mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder (NCT06701123), a non-randomized early/phase 1 study. The primary outcome is Cravings.

2. Clinical Question

3. Trial Design

The registry lists this study as early phase 1, completed, nonrandomized, unmasked, and parallel. Enrollment is listed as 125. The start date is 2023-07-01 and the primary completion date is 2024-10-01. These registry descriptors do not establish how many people contributed data to the craving analysis, or whether everyone enrolled was included in each analysis; those details are not reported in the registry record.

The listed intervention is a uMAT-R mobile app with a coaching component. The experimental group is described as having access to a coached program on the app. The control group is described as having access to uMAT-R but not engaging with it. Providers are also listed in the adverse-event information, but the record does not describe them as a comparison group for the primary outcome. The posted design is parallel, meaning the record presents groups rather than a crossover sequence; details of the timing of group assignment and outcome collection beyond the primary outcome timeframe are not reported in the registry record.

There is a notable inconsistency in the record: its brief summary refers to a pilot randomized controlled trial, but the allocation field says nonrandomized. The stated analysis cautions that the arms are not a like-for-like control comparison. Accordingly, the design should be read using the nonrandomized allocation description, while recognizing that the summary uses different language. The registry does not report why allocation was nonrandomized, how participants entered each group, or whether any adjustment was planned to address differences between groups.

The registry lists 2 outcome measures and 2 analyses, but the details available for the primary outcome do not include result values or the statistical analysis plan. Study status is completed, but completion status alone does not indicate that outcome results were posted or that a particular analysis was conducted.

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: Please note that outcome results are only included for pregnant and postpartum participants. Due to challenges recruiting pregnant and postpartum individuals, all pregnant and post-partum participants recruited were enrolled in the Aim 3 RCT and that sample is reported here.

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.

6. Primary Endpoint

The registry lists the primary outcome as Cravings, measured over Baseline, 1 month.

The primary outcome is craving, measured with a score on a scale from 0 to 30 at baseline and 1 month. The registry describes an adaptation of the Penn Alcohol Craving Scale for opioid craving. Although the original measure is described as having 5 items, this study’s version included 3 items concerning current craving, desire prompted by environmental reminders, and the likelihood of use in a familiar setting. Each item is scored from 0 to 10 and summed; higher total scores indicate greater craving and a worse outcome according to the registry description.

Craving is relevant to the study’s stated focus on recovery and support for medication-assisted treatment. A repeated assessment can describe scores at baseline and at the 1-month follow-up, and a comparison may examine whether scores differ between the listed groups. That kind of comparison requires the actual group results and a clear account of the analysis. Neither the mean scores nor standard deviations, changes, comparison estimates, confidence intervals, or p-values are reported in the registry record. The endpoint’s definition therefore explains what was intended to be measured, but does not establish what happened to participants’ scores.

The registry identifies the outcome as a mean of a continuous measure and names the standard deviation as its dispersion measure. It does not report how missing item responses were handled or how a total score was formed when an item was unanswered.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies craving as a continuous outcome summarized by a mean and standard deviation. General explanation: a mean describes the average score in a group, while a standard deviation describes how spread out individual scores are around that average. Neither measure alone describes the uncertainty in a group comparison. To assess a difference, an analysis would ordinarily report an estimate and some measure of its uncertainty, such as a confidence interval. The registry record does not report the primary outcome values or a comparison estimate.

What does a continuous outcome comparison describe?

General explanation: a comparison of means can describe how far apart group averages are on the outcome scale. For a repeated measure such as baseline and 1 month, possible approaches include comparing follow-up scores while accounting for baseline, or comparing within-person changes. These approaches answer related but not identical questions and can rely on different assumptions. The registry record does not report which approach was used, whether baseline scores were adjusted for, or how repeated measurements were handled. No comparison should be attributed to the investigators without those details.

The score is constructed from 3 items, each scored from 0 to 10, and summed to a total score from 0 to 30. General explanation: summing items creates a scale in which larger totals represent more of the measured construct, here greater craving as described in the registry. Interpretation depends on consistent measurement and handling of incomplete item responses. The registry does not report reliability results, a threshold for a clinically meaningful change, or missing-item rules. The score definition alone does not show whether a difference between groups occurred or whether a difference would be meaningful to participants.

Why does allocation matter?

General explanation: random allocation is intended to make groups comparable, on average, with respect to both measured and unmeasured factors. In a nonrandomized study, group membership may be related to characteristics that also influence the outcome. This can make a group difference difficult to attribute to the intervention. Here, the allocation is listed as nonrandomized, and the registry warns that the arms are not a like-for-like control comparison. The record does not report covariate adjustment, matching, weighting, or another strategy for addressing potential group differences. It also does not report whether such methods were part of the investigators’ analysis plan.

