Smartband Mindfulness Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Smartband Mindfulness Study (NCT03995225), a na na study. The primary outcome is Fidelity of Detecting Smoking Episodes.

2. Clinical Question

The study’s stated purpose was to determine treatment fidelity for a smartband and smartphone-based smoking-monitoring, notification, and brief mindfulness intervention. This is primarily a question about whether the monitoring and notification process functions as intended during use. It is distinct from asking whether the intervention causes a change in smoking behavior compared with another treatment.

The registry lists self-reported abstinence from smoking as a secondary outcome. However, the numerical result for that outcome is also not reported in the registry record. The listed endpoint and study description therefore identify what the investigators aimed to assess, but they do not establish the system’s detection performance or an effect on abstinence. With one study arm and no reported primary endpoint estimate, interpretation must focus on the study’s intended measurement and the limits of the available results.

3. Trial Design

NCT03995225, titled “Smartband Mindfulness Study,” is a completed behavioral study sponsored by Yale University. Its official title describes a smartband and smartphone-based approach to automatic smoking detection and real-time mindfulness intervention. The registry record lists the study as a single-group design, with one arm called “Smokers.” Enrollment was 155. Allocation and phase are listed as not applicable, and masking is listed as none.

Participants in the one arm were described as wearing a smartband to monitor, record, and notify them of smoking events, while receiving brief, real-time mindfulness exercises through a smartphone app. Because the record describes no separate comparator arm, the design does not support a direct comparison between the intervention and a control condition. It is therefore important to distinguish the study’s feasibility or fidelity question from a randomized test of treatment efficacy.

The study’s stated primary endpoint concerns the fidelity of detecting smoking episodes. The endpoint description specifies the first 60 days of wearing the smartband and includes the percentage of smoking episodes detected and the rate of false alarms. Self-reported abstinence from smoking is listed as a secondary outcome. The registry record lists 10 outcome measures, but the numerical results for these measures are not reported in the registry record.

The listed start date was 2020-11-22, and the primary completion date was 2022-03-03. The overall status is completed. Completion indicates the recorded study status; it does not by itself provide the endpoint estimates or establish how completely participants contributed data. Details about the protocol, the basis for the enrollment target, and the analysis populations 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: 155 participants completed onboarding and were considered enrolled and provided demographics data. Of these, 154 participants completed the baseline survey. Of these, 115 participants wore the smartband for at least one day. A modified intent to treat sample was analyzed for outcomes, defined as participants who completed onboarding and wore the smartband for at least one day (N=115).

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.

Population: Demographics were reported at enrollment, prior to the baseline survey, and therefore are reported for the enrolled sample (N=155).

6. Primary Endpoint

The registry lists the primary outcome as Fidelity of Detecting Smoking Episodes, measured over 60 days.

The primary endpoint is titled “Fidelity of Detecting Smoking Episodes.” It is a continuous measure summarized as a mean with a standard deviation, and its unit is percentage of events. The endpoint description refers to the percentage of smoking episodes detected and the rate of false alarms during the first 60 days of smartband use. It is intended to assess how closely the monitoring system’s detection and notification process performs during use.

Detection and false alarms capture different aspects of monitoring fidelity. The percentage detected concerns whether smoking episodes are identified by the system. False alarms concern notifications or detections that do not correspond to the intended event. Considering both aspects is relevant because a system could identify many true events while also producing unnecessary alerts, or could avoid alerts while missing events. This is a general explanation of why both measures can matter; it is not a claim about the results of this study.

The registry record does not report the observed mean, standard deviation, or a numerical false-alarm rate. It also does not report the number of smoking episodes contributing to the endpoint or the endpoint’s detailed operational definitions. Consequently, the endpoint description identifies the intended measurement, but the registry record does not permit assessment of the system’s observed detection performance or the precision of an estimate.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group behavioral study and a continuous primary endpoint summarized as a mean and standard deviation. These design and measurement labels indicate the general form of the analysis, but the registry record does not report a numerical endpoint estimate or a detailed statistical analysis plan. General explanations below describe what these methods mean; they do not imply that any unreported analysis was performed.

What does a mean describe?

A mean is an average across the observations included in an analysis. For this endpoint, the stated unit is percentage of events, and the mean would describe the average value of the measured detection-fidelity outcome in the analyzed data. The interpretation depends on the precise definition of the observation and the denominator used. The endpoint description identifies the percentage of smoking episodes detected and the rate of false alarms, but more detailed operational definitions and the actual mean are not reported in the registry record.

A mean alone does not show whether observations were similar or widely spread. The standard deviation is a descriptive measure of that spread. A small standard deviation, in general, indicates observations closer to the mean; a larger one indicates more variability. It is not the same as the uncertainty in the mean. The registry record lists standard deviation as the dispersion measure but does not report its value.

