Pilot Evaluation of AboutFace: Novel Peer Education Resource for Veterans: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pilot Evaluation of AboutFace: Novel Peer Education Resource for Veterans (NCT02486692), a randomized na study. The primary outcome is Endorsed and Anticipated Stigma Inventory (EASI).

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group pilot evaluation with no masking. Participants assigned to the experimental group received instructions and a link to the AboutFace website after baseline assessment; those assigned to usual care received instructions and a link to online PTSD education materials. The registry lists the study as completed and gives the study start as 2015-04 and primary completion as 2016-09.

The registry reports 60 enrolled, while its population description says only 49 were randomized: 26 to the experimental arm and 23 to usual care. It attributes the difference to 11 participants who did not access the website portal to obtain their randomization assignment. This distinction matters when interpreting the planned comparison: enrollment is not the same as randomized allocation, and the posted arm counts do not describe all enrolled participants.

The primary assessment was the EASI at pre-treatment baseline and post-treatment at two weeks. Phase I participants did not take part in Phase II, the clinical trial portion, and were not assessed with this measure. The registry does not report how participants were recruited, how randomization was generated or concealed, whether adherence to either website was assessed, or whether follow-up beyond the stated post-treatment assessment occurred. It also does not report a protocol description sufficient to determine how the pilot was intended to inform a later study.

Randomization can support a fair comparison when allocation and follow-up are implemented appropriately, but the label alone does not establish that groups were comparable in every respect or that all randomized participants were analyzed. With no masking, participants knew which educational resource they accessed; the registry does not say whether outcome assessment or analysis was masked. These design details limit what can be inferred from the 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access website portal to obtain their randomization assignment. The EASI was also missing for 1 participant at post.

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 Endorsed and Anticipated Stigma Inventory (EASI), measured over pre-treatment (baseline) & post-treatment (two-week) assessment.

The primary measure is the Endorsed and Anticipated Stigma Inventory (EASI), reported as a mean in units on a scale, with standard deviation as the measure of dispersion. Its description says it assesses perceptions of treatment effectiveness, stigma, and external barriers to seeking treatment. Responses are ranked from 1 to 5, from “Strongly Disagree” to “Strongly Agree.” Higher scores indicate greater stigma, and total scores can range from 40 to 190.

The measure is relevant to the study’s stated purpose because the evaluation concerns stigma and attitudes toward seeking mental health services. Measuring the EASI before treatment and at a two-week post-treatment assessment creates an opportunity to describe scores over time and compare the randomized groups. A score is a measure of the stated perceptions; it is not, by itself, evidence that a participant sought treatment or that access to services changed.

The registry record does not report baseline or post-treatment EASI means, standard deviations, changes, confidence intervals, or a group comparison. It notes that the EASI was missing for 1 participant at post. As a result, the recorded measure and assessment schedule can be described, but the posted record does not establish the observed pattern of scores or the precision of any difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The EASI is a continuous measure, and the registry identifies the mean as its parameter and the standard deviation as its dispersion measure. In general, a mean describes the center of observed scores, while a standard deviation describes their spread. Reporting both can help readers understand not only the average score but also how much scores vary among participants. Neither statistic alone describes the uncertainty in a comparison between groups; that is one reason a confidence interval or other inferential result is useful.

What would a group comparison describe?

In general, a comparison could focus on post-treatment scores, change from baseline, or a model that accounts for baseline and post-treatment measurements. These choices answer related but not identical questions. A post-treatment comparison describes the groups at follow-up; a change comparison describes within-participant shifts and then contrasts those shifts; a baseline-adjusted model estimates a group contrast while accounting for baseline score. The registry record does not report which approach was planned or used, so none should be attributed to this trial.

For a mean difference, a confidence interval expresses a range of values compatible with the data and the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while an interval spanning values on either side of no difference may leave the direction uncertain. This is general statistical interpretation, not a description of an interval from this trial: no confidence interval is reported in the registry record.

A p-value, when reported, addresses how compatible the observed data are with a specified null model under the assumptions of the test. It does not measure the size or importance of an effect, and it does not give the probability that the null hypothesis is true. The registry record does not report a p-value or identify a test. No significance conclusion can therefore be drawn from the posted record.

What does randomization contribute?

In general, random allocation is intended to reduce systematic differences between groups at the time of assignment. It does not guarantee identical groups, especially in a pilot with limited randomized participation, and it cannot resolve problems caused by missing outcomes, non-adherence, or unreported analysis choices. Here, 49 participants were randomized, with 26 assigned to the experimental group and 23 to usual care. The registry says 11 enrolled participants did not access the portal to obtain their assignment and were not randomized. It does not report the allocation sequence, concealment procedures, or baseline characteristics by randomized group.