The brief summary’s reference to a pilot randomized controlled trial conflicts with the nonrandomized allocation designation. This makes it especially important to distinguish the summary’s wording from the design field and from the posted caution about comparability. The registry record does not explain the discrepancy.

What does the planning illustration mean?

The registry describes sample-size planning illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is a stated fraction of the observed effect. General explanation: a planning calculation estimates the sample size that would be needed to detect a specified effect under chosen assumptions. Changing the target effect or assumptions changes the planning result. Such calculations do not show that an effect was detected in the completed study, and they are not observed power. The numerical effect and planning results are not reported in the registry record details, so no particular planning value can be interpreted.

General explanation: power is a design quantity tied to an assumed effect, variability, significance level, and analysis. It is not a measure of how persuasive the actual results are after data collection. The registry’s description of a planning illustration should therefore not be read as proof that the study had adequate power for its primary question. The record does not report a sample-size justification or the assumptions used in the original trial design.

What information is missing for statistical interpretation?

The registry record does not report the statistical analysis plan, the test or model used for the primary outcome, any adjustment variables, or how within-participant measurements were incorporated. It also does not report confidence intervals, p-values, diagnostics, or whether assumptions were assessed. General explanation: model assumptions matter because the reliability of estimates and uncertainty measures depends on the method fitting the data structure reasonably well. For example, repeated observations from the same person are related and should not automatically be treated as independent.

The record lists 2 outcome measures and 2 analyses, but does not provide enough detail to determine how they were selected, whether any outcomes were secondary or exploratory, or how multiple comparisons were handled. It does not report analysis populations, exclusions, or missing-data procedures. Those omissions prevent a fuller evaluation of reproducibility and the statistical strength of any reported result. They do not establish that the investigators failed to perform these steps; they mean the information is not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures and 2 analyses. The primary outcome described in detail is craving, but the available record does not describe the other outcome measure or explain the relationship between the analyses and outcomes. It does not report whether outcomes were designated as primary, secondary, or exploratory beyond the identification of craving as primary. The approach to multiplicity is not reported in the registry record.

General explanation: when several outcomes, time points, or analyses are examined, the chance of at least one apparently unusual result can increase if each is considered separately without accounting for the collection of tests. Methods to address multiplicity depend on the questions and analysis plan. Because the registry does not report the tests or any adjustment strategy, it is not possible to assess how multiplicity may affect interpretation.

Missing-data methods are also not reported in the registry record. The record does not state how many participants had craving measurements at baseline or 1 month, whether incomplete questionnaires were included, or how missing follow-up scores were treated. It does not describe imputation, complete-case analysis, or sensitivity analyses. The listed enrollment should not be treated as the number contributing to the primary outcome analysis.

The analysis populations are not reported in the registry record. It is not clear whether analyses included all enrolled participants, only those with follow-up data, or another defined group. General explanation: the population used for analysis can affect the interpretation of a group comparison, particularly in a nonrandomized study where engagement and follow-up may differ between groups. The registry does not provide enough detail to assess that issue or to determine whether the analysis followed a prespecified plan.

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 registry’s adverse-event listing reports zero serious adverse events, zero other adverse events, and zero deaths for each listed group. It gives the at-risk counts as 52 for the control group, 57 for the coached-app group, and 13 for providers. These are separate group entries, and the provider listing should not be read as another participant treatment arm. The record does not provide a narrative of events or additional event terms; no serious adverse-event terms are listed.

General explanation: an adverse-event table records events reported under the registry’s definitions and observation procedures. A recorded zero means that the registry lists no events in that category for the stated group; it does not by itself establish that no event could have occurred or that every participant was observed for the same length of time. The registry record does not report the adverse-event collection period, monitoring procedures, or the definitions used for serious and other events.

The at-risk figures are not outcome results for craving, and they do not establish the number with complete follow-up for the primary analysis. The record also does not report comparative safety estimates or uncertainty around event counts. These entries should therefore be read as the posted event counts, not as evidence for a causal safety comparison between groups.

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

The registry record establishes what the study set out to assess: craving on a 0-to-30 scale at baseline and 1 month, in a comparison involving a coached uMAT-R program and a control group with app access but no engagement. It also reports that the study was completed and lists enrollment as 125. These details describe the study’s stated context and design; they do not show what happened to the outcome scores.

The primary outcome means, standard deviations, and comparison results are not reported in the registry record. Consequently, the posted information cannot establish whether craving scores increased, decreased, or stayed similar, either within a group or between groups. It cannot establish the size or precision of any difference, or whether a difference was statistically significant. The record also does not provide a threshold for a clinically meaningful change.

