Using Mobile Technology to Address the Trauma Mental Health Treatment Gap: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Using Mobile Technology to Address the Trauma Mental Health Treatment Gap (NCT05374408), a registered phase not stated study. The primary outcome is Aim 1: Evaluation of Educational Materials.

2. Clinical Question

The project has two aims. One is to develop educational materials for patients and behavioral health providers; the other is to conduct a pilot of BBN with participants who have trauma histories in an integrated primary care setting. Focus groups are part of both aims, including feedback from participants and behavioral health providers and, for app deployment, clinic staff, providers, and administrators.

This is therefore a feasibility and implementation-oriented question, not a stated test of comparative clinical efficacy. The registry record does not report a control-based estimate of treatment effect, nor does it report numerical findings for acceptability, usability, or feasibility. The primary outcome is a participant count, so its description identifies participation in the evaluation rather than a scored measure of how acceptable or usable the materials were.

3. Trial Design

The registry identifies NCT05374408 as a completed study sponsored by the University of Nebraska. Its listed enrollment is 29. The recorded start date is 2022-08-03, and the primary completion date is 2024-03-22. The brief summary describes development of educational materials and a pilot study of BounceBack Now in integrated primary care. It also describes a feasibility study with 15 participants intended to identify procedural issues and refine the protocol before a full-scale study. How that stated pilot size relates to the registry enrollment is not reported in the registry record.

The work is organized around two aims rather than a stated randomized treatment comparison. Aim 1 concerns evaluating educational materials with patients and behavioral health providers using focus groups, think-aloud activities, and semi-structured interviews. Aim 2 concerns deploying BBN with participants who have trauma histories and gathering feedback about implementation. The listed intervention activities also include focus groups with behavioral health providers, participants, clinical staff, providers, and administrators.

The registry record does not state an allocation method. It does not describe the arms as a like-for-like control comparison, so differences between the listed participant and provider groups should not be interpreted as treatment effects. The arm descriptions identify people receiving care at designated integrated care clinics and personnel who can comment on app deployment. They do not provide a complete account of eligibility criteria, recruitment, or the number enrolled in each activity.

The primary outcome is the count of participants evaluating educational materials, with a timeframe of 5 months. The record lists 5 outcome measures and 0 analyses. It does not report a statistical analysis plan, sample-size justification, interim analyses, or detailed procedures for assigning participants to activities. The design information supports a description of an implementation and feasibility project, but does not establish what statistical methods were used to evaluate its findings.

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 pre-assignment details to report

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.

Population: Patients, BHPs, Clinical Staff, Providers and Administration individuals were recruited from designated integrated care clinical sites were recruited for Aim 1 and Aim 2 of the study.

6. Primary Endpoint

The registry lists the primary outcome as Aim 1: Evaluation of Educational Materials, measured over 5 months.

The primary outcome is titled “Aim 1: Evaluation of Educational Materials.” Its unit is participants, and it is described as a count of participants involved in evaluating materials developed for using a trauma-related mobile app. The evaluation involves focus groups with patients and behavioral health providers. Participants are asked to use a think-aloud approach during semi-structured interviews, with questions intended to assess acceptability, usability, and feasibility. The listed timeframe is 5 months.

A participant count can describe how many people took part in an evaluation activity. It does not, by itself, quantify how acceptable or usable the materials were, or establish that an implementation process is feasible. Those concepts ordinarily require defined measures or qualitative interpretation in addition to knowing who participated. The registry record does not report a scoring system, threshold, or numerical summary for those concepts.

In general, an endpoint should match the question a study is designed to address. A participation count can be useful in feasibility work because it documents engagement with an evaluation process. For the broader questions about acceptability, usability, and feasibility, the design description indicates that interviews and focus groups were used, but the resulting findings are not reported in the registry record. The record also does not describe a clinical symptom endpoint as the primary outcome.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a count of participants evaluating educational materials. It also classifies the outcome type as binary and describes its meaning as participants with an event, expressed as counts. The description does not define the event rule in more detail, such as exactly what qualifies a participant as having completed an evaluation. The registry record does not report a statistical test or model used to analyze this outcome.

