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 Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3 (NCT04098497), a randomized phase 1 study. The primary outcome is Number of Shortened YMRS Surveys Completed.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04098497 |
| Phase | Phase 1 |
| Condition | Bipolar Disorder, Psychosocial Intervention |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Wisconsin, Madison |
| Results posted | Yes |
2. Clinical Question
Population
People with bipolar disorder taking part in a mobile health study. The registry lists an enrollment of 30 and says all participants were included in the feasibility-outcome analysis. Eligibility details beyond the condition are not reported in the registry record.
Intervention
An acceptance and commitment therapy (ACT)-based microintervention delivered through a mobile app. The study evaluates participants’ responses to this intervention in a mobile health setting.
Comparator
No separate comparator group is listed for the primary outcome. The registry labels the study randomized but also identifies its model as single group. The comparison conditions or decision-time randomization details are not reported in the registry record.
Primary question
Can completion of shortened Young Mania Rating Scale (YMRS) surveys delivered through the app be used to assess feasibility during the study? The primary measure is the number of completed surveys, not a measure of treatment effectiveness.
The broader objective is to develop a mobile platform for delivering a psychosocial intervention for bipolar disorder as an adaptive intervention. This study’s stated aim is to evaluate how individuals with bipolar disorder respond to an ACT-based mobile microintervention. Its registered primary endpoint focuses on whether participants complete app-delivered symptom surveys; it does not directly quantify clinical benefit.
The registry also lists secondary outcomes concerning average changes in digiBP m and d scores and in Toward Energy and Away Energy scores from one decision time point to the next. Those outcomes are described as changes resulting from the intervention, but numerical results and detailed definitions are not reported in the registry record. The registry record therefore supports a feasibility-focused question, while leaving the size and precision of any intervention-related changes unresolved.
3. Trial Design
The registry describes a phase 1, randomized study with no masking and a single-group model. It is also described as a 6-week micro-randomized trial investigating the feasibility of a mobile health platform. These labels describe different aspects of the design: randomization is recorded, while the listed model does not identify a conventional multi-arm comparison. How randomization operated at decision points, and what conditions were compared, are not reported in the registry record.
The registered intervention is a behavioral mobile intervention: an ACT-based microintervention delivered by app. The arm description says participants complete app-based self-reports covering mania, depression, medication adherence, and activity at study time points. The primary feasibility measure concerns completion of the shortened YMRS survey. The registry lists 30 participants and states that participants were planned to receive 84 decision points, with a total possible 2520 surveys delivered.
The primary outcome is the number of shortened YMRS surveys completed during Days 1-43. Secondary outcomes concern changes in mood-related and energy scores between decision time points. The registry lists 8 outcome measures and 6 analyses. The study is marked completed, with a start date of 2019-09-13 and a primary completion date of 2020-10-21.
No separate control group, masking procedure, allocation ratio, detailed randomization schedule, or full statistical analysis plan is reported in the registry record. The design labels alone do not establish whether the primary endpoint was intended to support a treatment comparison. The registered outcome description instead makes survey completion the direct measure of feasibility.
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 recruited from a longitudinal cohort of bipolar disorder, so initial screening was not needed
Overall Study
| Stage | ACT-based Microintervention Delivered by Mobile App |
|---|---|
| STARTED | 30 |
| Initial Interview | 30 |
| Set Up Study App | 29 |
| Logged Symptoms Into Study App at Least Once | 26 |
| Linked Fitbit to Study Database | 27 |
| Used Fitbit | 24 |
| Exit Interview | 29 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants were included in the analysis of feasibility outcomes. 30 participants were planned to receive 84 decision points for a total possible number of 2520 surveys delivered.
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.
| Characteristic | Unit | ACT-based Microintervention Delivered by Mobile App |
|---|---|---|
| Participants analysed | 30 | |
| Age, Continuous | years | 42.70 (SD 11.11) |
| Sex: Female, Male: Female | Participants | 18 |
| Sex: Female, Male: Male | Participants | 12 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 28 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 25 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 30 |
| Diagnosis: Bipolar I | Participants | 24 |
| Diagnosis: Bipolar II | Participants | 6 |
| Diagnosis: Bipolar NOS | Participants | 0 |
| Baseline HRSD Score | score on a scale | 6.20 (SD 5.78) |
| Baseline YMRS Score | score on a scale | 1.83 (SD 3.29) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Shortened YMRS Surveys Completed, measured over Days 1-43.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | completed surveys |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of shortened YMRS surveys completed over Days 1-43. It is intended to assess feasibility by recording completion of the symptom surveys delivered through the mobile app. The registry describes feasibility as average completion, while specifying that the reported measure is the number of completed surveys. A numerical endpoint result is not reported in the registry record.