Even if a group difference were available, the nonrandomized allocation and the registry’s warning that the groups are not a like-for-like comparison would limit causal interpretation. People who engaged with a coached app may differ from people who had access but did not engage. The registry does not report the process leading to those group assignments or the methods, if any, used to account for group differences.

The record’s brief summary describes a pilot randomized controlled trial, but the allocation field lists nonrandomized. This discrepancy should remain visible in interpretation rather than being resolved by assuming randomization. The posted record also does not provide results for adherence, retention, sobriety, or attitudes, despite identifying those topics in the study summary.

General explanation: a trial’s aim and its results are different kinds of evidence. A stated aim explains what investigators intended to examine; a result requires reported observations and analysis. The registry information supports describing the aim and the measurement, but not claiming that the app improved or failed to improve an outcome. The absence of outcome values in the registry record is not itself evidence that the intervention had no effect.

13. Why This Trial Matters Statistically

This study is statistically notable because it addresses a digital intervention in a population and care context identified in its registry summary as having particular needs. Its primary outcome uses a defined craving scale assessed at baseline and 1 month. That makes the measurement question concrete: interpretation depends on the score’s construction, the timing of measurement, and a clear comparison of the groups.

The design description is central to how evidence from the study can be understood. The registry lists nonrandomized allocation and explicitly cautions that the arms are not a like-for-like control comparison, while the brief summary calls the project a pilot randomized controlled trial. Such differences in design language matter because the strength of a causal claim depends in part on how groups were formed and analyzed. The record does not resolve the inconsistency.

The record also illustrates why outcome reporting matters. A completed study and a defined endpoint do not, on their own, permit an estimate of effect or its uncertainty. Without the group results and analysis details, readers cannot evaluate precision, distinguish a small difference from a large one, or examine how missing observations affected the estimate.

Finally, the registry describes planning illustrations based on the observed effect. General explanation: such illustrations can help plan a future study under stated assumptions, but they are not a substitute for reporting the observed outcome and are not evidence of observed power. The record’s stated intention to use clinically meaningful effect-size and attrition estimates to plan a larger trial is relevant to future study planning, but the specific estimates are not reported in the registry record. These limitations make transparent reporting of group composition, analysis methods, outcome estimates, and uncertainty especially important for interpreting the study’s contribution.

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 most immediate limitation for interpretation is that primary outcome results are not reported in the registry record. The outcome definition is detailed, but numerical scores and comparisons are absent. This prevents assessment of the direction, magnitude, and precision of any finding.

The design information is internally inconsistent: the brief summary describes a pilot randomized controlled trial, while the allocation field lists a nonrandomized study. The record’s stated caution that the arms are not a like-for-like control comparison further limits causal interpretation. The process used to form groups and any methods for addressing differences between them are not reported in the registry record.

The control group had access to the app but did not engage, whereas the other group had access to a coached program. Thus, the groups differ not only in the listed coaching component but also in engagement. The record does not report app-use levels, coaching exposure, or other measures of intervention adherence. It is not possible to separate the association of engagement from the effect of being offered the coached program.

The listed enrollment does not establish the number of participants with complete outcome data. Group-specific outcome denominators, attrition, missing-data handling, analysis populations, and reasons for missing measurements are not reported in the registry record. No statistical analysis plan, covariate adjustment strategy, multiplicity procedure, or sensitivity analysis is described.

The primary follow-up timeframe is baseline and 1 month, so the available outcome description does not address longer-term craving. The record does not report a threshold for clinically meaningful change, measurement reliability in this study, or detailed eligibility criteria. These limitations concern what can be learned from the registry information; they do not establish that the study team did not collect or analyze such information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder — NCT06701123.
• Registry record last updated 2026-04-03; status last verified 2026-03.
• Results first posted 2026-04-03.
• 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.

18. Record Summary

The registry record describes a completed, early-phase, parallel study of uMAT-R for pregnant and postpartum women with opioid use disorder. Allocation is listed as nonrandomized and masking as none. Enrollment is listed as 125. The intervention group had access to a coached app program, while the control group had access to the app but did not engage.

Craving is the primary outcome, measured on a 0-to-30 scale at baseline and 1 month, with higher scores indicating greater craving. The brief summary calls the study a pilot randomized controlled trial, which conflicts with the nonrandomized allocation field. The record cautions that the groups are not a like-for-like control comparison.

Although the study status is completed, the primary outcome results and statistical analysis details are not reported in the registry record. The adverse-event listing reports zero serious events, zero other events, and zero deaths in each listed group. These registry entries support a description of the study design and reporting, but not an estimate of the intervention’s effect on craving.