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 A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder (NCT04824521), a na na study. The primary outcome is Client Satisfaction.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04824521 |
| Phase | NA |
| Condition | Opioid-use Disorder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Montana |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns pregnant women with opioid use disorder. The brief summary describes pregnant women with substance use disorder as the intended recruits, while the registered condition is opioid-use disorder. The record reports enrollment of 1, so the results do not describe a large participant group.
Intervention
The intervention is Mindfulness-Oriented Recovery Enhancement delivered via tele-health. The arm description specifies an 8-week program. The record does not report whether the enrolled participant completed the sessions.
Comparator
No separate comparator group is recorded. The study is listed as single-group, allocation is NA, and masking is none. Consequently, the registry record does not set out a like-for-like comparison between the intervention and another treatment or a control condition.
Primary question
The registered primary outcome is Client Satisfaction at 8 weeks, assessed with the Client Satisfaction Questionnaire. The registry record states that the participant did not complete this measure. It therefore does not provide a completed primary outcome from which to describe satisfaction or estimate change.
3. Trial Design
This is a pilot feasibility study of Mindfulness-Oriented Recovery Enhancement for pregnant women with opioid use disorder. The intervention is behavioral and is described as an 8-week program delivered via tele-health. The design is listed as single-group, with allocation recorded as NA and masking as none. There is no separate comparison arm recorded, so the design does not support a direct contrast with a control group.
The registry record lists enrollment of 1 and status as terminated. Its brief summary says that thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of MORE. That wording describes an intended recruitment plan, not the number enrolled: the recorded enrollment is 1. The record does not explain why enrollment was lower than the intended recruitment or why the study was terminated.
The recorded study start date is 2021-10-01 and the primary completion date is 2022-08-01. The phase is listed as NA. The sponsor is the University of Montana. These registry entries describe the study's administrative record; they do not establish how much of the intervention the enrolled participant received or whether feasibility criteria were met.
The primary outcome is Client Satisfaction at 8 weeks. A secondary outcome is SUD Symptoms - Mini Neuropsychiatric Interview. Two outcome measures are recorded, but the record lists zero analyses. It does not report outcome estimates, uncertainty intervals, or an inferential analysis. As a result, the study's posted record is insufficient for estimating a treatment effect, and it does not give a completed primary outcome assessment that can be interpreted as evidence about satisfaction.
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: We did not exclude any participants from the study before assignment to groups.
Overall Study
| Stage | Mindfulness-Oriented Recovery Enhancement Via Tele-health |
|---|---|
| STARTED | 1 |
| COMPLETED | 0 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Mindfulness-Oriented Recovery Enhancement Via Tele-health |
|---|---|
| Lost to Follow-up | 1 |
Analysis population for the primary outcome, as defined in the registry: Participant did not complete this measure.
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 | Mindfulness-Oriented Recovery Enhancement Via Tele-health |
|---|---|---|
| Participants analysed | 1 | |
| Age, Continuous | years | 31 (31 to 31) |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| 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 | 0 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 1 |
| SUD Symptoms - Mini Neuropsychiatric Interview - Alcohol Use Disorder | symptoms | 12 (12 to 12) |
6. Primary Endpoint
The registry lists the primary outcome as Client Satisfaction, measured over 8 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is Client Satisfaction, assessed at 8 weeks using the Client Satisfaction Questionnaire. The registry record says that the participant did not complete this measure. It does not give a score, a unit, a summary statistic, or a completed outcome result. Satisfaction therefore cannot be described from the posted primary endpoint.
In general, a satisfaction measure captures participants' reports of their experience with an intervention or service. Such measures can be useful in feasibility work because participants' views may inform whether an intervention is acceptable and how it is experienced. A satisfaction measure is conceptually different from a symptom measure: it does not by itself establish whether symptoms changed, nor does it compare outcomes against a control group.
The registry record does not report the questionnaire's scoring approach, interpretation thresholds, or any planned definition of a meaningful score. It also does not say whether the measure was intended to be analyzed as a total score, individual items, or another summary. Without a completed measure and a stated scoring method, neither the level of satisfaction nor its precision can be evaluated. The presence of an endpoint label alone is not an outcome result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the primary outcome was not completed. The record identifies Client Satisfaction at 8 weeks as the primary endpoint, but states that the participant did not complete the measure. There is no primary outcome score to summarize, and no estimate of satisfaction can be calculated from the registry record. No confidence interval or p-value is posted for this endpoint.