What does a count measure?

In general, a count records how many observations meet a defined condition. For an outcome framed as participants with an event, each participant must be classified according to whether the event occurred, and the resulting number is reported as a count. A count is not automatically a rate or proportion. To interpret it as a proportion, a clearly defined denominator is also needed, such as the number eligible for the activity or the number with evaluable data. The record identifies the unit as participants but does not report the observed primary count or its denominator.

Binary outcomes can be modeled using methods that account for the two possible participant-level states, such as event or no event. That is a general methodological explanation, not a claim about what the investigators did. The registry record does not report a model, a test, a confidence interval, or an adjustment strategy for the primary outcome. It also does not give the definition of a missing or incomplete evaluation. The count should therefore be read descriptively unless additional analysis details are available.

What can a confidence interval add?

In general, a confidence interval describes the uncertainty around an estimate under a specified statistical model and sampling process. A narrower interval indicates greater precision under those assumptions; a wider interval indicates less precision. An interval does not resolve weaknesses in measurement, recruitment, or study design, and it does not establish that a result is clinically important. No confidence interval for the primary outcome is reported in the registry record, so its precision cannot be assessed from the posted information.

For a feasibility evaluation, uncertainty is relevant because an observed count may depend on who was invited, who agreed to participate, and who completed the activity. In general, reporting both a count and a well-defined denominator helps readers distinguish low participation from a small eligible group or incomplete reporting. The record does not report those details for the primary endpoint. It also does not give the achieved results for acceptability, usability, or feasibility, although those concepts appear in the outcome description.

Why does the design affect interpretation?

Statistical methods must be matched to the study design and research question. A randomized comparison can, under suitable conditions, support estimating a between-group effect. A focus-group or feasibility design instead describes participation, experiences, or implementation issues, and it may not have a comparator that supports a treatment-effect estimate. The registry record does not state an allocation method and does not describe the arms as a like-for-like control comparison. A comparative app effect should not be inferred from the group labels.

The stated planning assumptions describe illustrations based on a stated proportion of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are planning assumptions, not evidence that this project used those methods for its outcome analysis. The registry record does not report the underlying observed effect or the analysis producing it. Sample-size illustrations are planning aids and are not observed power; they cannot substitute for reported outcome estimates, uncertainty, or a complete analysis plan.

In general, over-dispersion matters when observed variability in count data is greater than a model assumes. If ignored, standard errors and uncertainty estimates may be misleading. Whether over-dispersion is relevant depends on the outcome definition, data structure, and model. The registry record does not report a count model, a dispersion estimate, or a check for over-dispersion. The primary outcome is described as a count of participants, but the information does not establish that a model for count data was fitted.

What does the listed analysis information establish?

The registry lists 5 outcome measures and 0 analyses. This indicates that outcome measures are listed but that no analyses are reported in the record. It does not establish that no analysis occurred outside the registry, nor does it reveal what methods might have been used. The statistical plan, including prespecified contrasts, covariate adjustment, handling of repeated observations, and decision thresholds for the qualitative concepts, is not reported in the registry record.

In general, a well-described analysis connects each outcome to its measurement rule, analysis population, missing-data approach, and statistical method. For a count, that includes clarifying whether the result is simply a number of participants or a proportion with a stated denominator. For qualitative feedback, it includes explaining how interviews are interpreted and summarized. Those details are not reported in the registry record, so the planned outcome description cannot be treated as a full account of the analysis. The available record supports a cautious account of the study objectives and registered outcome, not a reconstruction of unreported analyses.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 5 outcome measures, but it does not report an analysis plan linking each measure to a prespecified statistical test or model. It lists 0 analyses. The primary outcome description concerns the number of participants evaluating educational materials, while the broader project also addresses acceptability, usability, feasibility, app deployment, and procedural refinement. The record does not identify which outcomes were treated as confirmatory, how qualitative findings were summarized, or whether any outcomes were exploratory.

