Telehealth Group Intervention for Perinatal Depressive Symptoms: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Telehealth Group Intervention for Perinatal Depressive Symptoms (NCT03932760), a randomized na study. The primary outcome is Change in Depressive Symptoms Over Time.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, parallel-group behavioral trial sponsored by the University of Utah. It is marked completed, with enrollment of 99. The record gives a start date of 2020-05-01 and a primary completion date of 2023-03-01. The phase is listed as NA, and masking is listed as none. These entries describe the registered design; they do not establish how participants or staff experienced allocation or whether procedures differed from the registration.

The UPLIFT Program is one arm. Its arm description specifies weekly, one-hour group sessions facilitated by a mental health professional for 10 weeks. The comparator arm description names the Pregnancy Skills Group and specifies weekly, one-hour sessions facilitated by a registered nurse for 10 weeks. However, the intervention list calls the comparator Attention Control Group. The brief summary describes sessions over 8 weeks, while the primary outcome timeframe places the post-intervention assessment immediately following week 9 of group intervention classes. These differences in naming and timing are present in the record and should not be resolved by assumption.

The trial’s stated aim is to evaluate telehealth group intervention for perinatal depressive symptoms in diverse populations. The brief summary describes participants connecting by videoconference using their own electronic devices and attending from a location of their choice. It also describes the intended relevance of urban and rural settings and several population groups. The registry record does not report the number of participants in each arm, allocation procedures, eligibility details, or actual participant demographics. It also does not report a protocol-level sample-size justification or a complete statistical analysis plan.

Randomization is intended to make assigned groups comparable on average, but it does not guarantee identical groups in a particular trial. With no masking, participants and intervention staff would not be masked to group assignment as registered; the record does not say whether outcome assessors or analysts were masked. These design features help frame the endpoint, but without the outcome estimates they do not establish the direction or precision of any group difference.

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: Out of the 535 women reached out to, 331 were unable to be contacted after four attempts. Of the remaining 204, 58 were ineligible for a combination of non-mutually exclusive factors including mental health diagnoses (n= 35), medication changes in the last 6 weeks (n=15), \>6 months postpartum (n=9), and other (n=6). Of the 147 who remained eligible to participate, 99 were consented. Of these, 17 were lost to contact prior to randomization, and 81participants were randomized.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Number Analyzed differs from Overall Number of Participants Analyzed due to participants becoming ineligible, withdrawing, and opting to not complete surveys at certain time points.

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 Change in Depressive Symptoms Over Time, measured over Time 1 = pre-intervention (Baseline); T2 = immediately following week 9 of group intervention classes (Post), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention.

The primary endpoint is change in depressive symptoms over time, measured with the self-completed Edinburgh Postnatal Depression Scale. The registry record describes the measure as a scale from 0-30, with 0 indicating no symptoms and 30 indicating the highest severity of symptoms. It gives score bands of less than 10 for no depressive symptoms, 10-15 for mild symptoms, 16-20 for moderate symptoms, and greater than 20 for severe symptoms.

Assessments are described at Time 1, before intervention at baseline; T2, immediately following week 9 of group intervention classes; T3, 2 months after intervention; T4, 4 months after intervention; T5, 6 months after intervention; and T6, described as 8 post-intervention. That final wording is not more precisely specified in the registry record. The endpoint is defined as a mean of a continuous measure, with standard deviation as the dispersion measure.

Repeated measurement can describe whether symptom scores change across the specified follow-up period, rather than focusing only on a single post-intervention measurement. In general, the mean summarizes the average score in a group, while the standard deviation describes variation among participants. The registry record does not report the mean scores, standard deviations, or comparative change estimates at these time points, so the endpoint’s observed trajectory cannot be characterized from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The trial is registered as randomized with a parallel model and no masking. In a parallel design, participants are assigned to one of the groups and remain in that assigned group for comparison. Random assignment is a design method intended to reduce systematic differences between groups at the outset. It does not guarantee that every characteristic is balanced in a particular trial, and it does not replace reporting of participant flow, baseline characteristics, or outcome results. Those details are not reported in the registry record.

What does a continuous outcome mean?

The primary measure is a continuous score, and the registered parameter is the mean. A mean represents the average score among the participants included in a particular calculation. The standard deviation describes how spread out individual scores are around that average. These answer different questions: the mean describes the group’s central level, while the standard deviation describes variation within the group. Neither is a comparative effect by itself. To interpret the trial’s primary question, a comparison between randomized groups over time would be needed.

In general, a continuous measure retains information across its range. Converting scores to categories can make them easier to describe, but it discards detail about differences within each category. The registry record gives symptom bands for the Edinburgh Postnatal Depression Scale as well as its continuous range. It does not report category-specific outcome counts, so the categorical thresholds cannot be used to reconstruct the results.

Why measure the outcome repeatedly?

The registered schedule includes a baseline measure, a post-intervention assessment, and follow-up assessments. Repeated measurement can show whether scores change during the period of observation and whether the pattern differs between groups. Statistical approaches for repeated observations can account for the fact that measurements from the same participant are related; observations from one participant are generally not independent of one another. The registry record does not report whether such an approach was used, which model was selected, or which time points were included in the primary contrast.

