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 Walk With Me for Perinatal Grief (NCT05318287), a na na study. The primary outcome is Traumatic Stress - Intrusion Subscale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05318287 |
| Phase | NA |
| Condition | Grief, Traumatic Stress, Usability |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 52 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Oregon Research Behavioral Intervention Strategies, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns bereaved parents following perinatal loss. The primary-outcome description reports 52 participants with pretest data, 48 with data at 4 weeks, and 44 with data at 8 weeks. Participants were instructed to answer questions in relation to the loss of their child. The registry does not give additional participant characteristics in the information available for this analysis.
Intervention
Walk With Me is a brief four-module behavioral intervention delivered by computer or mobile device. The modules use mindfulness and cognitive behavioral therapy strategies and are intended to offer tools for coping with distress following perinatal loss. The registry describes the intervention but does not report how many participants completed each module or the extent of their engagement.
Comparator
This is a single-group study, with allocation recorded as NA and no masking. The registry does not describe a separate control arm. Consequently, the study does not provide a randomized, like-for-like comparison between participants assigned to Walk With Me and participants assigned to another condition.
Primary question
The primary measure is the intrusion subscale of the Impact of Event Scale-Revised (IES-R), assessed at baseline immediately following loss, 4 weeks, and 8 weeks post loss. The registry describes estimating trajectories over these assessments. It does not report the measured means, standard deviations, changes over time, confidence intervals, or tests of those changes. The central question is therefore how traumatic-stress intrusion was assessed and analyzed, rather than what numerical change the participants experienced.
3. Trial Design
Walk With Me for Perinatal Grief (NCT05318287) is recorded as a completed, single-group behavioral study. The registry lists enrollment of 52, allocation as NA, masking as none, and phase as NA. The study began on 2021-02-01, and its primary completion date is 2023-09-12. These record details describe the study's structure and timeline; they do not establish an intervention effect.
The intervention, called Walk with Me, is described as a brief four-module program delivered using a computer or mobile device. Its modules use mindfulness and cognitive behavioral therapy strategies to address distress following perinatal loss. The registry's brief summary describes a mobile application intended to provide therapeutic modules, normalize grief, and offer coping skills. It does not report module completion, adherence, or actual exposure to the intervention for individual participants.
The primary outcome is a continuous measure, reported as a mean with standard deviation, of the IES-R intrusion subscale. The stated assessment points are baseline immediately following loss, 4 weeks, and 8 weeks post loss. The record says trajectories were estimated using maximum likelihood and that participants with at least one data point were included. It lists 52 participants as analyzed.
Because the study is single-group and has no described control arm, changes across assessment points cannot be separated by this design from other influences that may affect scores over time. Allocation and masking do not describe a randomized comparison. The registry does not report a protocol, a sample-size justification, an interim-analysis plan, or enough detail to determine what additional design procedures were used.
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.
Overall Study
| Stage | PeriGrief |
|---|---|
| STARTED | 52 |
| COMPLETED | 44 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | PeriGrief |
|---|---|
| Lost to Follow-up | 8 |
Analysis population for the primary outcome, as defined in the registry: There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed.
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 | PeriGrief |
|---|---|---|
| Participants analysed | 52 | |
| Age, Continuous | years | 31.7 (SD 6.2) |
| Sex: Female, Male: Female | Participants | 52 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 46 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 2 |
| Race (NIH/OMB): Black or African American | Participants | 6 |
| Race (NIH/OMB): White | Participants | 36 |
| Race (NIH/OMB): More than one race | Participants | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 |
| Relationship Status: Single, dating | Participants | 1 |
| Relationship Status: Married or domestic partner | Participants | 45 |
| Relationship Status: Partnered in a serious relationship | Participants | 5 |
| Relationship Status: Divorced or separated | Participants | 1 |
| Number of times pregnant: 1 | Participants | 13 |
| Number of times pregnant: 2 | Participants | 18 |
| Number of times pregnant: 3 | Participants | 12 |
| Number of times pregnant: 4 | Participants | 4 |
| Number of times pregnant: 5 or more | Participants | 5 |
| Type of loss experienced - Chemical Pregnancy (i.e., loss before the 5th week) | Participants | 4 |
| Type of loss experienced - Miscarriage in the first trimester | Participants | 21 |
| Type of loss experienced - Neonatal loss | Participants | 7 |
| Type of loss experienced - Stillbirth | Participants | 11 |
| Type of loss experienced - Termination due to fetal abnormality/viability | Participants | 4 |
| Type of loss experienced - Tubal or ectopic pregnancy | Participants | 1 |
| Type of loss experienced - Tubal or ectopic pregnancy | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Traumatic Stress - Intrusion Subscale, measured over Baseline (immediately following loss), 4 weeks and 8 weeks post loss.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the IES-R Traumatic Stress - Intrusion Subscale. The IES-R is described as a 22-item measure asking about symptoms during the past 7 days. Participants rate each symptom on a five-point scale, from 0, indicating “not at all,” to 4, indicating “extremely,” and are instructed to relate the items specifically to the loss of their child.
