Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA) (NCT06065020), a randomized na study. The primary outcome is Depressive Symptoms.

2. Clinical Question

The study is titled Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA), and its official title describes a pilot trial among Peruvian older adults. The registry lists depression and anxiety as conditions. Anxiety symptoms and loneliness are named as secondary outcomes. Its brief summary frames the main questions around whether the planned study procedures and participant activities are suitable for a larger study, and whether the intervention package can be delivered as planned.

This framing matters when interpreting the clinical question. A pilot trial can address feasibility and intervention development as well as measure clinical outcomes. The registry record does not report enough numerical outcome information to judge the size or precision of any group difference in depressive symptoms. It therefore supports a description of the question and design, but not a conclusion about the comparative effect of VIDACTIVA and standard care.

3. Trial Design

VIDACTIVA is registered as a randomized, single-masked, parallel-group pilot trial. The listed interventions are VIDACTIVA sessions and standard care; the arm descriptions call these the intervention group and control group. The registry reports enrollment of 72. It lists the study status as completed, with a start date of 2023-10-23 and primary completion date of 2025-02-03. The phase is listed as NA.

The study is intended to test the feasibility of conducting a larger clinical trial addressing both implementation and effectiveness outcomes for a community-based intervention in low-resource urban settings in Lima, Peru. That pilot purpose is distinct from a definitive estimate of effectiveness. The registry record does not report a detailed protocol, recruitment procedures, eligibility criteria, allocation sequence method, or the identity of the person or group masked. It also does not report how the intervention or standard care was delivered beyond the brief arm descriptions.

The primary outcome is depressive symptoms measured from enrollment through the end of treatment at the 14th week and the 22th week. The registry describes a linear mixed-effects model with a participant-level random intercept to incorporate all available observations. It notes that the number of observations differed across assessment time points because of missing follow-up data, and that missing outcome observations were not imputed.

These design details describe the planned comparison and the stated approach to repeated measurements. They do not supply a primary-outcome estimate. The registry lists zero analyses, and numerical group results, model estimates, confidence intervals, and p-values are not reported in the registry record. The record also does not report a sample-size justification for the trial itself. Any sample-size figures presented as planning illustrations should therefore be distinguished from the trial enrollment and from observed results.

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: A total of 72 participants provided informed consent and underwent eligibility screening. Eight participants were excluded before randomization because they did not meet the eligibility criteria (PHQ9\<6). The remaining 64 participants were randomized.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Linear mixed-effects models with a participant-level random intercept were used to incorporate all available observations. Sample sizes varied across assessment time points because of missing follow-up data. Missing outcome observations were not imputed.

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 Depressive Symptoms, measured over From enrollment to the end of treatment at 14th week , 22th week.

The primary endpoint is depressive symptoms measured with the Patient Health Questionnaire-9 (PHQ-9). The registry gives a minimum score of 0 and a maximum score of 27, with higher scores indicating worse symptoms. The outcome is treated as a continuous measure and summarized as a mean with standard deviation.

In general, a continuous symptom scale represents gradations in a measured experience rather than placing each participant into only one category. A mean describes the group’s average score, while a standard deviation describes how spread out scores are around that average. Those summaries can help characterize both the typical measured level and the variation among participants, but they do not by themselves show how an individual participant’s symptoms changed.

The registry specifies assessment from enrollment through the end of treatment at the 14th week and the 22th week. Repeated measurements can describe scores at more than one point in follow-up and support analysis of patterns over time. The registry record does not report the actual mean scores, standard deviations, or a numerical comparison between groups at these assessments. The PHQ-9 endpoint is therefore identifiable, but its observed results and precision cannot be described from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a linear mixed-effects model with a participant-level random intercept for the repeated PHQ-9 observations. In general, a mixed-effects model can represent both an average pattern shared across participants and variation among participants. A participant-level random intercept allows each participant to have an individual baseline level around the model’s overall level. This can be useful when measurements from the same person are related rather than statistically independent.

That relationship matters because repeated outcome measurements on one participant commonly share characteristics. A model that accounts for participant-level clustering can avoid treating every measurement as if it came from a different, unrelated person. The registry specifically says the random intercept was used to incorporate all available observations. It does not report the full model formula, covariates, time coding, covariance structure, estimation method, or a detailed account of how the group comparison was parameterized. Those details are not reported in the registry record and should not be inferred from the general model description.

The endpoint is a continuous PHQ-9 score, reported in points, with a mean and standard deviation as the stated summary. In general, a mean is a measure of central location, and a standard deviation describes dispersion around it. The score’s stated range is 0 to 27, and higher scores indicate worse symptoms. Interpreting a group comparison would require the estimated contrast and its uncertainty, not just the endpoint definition. Those numerical estimates are not reported in the registry record.