Enrollment was 1, and study status is terminated. The brief summary described recruitment of thirty pregnant women with substance use disorder, but this intended recruitment count should not be confused with observed enrollment. The record does not state why the study ended or why enrollment did not reach the intended number. It also does not report how many intervention sessions the enrolled participant attended or whether the intervention was completed.
The design is single-group, with no recorded comparator. Even if an outcome score had been posted, a single-group result would describe observations among participants in that group; it would not establish what would have happened under a different treatment or without the intervention. General changes over time, participant selection, and other influences cannot be separated from an intervention effect by a direct randomized comparison in this design. No causal conclusion should be drawn from the study record.
The registry records a secondary outcome, SUD Symptoms - Mini Neuropsychiatric Interview, but does not post a result for it. The record lists two outcome measures and zero analyses. It does not report summary estimates, model results, uncertainty measures, or hypothesis tests. That absence means there is no statistical result to evaluate for either the primary endpoint or the secondary outcome.
The safety counts are limited to the recorded group and denominator: 0 serious adverse events among 1 at risk, 0 other adverse events among 1 at risk, and 0 deaths. These entries describe what the registry reports; they do not establish that the intervention carries no risk. With enrollment of 1, safety observations are particularly limited, and the record provides no event terms to characterize. The absence of a recorded event is not a precise estimate of how often an event might occur in a wider population.
Planning calculations based on an observed effect are not the same as results from a trial. In this record, outcome analyses and effect estimates are not reported in the registry record. Any planning illustration should therefore be understood as hypothetical rather than as evidence of achieved power or an observed treatment effect. Overall, the posted record supports a description of the study's design, enrollment, endpoint status, and recorded safety counts, but not an estimate of clinical benefit or a reliable assessment of feasibility.
9. Statistical Methods Explained
What can an outcome estimate show?
In general, an outcome estimate is a numerical summary of what was observed, such as an average score or a difference between groups. Its interpretation depends on the outcome definition, the participants included, and the analysis method. Here, the primary outcome is named, but no completed questionnaire result or analysis estimate is reported in the registry record. There is therefore no estimate to interpret, and no uncertainty interval or test result with which to assess precision.
A confidence interval, in general, describes a range of values compatible with the data and the statistical method used. It communicates uncertainty around an estimate rather than guaranteeing that the true value lies within that range. Because no primary outcome estimate is posted, the record does not provide a confidence interval for Client Satisfaction. A missing interval should not be read as evidence that there is no uncertainty; it reflects that no analyzed primary result is reported.
What does the single-group design imply?
In general, a comparator helps distinguish what happened under an intervention from what might have happened under another condition. A single-group design observes participants in one group and does not provide a concurrent control arm for a direct comparison. The registry record lists a single-group model and allocation as NA, and it does not describe another arm. As a result, there is no between-group treatment contrast to estimate.
A before-and-after comparison, if one were reported, would still not by itself isolate an intervention effect. Changes could coincide with the intervention without having been caused by it. The record does not provide a before-and-after result for the primary endpoint, and the participant did not complete the Client Satisfaction Questionnaire. No such change should be inferred.
What can a p-value or statistical test establish?
In general, a p-value summarizes how unusual data would be under a stated null hypothesis and statistical model. It is not the probability that a treatment works, nor does it measure the size or practical importance of an effect. A statistical test also depends on a defined outcome, an analysis population, and assumptions appropriate to the design. The registry lists zero analyses and reports no p-value. There is no test result to interpret.
The absence of an analysis does not mean that a test was negative or that an effect was absent. It means no inferential result is posted in the registry record. This distinction matters because a non-significant finding, if one existed, would still need to be read alongside its effect estimate and precision. Here, neither is available for the registered primary outcome.
How should planning calculations be read?
In general, sample-size calculations ask how many observations a future study might need to detect a specified effect under stated assumptions. The record describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects set as a fraction of an observed effect. Those assumptions describe a planning exercise, not the actual design of this single-group study.