The instrument has three subscales: intrusions, avoidance, and hyperarousal. The primary endpoint is the intrusion subscale, which contains 8 items. The registry states that each subscale ranges from 0 to 4, with higher scores indicating greater levels of distress or trauma. The outcome is summarized as a mean and standard deviation, making it a continuous measure rather than a count of events or a yes-or-no classification.
Repeated assessment at baseline immediately following loss, 4 weeks, and 8 weeks post loss allows the analysis to describe the course of intrusion scores over time. Such a measure can characterize reported symptoms, but its interpretation depends on the observed values and the analysis. The registry record does not report the endpoint means, standard deviations, estimated trajectory, uncertainty intervals, or a test of change. It also does not give a threshold for interpreting a particular score as clinically important.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clear outcome and assessment schedule, but the numerical outcome results are not reported in the registry record. No baseline, 4-week, or 8-week intrusion means or standard deviations appear in the registry record for this analysis. Therefore, the direction, size, and precision of any change in the primary measure cannot be described. A statement that scores decreased, increased, or stayed similar would go beyond the record.
The analysis population is described more fully than the results. There were 52 participants with pretest data, 48 with 4-weeks data, and 44 with 8-weeks data. Maximum-likelihood trajectory estimation included participants with at least one data point, so the registry says all 52 participants were analyzed. The assessment-specific counts show that the number contributing data differed across time points. They do not, on their own, explain why data were unavailable or whether missingness was related to participants’ scores or circumstances.
The single-group design also sets an important limit on interpretation. Even if numerical changes had been reported, a trajectory within one group would describe what happened over time among the analyzed participants; it would not by itself identify what would have happened without the intervention. Without a concurrent control group and an appropriate comparison, influences other than the intervention cannot be distinguished from intervention-associated change by the design described in the registry.
There are no reported confidence intervals, p-values, or other inferential results for the primary endpoint in the available record. Precision therefore cannot be evaluated, and statistical evidence for change cannot be assessed. The registry also lists 14 outcome measures and 10 analyses, but does not report whether or how multiplicity was addressed. This leaves uncertainty about how the primary result fits within the broader set of recorded outcomes and analyses.
The appropriate reading is limited but useful: the registry describes a completed study, its intervention, a repeated continuous measure, and a maximum-likelihood approach that included participants with at least one observation. It does not provide the numerical endpoint findings needed to characterize the observed trajectory. The design and missing numerical results prevent a conclusion about the magnitude, precision, or causal interpretation of change.
9. Statistical Methods Explained
What does a continuous mean measure?
The primary endpoint is defined as a mean on a continuous scale, with standard deviation used to describe dispersion. A mean represents the average score in the analyzed group at a specified assessment. A standard deviation describes how spread out individual scores are around that average. These summaries answer different questions: the mean gives a group-level location, while the standard deviation describes variability among participants.
The registry gives the score range and the direction of interpretation: higher subscale scores indicate greater distress or trauma. It does not give the actual means or standard deviations at the assessment points. Consequently, the scale description explains how a future or reported value would be read, but it cannot substitute for the missing outcome values. No effect size can be characterized from the scale definition alone.
What does a trajectory analysis address?
A trajectory analysis represents the pattern of measurements over repeated assessment points. In this study, the stated points are baseline immediately following loss, 4 weeks, and 8 weeks post loss. Repeated measurements can describe how scores vary across time within the analyzed group. A trajectory is not automatically a causal estimate: in a single-group study, time trends may reflect the intervention, other changes over time, or a combination of influences.
The registry says that trajectories were estimated using maximum likelihood. In general, maximum likelihood estimates model parameters by finding values that make the observed data most compatible with the specified statistical model. With repeated outcomes, this approach can use available observations from participants who do not have measurements at every time point. The record says participants with at least one data point were included. It does not identify the model form, covariance structure, estimator details, or assumptions used to handle missing outcomes. Those details are not reported in the registry record.
Why does missingness matter?