What would uncertainty measures add?

In general, a confidence interval describes a range of values compatible with the data and a specified statistical procedure, and can help readers judge the precision of an estimate. A p-value addresses compatibility between data and a statistical null model under stated assumptions; it is not a measure of clinical importance or the probability that a hypothesis is true. Neither a confidence interval nor a p-value for the primary endpoint is reported in the registry record. Without an estimate and its uncertainty, the detection-fidelity result cannot be evaluated for precision.

The record lists sample-size planning assumptions for illustrative calculations: 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 the observed effect. It also distinguishes event totals for time-to-event illustrations from participants per arm for other illustrations. These are planning conventions, not observed results, and they do not describe the actual single-group study design. The registry record does not report the study’s own sample-size justification or the numerical inputs and outputs for the planning illustrations. Any such sample-size illustration is not observed power and should not be interpreted as evidence about the precision or success of the study.

Why does the single-group structure matter?

A single-group study can describe observations within the enrolled group, such as detection performance during monitoring. It does not provide a concurrent control group for separating an intervention-associated change from other influences. General sources of change could include participants’ behavior over time or differences in how much monitoring data are collected. These are general considerations, not findings about this study. The record’s allocation is listed as not applicable, and the study model is single group.

Because the endpoint concerns smoking events, the amount of usable monitoring and the number of events could affect how much information is available. Repeated events from the same participant may also be statistically related rather than independent. In general, analyses need to account for the structure of the observations when relevant. The registry record does not report event counts, the analytic unit, or methods for handling within-participant dependence, so it is not possible to determine how these issues were addressed.

What does over-dispersion mean in general?

For event-based measurements, over-dispersion means that the observed variability is greater than a simple statistical model expects. If present and ignored, uncertainty estimates may be too optimistic. This is a general methodological point, not a claim that over-dispersion occurred in this study. The record does not report a model for event counts, a dispersion assessment, or an analysis of false alarms.

What can be concluded from the analysis information?

The registry lists 10 outcome measures and zero analyses. The numerical outcome estimates and inferential results are not reported in the registry record. The record also does not report whether analyses were adjusted, whether any interim analyses were conducted, or which covariates were included. No statistical model, missing-data method, or prespecified analysis population is described in the registry entries. These details should not be inferred from the endpoint’s summary-statistic labels or from the planning assumptions.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, including the primary fidelity endpoint and self-reported abstinence from smoking as a secondary outcome. When a study examines multiple outcomes or multiple statistical tests, the chance of finding at least one apparently notable result can increase. General methods for addressing multiplicity include defining a primary outcome in advance, adjusting significance thresholds, or treating secondary results as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among outcomes, or the statistical tests used.

The registry records zero analyses, and numerical results for the primary and secondary outcomes are not reported in the registry record. It is therefore not possible to determine whether all listed outcomes were analyzed, whether the analyses followed a prespecified plan, or whether results were adjusted for multiple comparisons. The study’s protocol and statistical analysis plan are not reported in the registry record.

Missing-data handling is also not reported in the registry record. The enrollment figure of 155 does not establish how many participants contributed data to each outcome, whether participants stopped monitoring, or how incomplete monitoring periods were handled. For event-based detection outcomes, incomplete observation could affect the number of smoking episodes available for assessment. This is a general consideration; the record does not state whether it occurred.

Analysis populations are not reported in the registry record. The available information does not specify whether results were intended for all enrolled participants, participants who wore the device, or a defined subset with sufficient monitoring data. Without these details and endpoint results, readers cannot assess the extent of missingness or the robustness of findings to alternative analysis choices.

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.

The adverse-event figures list 155 participants at risk for serious adverse events and zero affected, 155 at risk for other adverse events and zero affected, and zero deaths. These are the counts recorded for the “Smokers” group. The registry lists no top serious adverse-event terms.

These entries should be read as the registry’s reported counts, not as evidence that every possible safety outcome was measured or that no event occurred outside the reporting definitions or observation period. The registry entries do not specify the adverse-event collection procedures, the observation period for these safety counts, or whether events were assessed as related to the intervention. Such details are not reported in the registry record.

The serious-event count and the other-event count are separate categories in the record. The zero counts do not provide information about detection fidelity or smoking abstinence, which are distinct outcomes. Nor do these figures permit comparison with another group, because the study had only one arm. They describe the adverse-event reporting for this group and should not be interpreted as a comparative safety estimate.

