Behavior, Biology and Well-Being Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Behavior, Biology and Well-Being Study (NCT05183867), a randomized na study. The primary outcome is Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score.

2. Clinical Question

The scientific question is therefore identifiable from the design and outcome description, but its answer cannot be inferred from the registry information summarized in the record. The registry entries establish what was intended to be compared and what was measured; they do not establish the direction, size, or precision of any between-group difference.

3. Trial Design

The registry record describes a randomized, double-masked, parallel-group trial. Participants were assigned to the Healthy Minds Program app, a psychoeducation app, or usual care. The allocation entry is randomized, and the model is parallel. The record does not explain which people were masked or how masking was implemented, so those details are not reported in the registry record.

The HMP arm involved access to a 4-week Foundations module. The active control used the HMP didactic material without guided meditation practices. The usual-care group was to receive HMP after the study and was encouraged to continue its usual care. These descriptions distinguish the intended intervention components, but the registry does not report adherence, actual use of the apps, or whether participants received every intended component.

The primary outcome timeframe includes baseline, weekly measurements during the 4-week intervention period, and a 3 month follow-up. This repeated measurement structure can describe outcomes across the intervention and follow-up period, but the registry record does not report how the repeated observations were incorporated into an analysis.

The record lists an enrollment of 1157 and a completed status. Its brief summary describes a plan involving 1100 participants. These are separate entries in the record; the reason for the difference is not reported in the registry record. The record also lists 43 outcome measures and zero analyses. No protocol-specific statistical plan, allocation details beyond randomization, or explanation of the completed status is 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Some participants did not provide data at all time points.

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 Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score, measured over Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up.

The primary endpoint is depression symptoms measured by the Patient Health Questionnaire - 8 (PHQ-8) score. The record describes the PHQ-8 as an 8-item questionnaire asking how often participants were bothered by specific problems in the past 2 weeks. Each item uses a 4-point Likert scale, from 0 for not at all to 3 for nearly every day. The total score ranges from 0-24, with higher scores indicating more depressive symptoms.

A questionnaire score provides a standardized way to represent participants’ reported symptoms and to compare measured outcomes across study groups and time points. A mean is the registry’s stated summary parameter, and the standard deviation is the stated measure of dispersion. In general, the mean describes the group’s average score, while the standard deviation describes how spread out individual scores are around that average. These summaries do not by themselves reveal how scores changed for each participant or whether a difference between groups is precise.

The planned timeframe spans baseline, week 1, week 2, week 3, week 4 of intervention, and 3 month follow-up. The registry record does not report numerical PHQ-8 means, standard deviations, changes from baseline, or between-group estimates at these times. It also does not report a threshold for interpreting a score change as clinically important.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies randomization, double masking, a parallel model, a mean outcome parameter, and standard deviation as the dispersion measure. These entries describe broad features of the design and intended outcome summary. They do not specify the full statistical methods used to analyze the trial. The statistical plan, model terms, comparison hierarchy, covariate adjustment, and approach to repeated measurements are not reported in the registry record.

What does randomization contribute?

In general, random assignment is intended to make study groups comparable at the outset, on average, with respect to both measured and unmeasured characteristics. It does not guarantee that every characteristic will be balanced in a particular trial. Comparing randomized groups can support an estimate of the effect of assignment to the study conditions, but interpretation still depends on the analysis population, adherence, missing outcome data, and the analysis method. The record confirms randomization but does not report the allocation sequence or any baseline comparison results.

What do mean and standard deviation describe?

For a continuous score such as the PHQ-8, a group mean gives the average score among the observations included in that summary. The standard deviation describes variability among those scores. In general, neither statistic alone gives the uncertainty in a between-group contrast. That uncertainty depends on the amount of observed information and the method used to estimate the contrast. The registry record names the summary parameter and dispersion measure but does not include the actual PHQ-8 summaries.

Why do repeated measurements matter?

The PHQ-8 timeframe includes baseline, weekly assessments over the intervention period, and follow-up. Repeated measurements allow a study to examine how scores are distributed at several points rather than at a single endpoint. General statistical methods for repeated observations need to account for the fact that measurements from the same participant may be related. They also need to define which time points and contrasts are central to the question. The registry record does not report the model used, whether baseline was included in an adjusted analysis, or how within-participant dependence was handled.

How should uncertainty be read?