When the number of observed measurements differs across assessment times, the analysis depends on the data that were available and the assumptions used to make inferences from them. Maximum likelihood can use incomplete records under suitable model and missing-data assumptions, but it does not make missing measurements equivalent to observed ones. In general, conclusions can be affected if the probability of a missing score is related to unobserved outcomes in ways the model does not account for. The registry reports the analysis population and observation counts, but does not describe missingness reasons or provide sensitivity analyses.
How should uncertainty be assessed?
In general, a confidence interval gives a range of values compatible with the data and model under the stated method. Its width helps indicate precision; it is not a guarantee that the true value lies within that specific interval. A p-value, when used, assesses how compatible the observed data are with a specified null hypothesis under the analysis assumptions. Neither measure conveys clinical importance by itself, and neither can be reconstructed from the scale definition or participant counts alone.
No confidence interval, p-value, or numerical trajectory estimate for the primary endpoint is reported in the registry record. Thus, the result's statistical uncertainty and the precision of any change cannot be evaluated. The registry also does not state the hypothesis tested, the model contrast used, or whether inference focused on a particular time point or an overall trajectory.
What can the design establish?
In general, a control group helps distinguish changes associated with an intervention from changes that might also occur without it. This study is recorded as single-group, with allocation NA and masking none; no control comparison is described. A within-group pattern could describe participants’ measured scores over time, but it would not provide the same evidence as a randomized comparison. It would be inappropriate to interpret a before-and-after change as an isolated treatment effect based on this design alone.
The registry gives enrollment of 52, but the available information does not describe a sample-size justification for the trial. The planning assumptions associated with a sample-size illustration are not a substitute for such a justification or for observed findings. A planning calculation estimates the sample size associated with chosen assumptions; it does not report study results. Sample-size illustrations are not observed power.
What is not available for reanalysis?
The registry record does not provide participant-level data, endpoint summary values, a complete statistical model specification, or the numerical estimates needed to independently reproduce an analysis. The available information supports a description of the endpoint, the assessment schedule, the reported analysis population, and the stated use of maximum likelihood. It does not support recalculating effects, uncertainty, or significance. General statistical concepts explain how such analyses are interpreted, but they cannot fill the gaps in the reported results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures and 10 analyses. These counts indicate that the study record includes outcomes and analyses beyond the primary endpoint, but do not identify the full set of hypotheses, their relationship, or which analyses were confirmatory. Whether adjustments were used to account for testing multiple outcomes or analyses is not reported in the registry record. Without that information, the possibility of multiplicity-related uncertainty cannot be evaluated from the record.
The primary outcome's data availability varies by assessment: 52 participants had pretest data, 48 had 4-weeks data, and 44 had 8-weeks data. The registry says maximum-likelihood trajectories included anyone with at least one data point, resulting in all 52 participants being analyzed. This describes the analysis population, but does not mean every participant contributed an observed score at every time point.
In general, maximum-likelihood methods can use incomplete repeated-measure records, provided the model and missing-data assumptions are appropriate. The record does not report why observations were missing, whether missingness was examined, or whether sensitivity analyses were conducted. It also does not give a separate per-protocol or complete-case analysis population. These omissions make it difficult to judge how robust the trajectory would be to different assumptions about unavailable measurements.
The statistical plan, including any prespecified multiplicity strategy, is not reported in the registry record. The reported counts and use of maximum likelihood should therefore be read as limited descriptions, not as evidence that all relevant analysis choices or missing-data concerns have been resolved.
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 |
|---|---|---|---|
| PeriGrief | 0 | 52 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PeriGrief | 0 of 52 |
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 |
|---|---|
| PeriGrief | 0 of 52 |
The registry's adverse-event record lists the PeriGrief group with 52 participants at risk for serious adverse events and 0 affected. It also lists 52 at risk for other adverse events and 0 affected, with 0 deaths. These are recorded counts; they should be interpreted as entries in the registry rather than as a complete account of every possible safety outcome or event.
The information does not describe how adverse events were solicited, defined, monitored, or adjudicated, nor does it specify the observation period for these counts. The record lists no serious adverse-event terms among the top serious terms. Absence of listed events does not provide information about unrecorded events, the completeness of reporting, or outcomes outside the record's specified monitoring.
There is only one listed group, consistent with the single-group design. These figures therefore do not support a comparison of event rates between intervention and control groups. They also do not establish that the intervention is safe or unsafe. They state only that, in the registry record, no participants were recorded as affected in the listed serious or other adverse-event categories and no deaths were listed.
12. What the Result Does, and Does Not, Mean
The study is relevant as a registry record of a behavioral intervention designed for bereaved parents following perinatal loss. It describes Walk With Me as a four-module program delivered by computer or mobile device, using mindfulness and cognitive behavioral therapy strategies. It also identifies traumatic-stress intrusion as the primary measure and states when that measure was assessed. These details make the study's intended focus and outcome definition understandable.