The record also distinguishes planning quantities for time-to-event outcomes from those for other outcomes. Such illustrations are hypothetical and do not show that a study had adequate power, nor do they represent observed results. They are not a substitute for an explanation of the trial's own design rationale. A sample-size justification for this study is not reported in the registry record. The observed effect estimate on which an illustration would depend is also not reported in the registry record, so there is no effect estimate in the posted results to assess.
Why does over-dispersion matter in general?
Over-dispersion is a general statistical issue in which observed variability is greater than a model assumes. If it is ignored, standard errors may be too small and uncertainty may be understated. The appropriate response depends on the outcome type and analysis model. The registry record does not report an analysis model or outcome estimates for this trial, so there is no basis to assess over-dispersion or its relevance to the posted results.
What do the safety counts measure?
In general, adverse-event counts describe events recorded within a defined group and observation period. A count depends on who was observed, how events were defined and collected, and the time participants were followed. The registry gives a denominator of 1 at risk for both serious and other adverse events in the intervention group, with zero affected in each category and zero deaths. The record does not provide further event terms, definitions, or analysis details. These counts should be read as a limited descriptive record, not as a comparative safety analysis or a precise estimate of risk.
10. Multiplicity, Missing Data and Analysis Populations
The registry records two outcome measures: Client Satisfaction as the primary outcome and SUD Symptoms - Mini Neuropsychiatric Interview as a secondary outcome. It lists zero analyses. Results for the secondary measure are not reported in the registry record, and the primary measure was not completed by the participant. There are no posted outcome estimates or tests across which to assess multiplicity.
In general, multiplicity arises when several outcomes, time points, or statistical tests are considered. Testing many hypotheses can increase the chance of a seemingly notable result arising by chance. Researchers may address this through prespecified outcome hierarchies or statistical adjustments. The registry record does not report a multiplicity strategy, a hierarchy beyond identifying the primary and secondary outcomes, or an analysis plan. It is not possible to determine whether any adjustment was intended.
The record does not report an analysis population, rules for including participants, or a plan for handling missing data. The primary measure is explicitly identified as not completed, but the reason for noncompletion and any other missingness information are not reported in the registry record. With enrollment of 1, the record also does not permit a meaningful comparison of participants with complete and incomplete outcomes. Missingness should not be treated as a score or as evidence that satisfaction was high or low.
Interim analyses, stopping rules, and other details of the statistical plan are not reported in the registry record. The study's terminated status does not reveal whether a statistical stopping criterion was used. Without analysis methods, outcome results, and missing-data procedures, the registry does not support reconstruction of an inferential analysis.
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 |
|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement Via Tele-health | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Mindfulness-Oriented Recovery Enhancement Via Tele-health | 0 of 1 |
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 |
|---|---|
| Mindfulness-Oriented Recovery Enhancement Via Tele-health | 0 of 1 |
The registry lists the Mindfulness-Oriented Recovery Enhancement via tele-health group with 1 participant at risk for serious adverse events and 0 affected. For other adverse events, it also lists 1 at risk and 0 affected. Deaths are recorded as 0, and no serious adverse-event terms are listed.
These are descriptive counts for the recorded group. They do not compare the intervention with another group, because no separate comparator is recorded. With only 1 participant at risk, the counts cannot provide a precise estimate of how frequently adverse events might occur in a broader population. A count of zero in this record does not establish that the intervention has no risk or that no event could occur.
The registry record does not report further details about how adverse events were defined, collected, assessed for relatedness, or monitored over time. It also does not report additional event descriptions. The safety entries should therefore be read narrowly as the posted counts, not as a complete safety profile or a causal assessment.
12. What the Result Does, and Does Not, Mean
This record documents a pilot feasibility study of Mindfulness-Oriented Recovery Enhancement delivered by tele-health to pregnant women with opioid use disorder. It records a single-group design, an intended 8-week intervention, enrollment of 1, and terminated status. It also shows that the registered primary endpoint was Client Satisfaction at 8 weeks, but the participant did not complete the questionnaire.
These registry entries do not establish whether participants found the intervention acceptable. A completed satisfaction score is not reported, and the record gives no result for the secondary SUD Symptoms - Mini Neuropsychiatric Interview outcome. It also lists zero analyses. As a result, there is no posted estimate of symptom change, no treatment-effect estimate, and no uncertainty measure for either outcome.
