Self-Management of Chronic Depressive Symptoms in Pregnancy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Self-Management of Chronic Depressive Symptoms in Pregnancy (NCT02953990), a na na study. The primary outcome is Recruitment Data.

2. Clinical Question

3. Trial Design

The registry describes a completed, single-group behavioral study titled “Self-Management of Chronic Depressive Symptoms in Pregnancy.” Virginia Commonwealth University is listed as the sponsor. The study began in 2016-09, and primary completion is recorded as 2019-02-12. The listed enrollment is 41. The phase field is NA, and the allocation field is NA; the model is SINGLE GROUP and masking is NONE.

The single-group structure matters for interpretation. There is no randomized arm assignment or concurrent comparison group in the record, so the design does not establish a like-for-like contrast between participants receiving MOMS and participants receiving another intervention or no intervention. The registry’s own description emphasizes feasibility, acceptability, and preliminary effects. Those aims differ from estimating a controlled treatment effect, and the available primary outcome is recruitment data.

The MOMS Program is classified as behavioral. Its description identifies symptom mindfulness and goal-setting through a nurse-participant partnership, plus a 12-week program of weekly community-based prenatal yoga classes lasting 75 minutes each and self-directed home activity. The record’s intervention description is incomplete in the available text, so other details cannot be characterized.

Thirteen outcome measures are recorded, including the primary recruitment measure and secondary measures. However, the registry reports zero analyses, and outcome values beyond the recruitment statement are not reported in the registry record. The study status is COMPLETED, but completion status alone does not establish that every outcome was analyzed or posted. A statistical analysis plan, sample-size justification, interim analyses, and details of analysis populations are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 41 enrolled/ 50 eligible

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 Recruitment Data, measured over baseline.

The primary outcome is titled Recruitment Data and is measured in participants at baseline. Its description defines the measure as the number of individuals enrolled relative to the number of individuals who expressed interest. The recorded population statement gives 41 enrolled and 50 eligible. Because the description uses “expressed interest” while the population statement uses “eligible,” the record does not make clear whether these terms refer to the same denominator. That ambiguity should be retained rather than resolved by assumption.

Recruitment measures are used to describe whether a study enrolled people from those considered or approached for participation. They can inform judgments about the feasibility of recruiting for a study and can help researchers understand how recruitment progressed. They do not measure symptom change, intervention adherence, or a causal effect of treatment. In this record, the primary outcome therefore addresses enrollment rather than whether depressive symptoms changed during the program.

The registry lists secondary outcomes covering PHQ9, state anxiety, rumination, physical-activity self-efficacy, maternal-fetal attachment, birth weight, stress, and minutes of physical activity including yoga. Those measures could address different clinical or behavioral domains, but their results are not reported in the registry record. Without posted outcome values and analysis details, they cannot support conclusions about change or associations.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a single-group design estimate?

General statistical explanation: a single-group study observes participants in one intervention group rather than comparing outcomes between randomized groups. It can describe recruitment, participation, measurements, and changes within that group when the relevant data are collected and reported. A within-group change is not automatically a treatment effect. Other events over time, measurement variation, or changes in who contributes data can also affect observed values. A controlled comparison is generally needed to distinguish an intervention contrast from these alternative explanations.

For this record, the registry identifies a SINGLE GROUP model and lists allocation as NA. It does not report a comparator arm. The primary posted measure is recruitment data, not a before-and-after symptom contrast. No clinical outcome values or analysis estimates are reported in the registry record. Accordingly, there is no reported treatment-effect estimate to interpret.

What does a confidence interval mean?

General statistical explanation: a confidence interval expresses uncertainty around an estimate under the assumptions of the statistical method. A narrower interval indicates greater precision for that estimate, while a wider interval indicates less precision. An interval is not a guarantee that the true value lies within its bounds, and its interpretation depends on the study design, data quality, and analysis model. A confidence interval for a controlled treatment contrast would have a different meaning from an interval for a recruitment measure or a within-group change.

No confidence intervals for clinical outcomes are reported in the registry record. The recruitment statement is given as counts, without a reported interval or uncertainty analysis. The record also does not describe an inferential method for the primary outcome.

Why does the comparator matter?

General statistical explanation: a comparison between groups can help account for influences that affect both groups over the same period. Random allocation, when used, aims to make comparison groups similar on average in factors that could affect outcomes. It does not guarantee identical groups, and the analysis still needs to respect the design. Without a comparator, a change observed in one group cannot be separated cleanly from background change or other influences.

This study is recorded as single-group, with no randomized comparison. The record does not report a control condition or an allocation procedure. As a result, the posted information cannot support a comparative effect estimate. The registration’s stated emphasis on feasibility, acceptability, and preliminary effects should not be read as a report of efficacy.