The shortened app-based measure includes three items from the YMRS: increased energy, rapid speech, and irritability. Each symptom is scored on a 0-3 scale, from absent or normal to severe. The full YMRS is described as an 11-item interview-based measure, with a total score ranging from 0 to 60; higher scores indicate more severe manic symptoms. The app version is a shortened measure, and the primary endpoint is survey completion rather than the symptom score itself.
Completion is useful as a feasibility indicator because it records whether participants engage with repeated app-based assessments. It does not, by itself, establish how symptoms changed, whether an intervention caused a change, or whether the app would be usable in other populations or settings. The registry’s planned survey opportunities provide context for the count, but the number actually completed and the handling of incomplete or unavailable surveys are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry record does not report a numerical result for the primary endpoint. It identifies the outcome as the number of completed shortened YMRS surveys during Days 1-43, but does not state how many were completed, how completion varied across participants, or how the observed count was analyzed. The feasibility question therefore cannot be answered from the registry record alone.
The registry lists an enrollment of 30. Its outcome description says participants were planned to receive 84 decision points, for a total possible 2520 surveys delivered. These are planned opportunities, not an observed completion count. Without the actual number completed and a clear account of the denominator used in analysis, it is not possible to quantify survey completion or characterize its precision.
The study is marked randomized, but the model is listed as single group. A separate comparator group is not listed for the primary endpoint, and the decision-point assignment details are not reported in the registry record. Consequently, the design labels do not establish a basis for interpreting survey completion as a randomized treatment contrast. Nor do the listed secondary outcomes establish that changes in digiBP or energy scores occurred: their numerical results are not reported in the registry record.
The adverse-event record lists 0 serious adverse events among 30 at risk, 10 other adverse events among 30 at risk, and 0 deaths. These are descriptive registry entries. The event definitions, timing, attribution to the intervention, and details of the other events are not reported in the registry record. The figures should not be treated as evidence that an intervention caused or prevented an event.
In general, a confidence interval communicates the range of values compatible with the data under a statistical model and indicates how precise an estimate is. No estimate or confidence interval for the primary outcome is reported in the registry record, so its precision cannot be assessed. Likewise, a p-value or analysis result for the primary endpoint is not reported in the registry record. The available record identifies the planned question and study context, but does not provide the outcome evidence needed to judge the observed feasibility or intervention-related changes.
9. Statistical Methods Explained
What kind of outcome is this? The primary endpoint is a count: the number of shortened YMRS surveys completed during the stated period. Counts differ from continuous measurements such as a symptom score because they record how many events or items occurred. A count can describe overall participation, but its interpretation depends on the opportunities to complete a survey and on how missing opportunities are treated. The registry gives a planned total possible number of surveys, but actual completion results and denominator rules are not reported in the registry record.
What does randomization mean in this setting? In general, randomization assigns participants or decision points to conditions by chance, helping limit systematic differences between the conditions being compared. The registry identifies the allocation as randomized and calls the trial micro-randomized. It also lists the model as single group. The comparison conditions, assignment probabilities, timing of assignments, and analysis that links assignments to outcomes are not reported in the registry record. The word “randomized” alone does not reveal which contrast was estimated or whether a particular analysis preserved the benefits of random assignment.
What does the endpoint measure statistically? The endpoint counts completed surveys rather than measuring the level of manic symptoms. The shortened YMRS items provide symptom ratings, but the primary endpoint is the number of survey completions. A high or low count cannot be inferred from the study’s objective or from its planned opportunities. The number observed, any measure of variation, and any model estimate are not reported in the registry record.
Why might count data need special attention? In general, a simple count model often assumes that the amount of variation in counts follows a particular relationship to the average count. If participants’ counts vary more than the model assumes, the data are over-dispersed. Ignoring over-dispersion can make uncertainty appear too small and statistical evidence appear stronger than it is. Other features can also matter, such as repeated measurements from the same participant and unequal numbers of available survey opportunities. These are general considerations for repeated count outcomes; the statistical model and its assumptions for this study are not reported in the registry record.
How should repeated observations be considered? The study description refers to repeated decision time points and lists outcomes comparing one time point with the next. In general, measurements from the same person are often correlated rather than independent. An analysis may need to account for that dependence, and a micro-randomized design may also require methods suited to repeated random assignments. The registry record does not report the analysis model, correlation structure, weighting, or other details needed to determine how repeated observations were handled.
