MOST EMPOWER: Optimizing An Emotion Regulation Intervention: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for MOST EMPOWER: Optimizing An Emotion Regulation Intervention (NCT04317417), a randomized na study. The primary outcome is T0 and T6 Positive Affect T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire.

2. Clinical Question

3. Trial Design

MOST EMPOWER is a randomized, unmasked, factorial behavioral study of EMPOWER, a digital health intervention intended to promote well-being among adolescent and young adult cancer survivors. The registry lists Wake Forest University Health Sciences as the sponsor and gives enrollment as 352. The study is marked completed. The recorded start date is 2022-01-06, and the primary completion date is 2025-04-30.

The factorial designation indicates that the design examines combinations of intervention components rather than only a single intervention-versus-control contrast. Arm names distinguish combinations using labels for PE, M, PR, PS, and AK, each marked present or absent. The registry record does not explain those abbreviations, describe all arm content in prose, or identify one arm as a conventional control. It also does not report the randomization procedure, allocation ratio, or whether any stratification was used.

The intervention is classified as behavioral, and masking is listed as none. The registry summary says the investigators intended to learn about wellness and health-related quality of life through skills for healthy coping and mood management. This describes the study purpose; it is not evidence that an outcome changed.

The primary outcome is assessed at baseline (T0) and at intervention completion, 10 weeks after baseline (T6). The listed secondary outcomes are anxiety, depression, and life satisfaction T-scores at T0 and T6. Although the registry record lists outcome measures, it reports no outcome analyses. Detailed eligibility criteria, participant characteristics, adherence information, and analysis-population definitions 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: The design of this study is a full factorial design with 5 arms.

Only the first 6 of 32 groups are shown.

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.

Only the first 6 of 33 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as T0 and T6 Positive Affect T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire, measured over At baseline (T0) and at intervention completion 10 weeks after baseline (T6).

The primary endpoint is positive affect measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test. Participants report feelings associated with pleasurable engagement with their environment, including happiness, joy, excitement, enthusiasm, and contentment over the past seven days. Scores are expressed as T-scores.

The registry describes 50 as the national average for the general population, with a standard deviation of 10. A score >50 indicates higher positive affect than the general population; a score <50 indicates lower positive affect. The registry gives 60 and 40 as examples of scores one standard deviation above and below that average, respectively. These reference points help give the score a population context; they do not provide a result for trial participants.

Positive affect is used as the primary measure because the intervention’s stated purpose is to promote well-being. The registered outcome description says a mixed model was used to estimate the mean within-group value at each time point. The assessment points are baseline (T0) and intervention completion 10 weeks after baseline (T6). The registry record does not report the estimated means, uncertainty intervals, changes over time, or contrasts between arms. Consequently, the endpoint definition is available, but the trial’s observed primary-outcome findings are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the study as randomized and factorial, and describes the primary outcome as a continuous measure analyzed using a mixed model. These labels provide a broad outline of the approach, but do not specify the complete statistical methods. The model formula, covariates, planned contrasts, assumptions, and treatment of incomplete data are not reported in the registry record.

What a mean describes

For a continuous outcome such as a T-score, a mean summarizes the central level of scores in a group. The registered outcome description specifies estimated within-group means at T0 and T6. Such estimates can describe the observed score level at each assessment, but they do not, by themselves, quantify the comparative effect of randomized assignment. A treatment or component effect requires a defined contrast, such as a difference between groups or a difference in change over time. The registry record does not report those contrasts.

Why use a mixed model

General explanation: a mixed model can account for the fact that measurements from the same participant over time are related rather than independent. It can estimate mean patterns across assessment times while representing within-participant correlation. The registry says a mixed model was used to estimate within-group outcome means at each time point. It does not report the particular covariance structure, fixed effects, random effects, estimation method, or diagnostics. Those details matter for reproducing the analysis and understanding which comparisons the model supports.

Interpreting uncertainty

General explanation: a standard error describes the estimated uncertainty of a statistic, such as a mean. It is not the spread of individual participant scores. A confidence interval uses an estimate and its uncertainty to express a range of values compatible with the data under the model and stated confidence procedure. Narrower intervals generally indicate greater precision, while wider intervals indicate less precision. The primary outcome’s measure type is a least-squares mean and its stated dispersion is a standard error, but no estimates or standard errors are reported in the registry record. There is consequently no numerical precision assessment available.

