This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Arena Labs - Improving Clinician Well Being (NCT05653700), a randomized na study. The primary outcome is Change in Amount of Burn Out (MBI) Malasch Burnout Inventory.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05653700 |
| Phase | NA |
| Condition | Mental Health Disorder |
| Allocation | Randomized |
| Design model | Factorial |
| Masking | None (open label) |
| Enrollment | 43 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Wake Forest University Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned full-time clinicians. The registry lists Mental Health Disorder as a condition and records an enrollment of 43. It also notes that the subject number differed because of non-responders; the number of respondents contributing to the primary outcome is not reported in the registry record.
Intervention
Arena Strive was the experimental intervention. Its described program comprised a 12-week, multi-phased experience: asynchronous learning and coaching for 6 weeks, followed by an exploration phase for 6 weeks. The study aimed to assess changes in physiological resilience, professional fulfillment, burnout, and self-valuation.
Comparator
The comparator was a control cohort. Participants in that cohort were to complete surveys at baseline and at the end of the study. The registry does not describe an active coaching or learning component for this group.
Primary question
The primary endpoint was change in burnout measured with the MBI at Week 16. The registry describes a score from 0 to 42, with higher scores indicating more burnout. It does not report the group-level scores, the between-group difference, or a statistical analysis, so the comparative result cannot be assessed from the registry record.
3. Trial Design
This was a randomized study with no masking and a factorial model listed in the registry. The registry does not describe the factors, their levels, or how the factorial structure was incorporated into the analysis. It identifies Arena Strive as a device intervention and the Control Cohort as the other study arm.
The Arena Strive intervention was described as a 12-week program, consisting of 6 weeks of asynchronous learning and coaching followed by a 6-week exploration phase. The control cohort was described as completing surveys at baseline and at the end of the study. The primary endpoint timeframe was Week 16, which is later than the stated intervention period. The registry does not explain the timing or content of any activities between the end of the intervention and the endpoint assessment.
The record lists an enrollment of 43 and a completed status. The study start date was 2023-03-16, and primary completion was 2023-07-25. The registry does not report the randomization sequence, allocation concealment, recruitment details, or a protocol rationale for the enrollment target. It also does not explain whether the factorial model involved additional assigned conditions beyond the two named cohorts.
Fourteen outcome measures are listed, including secondary outcomes concerning satisfaction with and recommendation of the Arena Strive platform. The registry records zero analyses. It therefore does not provide an analyzed primary comparison or results for those secondary outcomes.
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: Non Response is difference in Subject numbers
Overall Study
| Stage | Arena Strive | Control Cohort |
|---|---|---|
| STARTED | 29 | 14 |
| COMPLETED | 20 | 14 |
| NOT COMPLETED | 9 | 0 |
Reasons for not completing this period:
| Reason | Arena Strive | Control Cohort |
|---|---|---|
| Non Responders | 9 | 0 |
Analysis population for the primary outcome, as defined in the registry: non response
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 were randomized into either control or intervention group (Arena Strive)
| Characteristic | Unit | Arena Strive | Control Cohort | Total |
|---|---|---|---|---|
| Participants analysed | 29 | 14 | 43 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 29 | 14 | 43 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Amount of Burn Out (MBI) Malasch Burnout Inventory, measured over Week 16.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in burnout measured using the MBI, identified in the registry as the Malasch Burnout Inventory. It is a continuous score on a scale. The registry says each item is measured from 0 to 6 and that total scores range from 0 to 42. A lower total indicates less burnout, while a higher total indicates more burnout.
The registry also describes score categories: a total of 17 or less is low-level burnout, a total from 18 to 29 inclusive is moderate burnout, and a total over 30 is high-level burnout. These categories provide an interpretive framework for individual scores; they do not replace analysis of the continuous score or establish a treatment effect.
Burnout was selected as a primary measure within a study intended to assess clinician well-being, alongside physiological resilience, professional fulfillment, and self-valuation. A continuous score can describe the average level of the measured construct and its change over time. To compare randomized groups, however, the endpoint values and an appropriate estimate of the between-group difference are needed. Neither those values nor an analysis is reported in the registry record. The primary assessment timeframe is Week 16.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison of Arena Strive with a control cohort and names change in MBI burnout score at Week 16 as the primary outcome. It does not report the outcome values, a change estimate, a between-group contrast, a confidence interval, or a p-value. The record therefore does not establish the direction, size, or precision of any difference between groups.
This absence should not be interpreted as evidence that the groups were alike, or that the intervention had no effect. It means the registry record does not contain the results needed to judge the comparison. The status is listed as completed, but completion status is not itself an outcome finding.
The primary outcome description notes that the subject number differed because of non-responders. The registry does not state how many participants contributed data at Week 16, how missing observations were handled, or which analysis population was used. Without those details and the outcome estimates, it is not possible to determine how non-response affected the reported comparison.