However, the numerical results for the primary endpoint are not reported in the registry record. There are no reported means, standard deviations, estimates of change, confidence intervals, or p-values available in the registry record for this analysis. As a result, the observed level of intrusion, the direction or size of any trajectory, and its statistical precision cannot be stated. The endpoint's scale range and interpretation do not supply those missing results.
The study's single-group structure is also important. A pattern of scores over time, if reported, would not alone show that the intervention caused the pattern. Without a described control comparison, the design cannot isolate intervention-associated change from other influences over time. The registry does not report allocation to a separate comparison group or masking.
The record does report that all 52 participants with at least one data point were included in maximum-likelihood trajectory estimation, while fewer participants had data at the later assessments. This is useful information about the analysis population, but it does not reveal the reasons for missing observations or the assumptions used to address them.
Accordingly, the record supports a description of the study design, intervention, endpoint, analysis approach, and adverse-event counts. It does not support a conclusion about the size or cause of an outcome change. This distinction preserves what the registry reports without treating design intentions or a planned analysis as evidence of an observed effect.
13. Why This Trial Matters Statistically
Statistically, this study illustrates why a defined outcome and a reported result are different things. The registry identifies a continuous primary endpoint, gives its scale and direction, and specifies repeated assessments. It also describes a maximum-likelihood trajectory analysis. These details help readers understand what was intended to be measured and how incomplete repeated observations were handled at a broad level.
At the same time, none of those methodological details reveals the observed endpoint values. Without means, standard deviations, estimated changes, or uncertainty intervals, a reader cannot assess the magnitude or precision of the primary outcome. Reporting the analysis population is useful, but it does not replace reporting estimates and uncertainty.
The design also makes careful interpretation essential. A single-group trajectory can describe scores over time among participants, but it cannot by itself establish what would have occurred without the intervention. This remains true even if a future report gives a clear change estimate. The strength of a statistical conclusion depends not only on the method used, but also on the comparison the design can support.
Finally, the different observed counts across assessment times and the registry's inclusion of participants with at least one data point raise practical questions about missing data. Maximum likelihood is a recognized general approach for incomplete repeated measures, but its interpretation depends on model and missingness assumptions. Those assumptions and any sensitivity analyses are not reported in the registry record. The study therefore offers a useful example of how to separate a reported analysis method from information needed to judge its estimates and robustness.
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 consequential limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. Without means, standard deviations, trajectory estimates, confidence intervals, or tests, the outcome's direction, magnitude, and precision cannot be assessed. No numerical comparison between assessment times can be stated.
The study is single-group, and the registry does not describe a control arm. Thus, even a reported within-group trajectory would not isolate the effect of Walk With Me from other changes over time. Allocation is listed as NA and masking as none. The registry does not provide additional design details that would permit a stronger causal interpretation.
Data availability differs across the assessment schedule: the registry reports 52 participants with pretest data, 48 with 4-weeks data, and 44 with 8-weeks data. Although maximum likelihood included participants with at least one data point, reasons for unavailable assessments, missingness assumptions, and sensitivity analyses are not reported in the registry record. The model specification is also not given, limiting assessment of whether it adequately represents the repeated measurements.
The registry lists 14 outcome measures and 10 analyses, but does not report the analysis plan or whether multiplicity was addressed. It does not report a sample-size justification, participant-level results, intervention adherence, module completion, or a detailed account of adverse-event ascertainment. These limitations concern what can be evaluated from the registry record; they should not be taken as proof that the information does not exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Walk With Me for Perinatal Grief — NCT05318287.
- Registry record last updated 2025-06-04; status last verified 2025-06.
- Results first posted 2024-12-13.
- 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
NCT05318287, Walk With Me for Perinatal Grief, is recorded as completed, with enrollment of 52 and a primary completion date of 2023-09-12. It is a single-group behavioral study with allocation listed as NA and masking as none. The intervention is a brief four-module program delivered by computer or mobile device.
The primary endpoint is the IES-R intrusion subscale, measured at baseline immediately following loss, 4 weeks, and 8 weeks post loss. The registry describes maximum-likelihood trajectory estimation and includes participants with at least one data point, reporting all 52 as analyzed. Assessment-specific counts are 52, 48, and 44, respectively. Numerical primary-outcome estimates and their uncertainty are not reported in the registry record. The adverse-event record lists zero affected participants for serious and other adverse events and zero deaths among 52 at risk in each listed category.