The timing descriptions should also be read with care. The brief summary says the group connection period is 8 weeks, the arm descriptions specify 10 weeks, and the primary endpoint description identifies the post-intervention assessment as following week 9 of classes. These entries do not align exactly. The record does not explain the difference, so it is not possible to determine from the registration which duration or timing governed the delivered intervention.

What does a confidence interval convey?

In general, a confidence interval communicates uncertainty around an estimated effect under the assumptions of the statistical method. It is not a guarantee that the true effect lies within the interval, and it does not describe the range of individual participant outcomes. Its width depends on factors such as variability and the amount of information available. Since the registry record does not report a primary effect estimate or confidence interval, neither the magnitude nor the precision of a comparative finding can be assessed.

A p-value, when reported, is a measure of how compatible the observed data are with a specified null hypothesis under the analysis assumptions. It is not the probability that the null hypothesis is true, and it does not convey the size or practical importance of an effect. No primary outcome p-value is reported in the registry record. The record also does not report a detailed statistical analysis plan, including the chosen hypothesis test, model, covariates, or decision criteria.

How should planning calculations be understood?

The registry record describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect, and that non-time-to-event planning values are participants per arm. These are planning assumptions, not trial findings or evidence of achieved statistical power. No particular planning result or observed effect estimate is reported in the registry record. The trial’s own sample-size justification is not reported in the registry record, so the planning assumptions should not be taken as the documented basis for enrollment.

In general, sample-size planning estimates how many participants may be needed to detect a prespecified effect under selected assumptions. Changing the effect assumed, variability, significance level, allocation, or analysis can change such an estimate. A calculation based on an effect observed after a study is completed is not the same as a prospective justification and cannot establish that the trial was adequately powered. It also cannot replace confidence intervals or a transparent account of missing outcomes.

Why can over-dispersion matter?

In general, over-dispersion refers to variation in data that is greater than a statistical model assumes. If a model underestimates variation, its uncertainty estimates may be too small, and inference can become misleading. This concept is most relevant when the outcome and model involve variance assumptions that can be violated; it should not be presumed to have occurred in this trial. The registry record does not report a fitted model or diagnostics, so no claim about over-dispersion or its handling can be made for these data.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is change in depressive symptoms over time, with assessments described from baseline through follow-up. The record also lists change in anxiety symptoms over time as a secondary outcome and indicates 2 outcome measures and 2 analyses. Multiple outcomes, time points, or statistical contrasts can create multiplicity: in general, testing more hypotheses can increase the chance of at least one apparently unusual result even when no underlying effect exists. Whether and how to account for that issue depends on the prespecified analysis plan.

The registry record does not report whether an adjustment for multiple comparisons was planned or used. It does not identify a single primary time-point contrast, specify a hierarchy among time points, or report the statistical model. It is therefore not possible to determine which comparisons were considered confirmatory or how their uncertainty should be interpreted. No results are reported for either the primary or secondary outcome.

The primary outcome description says the number analyzed varies from the overall number analyzed because participants became ineligible, withdrew, or chose not to complete surveys at certain time points. This indicates that outcome availability differed over time, but the record does not report how many observations were missing at each assessment or by arm. It also does not report whether missingness was handled using a model, imputation, complete-case analysis, or another method. In general, missing-data methods rely on assumptions about why measurements are absent; without the method and relevant information, the sensitivity of the findings to those assumptions cannot be assessed.

The registry record does not define an intention-to-treat or per-protocol analysis population, nor does it explain how participants who became ineligible or withdrew were treated in the analysis. Such populations can answer different questions. No conclusion about the analysis population or robustness to missing data can be drawn from the registration alone.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry safety listing reports 40 participants at risk for serious adverse events in the UPLIFT Program group and 41 in the Pregnancy Skills Group. Serious adverse events are recorded as 0 in each group. Other adverse events are also recorded as 0 in both groups, with 40 and 41 participants at risk, respectively. Deaths are recorded as 0 in both groups. No top serious-event terms are listed.

These entries are counts in the registry safety listing. They do not provide detail about how events were defined, how they were collected, the observation period for safety, or whether all participants contributed the same amount of follow-up. The safety denominators are not a substitute for the number analyzed at each depressive-symptom time point. The registry record separately notes that the number analyzed varied because of ineligibility, withdrawal, and survey noncompletion.

In general, a recorded count of zero means that no events were entered for that category in the reported listing; it does not establish that no event could occur or that every possible harm was measured. These safety figures should be interpreted as registry-reported event counts, not as a comprehensive assessment of safety or as a measure of the primary symptom outcome.

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

The registry record establishes that a randomized, parallel-group trial was registered to examine a telehealth group intervention for perinatal depressive symptoms. It identifies the UPLIFT Program and a comparator described as the Pregnancy Skills Group, and it specifies depressive symptom change over time as the primary outcome. It also describes the Edinburgh Postnatal Depression Scale and repeated assessment during follow-up.