What can be inferred from the design labels? The registry records phase 1, randomized allocation, no masking, and a single-group model. Phase labels do not by themselves specify the statistical test or the strength of evidence. No masking means the record does not identify a masking procedure; it does not establish how participants’ expectations or outcome reporting were addressed. A single-group label does not establish that all participants received identical assignments at every time point. Details of the treatment and comparison options at decision points are not reported in the registry record.
What would a precision estimate add? In general, a confidence interval around an estimate shows the range of values that remain compatible with the observed data under the analysis assumptions. Its width reflects precision, not whether an effect is important. A p-value addresses compatibility with a specified null hypothesis under a statistical model; it does not measure effect size or prove a hypothesis. No primary-outcome estimate, confidence interval, or p-value is reported in the registry record, so these interpretations cannot be applied to a reported result.
What is the role of sample-size calculations? In general, a sample-size calculation is a planning tool based on an assumed effect, variability, significance level, and design. It is not an observed outcome and does not establish that a study had a particular probability of detecting an effect. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation for an illustration based on a fraction of the observed effect. The record does not report a trial-specific sample-size justification or a numerical planning result for the primary endpoint. Any such planning illustration should not be interpreted as observed power.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures and 6 analyses, including the primary survey-completion outcome and secondary outcomes concerning changes in digiBP m and d scores and Toward Energy and Away Energy scores. When a study assesses multiple outcomes or performs multiple analyses, the chance of at least one apparently noteworthy result can increase if no adjustment or prespecified hierarchy is used. In general, a multiplicity plan can address that issue by defining which outcomes are primary, how comparisons are grouped, or whether significance thresholds are adjusted. A multiplicity procedure or hierarchy is not reported in the registry record.
The primary outcome description states that all participants were included in the analysis of feasibility outcomes. This identifies the stated analysis population for feasibility, but does not explain how missing surveys, missed decision points, withdrawals, or unavailable app data were handled. A missing-data method, including any assumptions or sensitivity analyses, is not reported in the registry record. The record also does not state whether analyses followed an intention-to-treat principle or another analysis population for the secondary outcomes.
These omissions matter because a completion count can be affected by the number of opportunities available and by whether missing assessments are treated as non-completions, excluded, or otherwise handled. The registry’s planned survey opportunities do not establish the denominator used for an observed analysis. Without the analysis population, missing-data rules, and multiplicity plan, the reliability and interpretation of any outcome comparisons cannot be assessed 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 |
|---|---|---|---|
| ACT-based Microintervention Delivered by Mobile App | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| ACT-based Microintervention Delivered by Mobile App | 0 of 30 |
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 |
|---|---|
| ACT-based Microintervention Delivered by Mobile App | 10 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | ACT-based Microintervention Delivered by Mobile App |
|---|---|---|
| Fitbit Specific Device Issues | Product Issues | 9 of 30 |
| Technology Issues | Product Issues | 5 of 30 |
| Sensory Processing Disorder | Nervous system disorders | 1 of 30 |
The registry lists 0 serious adverse events among 30 participants at risk, 10 other adverse events among 30 participants at risk, and 0 deaths. No serious adverse-event terms are listed. These are counts recorded in the registry; they do not identify whether an event was caused by the intervention or whether all events were captured in the same way.
In general, adverse-event counts need context, including the definitions used, the period of observation, the severity and type of each event, and how events were assessed for possible relationship to an intervention. The registry record does not report those details for the listed other events. It also does not provide event-level descriptions or a comparison group for interpreting the counts. Therefore, the figures should be read as descriptive safety entries, not as a causal estimate or a complete characterization of safety.
Zero recorded serious adverse events and zero deaths do not establish that no risk exists. The count of other adverse events does not, by itself, establish a treatment-related harm. The available record supports reporting the listed counts and their limits, without inferring more than they show.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a completed phase 1 study of an ACT-based mobile microintervention for people with bipolar disorder. It identifies survey completion as the primary feasibility outcome and lists several secondary outcomes concerning changes in mood-related and energy scores. It also records enrollment of 30, a planned 84 decision points per participant, and a total possible 2520 surveys delivered.
Those details describe the study’s aims and planned assessment structure; they do not provide the observed primary outcome. The number of surveys completed, the distribution of completion across participants, and the analysis of that count are not reported in the registry record. As a result, the record does not establish whether the survey process met a feasibility target or how precisely completion was estimated. No feasibility threshold is reported in the registry record either.
