Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador (NCT06219642), a randomized na study. The primary outcome is Behavioral Activation Scale for Depression (BADS).

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. The study is marked completed, and the sponsor is Universidad San Francisco de Quito. The listed study dates are March 15, 2023, for the start and April 24, 2024, for primary completion. These record entries describe the study timeline; they do not establish when each participant completed a session or assessment.

The planned comparison was between a VR mindfulness intervention and a control group receiving check-in calls. The VR intervention description specifies 10 sessions of 30 minutes each. The control description says investigators would call participants every week and ask how they were doing. The week 10 primary outcome description refers to an experimental-group post-intervention assessment and a control-group wait-list condition.

Enrollment is listed as 84. The primary endpoint summaries report 37 participants in the control group and 36 in the VR intervention group. These endpoint counts are not the same as the enrollment figure. Reasons for the difference, participant flow, and the number randomized to each group are not reported in the registry record. Safety summaries list 42 participants at risk in each group, so the denominators differ from those in the primary endpoint summaries; the record does not explain the difference.

The registry lists one primary outcome, the Behavioral Activation for Depression Scale score at week 10, and four outcome measures overall. Secondary outcome results are not posted. Details such as the randomization sequence, allocation concealment, the planned analysis population, and the trial's original sample-size justification 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.

Before assignment: A total of 158 individuals initially completed the screening process. Of these, 74 did not meet the inclusion criteria and were excluded from the study. The remaining 84 participants met the eligibility criteria and were enrolled in the study.

Overall Study

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.

Population: The population assessed were non-institutionalized older adults aged sixty years or older who had the capacity to give consent and who had minimal cognitive impairment, anxiety, and depressive symptoms.

6. Primary Endpoint

The registry lists the primary outcome as Behavioral Activation Scale for Depression (BADS), measured over Week 10 (Experimental group post-intervention vs. Control group wait-list condition)..

The primary endpoint is the Behavioral Activation for Depression Scale (BADS), a 25-item self-report measure of behavioral activation and avoidance associated with depression. Participants rate items on a seven-point Likert scale from 0 (not at all) to 6 (completely), and item scores are summed to a total score ranging from 0 to 150. Higher total scores indicate greater behavioral activation, more engagement in goal-directed activities, and lower levels of depressive avoidance.

This measure is relevant to the study question because it quantifies a behavioral dimension related to depressive symptoms, rather than serving as a direct count of sessions or a general measure of wellbeing. The posted primary outcome compares mean scores at week 10, described as the intervention group's post-intervention assessment and the control group's wait-list condition. The registry record does not report a minimum clinically important difference or another threshold for interpreting how large a score change would be meaningful to participants.

The endpoint is continuous, and the record reports a mean and standard deviation for each group. Those summaries describe the average scores and the spread of participant scores, respectively. They do not show how individual scores changed from baseline, because baseline endpoint values and within-person change summaries are not reported in the registry record.

7. Results Posted in the Registry

• VR Intervention: mean 89.90 versus 77.00 on control; difference 12.90 (95% CI 3.24 to 22.56), standardized effect d = 0.61; z-test p = 0.009.

8. Statistical Interpretation

9. Statistical Methods Explained

The outcome is a continuous score, so the posted group summaries use means and standard deviations. A mean describes the average score in a group; a standard deviation describes how dispersed individual scores are around that average. The control mean was 77.0, with a standard deviation of 21.9, and the VR intervention mean was 89.9, with a standard deviation of 20.2. These summaries do not reveal the full distribution of scores, whether scores were skewed, or whether a small number of participants had unusually high or low values.

What does the mean difference describe?

The mean difference is 12.9 points, calculated in the posted comparison as the intervention-group mean minus the control-group mean. It is expressed in the BADS scale's original points, making it directly interpretable alongside the scale range from 0 to 150. Since larger scores correspond to greater behavioral activation, the positive direction indicates a higher group average in the intervention arm at the stated assessment. It does not mean that every intervention participant scored higher than every control participant, nor does it describe individual change from baseline.