The record lists a factorial model, but does not identify the factors or report any factorial effects, interaction estimates, or analysis method. It also lists fourteen outcome measures and two secondary measures concerning satisfaction with and recommendation of the platform. No outcome analysis is recorded. Thus, the primary result and the secondary findings are not available for statistical interpretation in this record.
Planning assumptions are described for sample-size illustrations: a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and effects expressed as fractions of an observed effect. These are planning assumptions, not evidence of the trial's actual design rationale or of its statistical power. The observed effect needed for such illustrations is not reported in the registry record. The illustrations should not be read as observed power or as a substitute for the missing treatment-effect estimate.
9. Statistical Methods Explained
The registry identifies the primary measure as a mean of a continuous outcome, with standard deviation as the stated dispersion measure. It does not report the means, standard deviations, or analysis results. The following explains the statistical concepts relevant to this type of outcome; it does not describe an analysis method confirmed for this study.
What does a continuous score represent?
A continuous score can take values across a measurement scale, rather than being limited to a category such as yes or no. For the MBI endpoint, the registry gives a total-score range from 0 to 42 and states that higher totals represent more burnout. A group mean describes the average score among the participants included in that calculation. A standard deviation describes how spread out individual scores are around that mean. The mean and standard deviation answer different questions: one concerns the group average, while the other concerns variation among individual observations.
A mean change within one group is not, by itself, the randomized comparison. The central comparative quantity would ordinarily describe how change differs between the intervention and control groups, with its uncertainty. The registry does not report such an estimate. It also does not say whether the analysis compared change scores, endpoint scores adjusted for baseline, or another quantity.
How should uncertainty be understood?
In general, a confidence interval gives a range of values compatible with the data and the statistical model at a stated confidence level. Its width reflects precision: a narrower interval indicates a more precise estimate, while a wider interval indicates greater uncertainty. Interpreting an interval requires the estimate, the interval itself, and the analysis assumptions. None of these outcome statistics is reported for the primary comparison in the registry record.
A p-value, in general, describes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the model assumptions were true. It does not measure the size or clinical importance of an effect, and it is not the probability that the null hypothesis is true. No primary-outcome p-value is reported in the registry record, so there is no p-value to interpret for this comparison.
What does randomization contribute?
In general, random allocation is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics at assignment. It does not guarantee identical groups, particularly in a small study, and it does not resolve missing outcome data. A valid interpretation also depends on how participants were assigned, how outcomes were collected, and how the analysis handled deviations and non-response. Details about the randomization procedure and the analysis are not reported in the registry record.
The record labels the model factorial but gives no description of its factors or analysis. In general, a factorial design can examine more than one assigned intervention factor and may estimate both main effects and interactions. An interaction asks whether the effect associated with one factor differs across levels of another. Without the factor definitions and statistical model, the meaning of the factorial label for this study cannot be determined.
What do the planning assumptions mean?
The registry describes planning illustrations based on a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The target effect is described as a stated fraction of the observed effect. These are assumptions for planning calculations, not documented evidence that the trial used those assumptions to set its enrollment target. The registry does not report the protocol's sample-size justification.
Planning calculations ask what sample size might be needed to detect a specified effect under stated assumptions. They are distinct from observed power, which should not be inferred from a completed study's results. Because the primary effect estimate is not reported, the assumptions alone cannot establish whether the study had adequate precision or whether a particular effect was detectable.
The normal approximation is a general mathematical approach that can be useful when its assumptions are appropriate. For continuous outcomes, the relevance of such an approximation depends on the data and the planned analysis. No diagnostic information or statistical plan for assessing its suitability is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists fourteen outcome measures, including the primary burnout measure and secondary outcomes concerning satisfaction with and recommendation of the Arena Strive platform. When a study evaluates multiple outcomes or multiple comparisons, the chance of at least one apparently notable finding can increase if each is tested separately without accounting for multiplicity. In general, prespecified outcome hierarchies or multiplicity adjustments can help control how multiple findings are interpreted.
The registry does not report whether outcomes were prioritized in a testing hierarchy, whether any multiplicity adjustment was planned, or how secondary outcomes were to be interpreted. It records zero analyses, so no adjusted or unadjusted outcome findings are available in this record. The existence of multiple outcomes alone does not show that any particular adjustment was used or required.
The primary outcome description notes a difference in subject number due to non-responders. The number of non-responders, the amount of missing primary-outcome data, and the reasons for non-response are not reported in the registry record. Nor does the record describe imputation, a complete-case analysis, sensitivity analyses, or another approach to missing data.