What is over-dispersion, and does it apply?

General statistical explanation: over-dispersion occurs when the variability in count data exceeds what a simple count model assumes. If over-dispersion is present and ignored, standard errors can be too small and confidence intervals too narrow. Analysts may use models or variance estimates that allow for extra variability when the data and design call for them. That choice depends on the outcome scale and structure of the observations.

The primary outcome is described as a participant count, but the registry does not report a fitted count model, variance estimate, or over-dispersion assessment. It would not be appropriate to claim that over-dispersion was tested or that a particular model was used. The record gives no analysis details for the listed secondary outcomes either.

How should sample-size illustrations be read?

General statistical explanation: a sample-size calculation is a planning exercise that estimates the amount of information needed to detect a specified effect under chosen assumptions. It is not a result from participants and does not show that a study had a particular probability of success after the fact. “Observed power” is not a substitute for presenting an effect estimate and its uncertainty; interpretation should focus on the observed estimate and interval when those are available.

The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It treats the target effect as a stated fraction of an observed effect. These are planning assumptions, not reported features of this single-group study. The registry does not report a comparative observed effect from which such an illustration could be grounded. The study’s sample-size justification and design rationale are not reported in the registry record.

What can the outcome list tell readers?

General statistical explanation: a registry outcome list identifies measures of interest, but it does not supply the results, clarify every analytic decision, or show whether all planned measurements were obtained. Outcome definitions, time points, analysis populations, handling of missing observations, and adjustment for multiple testing are needed to interpret a collection of outcome analyses. If those details are unavailable, the existence of an outcome entry should not be treated as evidence of a finding.

The registry lists 13 outcome measures and zero analyses. It identifies PHQ9, STAI-S, RRS-10, self-efficacy for physical activity, MFAS, birth weight, stress, and total minutes in physical activity including yoga among secondary outcomes. Results and analysis methods for these outcomes are not reported in the registry record. The primary outcome itself supplies a recruitment count, not an inferential analysis. These limits mean that statistical precision for clinical outcomes cannot be assessed from the posted record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("MOMS Program")
n      <- c(50)
events <- c(41)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  MOMS Program  50  41  82.0  68.6  91.4  69.2  90.2  69.1  90.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures, spanning recruitment, depressive symptoms, anxiety, rumination, physical activity, maternal-fetal attachment, birth weight, and stress. When a study tests several outcomes, the chance of obtaining at least one apparently notable result by chance can increase if the analyses are treated as a single family. General statistical practice may address this through prespecified outcome hierarchies, adjusted testing, or careful emphasis on effect estimates and uncertainty. Which approach is appropriate depends on the design and analysis plan.

The registry records zero analyses. A multiplicity strategy, including whether outcomes were prioritized or adjusted, is not reported in the registry record. It is therefore not possible to determine how multiple outcomes would have been handled or to distinguish confirmatory from exploratory analyses.

Missing-data methods and analysis populations are also not reported in the registry record. The record does not state how missing measurements, withdrawals, or incomplete follow-up were handled, nor does it define a primary analysis population. These details can affect the interpretation of outcome estimates, particularly when participants with missing observations differ from those with complete data. No assumptions about missingness or imputation should be attributed to the study.

The registry’s recruitment statement gives 41 enrolled and 50 eligible, while the outcome description refers to people who expressed interest. It does not clarify this denominator wording or provide further recruitment flow. That reporting gap is separate from missing outcome data and should not be mistaken for an analytic method.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event record lists the MOMS Program group with 41 at risk for serious adverse events and 0 affected. It also lists 41 at risk for other adverse events and 0 affected, with 0 deaths. These are the recorded counts in the registry record. No serious-event terms are listed.

Zero recorded events means that no events of those categories appear in the posted counts for this group. It does not establish that the intervention has no safety risks. Counts from a single-group study do not provide a controlled comparison of event rates, and the registry does not give further detail about how events were collected, defined, or monitored. The available information also does not describe follow-up duration for safety reporting.

For this reason, the safety figures should be treated as descriptive reporting, not as a comparative estimate or a guarantee of safety. The registry does not report an analysis of adverse events, and the zero counts do not address whether other events occurred outside the recorded categories or reporting period.

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

The posted result establishes that the registry records 41 enrolled and 50 eligible for the recruitment outcome. It supports a limited description of recruitment in this study. Because the endpoint description refers to people who expressed interest while the population statement refers to eligible people, the exact denominator definition remains unclear. No rate should be inferred from these entries without resolving that wording.

