The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury (NCT02432300), a na na study. The primary outcome is Toronto Alexithymia Scale-20 (TAS-20).

2. Clinical Question

3. Trial Design

The registry record describes a completed, single-group behavioral study of Emotion Builder, a web-based training program intended for people with emotional problems after traumatic brain injury. The listed conditions are Traumatic Brain Injury and Alexithymia. Enrollment was 17. The study began in 2015-05, reached primary completion in 2016-06, and is listed as completed. The sponsor is EmotEd.

There was one intervention group, described as receiving treatment sessions with a virtual treatment program called Emotion Builder. Allocation is recorded as not applicable, and the study model is single group. Masking is recorded as none. The record therefore does not describe random assignment or a blinded comparison. A control group or another like-for-like comparator is not reported in the registry record.

The primary outcome was the Toronto Alexithymia Scale-20 (TAS-20), expressed as a mean with standard deviation and assessed at Week 6. The registry record also names the Patient Health Questionnaire-9 (PHQ-9), described as an assessment of depression, and the State Trait Anxiety Inventory (STAI) as secondary outcomes. Four outcome measures are indicated in total, but the record does not name all of them in the information available for this analysis.

The phase is listed as not applicable. The registry record does not report a protocol-level sample-size justification, a detailed intervention schedule, eligibility criteria, recruitment setting, or a statistical analysis plan. These omissions limit what can be concluded about how participants were selected, how treatment was delivered, and how outcome data were intended to be analyzed. Completion status indicates the study is listed as completed; it does not supply outcome results or establish that every planned analysis was carried out.

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: Participants were only enrolled in the treatment if they were found to have met the criteria for moderate to severe alexithymia on the Toronto Alexithymia Scale 20 (\>=52).

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 Toronto Alexithymia Scale-20 (TAS-20), measured over Week 6.

The primary endpoint is the Toronto Alexithymia Scale-20, or TAS-20, at Week 6. It is a 20-item self-report questionnaire with three sub-constructs: difficulty identifying feelings, difficulty describing feelings, and externally-oriented thinking. The subscales are summed to produce a total score. Its stated full scale range is 20-100, and higher scores indicate higher alexithymia.

The record describes scores between 52 and 60 as indicating moderate alexithymia and scores of 61 and higher as indicating high alexithymia. These categories help describe how the scale is framed in the registry record; they do not substitute for an outcome estimate or show how participants scored. No Week 6 mean or standard deviation is reported in the registry record.

A self-report scale can quantify participants’ reported experiences using a consistent set of items. The mean describes the group’s average score, while the standard deviation describes how dispersed individual scores are around that average. The registry record does not explain why this endpoint was selected over other measures. It also does not report baseline TAS-20 results, so a Week 6 value alone, even if it were available, would not establish change from the start of the study. The endpoint identifies the construct and assessment time, but the posted results do not include the numerical outcome needed to describe the group’s observed score.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean and standard deviation describe?

The primary measure is continuous and is summarized in the registry record as a mean with a standard deviation. In general, a mean is an average that represents the center of a set of scores. A standard deviation describes how spread out those scores are around the mean. Together, they can provide a compact description of a group’s score distribution, although they do not show every individual score or the full shape of that distribution.

The registry record does not include either statistic for the Week 6 TAS-20 outcome. It is therefore not possible to describe the group’s average score or how much participants’ scores varied. A scale range and score categories explain how a score may be interpreted, but they cannot recover the missing group summary.

What would a confidence interval add?

In general, a confidence interval expresses the uncertainty around an estimated quantity under a specified statistical procedure. A narrow interval indicates greater precision than a wide interval, while an interval that spans a broad range of plausible values leaves more uncertainty about the estimate. Interpretation depends on the quantity being estimated and the assumptions behind the procedure. No confidence interval for the primary outcome is reported in the registry record, so there is no reported precision estimate to assess.

A p-value, when reported, is a statistic calculated under a stated null hypothesis and analysis method. It does not measure the size or practical importance of an outcome, and it is not a substitute for an estimate with its uncertainty. The registry record lists no analyses and reports no p-value. It is not possible to infer a test, its null hypothesis, or a statistical conclusion from the outcome description alone.

What can a single-group study estimate?

In general, a single-group study can describe outcomes observed in the participants who received an intervention. If comparable baseline and follow-up measurements are collected and reported, an analysis may describe within-group change. Such a change is not automatically an estimate of the intervention’s causal effect. Without a concurrent comparator, the observed pattern cannot by itself distinguish an intervention effect from other influences, including changes over time or differences in participants’ experiences.