The analysis population is also not specified. The registry does not state whether analyses were to follow randomized assignment regardless of participation, include only participants with observed outcomes, or use another definition. These distinctions matter because missingness and exclusions can affect both the representativeness of the analyzed participants and the interpretation of a randomized comparison. No conclusion about the handling or impact of missing data can be drawn from the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Arena Strive | 0 | 29 | 0.0% |
| Control Cohort | 0 | 14 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arena Strive | 0 of 29 |
| Control Cohort | 0 of 14 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Arena Strive | 0 of 29 |
| Control Cohort | 0 of 14 |
The registry reports serious adverse event figures separately for Arena Strive and the Control Cohort. For Arena Strive, the serious-event at-risk count is 29 and the number affected is 0; for the Control Cohort, the at-risk count is 14 and the number affected is 0. The registry also records 0 deaths in each cohort. No top serious adverse event terms are listed.
These figures describe what is entered in the registry for the recorded groups. They do not show that no other health events occurred, and they should not be interpreted as proof that an intervention is free of risk. The record does not provide details about event definitions, how events were collected, the observation period for safety, or whether all participants had the same opportunity for follow-up. The serious adverse event figures therefore have a limited scope and do not replace a full safety assessment.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized study of Arena Strive compared with a control cohort, with clinician burnout measured as the primary outcome at Week 16. It provides the score scale and category thresholds, the intervention description, and selected serious adverse event counts. The record does not provide primary-outcome data or any statistical analysis.
Consequently, it is not possible to determine from this record whether burnout scores changed, whether changes differed between groups, or how precise a group comparison might be. This is an absence of reported results, not a finding of no difference. The completed status indicates the study is marked completed in the registry, but does not supply evidence about the outcome.
The registry also lists measures related to physiological resilience, professional fulfillment, self-valuation, satisfaction with the platform, and recommendation of the platform. It does not report analyses for these outcomes. The factorial model is named but its components and results are not described, and the record does not explain how non-responders were handled.
The serious adverse event entries show zero affected participants and zero deaths in each listed cohort, with no top serious-event terms listed. These entries should be read as registry-recorded counts, not as comprehensive evidence that no safety concerns occurred. Overall, the record supports a description of the study's intended question and some design details, but it does not support a statistical conclusion about the intervention's comparative effect.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it illustrates the difference between a completed study record and an interpretable results record. The registry describes a randomized comparison and names a continuous primary outcome, but does not report the group data or a treatment-effect estimate. Without those pieces, readers cannot assess the direction, magnitude, or precision of the comparison.
It also highlights why outcome reporting needs to include more than a scale definition. The MBI score range and interpretation thresholds clarify what the endpoint measures, but they do not reveal what participants scored or whether the groups differed. Group summaries, a clear comparative estimate, and uncertainty measures are needed to make the statistical result interpretable.
The record's note about non-responders raises a related issue: a planned outcome can be difficult to interpret when the number and handling of missing observations are not described. The factorial label and list of multiple outcomes also point to the importance of explaining the analysis structure and how multiple comparisons are addressed. Those details are not reported in the registry record.
These limitations do not establish that the study was poorly conducted. They identify what cannot be evaluated from the registered information. Clear reporting of analysis populations, missing-data methods, outcome estimates, and uncertainty would allow readers to distinguish the study's design from its findings and judge the evidence more fully.
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 registry record contains no primary-outcome values or analysis despite listing the study as completed. It gives no group means, changes, between-group estimate, confidence interval, or p-value for burnout at Week 16. As a result, the primary comparison cannot be evaluated statistically.
The record identifies a factorial model but does not explain its factors, allocation structure, or statistical model. The randomization method and allocation concealment are also not reported in the registry record. The intervention description covers 12 weeks, while the primary outcome timeframe is Week 16; the record does not explain what occurred between those time points.
Non-responders are noted as the reason for a difference in subject number, but the number affected, missing-data approach, and analysis population are not reported in the registry record. In addition, the registry lists fourteen outcome measures but does not describe a multiplicity strategy or provide analyses for the primary and secondary outcomes.
Finally, serious adverse event counts are reported without detail on event collection, definitions, or follow-up. These gaps limit interpretation of efficacy, precision, missingness, and safety from the registry record. They should be understood as reporting limitations, not as evidence about what the full study team may have collected or analyzed elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Arena Labs - Improving Clinician Well Being — NCT05653700.
- Registry record last updated 2024-12-04; status last verified 2023-08.
- Results first posted 2024-12-04.
- 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.
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18. Record Summary
The registry identifies NCT05653700 as a completed randomized study titled Arena Labs - Improving Clinician Well Being. Wake Forest University Health Sciences is listed as sponsor. The study enrolled 43 and compared Arena Strive with a control cohort; masking is listed as none and the model as factorial.
The Arena Strive program is described as a 12-week intervention, and the primary outcome is change in MBI burnout score at Week 16. The registry lists fourteen outcome measures and zero analyses. It notes non-responders but does not report their number or the missing-data approach. Primary outcome results and statistical comparisons are not reported in the registry record.