The record says that follow-up observations were missing and that sample sizes varied across assessment time points. It also states that missing outcome observations were not imputed. In general, not imputing missing values means the absent outcome values were not filled in with substituted values before analysis. A mixed-effects model can use observed repeated measurements without such substitutions. However, using the available measurements does not make incomplete follow-up irrelevant: interpretation can depend on why outcomes are missing and on assumptions about the relationship between missingness and observed or unobserved outcomes. The registry record does not report a missing-data assumption, an investigation of reasons for missingness, or sensitivity analyses.

General explanation of missing-data assumptions is important. If participants with missing assessments differ in relevant ways from those with observed assessments, the available observations may not fully represent the intended comparison. A model may provide a valid estimate under particular assumptions, but the registry description does not establish that those assumptions hold. The record’s statement that no outcome observations were imputed describes a procedure; it is not, by itself, evidence that missing data could not affect the estimate.

Randomization is intended in general to support a fair comparison by assigning participants to groups through a chance-based process. The registry lists allocation as randomized and describes a parallel comparison. It does not report the sequence-generation method, concealment procedures, or details about who was masked. The single-masked designation does not identify the masked party in the registry record. These unreported implementation details limit how specifically the masking and allocation procedures can be evaluated.

The registry lists zero analyses. That means numerical analysis results are not recorded in the information available for interpretation; it should not be read as a numerical finding about the primary outcome. No primary comparison estimate, uncertainty interval, or p-value is reported in the registry record. The sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not the trial’s own design justification or observed power. The record does not report the numerical planning illustrations. It also distinguishes planning outputs for time-to-event outcomes, which would count total events, from other outputs, which would count participants per arm; the primary endpoint in this trial is continuous.

In general, a confidence interval is useful alongside an estimate because it conveys statistical uncertainty, while a p-value addresses compatibility with a null hypothesis under a model. Neither conveys all sources of uncertainty, including limitations in measurement, missing follow-up, or generalizability. Since the registry record does not report these primary-outcome statistics, the design and analysis description can be explained, but the fitted model’s results cannot be interpreted quantitatively.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies depressive symptoms as the primary outcome and lists anxiety symptoms and loneliness as secondary outcomes. It reports three outcome measures and zero analyses. The record does not report a multiplicity plan, such as whether or how inference across outcomes or assessment times was adjusted. It also does not report a prespecified hierarchy among the secondary outcomes or a detailed plan for selecting which time-point comparisons would be emphasized.

In general, examining multiple outcomes or multiple comparisons can increase the chance of observing an apparently notable result by chance. A prespecified analysis plan and an explicit approach to multiplicity help readers understand how such findings should be interpreted. No multiplicity adjustment should be presumed from the registry description. Numerical results for the primary or secondary outcomes are not reported in the registry record.

For missing data, the record states that sample sizes varied across assessment time points because of missing follow-up and that missing outcome observations were not imputed. The model incorporated available observations. It does not report the amount or pattern of missingness by assessment, reasons for missingness, or sensitivity analyses. In general, an analysis using observed data still relies on assumptions about how missingness relates to measured and unmeasured outcomes. Not imputing values does not remove the need to consider those assumptions.

The analysis population is described as using all available observations, but the registry does not report a more detailed definition of the analysis population or how participants with no follow-up outcome were handled. The record does not report a separate per-protocol or intention-to-treat analysis. Consequently, neither a specific analysis-population rule nor robustness across alternative missing-data approaches can be evaluated from the registry record.

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 5% reporting threshold.

The registry lists serious adverse event counts for the intervention group and active control group. The serious-event at-risk counts are 31 for the intervention group and 33 for the active control group; the reported number with serious adverse events is 0 in each group. The registry reports 0 deaths in each group. No serious adverse event terms are listed.

For other adverse events, the at-risk count is 31 in each group, and the reported number affected is 0 in each group. These are descriptive registry counts. The serious-event and other-event at-risk counts are not identical for the active control group, and the record does not explain the difference. The listed at-risk counts should not be confused with the enrollment figure.

In general, a zero count means that no events of that type were recorded among the listed participants at risk in the registry record. It does not establish that the underlying risk is zero, nor does it by itself establish equivalence in safety between groups. Interpretation depends on how events were defined, collected, and followed over time. The registry record does not report those details, event-specific follow-up duration, or an inferential comparison of adverse events. These counts describe what is recorded and do not support broader safety conclusions.

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

The registry record establishes that VIDACTIVA was a randomized, single-masked, parallel-group pilot trial comparing a community intervention with standard care. Its primary measure was depressive symptoms on the PHQ-9, assessed from enrollment through the end of treatment at the 14th week and the 22th week. The record also describes a mixed-effects analysis intended to use all available observations despite missing follow-up.