Factorial comparisons

General explanation: factorial designs study multiple intervention components through combinations of component assignments. A main-effect contrast evaluates a component across the levels of other components, while an interaction asks whether the effect of one component varies according to another. Which effects can be estimated depends on the design, the model, and the prespecified analysis. Here, the record identifies the factorial model and lists arm labels built from component indicators, but does not define the abbreviations, state the target contrasts, or report any component or interaction results. It would be inappropriate to infer the planned analysis from the arm names alone.

Multiplicity and model interpretation

General explanation: when many outcomes, time points, components, or contrasts are tested, the chance of at least one apparently notable result can increase. Statistical plans may address this through a hierarchy of outcomes, adjusted testing, or other prespecified procedures. The registry lists a primary outcome and secondary outcomes, but does not report a multiplicity procedure or the full testing plan. The absence of reported analyses means there are no p-values to assess, adjusted or otherwise.

Planning calculations versus observed results

General explanation: a sample-size calculation is a planning exercise that uses assumptions about an effect, variability, allocation, and a significance threshold. A calculation based on an observed effect is an illustration of how a future study might be planned under chosen assumptions; it is not observed power and does not establish the reliability of the original result. The record describes a planning approach using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. However, the primary outcome has several categories or time points and is not reduced to one comparison in the posted analysis. No observed primary-outcome effect is reported, so no effect-based planning illustration can establish a trial finding.

Overall, the record supplies a broad model description but not enough detail to reproduce or fully evaluate the analysis. It does not report an analysis plan, model specification, outcome estimates, or inferential results. General statistical concepts explain how such methods could be interpreted; they cannot fill in those missing trial-specific details.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists the positive-affect T-score as the primary outcome and lists anxiety, depression, and life satisfaction T-scores as secondary outcomes. Each is described at T0 and T6. The record does not report whether the investigators prespecified a hierarchy among outcomes, adjusted for multiple comparisons, or selected a primary contrast among the factorial components. The multiplicity strategy is not reported in the registry record.

General explanation: testing several outcomes, time points, or component contrasts can create multiple opportunities for a seemingly unusual result. A prespecified testing strategy helps readers distinguish the main confirmatory question from exploratory comparisons. Without the strategy and the actual analyses, neither the number of tests conducted nor the handling of multiplicity can be evaluated.

Missing-data handling is also not reported in the registry record. The outcome description names a mixed model, but does not state how missing questionnaire responses were handled, what assumptions were made about missingness, or whether sensitivity analyses were conducted. The registry does not report outcome-specific numbers analyzed at T0 or T6, reasons for missing data, or whether missingness differed by arm.

Analysis populations are not defined in the record. It is not stated whether the primary analysis followed randomized assignment, included only participants with complete outcome data, or used another population definition. The enrollment value of 352 does not establish the number included in any particular analysis. With no outcome analyses listed, it is also not possible to compare the number randomized, the number assessed, and the number contributing to an estimate. These omissions limit assessment of potential bias and the applicability of any eventual estimates.

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 non-serious adverse event terms

The registry’s serious-adverse-event entries list zero serious events and zero deaths for each displayed group and reporting time. The entries also list other, non-serious adverse events, with counts of 1 or 2 in the individual rows. These figures are reported for specific arm and time-point entries, not as a single overall count across the trial.

Each row also gives a number at risk for serious and other adverse events. Those numbers vary across entries, and the registry does not explain in the available record how these safety groups were selected or whether the same participants appear in more than one reporting period. Because events may be reported across different time points, the row counts should not be added to produce an overall number of affected participants. The record does not identify the event terms in the serious-event list, which is empty.

These safety entries are descriptive. They do not compare risks between factorial components, establish whether an event was caused by the intervention, or provide a formal safety analysis. The registry record does not report the method for collecting or classifying adverse events, or a statistical comparison of safety outcomes. The displayed zero counts should therefore be read as zero serious events recorded in each listed entry, not as a broader conclusion about safety beyond those entries.

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

The registry record establishes that MOST EMPOWER was a completed randomized factorial behavioral study of a digital intervention intended to promote well-being among adolescent and young adult cancer survivors. It defines positive affect as the primary outcome, identifies the PROMIS measure, and specifies baseline and intervention-completion assessments. It also lists anxiety, depression, and life satisfaction as secondary measures.

Those design details do not establish whether positive affect changed or whether any intervention component produced a different result. The registry reports no primary-outcome analyses and no outcome estimates. There is no reported effect size, confidence interval, standard error, or p-value for positive affect. It is therefore not possible to state the direction or magnitude of a result, or how precisely it was estimated.

The registry’s reference to a general-population average of 50 helps interpret the scale, but it is not a trial finding. Nor does the completed status indicate whether the intervention changed scores. The safety entries document zero serious events and zero deaths in each listed entry, alongside some other adverse events, but they do not provide a comparative safety analysis or establish causation.