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

The registry record establishes that NCT03995225 was a completed, single-group study of a smartband and smartphone-based smoking-monitoring and brief mindfulness intervention. It identifies the primary measurement as fidelity of detecting smoking episodes during the first 60 days, including the percentage of episodes detected and the rate of false alarms. This describes the question the study set out to address.

The primary endpoint’s numerical result is not reported in the registry record. As a result, the record does not show the observed detection percentage, the false-alarm rate, or the variability and precision of these measures. The listed mean and standard deviation are the planned summary form, not reported findings. The record also lists self-reported abstinence as a secondary outcome, but its numerical result is not reported in the registry record.

The single-group design means there is no concurrent control group in the record for a between-group comparison. Accordingly, the registry entries do not support a causal estimate of the intervention’s effect relative to another condition. Even if an outcome estimate were available, interpretation would need to account for the absence of a comparator and for details such as event counts, monitoring completeness, and analysis methods. Those details are not reported in the registry record.

The record lists an enrollment of 155 and zero adverse-event counts in the recorded categories. These figures describe enrollment and reported safety counts; they do not fill the gap in primary endpoint results. A completed status likewise does not supply missing numerical outcomes. The most defensible conclusion is that the registry describes a study designed to assess monitoring fidelity, but the registry entries do not permit a judgment about the observed detection performance or smoking abstinence.

13. Why This Trial Matters Statistically

This study raises a statistical question that differs from a conventional comparison of two treatments: how well a wearable system identifies the events it is intended to monitor. For a monitoring intervention, both missed events and false alarms can matter. Clear definitions of the event, the detection window, and the denominator are important for interpreting a percentage-of-events endpoint. The registry record gives the broad endpoint description and a 60-day timeframe, but not the numerical results or detailed operational definitions.

The study also illustrates why design and outcome must be considered together. A single-group design can be used to describe performance during use, but it does not provide a like-for-like control comparison for a treatment effect. The study’s stated goal of determining treatment fidelity is therefore analytically distinct from establishing whether the intervention changes smoking behavior. Self-reported abstinence is listed as a secondary outcome, yet its result is not reported in the registry record.

Event-based monitoring can create data structures in which multiple observations come from the same participant. In general, event counts, observation time, missing monitoring, and within-participant dependence can influence uncertainty estimates. The registry record does not report these analytic details, making it impossible to assess how the fidelity endpoint was calculated or how precisely it was estimated.

Finally, a registry record can identify study status, design, outcomes, and enrollment without reporting endpoint findings. Here, the completed status and the stated measurement objective are available, while the primary result and statistical analysis details are not reported in the registry record. That distinction is important: knowing what investigators intended to measure is not the same as knowing what they observed.

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 principal limitation for statistical interpretation is that numerical results for the primary endpoint are not reported in the registry record. The mean, standard deviation, percentage of events detected, and false-alarm rate are unavailable in the listed details. Consequently, neither the size of the observed performance nor its precision can be assessed.

The study is described as single group with one arm and no masking. There is no like-for-like control comparison in the record, limiting interpretation of changes in outcomes as effects attributable to the intervention. The record also does not report the number of participants contributing endpoint data, the number of smoking episodes monitored, or the amount of usable observation for each participant.

The endpoint description does not provide detailed definitions for a smoking episode, a detected event, or a false alarm. The registry record does not report how device or app nonuse, incomplete monitoring, or repeated observations were handled. Missing-data methods, analysis populations, and the statistical model are also not reported in the registry record.

Although 10 outcome measures are listed, the record provides no outcome estimates or analysis results and records zero analyses. Multiplicity handling and the relationship between the stated primary and secondary outcomes are not reported in the registry record. The listed enrollment does not establish the effective sample size for any endpoint, and the planning assumptions do not substitute for the study’s own sample-size justification, which is not reported in the registry record.

These limitations concern what can be inferred from the registry record. They do not establish that the study lacked additional procedures or analyses; those details are simply not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Smartband Mindfulness Study — NCT03995225.
• Registry record last updated 2024-02-15; status last verified 2024-02.
• Results first posted 2023-11-21.
• 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

NCT03995225 is a completed, single-group behavioral study sponsored by Yale University, with an enrollment of 155. The intervention combined a smartband for smoking-event monitoring and notification with brief mindfulness exercises delivered through a smartphone app.

The primary endpoint concerns fidelity of detecting smoking episodes, including the percentage detected and the rate of false alarms during the first 60 days. Self-reported abstinence from smoking is listed as a secondary outcome. The registry lists 10 outcome measures and zero analyses, but numerical outcome results are not reported in the registry record.

The record reports zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths among 155 listed at risk in each adverse-event category. A separate comparison group, detailed analysis methods, missing-data procedures, and numerical primary endpoint results are not reported in the registry record.