For this study, the registry record identifies a Week 6 TAS-20 endpoint but does not report a baseline value or a Week 6 result. It also does not report an analysis population or the number of participants whose Week 6 scores were available. Accordingly, neither a within-group change nor a comparison between groups can be reconstructed from the registry record.

How should the planning assumptions be read?

The sample-size planning illustrations are described as hypothetical planning calculations, not as observed power. Their stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions and do not describe the design actually listed in the registry record, which is single group with no like-for-like control comparison.

Planning calculations depend on assumptions about the effect to detect, variability, and analysis design. They can illustrate how a hypothetical two-arm design might be planned; they cannot establish the chance that this completed single-group study detected an effect. The registry record does not report the trial’s own sample-size justification. Since the primary outcome estimate and its variability are also not reported, the basis for any planning illustration cannot be evaluated from the outcome results in the record. Such illustrations should not be read as observed power or as evidence that a clinical effect was present.

Which analysis choices are not documented?

The registry record does not report the statistical test or model used, whether any adjustment was made, how missing measurements were handled, or which participants were included in an analysis. It also does not report checks of model assumptions. These details matter because the method should correspond to the study design, the outcome distribution, the available observations, and the question being estimated. Their absence means readers cannot verify an analysis procedure or assess whether its assumptions were reasonable.

General statistical interpretation also depends on distinguishing a descriptive summary from an inferential estimate. A group mean describes the observed participants, whereas an inferential analysis may quantify uncertainty about a broader target. Neither form is available for the primary outcome in the registry record. The study description and measure definitions are not a substitute for an analysis result.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Treatment Group (Emotion Builder)")
n   <- c(13)
m   <- c(52.54)
sp  <- c(11.95)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Treatment Group (Emotion Builder)  13  52.540  11.950  45.319  59.761

11. Multiplicity, Missing Data and Analysis Populations

The registry record identifies the TAS-20 as the primary outcome and names PHQ-9 and STAI as secondary outcomes. It indicates four outcome measures in total. When a study considers multiple outcomes, general statistical practice requires clarity about which outcomes are primary, which analyses are confirmatory or exploratory, and whether any adjustment for multiple testing was planned. Testing several outcomes can increase the chance of finding an apparently notable result by chance. The registry record does not report a multiplicity strategy or explain how secondary outcomes were to be interpreted.

No analyses are listed, and numerical results for the primary and named secondary outcomes are not reported in the registry record. Consequently, there is no set of reported outcome tests to evaluate for multiplicity, and no basis for determining whether any reported inference was adjusted. The absence of analyses should not be interpreted as evidence that outcomes were identical or that no changes occurred.

Missing-data methods and analysis populations are also not reported in the registry record. The number enrolled is 17, but the record does not specify how many participants contributed to each outcome, whether measurements were missing, or how incomplete observations were handled. In general, missing data can affect both the description of the observed participants and the interpretation of estimates, particularly if availability of measurements is related to participant characteristics or outcomes. No pattern or reason for missingness can be inferred.

The record does not state whether the analysis was intended to include all enrolled participants, only those who completed treatment, or another defined group. It also does not report an approach to missing outcome measurements. These omissions limit reproducibility and make it impossible to assess the extent to which the posted outcome population, if any, corresponds to the enrolled group.

12. Safety Results

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

Other (non-serious) adverse events

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

Most frequent non-serious adverse event terms

The registry record reports no serious adverse events among 17 participants at risk in the Treatment Group (Emotion Builder). It reports one other adverse event among 17 participants at risk. The record does not list a serious adverse-event term, and the type or description of the other adverse event is not reported in the registry record. The deaths field is not reported in the registry record.

These are event counts from a single intervention group. They are not a comparison of risks between treatment and control, because no control group is listed. The counts should be read as registry-recorded events among participants identified as at risk, rather than as a complete characterization of safety. The record does not provide event timing, severity details for the other event, relatedness to the intervention, or the method used to collect and classify events.

A zero serious-event count in this group is a description of what the record reports; it does not establish that serious events are impossible or provide a precise estimate of event risk. Likewise, the one other event cannot be interpreted as caused by the intervention based on the information recorded. The safety information is limited to the counts and reporting details stated above.

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

The registry record establishes that a completed, single-group study examined Emotion Builder and named the TAS-20 at Week 6 as its primary outcome. It also identifies PHQ-9 and STAI as secondary measures. These registry entries describe the study question and measurement plan, but they do not establish the outcomes observed among participants.