In general, a confidence interval describes uncertainty around an estimate under the assumptions of the statistical method. A narrow interval indicates greater precision than a wide interval, but precision is distinct from whether an effect is important. A p-value addresses compatibility between the data and a specified null hypothesis under a particular model; it is not a measure of the probability that a treatment works. The record does not report a confidence interval, p-value, or formal primary comparison, so no inference of this kind can be made from the registry entries.

What is the role of a planning illustration?

The described sample-size illustrations are planning calculations based on an observed effect, rather than the trial’s original design justification. Their assumptions include a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the target effect is expressed as a stated fraction of the observed effect. For time-to-event outcomes, such calculations would describe total events, while other outcomes are expressed as participants per arm. This trial’s primary measure is a continuous score, so the stated general distinction indicates how to interpret the units of a planning calculation.

Such calculations are prospective planning illustrations, not observed power. They do not show the probability that the completed trial detected an effect, and they do not replace an effect estimate with uncertainty from the trial itself. The underlying observed effect, the particular fractions used, and numerical planning results are not reported in the registry record. No planning illustration can therefore be interpreted as an outcome finding for this comparison.

What statistical details remain unknown?

The registry record does not report the exact inferential test, confidence-interval method, sidedness of the primary test, model specification, handling of deviations from assumptions, or approach to multiple comparisons. It also does not say whether analyses were adjusted, whether an intention-to-treat population was used, or whether any sensitivity analyses were conducted. These omissions do not establish that the study did not use such methods; they mean that the methods are not reported in the registry record.

General statistical interpretation should distinguish the trial’s design from its analysis and its numerical results. The design specifies randomized groups and repeated PHQ-8 measurement. The analysis would turn observed scores into estimates and uncertainty measures. The posted the registry entries describe the design but do not provide those estimates or the analysis details needed to evaluate them.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 43 outcome measures, including the primary PHQ-8 outcome and secondary outcomes such as anxiety symptoms, sleep disturbance, flourishing, awareness, connection, decentering, meaning in life, and pain intensity. Multiple outcomes and multiple measurement times create several possible statistical comparisons. In general, testing many comparisons can increase the chance of at least one apparently notable result when all null hypotheses are true. Methods such as designating a primary outcome, controlling a family-wise error rate, or using a false-discovery approach can address different multiplicity concerns. The registry record does not report a multiplicity strategy, testing hierarchy, or adjustment method.

The record gives the primary outcome timeframe as baseline, week 1, week 2, week 3, week 4, and 3 month follow-up. It does not identify which time point or contrast is the principal treatment comparison, nor does it state how repeated time points were handled in statistical testing. It also reports zero analyses, so no inferential results or analysis-specific multiplicity decisions are available in the registry record.

For missing data, the primary outcome description says that some participants did not provide data at all time points. This establishes that complete follow-up observations were not available for everyone, but it does not specify the number missing at each time, the reasons for missingness, or the groups and outcomes affected. The record does not report whether missing scores were imputed, whether available observations were analyzed, or whether sensitivity analyses assessed departures from assumptions about missingness.

The analysis population is also not reported in the registry record. The registry does not state whether the primary analysis included all randomized participants, only participants with observed outcome data, or another defined population. These details matter because exclusions and missing-data assumptions can affect the interpretation of a group comparison. The available information supports noting these uncertainties, not choosing an analysis approach on the study’s behalf.

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 safety entries list serious adverse events, other adverse events, and deaths by study group. For the Healthy Minds Program app, the record lists 462 at risk, 0 serious adverse events, 78 under other adverse events, and 0 deaths. For the psychoeducation app, it lists 463 at risk, 0 serious adverse events, 64 under other adverse events, and 0 deaths. For usual care, it lists 232 at risk, 0 serious adverse events, 44 under other adverse events, and 0 deaths.

These are the counts recorded in the registry. They should not be turned into rates or compared by calculating proportions. The record does not define the other-adverse-event category in detail, describe event severity or timing, or explain whether the counts represent participants, events, or a particular reporting window. Serious adverse event counts of 0 and death counts of 0 mean none were recorded in those fields; they do not establish that no event of any kind occurred. The other-adverse-event entries are distinct registry fields and should not be conflated with serious events.

The record lists no serious-event terms. Safety entries alone do not answer the primary question about PHQ-8 scores, and they do not provide a complete benefit-harm assessment.

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

The registry record makes the trial’s intended comparison understandable: a meditation-based app was compared with a psychoeducation app without guided meditation and with usual care, using depression symptoms as the primary outcome. The PHQ-8 provides a defined score with higher values indicating more depressive symptoms. The trial is recorded as randomized, double-masked, parallel, and completed.