Those details do not establish the intervention’s comparative effect. The registry record does not report primary-outcome group summaries, a between-group estimate, a confidence interval, or a p-value. As a result, the direction and size of any observed difference, and the precision of that difference, cannot be evaluated. The absence of these estimates should not be interpreted as evidence of no effect or as evidence of benefit.

The pilot purpose is also relevant. The stated aim was to test feasibility for a larger study addressing implementation and effectiveness outcomes and to examine whether the intervention package could be delivered as planned. The registry record does not report detailed findings on these feasibility questions. Enrollment of 72 and completed status describe the study record, but do not alone demonstrate that all implementation targets were met or that the intervention would be feasible in a larger study.

The reported safety counts are descriptive: no serious adverse events or deaths are recorded in either group, and no other adverse events are recorded among the listed at-risk participants. Such counts do not establish absence of risk, especially without more information about event collection and follow-up.

In general, a trial’s results should be interpreted using effect estimates, uncertainty, outcome definitions, missing-data handling, and the population and setting studied. Here, the available record supports a description of the trial and its intended methods, but not a quantitative conclusion about depressive symptoms, secondary outcomes, or comparative safety.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of a pilot study whose stated objectives combine feasibility, implementation, and clinical measurement. Those aims are related but not interchangeable. A feasibility question concerns whether a larger study and its procedures can be conducted; an effectiveness question concerns outcome differences under the intervention and comparator. The registry describes both aims, so interpretation should not reduce the study to a single clinical comparison.

The repeated PHQ-9 assessments also make the analysis structure important. Measurements from the same participant are not necessarily independent, and the registry’s participant-level random intercept is a stated way to represent participant-level differences in a mixed-effects model. At the same time, missing follow-up means the number of observations differed by assessment. The record’s explanation of available-observation analysis is therefore important context, while the missing-data assumptions and sensitivity analyses are not reported.

The record demonstrates why outcome definitions and numerical results must be distinguished. It specifies a continuous measure, its score range, the direction of interpretation, and assessment timing. Yet those details cannot substitute for group estimates and uncertainty intervals. Without the latter, readers cannot quantify the comparative result or judge its precision.

Finally, the registry’s planning assumptions should be kept separate from evidence observed in the trial. Planning illustrations based on an observed effect are not observed power and are not the trial’s own sample-size justification. The registry record does not report numerical planning outputs or primary-outcome estimates. This separation helps avoid treating planning calculations, study completion, or descriptive adverse-event counts as substitutes for an effect estimate.

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 limited detail about who could participate, how participants were recruited, and the characteristics of those enrolled. Although it situates the study among older adults with depression in low-resource urban settings in Lima, Peru, it does not report more specific eligibility criteria or participant characteristics. This limits assessment of how closely the enrolled population represents the intended setting or other populations.

Intervention and comparator descriptions are brief. VIDACTIVA is named as a program and standard care as the control, but the registry does not report session content, delivery procedures, adherence, or the components of standard care. It also does not identify who was masked under the single-masked designation. These gaps limit assessment of intervention fidelity and the practical meaning of the comparison.

For the primary outcome, the registry specifies the PHQ-9 and multiple assessment times but reports no numerical outcome results. The registry lists zero analyses, and no primary estimate, confidence interval, or p-value is reported. Consequently, the comparative outcome and its precision cannot be evaluated. The record also does not report detailed results for anxiety symptoms or loneliness.

Missing follow-up is acknowledged, and the analysis is described as using available observations without imputation. However, the record does not report the amount or reasons for missingness, assumptions about missing data, or sensitivity analyses. Details of the model beyond the participant-level random intercept are also not reported. These omissions limit evaluation of the model specification and the robustness of conclusions to incomplete follow-up.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA) — NCT06065020.
• Registry record last updated 2026-09-16; status last verified 2026-09.
• Results first posted 2026-09-16.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT06065020 is the completed VIDACTIVA pilot trial, a randomized, single-masked, parallel-group study of a community intervention versus standard care for older adults with depression in low-resource urban settings in Lima, Peru. The registry reports enrollment of 72 and lists depression and anxiety as conditions. The primary outcome is depressive symptoms measured by the PHQ-9, with higher scores indicating worse symptoms. Anxiety symptoms and loneliness are listed as secondary outcomes.

The registry describes a linear mixed-effects model with a participant-level random intercept, use of all available observations, variable sample sizes across assessment times due to missing follow-up, and no imputation of missing outcome observations. Numerical primary and secondary outcome results and analysis estimates are not reported in the registry record. Serious adverse events and deaths are recorded as 0 in each group; other adverse events are also recorded as 0 among the listed at-risk participants.