Without the analysis plan and reported comparisons, the treatment of multiplicity cannot be assessed.

The registry does not report how missing PHQ-9 assessments were handled, whether any imputation or sensitivity analysis was used, or how many participants contributed data at 12 weeks. It also does not define the analysis population for the primary endpoint. In general, these choices matter because the set of participants analyzed and the assumptions about unavailable outcomes can affect an estimated group comparison.

The record lists no analyses. The planned statistical analysis, the analysis populations, and the missing-data methods are not reported in the registry record. No conclusion about these methods should be inferred from the randomized design or the listed endpoint format.

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.

The registry’s safety figures list 65 participants at risk in each group. For the sensor-enabled digital mental health intervention, serious adverse events are recorded as 0, other adverse events as 0, and deaths as 0. For the Control Treatment group, the corresponding figures are also 0, 0, and 0. No serious-event terms are listed.

These entries describe the events recorded in the registry for the listed groups. They should not be read as proof that no participant experienced any unwanted event, or that the interventions have no risk. The record does not provide event descriptions beyond the absence of listed serious-event terms, nor does it give details about how events were collected, monitored, or classified. Follow-up duration and completeness for safety reporting are not reported in the registry record.

In general, a zero event count is interpreted alongside the number of participants observed, the duration and completeness of observation, and the definitions used for event reporting. The at-risk counts and zero counts are the available safety figures; they do not provide a comparison estimate or establish equivalence between groups.

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

The registry record describes a randomized comparison of two digital mental health interventions, with PHQ-9 score at 12 weeks identified as the primary measure. It gives the scale’s range and direction and specifies least-squares means with a 95% confidence interval as the statistical format. It also describes the intervention packages and the intended care setting.

It does not report the numerical PHQ-9 results, a contrast between groups, or a confidence interval for that contrast. The primary outcome is not reduced to one comparison in the record, and no analyses are listed. As a result, the posted information does not show whether the groups differed, in which direction, by how much, or with what precision. It also does not establish that the interventions had the same results.

Even if outcome estimates were available, a statistical difference would not by itself describe every feature of an intervention or its relevance to every patient. The randomized contrast would concern assignment to the complete conditions studied: the Vira platform with study-coach support versus a Mood Education App delivering psychoeducational content. It would not isolate the effect of any single component. The registry does not report adherence, coaching exposure, or participant-level characteristics that would help describe variation in response.

The safety entries record zero serious adverse events, zero other adverse events, and zero deaths in each group, with 65 at risk in each. Those counts are limited to the registry’s listed safety data and are not evidence that no adverse experiences occurred outside what was recorded. The available record supports a factual account of the design and reported safety counts, but not a conclusion about the comparative primary outcome or the overall performance of either intervention.

13. Why This Trial Matters Statistically

This trial addresses a comparison between two digital approaches that have different components: a sensor-enabled app with study-coach support and an app delivering educational content. Statistically, that distinction matters because the randomized comparison, if reported, would estimate the contrast between intervention packages. It would not identify the independent contribution of the technology, coaching, messaging, or educational material.

The registry’s description of patients receiving care in Rush University Medical Center primary care and family medicine clinics provides an important setting for interpreting a study question. The record describes those communities as racially, ethnically, and economically diverse and notes that evaluation may extend beyond Rush patients. However, participant characteristics and any results by population subgroup are not reported, so the degree to which findings might apply across different groups cannot be evaluated from this record.

The endpoint is a continuous symptom-severity score at a specified follow-up timeframe, and the registry identifies a model-based summary and confidence interval. This makes clear what kind of statistical result would be needed to interpret the question: a group estimate, a defined contrast, and uncertainty around that contrast. In this case those results are not reported, and the record notes that the primary outcome includes several categories or time points without a single comparison.

That gap is statistically important. A study’s design and endpoint description establish what it set out to compare, but they do not answer the comparison without outcome estimates and analysis details. The record can therefore inform readers about the study structure and the limits of what is available, while leaving the primary comparative question unresolved.

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 most direct limitation for interpreting this trial is that the registry does not report a single primary PHQ-9 comparison or numerical results. Although the endpoint and its timeframe are identified, there is no reported group estimate, contrast, confidence interval, or p-value from which to assess direction, magnitude, or precision. The registry also indicates that the primary outcome has several categories or time points and was not reduced to one comparison.

The registry lists no analyses, and does not report the primary analysis population, the number of participants contributing PHQ-9 data at 12 weeks, or the handling of missing assessments. It also does not report the statistical model or its covariates, despite specifying least-squares means. These omissions prevent evaluation of how the intended endpoint was analyzed.

The study is described as having no masking. The registry does not give further details about who knew assignments during outcome collection or analysis. It also does not report intervention adherence, coaching exposure, or the completeness of follow-up. Such information would help characterize how closely participants received the assigned intervention and how much outcome information was available.

The two conditions are packages with distinct components, so a comparison would not isolate the contribution of individual components. The registry describes the care setting but does not report participant characteristics or subgroup estimates that would allow assessment of the enrolled population’s composition. Finally, the zero safety counts lack accompanying event-collection and follow-up details. These are limitations of the registry information available and should not be mistaken for proof that unreported procedures or data do not exist elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Technology Enabled Services to Enhance Depression Care — NCT05406791.
• Registry record last updated 2025-04-09; status last verified 2025-04.
• Results first posted 2025-04-09.
• 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

NCT05406791 is a completed, randomized, parallel-group study sponsored by Northwestern University. The registry lists enrollment of 130, no masking, and a study phase of NA. The listed study start date is 2022-06-10, and the primary completion date is 2023-09-30.

The study compares a sensor-enabled digital mental health intervention using the Vira platform with coach support against a Mood Education App. The primary measure is PHQ-9 score at 12 weeks, described on a 0-27 scale, with higher scores indicating greater symptom severity. The registry specifies least-squares means and a 95% confidence interval but does not report a single primary comparison or numerical outcome results.

Safety entries list zero serious adverse events, zero other adverse events, and zero deaths in each group, with 65 participants at risk in each. The registry lists two outcome measures and no analyses. Details of the primary analysis, missing-data handling, and analysis populations are not reported in the registry record.