The study is described as having no masking. In general, participants who know which resource they receive may respond differently or report perceptions differently, particularly when outcomes involve attitudes and beliefs. This does not establish that such bias occurred in this study. The registry does not say whether outcome collection or data analysis was masked, and it does not report steps taken to reduce response or assessment bias.

How should the planning framework be read?

The registry describes a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. In general, such a calculation asks how many participants per arm might be needed to detect a chosen fraction of an assumed effect under specified statistical assumptions. It is conditional on the effect used as its starting point and does not demonstrate that a study had a particular probability of detecting an effect after it was conducted.

These planning calculations are illustrations, not observed power. The registry record does not state the observed EASI effect or the resulting participant estimates in the registry record for interpretation. It also does not report the trial’s own sample-size justification. The planning framework should not be mistaken for evidence that the pilot was designed around a stated effect, or that its results were sufficiently precise.

Why do outcome and analysis details matter?

The registry lists three outcome measures and zero analyses. It also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. This means the record does not identify a single reported contrast to interpret. When studies examine multiple outcomes, time points, or categories, the analysis plan and multiplicity approach can affect how results are evaluated. In general, multiplicity adjustments or a prespecified hierarchy may be used to address the increased chance of false-positive findings across multiple tests. The registry record does not report such a plan, and there are no reported test results to which one could apply it.

For this trial, the key statistical information needed to interpret the primary endpoint—group summaries, the contrast being estimated, uncertainty, and the method used—is not reported in the registry record. General statistical concepts explain what those quantities would mean, but they cannot substitute for the missing trial-specific analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures, but no analyses are listed. It does not identify a multiplicity strategy, such as a hierarchy among outcomes or an adjustment for multiple comparisons. The primary outcome entry also notes several categories or time points and that it was not reduced to one comparison. Consequently, the record does not establish which EASI contrast was treated as the main inferential test, or how any multiple testing was handled.

For the EASI, the registry identifies a pre-treatment baseline assessment and a post-treatment assessment at two weeks. It reports that the measure was missing for 1 participant at post. The record does not say which group this participant belonged to, why the value was missing, or how missing outcomes were handled. It does not report imputation, a complete-case analysis, a sensitivity analysis, or another approach. These methods cannot be assumed.

The population description distinguishes 60 enrolled from 49 randomized and explains that 11 did not access the portal to obtain randomization assignment. The record does not report whether those participants contributed any outcomes or whether they were included in any analysis. It also does not state whether the primary analysis followed randomized assignment or used another population. Thus, the analysis population and the handling of post-randomization missingness are not reported in the registry record.

These are reporting limitations rather than proof that no analysis plan or analysis existed outside the registry. They mean the posted record is insufficient to assess multiplicity, missing-data assumptions, or alignment between the intended and analyzed populations.

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 two adverse-event groups: Phase II- Experimental and Phase II- Usual Care Condition. For each group, it records 30 participants at risk, zero serious adverse events, zero other adverse events, and zero deaths. No serious adverse-event terms are listed.

These entries should be interpreted as the safety figures recorded for those named groups. They are distinct from the randomized arm counts in the primary outcome description, which are 26 in the experimental group and 23 in usual care. The registry does not explain why the at-risk counts differ, how the safety groups relate to the randomized participants, or what observation period was used for adverse-event collection. The entries therefore should not be treated as a reconciliation of the trial’s enrolled, randomized, and outcome-assessed populations.

A zero count in a registry entry means no events are recorded in that category for the listed group; it does not, on its own, establish that no events occurred outside the recorded scope or observation period. The record does not provide event definitions, collection procedures, or additional context for these figures. They do not answer the primary EASI question and do not establish the comparative effect of the educational resources.

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

The registry record establishes that this was a randomized pilot evaluation of AboutFace compared with online PTSD education materials, with the EASI identified as the primary measure. It describes the intervention timing, the two-week post-treatment assessment, the scale’s subject matter, and the randomized group counts. It also explains that some enrolled participants were not randomized because they did not access the portal needed to obtain an assignment.

Those design details do not establish the outcome. No EASI means, standard deviations, changes, between-group contrast, confidence interval, or test result are reported. Without those results, it is not possible to say whether scores increased or decreased, whether the groups differed, or how precisely any estimated difference was measured. The missing analysis cannot be interpreted as evidence that the groups were the same.