In general, multiplicity arises when several outcomes, comparisons, or analyses are considered. Without a prespecified plan, it can be difficult to distinguish a primary statistical test from exploratory examination. Statistical adjustments can be used in some settings to address multiplicity, but the appropriate approach depends on the questions and design. Whether any adjustment was used is not reported in the registry record. The number of listed outcome measures alone does not establish how many formal statistical tests were conducted.

The registry record does not report how missing or incomplete endpoint information was handled. It does not describe an analysis population, such as whether the primary count includes all enrolled participants, those who began the evaluation, or those who completed it. Nor does it report participant flow for the focus groups or explain how unavailable interview feedback was treated. These omissions limit assessment of potential selection and missing-data effects.

In general, missingness can affect interpretation when people without observed outcomes differ from those with observed outcomes. A transparent report describes what data were missing, why they were missing, and what assumptions or procedures informed the analysis. None of those details is reported for the primary outcome. The record also does not report interim analyses, and no such analyses should be assumed.

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 lists four groups in its adverse-event information. In the Aim 1 participant group, 0 serious adverse events affected participants among 5 at risk; 0 other adverse events affected participants, and deaths were 0. In the Aim 1 behavioral health provider group, the corresponding entries are 0 serious events among 2 at risk, 0 other events, and 0 deaths. In the Aim 2 participant group, they are 0 serious events among 12 at risk, 0 other events, and 0 deaths. In the Aim 2 behavioral health provider, clinical staff, provider, and administration group, they are 0 serious events among 10 at risk, 0 other events, and 0 deaths.

These entries describe events recorded as affecting participants in those listed groups. They do not provide a comparative safety estimate, and the groups are not described as randomized treatment and control arms. The registry record does not report event definitions, monitoring procedures, event timing, or the observation period for these entries. It also does not report whether all participants were assessed in the same way. The zero affected counts should therefore be interpreted as the posted counts in the registry, not as proof that no events occurred under any circumstances.

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

The record’s principal contribution is to describe a project focused on developing and evaluating educational materials and piloting a mobile app within integrated primary care. Its registered primary outcome concerns participation in an evaluation activity. The stated methods for eliciting feedback include focus groups, think-aloud activities, and semi-structured interviews. These details clarify the project’s implementation and feasibility orientation, but the registry does not report the resulting participant count or the findings from the feedback activities.

The record does not provide numerical estimates for acceptability, usability, feasibility, symptom change, or app-related clinical outcomes. It does not report a control-based treatment effect or an analysis comparing the listed groups. The absence of those results from the registry record means that the posted information cannot establish the magnitude or precision of any clinical or implementation effect. It should not be interpreted as evidence that the app did or did not improve outcomes.

The listed enrollment is 29, and the brief summary separately describes a feasibility study with 15 participants. The record does not explain how those entries relate, or how many people participated in each activity. Therefore, they cannot be used to infer completion, retention, or the number contributing to the primary endpoint. Activity-specific counts and denominators are not reported in the registry record.

In general, feasibility findings can inform whether procedures and materials merit further evaluation, but they do not by themselves establish effectiveness. To make a treatment-effect claim, readers would need an appropriate design, defined outcome measurements, reported estimates, and uncertainty measures. To assess implementation, readers would need the actual feedback results and transparent reporting of who participated and how the findings were analyzed. Those details are not available in the registry record.

The appropriate interpretation is consequently limited: the registered objectives and outcome definitions are visible, while quantitative outcome analyses and their precision are not reported. The safety entries record zero affected events in the listed categories and groups, but do not establish broader safety conclusions beyond those recorded entries.