However, the record does not report the primary outcome results. There are no group-specific means, standard deviations, comparative effect estimates, confidence intervals, or p-values. The trial’s observed direction and magnitude of effect, and the precision of any comparison, are therefore not reported in the registry record. The intended study question is not itself evidence of a particular result.

In general, a statistically detectable difference and a meaningful difference are not interchangeable concepts. Statistical uncertainty concerns how precisely a contrast is estimated under a model; practical interpretation also depends on the size and context of that contrast. The registry record does not provide the estimates needed to assess either consideration. The score ranges and symptom categories describe the measurement instrument, not the distribution of participant outcomes.

The record also cannot establish whether the registered intervention was delivered exactly as described. The brief summary specifies an 8-week schedule, while arm descriptions specify 10 weeks, and the post-intervention assessment is described in relation to week 9. The comparator is named differently in the intervention list and arm descriptions. The record does not explain these discrepancies.

The safety listing records zero serious adverse events, zero other adverse events, and zero deaths in each arm. Those entries should be read as reported counts, not as proof that no possible adverse event occurred. Overall, the registry record supports a description of the planned question, registered design, and recorded safety counts; it does not support a conclusion about the comparative depressive-symptom outcome.

13. Why This Trial Matters Statistically

This trial raises statistical questions that are common in studies of behavioral interventions delivered over time. The primary endpoint is a repeated continuous measure, so interpretation depends not only on average scores but also on how observations from the same participant are handled and how the comparison between randomized groups is defined. The registry record identifies the measurement schedule but does not report the model or primary contrast.

Outcome availability is also relevant. The record states that the number analyzed differs across the overall population because participants became ineligible, withdrew, or did not complete surveys at some time points. In repeated-measure studies, changing availability can affect which observations contribute to estimates. Without counts by time point and arm, a missing-data method, or sensitivity analyses, readers cannot assess how much the missing observations might influence a result.

The registration also illustrates why analysis plans and outcome reporting matter. Multiple assessment points and a secondary anxiety outcome create choices about which comparisons are primary and how uncertainty is described. The record indicates 2 outcome measures and 2 analyses, but does not report multiplicity procedures or results. Transparent methods and estimates would be needed to distinguish a prespecified comparison from exploratory analyses.

Finally, differences among the registered descriptions of intervention duration, post-intervention timing, and comparator naming complicate interpretation of the intervention contrast. Clear documentation of delivered treatment and analysis timing would help readers connect the registered question to the analyzed data. These points do not imply a particular outcome; they define what information is needed to interpret one.

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.

Outcome reporting is the central limitation for interpreting this registry record. The primary endpoint is identified, but no numerical outcome estimates or inferential results are reported. Without group-specific scores and a defined comparison, the magnitude and precision of any difference cannot be assessed. The record also does not report results for the secondary anxiety outcome.

The description of intervention duration is inconsistent across registry entries: the brief summary describes 8 weeks, whereas the arm descriptions specify 10 weeks. The primary outcome timeframe describes the post-intervention assessment as following week 9 of classes. The comparator is called Attention Control Group in the intervention list and Pregnancy Skills Group in the arm descriptions. The registry record does not explain these differences, so the delivered schedule and comparator identity cannot be clarified from the record alone.

Participant accounting is incomplete for evaluating repeated outcome data. The record notes ineligibility, withdrawal, and survey noncompletion but does not report the number missing at each time point or by arm. It does not report the method for handling missing data, the analysis population, or sensitivity analyses. Actual demographic composition and arm-specific analyzed sample sizes are also not reported in the registry record.

Statistical details are limited. The registry record does not report a detailed analysis plan, model specification, primary time-point contrast, adjustment for multiple comparisons, or the trial’s sample-size justification. The planning assumptions described in the record are not a substitute for these details. The safety listing provides event counts but not event definitions, collection methods, or follow-up detail. These limitations constrain interpretation of the registered design and prevent conclusions about efficacy, precision, or comprehensive safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Telehealth Group Intervention for Perinatal Depressive Symptoms — NCT03932760.
• Registry record last updated 2024-06-04; status last verified 2024-05.
• Results first posted 2024-06-04.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The University of Utah sponsored this completed randomized, parallel-group behavioral trial, with enrollment of 99. The registry record lists no masking and identifies the primary outcome as change in depressive symptoms over time, measured with the Edinburgh Postnatal Depression Scale. The stated project aim concerns telehealth group intervention for perinatal depressive symptoms in diverse populations.

The UPLIFT Program is compared with an arm described as Pregnancy Skills Group, although the intervention list uses Attention Control Group. Intervention-duration descriptions also differ. The record lists anxiety symptom change over time as a secondary outcome and notes that outcome analysis counts varied because of ineligibility, withdrawal, and incomplete surveys.

Serious adverse events, other adverse events, and deaths are recorded as zero in both groups. The primary and secondary outcome results, detailed statistical methods, missing-data approach, and sample-size justification are not reported in the registry record. Accordingly, the registered question and design can be described, but the comparative symptom outcome cannot be evaluated from the record.