The study’s purpose includes reducing stigma and improving attitudes toward seeking mental health services. Those are goals motivating the evaluation, not findings in the registry record. The EASI measures perceptions concerning treatment effectiveness, stigma, and external barriers; it does not directly document service use. Even a reported change in an attitude measure would need to be interpreted according to the analysis and measurement context, rather than automatically treated as a change in behavior.

The record also does not report the statistical analysis plan, the primary contrast, multiplicity handling, or the approach to the post-treatment missing value. These omissions prevent an assessment of whether the analysis followed prespecified methods and how robust any result might be. Safety entries list zero events in the recorded categories, but their group denominators differ from the randomized counts and the record does not clarify the relationship.

Accordingly, the defensible reading is descriptive: the registry records a randomized pilot design and an intended stigma-related endpoint, but no comparative outcome result is available in the registry record. It cannot support a conclusion that AboutFace did or did not change stigma or treatment-seeking attitudes.

13. Why This Trial Matters Statistically

This trial is statistically notable because its registry record separates the number enrolled from the number randomized. It reports 60 enrolled but says 49 were randomized, with 11 not accessing the portal to obtain their assignment. That distinction is central to understanding who entered the randomized comparison and why enrollment alone does not describe the analysis population.

The evaluation also concerns a continuous attitude measure assessed at baseline and two weeks after treatment. Such a design can generate several possible summaries: scores at each assessment, changes over time, or a between-group contrast. Those choices can lead to different interpretations, which is why a clearly identified estimand and analysis method matter. The registry does not report which comparison was planned or performed, and it supplies no EASI results.

The record further illustrates that a named primary outcome does not by itself provide an interpretable statistical finding. Means, variability, an effect estimate, and uncertainty would be needed to describe what the randomized comparison showed. Because these are absent, the absence of a reported result must not be confused with a null result.

Finally, the safety figures use at-risk counts that differ from the randomized arm counts. That makes clear why group definitions and denominators should be stated and interpreted in context. Together, the record’s population distinctions, repeated assessment, missing post-treatment value, and absence of analyses highlight the importance of transparent reporting for pilot trials.

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 important trial-specific limitation in the registry record is the absence of outcome analyses. Although the EASI is identified as primary, no score summaries, effect estimates, uncertainty intervals, or tests are reported. The direction and precision of the primary comparison therefore cannot be assessed.

The enrolled and randomized counts differ. The record says 11 participants did not access the portal to obtain a randomization assignment, leaving 49 randomized, but does not report whether those not randomized contributed other study information or whether they differed from randomized participants. The EASI is also missing at post for 1 participant; the group, reason, and handling of that value are not stated.

The registry describes several categories or time points for the primary outcome without reducing them to one comparison. It does not report the statistical analysis plan, multiplicity approach, analysis population, or method for comparing baseline and post-treatment scores. These gaps make it difficult to assess the intended estimand or the reliability of any result beyond the registry.

No masking was used. Because the outcome concerns perceptions and attitudes, awareness of the educational resource could be relevant to responses, although the record does not establish that this influenced results. The registry does not describe recruitment, adherence, resource-use measurement, or follow-up beyond the two-week assessment.

Finally, the safety-group at-risk counts are 30 in each group, unlike the randomized arm counts, and their relationship is not explained. The registry also does not report adverse-event definitions or observation time. These limitations concern what can be determined from the record; they do not prove that unreported procedures or analyses did not occur.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pilot Evaluation of AboutFace: Novel Peer Education Resource for Veterans — NCT02486692.
• Registry record last updated 2019-06-05; status last verified 2019-05.
• Results first posted 2019-05-06.
• 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

NCT02486692 is a completed randomized, parallel-group pilot evaluation of the AboutFace peer education website for Veterans with PTSD. After baseline assessment, the experimental group received instructions and a link to AboutFace; the usual care group received instructions and a link to online PTSD education materials. The study was not masked.

The registry reports 60 enrolled and 49 randomized: 26 in the experimental group and 23 in usual care. It states that 11 participants did not access the portal to obtain their assignment. The primary measure was the EASI, assessed at baseline and two weeks post-treatment; the record notes one missing post-treatment EASI value.

The registry lists three outcome measures and zero analyses. It does not report EASI results or a comparative analysis. Adverse-event entries list zero serious events, zero other events, and zero deaths in each of two groups, with 30 at risk in each group. The relationship of those safety counts to the randomized counts is not explained in the registry record.