Minds and Mentors Program (MiMP)- R61: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Minds and Mentors Program (MiMP)- R61 (NCT04233671), a randomized na study. The primary outcome is Number of Days Adherence to Medication Assisted Treatment.

2. Clinical Question

The study also set out to assess feasibility and acceptability of the combined program and to examine relapse, cravings, and psychosocial outcomes. Those aims provide context for the primary adherence question, but the posted primary endpoint concerns days of medication adherence rather than a direct measure of relapse or broader psychosocial change.

The intervention and control are described as group programs. The registry record identifies a randomized, parallel design with triple masking. It does not report the masking roles or additional details about how assignment was implemented. The registry enrollment is 21. The posted primary endpoint lists 8 participants in the mindfulness and peer mentoring arm and 4 in the control arm; the record does not explain the relationship between these endpoint counts and the enrollment figure.

3. Trial Design

NCT04233671 is listed as a randomized, triple-masked, parallel-group study. It is titled “Minds and Mentors Program (MiMP)- R61,” and its official title describes a mindfulness and peer mentoring program intended to improve adherence to medication-assisted treatment for opioid use disorders. The phase is recorded as NA, the status as completed, and enrollment as 21. The registry record lists the University of Alabama, Tuscaloosa as sponsor.

The intervention arm received mindfulness-based relapse prevention with peer mentoring. The program description specifies weekly meetings for 12 weeks, approximately two hours per meeting. A licensed counselor facilitated 8 weeks, and a peer mentor facilitated 4 weeks. The comparator arm is named 12 Step Treatment Program Control and is described as meeting for 12 weeks for standard 12 Step Facilitation meetings. Although the brief summary calls the comparison group an attentional control group, the arm description names the 12 Step program; the record does not further clarify that wording.

The study began on 2020-01-28, and primary completion is recorded as 2021-08-31. The primary outcome was adherence to medication-assisted treatment, measured as the number of days participants received MAT during the last 4 weeks of the intervention period. The study description frames the comparison as the mean number of days adherent at week 12.

The registry lists 15 outcome measures and 13 posted secondary outcomes. The primary endpoint result lists 8 participants in the intervention arm and 4 in the control arm. These are the counts attached to the posted endpoint, not a description of all randomized participants. The registry record does not report further details about allocation procedures, masking roles, or the analysis population.

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 consented 43 participants total over the course of the study. However, participants were only considered enrolled in the study once they completed their baseline data collection and were ready to be randomized. Therefore, there were some participants who signed informed consent but did not follow through to complete baseline data collection. We had 21 participants who followed through and completed the baseline data collection. These were considered enrolled in the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: comparing means for the number of days participants were adherent to MOUD at week 12 (end of intervention). These data are accurate. All participants in the mindfulness-based relapse prevention and peer mentoring arm reported taking medications for 28 days.

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 Number of Days Adherence to Medication Assisted Treatment, measured over Last 4 weeks of the intervention period.

The primary endpoint measures the number of days participants received medication-assisted treatment, as indicated during the last 4 weeks of the intervention period. It is expressed in days, and the registry describes it as a continuous measure to be analyzed through comparisons of means in regression models. The stated comparison is at week 12, the end of the intervention.

Adherence is relevant to the study’s stated aim of improving engagement with medication-assisted treatment. Counting days provides a measure of how consistently participants reported receiving treatment during the specified period. It is not the same as measuring relapse, cravings, or psychosocial outcomes; the registry lists those as separate study aims or secondary outcomes. Nor does the endpoint, by itself, describe why a participant did or did not receive treatment on a given day.

The posted mean is 28 days for the mindfulness and peer mentoring arm, based on 8 participants, with a standard deviation of 0. The control arm mean is 23.25 days, based on 4 participants, with a standard deviation of 9.5. The registry’s endpoint description states that all participants in the mindfulness-based relapse prevention and peer mentoring arm reported taking medications for 28 days. These figures describe the posted endpoint data; the registry record does not list an inferential comparison for this outcome.

Because the measure is a count of days within a fixed observation period, its interpretation depends on the stated period and on how adherence was ascertained. The record describes the measurement period and says the data indicate days receiving MAT, but further details on verification or handling of incomplete reports are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous measure summarized by a mean and standard deviation in each arm. The registry describes the outcome as the number of days adherent to medication-assisted treatment during the last 4 weeks of the intervention period, and says the measure can be treated as continuous in regression models. The posted summaries are a mean of 28 days and standard deviation of 0 for the mindfulness and peer mentoring arm, and a mean of 23.25 days and standard deviation of 9.5 for the control arm.

What does a mean describe? A mean is the arithmetic average of the observations represented in an arm. It gives a central summary but does not show the full distribution of responses. In this study, the means describe the reported days adherent in the endpoint counts listed for each arm. They do not, without an inferential analysis, indicate how precise a comparison between arms is or whether a difference is compatible with chance variation.