General explanation: a registry description answers what investigators planned to study and how outcomes were defined; a results analysis is needed to estimate what happened in the study and quantify uncertainty. A randomized design can support comparisons when the assigned groups and analysis are appropriately reported, but randomization alone does not supply the missing estimates. The record does not report the detailed analysis plan, missing-data approach, or populations analyzed. Thus, the information supports a description of the study’s question and measurement framework, not a conclusion about intervention benefit, lack of benefit, or comparative safety.

13. Why This Trial Matters Statistically

The study is statistically notable for its factorial design and repeated measurement of a patient-reported well-being outcome. A factorial approach can be useful when investigators want to evaluate combinations of intervention components rather than treat a multicomponent program as one indivisible package. Repeated assessments can also distinguish the baseline score from the score at intervention completion. These design features make careful definition of contrasts and model terms especially important.

The registry identifies the primary measure and says a mixed model was used to estimate means at T0 and T6. That gives readers a starting point for understanding the intended analysis. However, the record does not describe the component abbreviations, planned contrasts, model specification, or multiplicity procedure. It also does not report any primary-outcome results. As a result, the potential statistical value of the factorial design cannot be assessed from the posted record alone.

The study also illustrates why a registry’s design description and outcome results serve different purposes. A completed status and an enrollment value describe the trial record, while estimates and uncertainty are required to evaluate findings. Without those estimates, readers cannot determine whether observed scores differed, how large any contrast might have been, or how precisely it was estimated. This is an important distinction when interpreting studies of behavioral interventions, where outcomes are measured using participant reports and may be assessed repeatedly.

For biostatisticians and clinical researchers, the record highlights the need for transparent reporting of the estimand, model, analysis population, missing-data methods, and multiplicity plan alongside outcome estimates. Those details would be needed to interpret the factorial comparisons and judge their precision. The registry record provides the broad design and endpoint framework, but not the evidence needed to evaluate the trial’s primary statistical question.

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 main limitation for statistical interpretation is that the registry record does not report primary-outcome results. It lists zero analyses, so the positive-affect means and any between-arm comparisons are unavailable. No uncertainty estimates or inferential statistics are reported. This prevents evaluation of effect direction, size, precision, and statistical significance.

The factorial arm descriptions use abbreviated component labels, but the record does not define them or provide full descriptions for the arms. It does not identify a single comparator, state which component contrasts were planned, or report the analysis model beyond the general mixed-model description for within-group means. This makes it difficult to reconstruct the intended estimand or understand how component effects and potential interactions were to be evaluated.

The registry does not report detailed eligibility criteria, participant characteristics, outcome-specific analysis counts, or an analysis-population definition. It also does not report missing-data methods, sensitivity analyses, model diagnostics, or the multiplicity strategy. The enrollment value of 352 cannot answer how many participants contributed data at either assessment or to any particular comparison.

The safety information is presented in separate arm and time-point entries, without a reported overall comparative analysis. The event terms for serious adverse events are not listed, and the record does not explain how repeated reporting periods relate to unique participants. Therefore, those entries cannot support a broader comparative safety conclusion.

Finally, the record’s completed status does not resolve these information gaps. The outcome definitions and design labels describe the trial framework, but the absence of results and analytic details limits independent assessment of the trial’s findings and reproducibility.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: MOST EMPOWER: Optimizing An Emotion Regulation Intervention — NCT04317417.
• Registry record last updated 2026-07-09; status last verified 2026-06.
• Results first posted 2026-07-09.
• 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

MOST EMPOWER (NCT04317417) is a randomized, unmasked, factorial behavioral study sponsored by Wake Forest University Health Sciences. It evaluates EMPOWER, a digital health intervention intended to promote well-being among adolescent and young adult cancer survivors. The registry lists enrollment as 352 and study status as completed, with a start date of 2022-01-06 and primary completion date of 2025-04-30.

The primary outcome is the PROMIS Positive Affect Computer Adaptive Test T-score at baseline (T0) and intervention completion 10 weeks after baseline (T6). Anxiety, depression, and life satisfaction T-scores are listed as secondary outcomes at the same assessment points. The registry describes a mixed model for estimating within-group means, but reports no outcome analyses or primary-outcome estimates. Safety entries list zero serious events and zero deaths in each displayed group and time point, with other adverse events also recorded.

Detailed eligibility criteria, arm-component definitions, statistical plan, missing-data approach, analysis populations, and comparative results are not reported in the registry record.