The record does not establish whether MOMS reduced depressive symptoms, changed anxiety or activity, or affected any of the other listed secondary outcomes. Those outcome results are not reported in the registry record. A completed status and a list of planned measures do not replace posted estimates, uncertainty intervals, and analysis details.

The study is single-group and does not list a randomized comparator. As a general statistical principle, observations in one group cannot by themselves distinguish a program effect from other changes over time. Even a reported before-and-after difference would need cautious interpretation without a suitable comparison. In this record, no clinical before-and-after values are available for interpretation.

The registry’s research summary describes feasibility, acceptability, and preliminary effects as areas of interest. The recruitment count is relevant to feasibility, but acceptability results are not reported in the registry record. Nor does recruitment alone demonstrate clinical benefit. The listed adverse-event counts are descriptive and do not establish absence of risk.

The most defensible reading is therefore narrow: the study enrolled participants and recorded recruitment data, while the posted record does not provide inferential clinical outcome results. It cannot support a conclusion for or against the effectiveness of the program. Broader conclusions would require outcome data, defined analyses, and a design capable of supporting the comparison being asked.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of why study aims and outcome types need to be kept distinct. A recruitment measure can address whether enrollment occurred and may contribute to feasibility assessment. It is not interchangeable with an endpoint measuring symptoms, functioning, or treatment effect. The posted primary outcome is recruitment data, so the interpretation should remain centered on enrollment rather than clinical change.

The single-group design is another important feature. Without a comparator, an observed outcome cannot provide the same type of evidence as a randomized contrast. This matters especially when a study concerns symptoms that may change over time for reasons beyond the intervention. The registry record does not report a controlled outcome estimate, and it does not provide results for the listed clinical measures.

The breadth of the outcome list also illustrates why prespecification and transparent reporting matter. Multiple measures can describe different aspects of a program, but readers need results, time points, analysis populations, missing-data handling, and a multiplicity approach to understand how evidence was generated. Those details are not reported in the registry record, and the analysis count is zero.

Finally, a planning illustration should not be mistaken for study evidence. Sample-size calculations rely on design and effect assumptions, while the registered study is single-group and does not report a comparative observed effect. Keeping planning, feasibility, safety counts, and clinical outcomes separate prevents an enrollment result from being overstated as evidence of efficacy or definitive safety.

15. 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 central limitation for interpreting clinical effects is that the registry identifies a single-group model and no comparator. The record therefore does not provide a like-for-like contrast that could isolate the program’s effect from other influences. The primary outcome is recruitment data, and the registry does not report values for the listed symptom or behavioral outcomes.

Outcome reporting is limited. Thirteen outcome measures are listed, but the record reports zero analyses. Analysis methods, estimates, uncertainty intervals, outcome time points beyond the primary measure’s baseline designation, and analysis populations are not reported in the registry record. The registry also does not state how missing data were handled or whether any multiplicity procedure was used.

The recruitment denominator is not fully clear because the primary outcome description refers to people who expressed interest, while the population statement refers to eligible people. The record does not explain how those terms relate or describe further recruitment flow. This prevents a confident interpretation of the recruitment measure as a rate.

The available intervention description is incomplete, ending during its account of the weekly group prenatal yoga and home activity. Additional intervention details, adherence information, acceptability findings, and fidelity measures are not reported in the registry record. Participant characteristics beyond the condition and pregnancy context are also not available in the stated information, limiting assessment of how broadly the findings might apply.

Safety reporting is limited to the listed event counts. Definitions, ascertainment procedures, and safety follow-up details are not reported in the registry record. These limitations mean the zero event counts should remain descriptive rather than being interpreted as evidence that risks are absent.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Self-Management of Chronic Depressive Symptoms in Pregnancy — NCT02953990.
• Registry record last updated 2024-03-25; status last verified 2024-03.
• Results first posted 2024-03-25.
• 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.

19. Record Summary

The registry record describes a completed, single-group behavioral study of the MOMS Program for chronic depressive symptoms in pregnancy. Virginia Commonwealth University is the sponsor. The study began in 2016-09, primary completion is recorded as 2019-02-12, and enrollment is listed as 41.

The primary outcome is baseline recruitment data, with the record stating 41 enrolled and 50 eligible. The outcome description uses “expressed interest” for the denominator, so its relationship to the eligible count is unclear. The registry lists 13 outcome measures and zero analyses. Results for the listed secondary outcomes are not reported in the registry record.

The study has no listed randomized comparator. Its posted recruitment result does not establish a clinical treatment effect. Serious adverse events, other adverse events, and deaths are recorded as zero in the group, but those counts are descriptive and do not establish absence of risk.