The registry also posts a pooled standard deviation of 21.08 and a standardized effect of 0.612. In general, a standardized effect expresses a contrast relative to a measure of score variability, rather than in the original scale units. This can be useful when comparing magnitudes across different scales, but its interpretation depends on context and does not by itself establish importance to patients. The precise analysis procedure used to obtain the standardized effect is not reported in the registry record.

How should the p-value be read?

The unadjusted p-value is 0.009. In general, a p-value describes how unusual data at least as discrepant as those observed would be if a specified null hypothesis and statistical model were true. It is not the probability that the intervention has no effect, and it is not a measure of the chance that the result will replicate. The registry labels this result unadjusted, but does not identify the test, its assumptions, or whether any covariates were included. The value should therefore be understood as the posted nominal comparison, not as a complete description of the statistical analysis plan.

A statistical test for a mean difference commonly relies on assumptions about observations and the distribution or sampling behavior of the outcome. General considerations include whether observations are independent and whether the analysis accommodates unequal variability or departures from a normal model. The registry does not report diagnostic checks, a method for handling non-normal scores, or whether an alternative analysis was considered. The posted summaries alone cannot resolve those questions.

What does the confidence interval add?

The 95% confidence interval for the mean difference runs from 3.239 to 22.56 points. In general, a confidence interval presents a range of values compatible with the data and the method used to construct the interval. A narrower interval indicates greater precision for the estimated contrast; a wider interval indicates more uncertainty. The interval is not a range containing 95% of participant scores, and it does not mean there is a 95% probability that the true effect lies within these particular limits.

The registry does not state how the interval was constructed, whether it corresponds to the same test used for the p-value, or whether the analysis was adjusted. The interval and p-value can be read together as evidence about the estimated group contrast, while keeping in mind that neither addresses bias from missing data, deviations from the intended analysis, or limitations in the trial design.

Why can variability matter?

General statistical reasoning: a mean difference is easier to estimate precisely when outcome values are not highly dispersed and when more outcome observations contribute information. Greater spread among individual scores makes it harder to distinguish a group contrast from random variation. If variation differs between groups, a method that assumes equal variability may not provide appropriate uncertainty estimates. The registry does not report a variance-assumption check or the specific test used, so these are methodological considerations rather than claims about what occurred in this analysis.

Randomization can support a fair group comparison by reducing systematic differences in expectation, but it does not guarantee identical groups on every characteristic, especially in a finite sample. The registry says allocation was randomized, but details of sequence generation, concealment, baseline characteristics, and analysis population are not reported. An intention-to-treat approach, per-protocol approach, or another population definition cannot be inferred from the endpoint counts.

Finally, statistical significance and clinical relevance are distinct concepts. Statistical uncertainty is described in part by the confidence interval and p-value; clinical relevance requires context about the meaning of score differences, which the registry does not provide as a threshold. No conclusion about effectiveness follows from statistical significance alone. The appropriate reading is limited to the reported group means, their estimated contrast, and the uncertainty measure posted for that comparison.

10. Confidence Intervals and Precision

The mean difference is 12.9 BADS points, and its 95% confidence interval extends from 3.239 to 22.56. This interval gives a range of plausible values for the group contrast under the method used to calculate it. Its lower limit is above zero, consistent with the positive direction of the posted mean difference. The interval nevertheless spans values of different magnitudes, so the point estimate should not be treated as an exact value known without uncertainty.

Precision refers to how tightly an estimate is determined, not whether the result is unbiased or clinically important. A confidence interval captures sampling uncertainty under its assumptions. It does not automatically account for missing outcomes, selection, imperfect implementation, unblinded assessment, or other sources of uncertainty. The registry record does not report the interval construction method or details that would show how these issues were handled.

The group standard deviations, 20.2 for the intervention group and 21.9 for control, indicate substantial participant-to-participant spread relative to the group means. They do not reveal the shape of each score distribution or the precision of every subgroup estimate. The endpoint group counts are 36 for the intervention group and 37 for control. The registry lists enrollment as 84, and reasons for the difference between enrollment and endpoint counts are not reported.