The record does not report a Week 6 TAS-20 mean or standard deviation, baseline TAS-20 results, confidence intervals, p-values, or analyses. Therefore, it does not show whether participants’ scores were higher, lower, or unchanged, and it does not quantify the precision of an outcome estimate. The scale’s stated direction and score bands help explain how a reported score could be read, but no group score is available to place within those categories.

The single-group design also limits causal interpretation. A result from one group, even if reported, would not provide a direct comparison with what happened without the intervention. Because the registry record does not report baseline outcomes or a comparator, it does not establish a treatment-associated change or a causal effect. This is a limitation of what the design and recorded results can answer, not a finding that the intervention had no effect.

The adverse-event record reports no serious events among 17 at risk and one other event among 17 at risk. It does not report the other event’s type or the death count. These limited safety counts do not provide a comparative assessment and do not resolve the missing outcome information.

The most defensible interpretation is narrow: the registry record describes the intervention, study structure, intended endpoint, and a small amount of safety information, but does not report statistical results for the clinical outcomes. Neither benefit nor lack of benefit can be concluded from an unreported result. Claims about effect size, statistical significance, outcome change, or the consistency of effects across measures are unsupported by the record.

14. Why This Trial Matters Statistically

This trial matters statistically because its study structure and outcome reporting illustrate the difference between defining a question and answering it with results. The registry record specifies an intervention, a single-group design, a Week 6 TAS-20 endpoint, and a mean with standard deviation as the intended summary. Those details make the target measurement understandable. Without the reported mean, standard deviation, or an analysis, however, the endpoint cannot be evaluated empirically.

The design also makes the comparison question important. A single group can contribute descriptive information about participants who received the program, but it does not supply a concurrent control for interpreting change. Statistical significance, even if available, would not on its own overcome the absence of a comparison group. Design determines which quantities an analysis can estimate and what causal interpretation is reasonable.

The listed secondary measures raise a separate issue: a study with several outcomes needs transparent reporting of outcome priorities and analysis choices. The registry record names two secondary measures and indicates four outcomes overall, but does not list analyses or a multiplicity approach. Without results and analysis details, readers cannot assess whether evidence is consistent across measures or how uncertainty was handled.

Finally, the planning assumptions should be distinguished from the actual study design and from observed evidence. The described calculations are planning illustrations based on a hypothetical two-arm framework; the registered study is single group. That distinction helps prevent planning quantities from being mistaken for a result or for observed power. Overall, the record is useful for understanding the intended measurement and design, while its missing outcome and analysis reporting sharply limits statistical interpretation.

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.

Several limitations are specific to the information recorded for this study. First, the study is single group, with no like-for-like control comparison listed. This prevents a direct comparison of outcomes between participants receiving Emotion Builder and a control group. Masking is recorded as none, so the record does not describe a masked study.

Second, the primary endpoint is identified at Week 6, but its mean and standard deviation are not reported. Baseline TAS-20 values, a change estimate, and an uncertainty estimate are also not reported in the registry record. The outcome description therefore cannot establish the participants’ measured scores or how they changed over time.

Third, enrollment was 17, and the record does not report the number included in each outcome analysis or describe missing measurements. Eligibility criteria and participant characteristics are not reported in the information, limiting assessment of whom the results might represent even if results were available. The registry record does not provide the intervention schedule or detailed delivery information, which restricts understanding of exposure to the program.

Fourth, although PHQ-9 and STAI are named as secondary outcomes and four outcome measures are indicated overall, no analyses are listed. The record does not describe the statistical model, missing-data approach, analysis population, or multiplicity handling. These omissions prevent review of the intended analysis and its assumptions.

Finally, the safety record gives event counts but not the type of the other adverse event, event timing, or deaths. The stated planning illustrations use a two-arm framework that does not match the single-group design described in the registry record. These limitations concern both study design and the completeness of recorded results; they should not be mistaken for evidence that an unreported outcome was favorable, unfavorable, or unchanged.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury — NCT02432300.
• Registry record last updated 2017-11-22; status last verified 2017-11.
• Results first posted 2017-11-22.
• 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

NCT02432300 is a completed, single-group behavioral study sponsored by EmotEd. It examined Emotion Builder, a web-based training program for emotional problems after traumatic brain injury. The registry record lists enrollment of 17, a start date of 2015-05, and primary completion in 2016-06. Allocation is not applicable, and masking is recorded as none.

The primary outcome is the mean TAS-20 score at Week 6, with standard deviation specified as the measure of dispersion. PHQ-9 and STAI are named as secondary outcomes. The primary outcome’s numerical results and statistical analyses are not reported in the registry record. The safety record reports no serious adverse events among 17 at risk and one other adverse event among 17 at risk; further event details and the death count are not reported.