The design does not include a recorded comparator, so even a measured change could not be directly contrasted with outcomes under another condition in this registry record. The study should not be interpreted as showing that the intervention improves outcomes or that it fails to do so. Neither conclusion follows from an absent outcome analysis.
The safety record reports zero serious adverse events, zero other adverse events, and zero deaths in the group, with 1 at risk for each adverse-event category. These limited counts describe the registry entries; they cannot establish the absence of risk or characterize uncommon events.
In general, a pilot feasibility study can inform questions about whether a larger study can be carried out and how its procedures might be improved. For this record, however, the reason for termination, completion of intervention sessions, and feasibility criteria or results are not reported in the registry record. The enrollment information alone cannot identify why recruitment was limited or whether any particular feasibility goal was achieved. The most defensible interpretation is therefore descriptive: the record documents a small terminated study without a completed primary outcome or posted statistical analysis.
13. Why This Trial Matters Statistically
This trial matters statistically because its registry record illustrates the difference between a planned study question and an analyzable result. The study identifies Client Satisfaction at 8 weeks as the primary endpoint, but the participant did not complete the measure. Naming an outcome does not create an estimate: without a completed score and a reported analysis, there is no primary result whose magnitude or precision can be evaluated.
It also highlights why enrollment and outcome completion need to be distinguished. The brief summary describes an intention to recruit thirty pregnant women with substance use disorder, while recorded enrollment is 1. The record does not explain this gap or the termination. Consequently, the posted information cannot establish whether the intervention was feasible in practice or identify barriers to recruitment or delivery.
The single-group design is another important statistical feature. Without a separate comparator, the registry record cannot support a direct treatment contrast. Even outcome observations from a single group would require cautious interpretation because they cannot independently separate an intervention effect from other explanations for change.
Finally, the record has two outcome measures and zero analyses. That combination makes clear that an outcome listing is not equivalent to a reported result, and that questions about multiplicity, missing data, and statistical modeling remain unanswered when the analysis is not posted. The safety counts likewise show the limits of interpreting zero events in a group with enrollment of 1. The statistical value of the record is thus chiefly in clarifying what it does and does not document, rather than in estimating an intervention effect.
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 direct limitation is the mismatch between the intended recruitment described in the brief summary and the recorded enrollment of 1. The study is marked terminated, but the reason for termination is not reported in the registry record. The record does not say whether recruitment, intervention delivery, or another factor led to termination, so no specific explanation should be inferred.
The primary endpoint cannot be analyzed from the posted record because the participant did not complete the Client Satisfaction Questionnaire. The reason for noncompletion is not reported in the registry record. Although SUD Symptoms - Mini Neuropsychiatric Interview is listed as a secondary outcome, a result is not reported. The record lists zero analyses and does not provide outcome estimates or precision measures.
The single-group design has no registered comparator, and allocation is recorded as NA. There is therefore no like-for-like control comparison. Masking is listed as none. Other methodological details, including analysis populations, missing-data handling, and the statistical plan, are not reported in the registry record.
The intervention is described as an 8-week tele-health program, while the brief summary refers to eight sessions. The record does not report whether the enrolled participant attended or completed the program. It also does not report feasibility criteria or results, so the study's feasibility aims cannot be assessed from the posted results.
Safety interpretation is limited by the recorded denominator of 1 and the absence of event terms. The registry does not provide further safety-monitoring or follow-up details. These limitations mean that the record cannot establish efficacy, characterize feasibility comprehensively, or provide a precise assessment of safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder — NCT04824521.
- Registry record last updated 2024-01-16; status last verified 2024-01.
- Results first posted 2024-01-16.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a pilot feasibility study of Mindfulness-Oriented Recovery Enhancement via tele-health for pregnant women with opioid use disorder. The intervention is behavioral and is described as an 8-week program. The study is single-group, allocation is listed as NA, masking as none, and status as terminated. Recorded enrollment is 1; the brief summary describes an intention to recruit thirty pregnant women with substance use disorder.
Client Satisfaction at 8 weeks is the primary outcome, but the participant did not complete the measure. SUD Symptoms - Mini Neuropsychiatric Interview is listed as a secondary outcome. Two outcome measures and zero analyses are recorded. Outcome estimates and reasons for termination are not reported in the registry record.
The safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths, with 1 at risk for each adverse-event category. These limited counts do not support a comparative safety assessment.