What does a standard deviation describe? In general, a standard deviation describes how dispersed observations are around their mean. A standard deviation of 0 means that the listed values in that arm show no observed variation; this is consistent with the endpoint description that all participants in the mindfulness and peer mentoring arm reported taking medications for 28 days. The control-arm standard deviation of 9.5 describes greater observed variation in its endpoint values. The standard deviation is not the uncertainty around the arm mean and is not a confidence interval for the arm comparison.

Why would an inferential comparison be useful? In general, an estimate of the difference between group means can be paired with a standard error and confidence interval to show uncertainty about the contrast. A hypothesis test can assess compatibility of the data with a specified null hypothesis, subject to its assumptions and analysis plan. The registry record does not list a test, a confidence interval, a standard error, a p-value, or an adjusted model result for the primary endpoint. The posted means and standard deviations alone do not supply those inferential quantities.

The registry description proposes comparing means and says regression models may be used. A regression model can estimate an association between treatment group and outcome, with the exact interpretation depending on the model specification and any covariates. The specification, covariates, diagnostics, and treatment of the endpoint distribution are not reported in the registry record. The record also does not establish that a particular regression model was actually used for the posted summaries.

Why can endpoint distribution matter? General statistical considerations include whether the outcome distribution is reasonably represented by the chosen model, whether observations are independent as assumed, and whether variability is adequately captured. A measure counted in days may have bounded values, and an arm with no observed spread raises particular challenges for procedures that rely on estimating within-arm variability. These are general considerations, not reported findings about the investigators’ model. The registry record does not report model checks or an alternative approach to zero observed spread.

How should planning calculations be read? In general, sample-size calculations depend on the target effect, variability assumptions, significance level, allocation, and analysis method. The record’s planning-illustration description specifies a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. These calculations are described as illustrations based on the observed effect, not as the trial’s own design justification. Any calculated participant counts are planning quantities, not observed sample sizes and not observed power. The registry record does not report its original sample-size justification or the assumptions used when the trial was designed.

The record identifies a randomized parallel design, but a randomized design label does not itself provide the analysis details needed to interpret an estimate. The record does not report the allocation sequence, the roles of masking, any stratification, model covariates, interim analyses, or the prespecified inferential plan. Those details should not be inferred from the arm summaries.

Multiplicity is another general issue when a study measures more than one outcome or conducts multiple tests. Testing many outcomes can increase the chance of at least one apparently unusual result unless the analysis plan addresses that issue. The registry lists 15 outcome measures and 13 posted secondary outcomes, but the record lists zero analyses. No multiplicity adjustment or hierarchy of testing is reported in the registry record. Consequently, the posted primary summaries cannot be interpreted as a result selected from a documented set of inferential tests.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 15 outcome measures, including the primary adherence outcome and secondary measures concerning feasibility, acceptability, relapse, cravings, and social support. It lists 13 posted secondary outcomes and zero analyses. The record therefore does not provide a set of inferential results from which the handling of multiple comparisons can be assessed. No adjustment method, testing hierarchy, or distinction between confirmatory and exploratory analyses is reported in the registry record.

In general, multiplicity matters when several outcomes or tests are examined, because the chance of a false-positive finding can rise across a collection of tests. An analysis plan may address this through a prespecified hierarchy or statistical adjustment. That is general context; the registry record does not say that such a procedure was used, or that it was not used outside the posted registry results.

The endpoint counts are 8 in the intervention arm and 4 in the control arm, while registry enrollment is 21. The record does not explain this difference. It does not report whether endpoint data were unavailable, whether participants were excluded from a particular analysis, or whether the counts reflect a defined analysis population. It also does not describe imputation, complete-case analysis, or other missing-data handling. The difference in reported counts should not be assigned a cause without that information.

The record does not report an intention-to-treat definition, a per-protocol population, or rules for handling participants who did not complete the intervention. Although feasibility and retention appear among the study outcomes, the posted information does not establish which participants contributed to the primary endpoint estimate. These omissions limit interpretation of how representative the arm summaries are of all enrolled participants.

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 safety record reports serious adverse events for 13 participants at risk in the mindfulness and peer mentoring group, with 0 serious adverse events affecting participants and 0 deaths. For the 12 Step Treatment Program Control group, 8 participants are listed as at risk, with 0 serious adverse events affecting participants and 0 deaths. The record also lists 13 and 8 participants at risk, respectively, for other adverse events, with 0 other adverse events affecting participants in either group.

These figures are counts in the registry’s safety reporting. The “at risk” counts are the reported group denominators for that safety information; they are distinct from the endpoint counts attached to the adherence outcome. The record does not provide serious adverse event terms, and its list of top serious-event terms is empty. It does not describe event ascertainment, the observation period for safety reporting, or how events were classified.

A zero reported count means that no event in that category is listed as affecting participants in the posted safety record. It does not, by itself, establish that no events occurred outside the reported categories or observation process. Differences between safety denominators and endpoint counts should not be treated as evidence of missingness or exclusion without additional information. These registry figures are descriptive safety data and do not establish comparative risk.

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

The posted primary endpoint shows that the intervention arm had a reported mean of 28 days adherent and the control arm had a mean of 23.25 days during the specified period. The means are based on endpoint counts of 8 and 4 participants, respectively. The reported standard deviations are 0 and 9.5. These are descriptive summaries of the participants represented in the endpoint record.