13. Why This Trial Matters Statistically

Clinical implementation studies raise statistical questions that differ from those in conventional efficacy trials. A project can seek to understand whether an intervention and its supporting materials can be introduced into a care setting, how participants and staff respond to the process, and what practical issues may need attention. This record explicitly describes educational-material development, focus groups, and a pilot intended to identify procedural issues and refine a protocol.

That purpose makes clear outcome definitions particularly important. A count of people taking part in an evaluation can document engagement, while acceptability, usability, and feasibility are broader constructs. In general, those constructs need clear measurement or a transparent approach to interpreting qualitative feedback. The registry record names these concepts and describes interview activities, but does not report their findings or the method used to summarize them. Readers cannot tell from the posted results how the feedback related to implementation decisions.

The trial also illustrates why group labels should not be mistaken for a comparison design. Participant and provider groups contribute different kinds of information, and the record does not state random allocation or a like-for-like control comparison. Statistical comparisons across such groups would not automatically estimate an intervention effect. Study design and analysis need to match the question being asked.

Finally, statistical interpretation depends not only on the aim and endpoint but also on reported results, denominators, missing-data handling, and uncertainty. The record lists enrollment and outcome measures but does not report the primary count or analyses. Without those elements, readers can understand the project’s intended scope, but cannot assess the precision of its findings or the robustness of conclusions. That distinction is important when feasibility work is considered as a basis for later research.

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 statistical interpretation is that the registry record does not report the observed primary outcome count or any outcome analysis. The registered endpoint is described, but its numerical result, denominator, confidence interval, and analysis method are absent. The record lists 0 analyses, so there is no reported inferential result to evaluate. The status is completed, but completion status does not supply the missing outcome estimates.

The record does not explain the relationship between enrollment of 29 and the brief summary’s description of a feasibility study with 15 participants. It does not provide enrollment or completion counts for each focus-group activity, or clarify which participants contributed to the primary endpoint. This prevents assessment of participation and retention for the specific evaluation described.

The registered primary outcome is a count of participants, while acceptability, usability, and feasibility are also named as concepts of interest. The record does not report how those concepts were operationalized, scored, or interpreted, or provide the qualitative findings. It also does not define the event rule for the count in detail. The outcome description therefore does not fully specify how to reproduce or evaluate the measurement.

The registry does not report eligibility criteria in detail, participant characteristics, recruitment procedures, missing-data handling, or analysis populations. The focus-group and provider activities may involve different types of contributors, but activity-specific denominators are not stated. The record does not report a statistical analysis plan, interim analyses, or a multiplicity approach. These omissions limit evaluation of selection, measurement, and analytical uncertainty.

The study is not described as a randomized comparison, and no like-for-like control comparison is identified. Consequently, the posted record does not support a causal estimate of app effects relative to a comparator. Safety entries are descriptive and lack reported event definitions and observation periods. Together, these limitations restrict conclusions to the project’s stated objectives, registered endpoint description, and posted event counts.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Using Mobile Technology to Address the Trauma Mental Health Treatment Gap — NCT05374408.
• Registry record last updated 2025-09-09; status last verified 2025-06.
• Results first posted 2025-09-09.
• 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

NCT05374408 is a completed University of Nebraska study titled “Using Mobile Technology to Address the Trauma Mental Health Treatment Gap.” It describes developing educational materials and piloting BounceBack Now in integrated primary care. The registry lists enrollment of 29, a start date of 2022-08-03, and primary completion on 2024-03-22. The brief summary describes a feasibility study with 15 participants; the relationship between that figure and the listed enrollment is not reported in the registry record.

The primary outcome is a count of participants evaluating educational materials during a 5-month timeframe. Focus groups and think-aloud, semi-structured interviews are described as methods for considering acceptability, usability, and feasibility. The record lists 5 outcome measures and 0 analyses. It does not report the primary count, statistical estimates, or feedback findings. No randomized allocation method or like-for-like control comparison is described. The adverse-event entries record 0 serious events, 0 other events, and 0 deaths affected in each listed group.