Those design details do not reveal the outcome. The record contains no numerical primary results, no estimated group contrast, and no uncertainty interval or p-value. It is therefore not possible from these registry entries to say whether PHQ-8 scores differed between groups, whether scores changed over time, or how precisely any difference was estimated. No conclusion about efficacy should be drawn from the registry design or completion status alone.

Nor does the absence of reported numerical results demonstrate that there was no effect. It means the registry information available for this description does not report the estimates needed to assess the question. The listed adverse-event counts are safety information, not a substitute for missing symptom results. Likewise, the number of registered outcome measures does not indicate which findings were favorable or statistically notable.

In general, a clinical trial result is best interpreted through the estimated effect, its precision, the analysis population, the handling of missing data, and the outcome’s clinical meaning. The registry record does not supply those elements for the primary comparison. The available evidence therefore supports a careful account of the question and methods, but not a verdict about whether the intervention changed depression symptoms relative to either control.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it distinguishes an intervention component from the surrounding educational content. The HMP app includes guided meditation practices, while the active psychoeducation control retains didactic content but removes those practices. The usual-care arm provides a further comparator. This arrangement frames a question about the whole app and a more specific contrast involving the guided practices, although the registry record does not report the estimates needed to answer either comparison.

The outcome plan also includes repeated PHQ-8 assessments across baseline, the 4-week intervention period, and 3 month follow-up. Repeated measurement can be informative about both the timing and persistence of observed differences, but it requires clear specification of the primary time point, contrasts, and analysis of correlated observations. Those analysis details are not reported in the registry record.

The listed secondary outcomes cover several domains, including anxiety, sleep, flourishing, awareness, connection, decentering, meaning in life, and pain intensity. This breadth highlights the importance of prespecifying priorities and explaining how multiple outcomes are interpreted. The record lists 43 outcome measures but does not report a multiplicity plan or results for those measures.

Finally, the primary outcome description notes that some participants did not contribute data at every time point. This makes the missing-data strategy an important part of interpreting any eventual repeated-measures comparison. Because the registry record reports zero analyses and no numerical primary results, it illustrates a distinction central to biostatistics: a well-defined trial question and design are not the same as an interpretable treatment-effect estimate.

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.

A key limitation of the available registry information is the absence of numerical results for the primary PHQ-8 outcome. The record does not provide group summaries, treatment contrasts, confidence intervals, p-values, or the results of analyses across the stated time points. This prevents assessment of effect size, precision, and direction.

The registry records 1157 as enrollment, while the brief summary describes a planned trial involving 1100 participants. The reason these entries differ is not reported in the registry record. The number contributing data to each PHQ-8 time point is also not reported, and the record notes that some participants did not provide data at all time points.

Important analysis details are not reported in the registry record, including the primary contrast and time point, the statistical model, adjustment choices, analysis population, handling of missing observations, and any multiplicity strategy. The registry’s double-masking entry does not identify who was masked or how masking was maintained. Intervention adherence, app use, and deviations from intended assignment are also not described in the registry record.

The adverse-event entries provide counts but not fuller definitions, timing, severity, or a detailed account of the reporting process. No serious-event terms are listed. The record’s completed status and its design description cannot fill these information gaps. These limitations concern what can be interpreted from the registry record; they do not establish that unreported procedures or results do not exist elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Behavior, Biology and Well-Being Study — NCT05183867.
• Registry record last updated 2026-09-21; status last verified 2026-08.
• Results first posted 2025-08-01.
• 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

NCT05183867 is the registry identifier for the Behavior, Biology and Well-Being Study, whose official title describes comparing the Healthy Minds Program with an active control and waitlist control in depression. The sponsor is the University of Wisconsin, Madison. The registry lists the study as randomized, double-masked, parallel, and completed. Its enrollment entry is 1157.

The intervention is the Healthy Minds Program app. Comparators are a psychoeducation app without guided meditation practices and usual care, with access to HMP after the study described for the usual-care group. The primary outcome is PHQ-8 depression symptom score, assessed from baseline through the intervention period and at 3 month follow-up. The record lists secondary outcomes across several well-being and symptom domains and reports 43 outcome measures.

Although the study is recorded as completed, the registry record reports zero analyses and does not provide numerical primary outcome results or the statistical details needed to interpret a treatment contrast. It notes that some participants did not provide data at all time points. The listed safety entries show zero serious adverse events and zero deaths in each group, alongside counts for other adverse events.