They do not show whether the group comparison is statistically significant. No inferential analysis, confidence interval, or p-value is listed for the primary endpoint, and the registry records zero analyses. Without an inferential estimate and its uncertainty, the observed means do not determine how compatible the results are with sampling variability. They also do not establish the size or precision of an effect in a broader population.

The summaries do not establish that the intervention caused a change in adherence. Randomization is part of the recorded design, but interpretation of a causal estimate also depends on the analysis population, missing-data handling, adherence to the assigned programs, and the analysis plan. Those details are not reported in the registry record. The endpoint counts are not the same as registry enrollment, and the record does not explain the difference.

The primary endpoint is limited to reported days receiving medication-assisted treatment during the last 4 weeks of the intervention period. It does not directly answer whether relapse, cravings, depression, anxiety, stress, or social support changed. Those topics appear among the study aims or secondary outcomes, but their listing is not itself a result. Nor do the available primary summaries establish feasibility or acceptability.

Accordingly, the defensible reading is narrow: the registry posts arm-level adherence summaries, including a mean and spread for each group, but does not post an inferential comparison or the analysis details needed to assess its precision. The result should be understood as descriptive rather than as proof for or against an effect.

13. Why This Trial Matters Statistically

This trial raises several statistical issues that are important when evaluating small clinical studies. The registry enrollment is 21, while the primary endpoint summaries represent 8 participants in the intervention arm and 4 in the control arm. The record does not explain how those endpoint counts relate to enrollment. Making that relationship explicit is important because the analyzed participants determine what the reported means describe.

The outcome also has very different observed spreads across arms: the intervention standard deviation is 0, while the control standard deviation is 9.5. In general, variability affects the precision of estimated means and contrasts. No observed variation in one arm does not mean there is no uncertainty about the population mean, particularly when the endpoint count is limited. An inferential method and its assumptions are needed to quantify uncertainty; the registry record does not post that analysis.

The record’s planning-illustration description distinguishes calculations based on an observed effect from the original trial design. This distinction is important: retrospective planning calculations cannot replace a design-stage sample-size rationale and are not observed power. The registry does not report its own sample-size justification, so the listed enrollment should not be interpreted as evidence of the assumptions or power used at design.

Finally, the study includes several outcomes, but the record lists zero analyses. Knowing the number of registered outcomes without corresponding inferential results does not permit evaluation of multiplicity or selective reporting. Together, the incomplete connection between enrollment and endpoint counts, the unusual spread pattern, and the absence of posted inferential results limit statistical interpretation while still allowing a transparent description of the registry’s endpoint summaries.

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 registry record provides arm-level summaries for the primary endpoint but does not report an inferential comparison. There is no listed confidence interval, test statistic, p-value, or model estimate. As a result, precision and compatibility with sampling variability cannot be assessed from the posted primary result alone.

The endpoint counts are 8 and 4, whereas enrollment is 21. The record does not explain the difference, define the analysis population, or report missing-data methods. It is therefore unclear from the registry record which participants contributed to the endpoint summaries and why other enrolled participants are not represented in those counts.

The intervention arm has a standard deviation of 0, and the control arm has a standard deviation of 9.5. The former indicates no observed spread in the listed intervention values, which the endpoint description says were 28 days for all participants in that arm. The record does not describe how the investigators modeled this outcome, assessed assumptions, or addressed the contrast between the observed spreads.

The brief summary describes an attentional control group, while the named control arm is the 12 Step Treatment Program Control and its description specifies standard 12 Step Facilitation meetings. The record does not further clarify this terminology. It also does not report masking roles, allocation procedures, the analysis plan, the original sample-size justification, or any interim analyses. These details should not be inferred from the randomized and triple-masked design labels.

Finally, the registry lists multiple outcomes but zero analyses. The listed secondary outcomes do not establish which results were analyzed or how multiplicity was handled. Further details about adherence measurement verification, safety ascertainment, and the observation period for adverse events are also not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Minds and Mentors Program (MiMP)- R61 — NCT04233671.
• Registry record last updated 2023-07-21; status last verified 2023-05.
• Results first posted 2023-07-21.
• 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

NCT04233671, “Minds and Mentors Program (MiMP)- R61,” is recorded as a completed randomized, triple-masked, parallel-group study sponsored by the University of Alabama, Tuscaloosa. Enrollment is 21. The intervention combines mindfulness-based relapse prevention and peer mentoring; the named control is a 12 Step Treatment Program Control.

The primary endpoint is days adherent to medication-assisted treatment during the last 4 weeks of the intervention period. The posted means are 28 days for the intervention arm and 23.25 days for control, with endpoint counts of 8 and 4 and standard deviations of 0 and 9.5, respectively. No inferential analyses are listed.

The registry lists 15 outcome measures and 13 posted secondary outcomes. It does not report the original sample-size justification, analysis population, missing-data methods, or inferential plan in the information considered. Safety reporting lists 0 serious adverse events and 0 deaths in each group.