The registry’s secondary-outcome titles refer to changes from one decision time point to the next, but numerical results are not reported in the registry record. The record therefore does not support a conclusion about the direction, size, or precision of changes in those scores. The stated long-term objective of developing an adaptive intervention is a research objective, not evidence that the intervention was effective.
More generally, a feasibility outcome and an efficacy outcome answer different questions. Survey completion can inform whether repeated app-based assessments were completed; it is not itself proof of symptom improvement. A randomized label also does not, by itself, demonstrate a treatment effect. Interpretation of a causal contrast requires details of the randomized conditions and an appropriate analysis, which are not reported in the registry record.
The adverse-event entries are likewise descriptive and do not establish causation. Overall, the registry record documents the study’s design labels, intended mobile intervention, planned assessment schedule, and selected outcomes. Without numerical primary and secondary results and their analysis details, it does not show how the intervention performed or how certain any estimated effect would be.
13. Why This Trial Matters Statistically
This study raises a statistical question that is central to adaptive interventions: how to evaluate an intervention delivered repeatedly within a person while also measuring what happens over time. A micro-randomized design can, in general, support questions about intervention effects at decision points, but the estimand and analysis depend on how randomization and outcomes are defined. The registry identifies the study as randomized and micro-randomized, yet the relevant assignment details and analysis are not reported in the registry record.
The primary endpoint also highlights a practical distinction between collecting a measure and measuring a clinical outcome. Counting completed app surveys can describe engagement with repeated assessment. It does not directly establish a change in symptoms. Keeping those questions separate helps prevent a feasibility measure from being interpreted as evidence of clinical benefit.
The planned structure gives context for understanding the intended measurement burden: the registry states 84 decision points per participant and a total possible 2520 surveys. To interpret completion meaningfully, a reader would also need the observed count, the number of opportunities actually available, and the way missed assessments were handled. Those results and rules are not reported in the registry record.
The record also illustrates why transparent reporting of analysis plans matters. Multiple outcomes and repeated observations can require clear definitions of the target contrast, handling of within-person dependence, missing-data procedures, and multiplicity. These are general statistical considerations; the corresponding details for this study are not reported in the registry record. The study’s stated aim is important for developing adaptive-intervention methods, but the available registry information does not supply the results needed to assess its statistical findings.
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 interpreting this trial is the absence of numerical results for the primary endpoint in the registry record. The outcome is defined, but the number of completed surveys and its variability are not reported. This prevents assessment of the observed feasibility and its precision. The planned survey opportunities do not substitute for observed completion data.
The registry identifies randomized allocation and a single-group model, but it does not report the conditions assigned at decision points, assignment probabilities, or the contrast targeted by the analysis. This makes it difficult to determine what treatment effect, if any, the design was intended to estimate. The presence of a randomized label alone does not resolve that ambiguity.
The record does not report the statistical model, handling of repeated observations, missing-data methods, or multiplicity procedures. Those details are especially relevant because the study concerns repeated assessments and lists several outcomes and analyses. Numerical results for the listed secondary outcomes are also not reported in the registry record.
The primary measure is survey completion, not the symptom score itself. The registry describes the shortened YMRS items but does not report symptom-score results for the primary outcome. This limits what can be learned about clinical change from the endpoint as registered. Eligibility criteria, the characteristics of the enrolled participants, and details about adherence to intervention delivery are not reported in the registry record, limiting assessment of how findings might apply beyond the study population.
Finally, adverse-event entries are provided as aggregate counts without event descriptions, observation details, or attribution. They cannot establish a causal safety profile. These limitations concern what can be interpreted from the registry record; they do not imply that the unreported analyses were not conducted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3 — NCT04098497.
- Registry record last updated 2022-01-03; status last verified 2021-12.
- Results first posted 2022-01-03.
- 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
NCT04098497 is a completed phase 1 study titled “Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3.” The registry describes a 6-week randomized micro-randomized trial, with no masking and a single-group model, evaluating an ACT-based mobile app intervention for bipolar disorder. The listed enrollment is 30.
The primary outcome is the number of shortened YMRS surveys completed during Days 1-43. The registry states that participants were planned to receive 84 decision points, for a total possible 2520 surveys delivered. It lists 8 outcome measures and 6 analyses. Numerical results for the primary and secondary outcomes are not reported in the registry record.
The adverse-event entries list 0 serious events, 10 other events, and 0 deaths. Details of event types, attribution, missing-data handling, and statistical analysis methods are not reported in the registry record.