The confidence interval should be considered alongside the unadjusted p-value of 0.009, while recognizing that a p-value is not an uncertainty range and does not convey clinical importance. The record does not report a clinically important difference threshold for BADS. Consequently, precision about the statistical contrast cannot settle whether its magnitude would be important in practice.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning estimates are participants per arm, not total events. They are illustrations based on the observed mean difference, rather than a report of the trial's original sample-size calculation. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. For each scenario, the effect to detect is a stated fraction of the observed effect.

The 80% power column gives the number of participants per arm estimated to provide an 80% chance of detecting the specified effect under those assumptions, if that effect and model were the planning basis. The 90% power column gives the corresponding estimate for a 90% chance. These are prospective planning quantities; they are not observed power. For planning at 100% of the observed effect, the estimates are 42 participants per arm for 80% power and 57 participants per arm for 90% power. For planning at 75% of the observed effect, they are 75 and 100 participants per arm, respectively. For planning at 50% of the observed effect, they are 168 and 225 participants per arm, respectively.

The general pattern is that smaller target effects require more participants to detect them with the same planned power. The estimates are conditional on the stated assumptions and should not be read as a reconstruction of the trial's original design. The original sample-size justification and its assumptions are not reported in the registry record. The estimates also do not account for details not specified in the planning assumptions, such as loss to follow-up or changes to the analysis approach.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 12.900; pooled standard deviation σ = 21.079.
2. n = 2 × (1.96 + 0.842)² × 21.079² / 12.900² = 41.9, rounded up to 42 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 12.9                      # observed difference in means
sigma <- 21.0791132186462                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(6219642)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 42 (80% power), 57 (90% power)
 75% of observed effect: n per arm = 75 (80% power), 100 (90% power)
 50% of observed effect: n per arm = 168 (80% power), 225 (90% power)
power.t.test: 42.9 
Simulated power at n = 42 per arm: 0.794 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Multiplicity, Missing Data and Analysis Populations

The registry record lists four outcome measures overall, but only the primary BADS outcome result is posted. It lists no secondary outcome results and no analysis entries. A plan for controlling multiplicity across outcomes or analyses is not reported in the registry record. Without that information, the unadjusted p-value should be treated as a nominal result for the posted comparison rather than as evidence that accounts for all possible outcomes or analyses.

Missing-data handling is not reported in the registry record. The enrollment figure is 84, while the primary endpoint summaries include 37 control participants and 36 intervention participants. The record does not give a participant flow diagram or explanation for the endpoint counts, nor does it say whether participants without an endpoint score were excluded, imputed, or handled using another method. The safety summaries list 42 participants at risk per group, and the record does not reconcile those denominators with the endpoint counts.

The analysis population is also not reported. The registry does not state whether all randomized participants were included, whether eligibility for analysis depended on intervention attendance, or whether another population definition was used. The original sample-size justification, the prespecified statistical analysis plan, any interim analyses, and whether the primary outcome analysis was adjusted for baseline values are not reported in the registry record.

These omissions matter because analysis choices can influence both the estimated contrast and its uncertainty. A statistical result is most straightforward to interpret when outcome definitions, analysis populations, missing-data procedures, and multiplicity plans are clear in advance. The record does not supply those details, so they cannot be assumed from the posted mean difference, confidence interval, or p-value.

14. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The safety summaries list 42 participants at risk in each group. In both the control and VR intervention groups, the reported number affected by serious adverse events is 0, the number affected in the other adverse-event category is 0, and deaths are 0. The registry lists no serious adverse-event terms.

These are reported counts for the listed categories, not evidence that no event of any kind occurred outside the categories or reporting period captured in the record. The safety assessment timeframe, methods for collecting events, and definitions used for the categories are not reported in the registry record. The record also does not explain why the safety denominators differ from the primary endpoint group counts.

Zero reported events should be read as zero events recorded in these registry fields. It does not establish that an intervention is free of risk, and the summaries alone do not allow a detailed comparison of safety between groups. No inference should be drawn about events not described in the record.

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

The posted data show a higher mean BADS score in the VR intervention group than in the phone-call check-in control group at week 10. The mean difference is 12.9 points, with a 95% confidence interval from 3.239 to 22.56, and the unadjusted p-value is 0.009. Since higher scores indicate greater behavioral activation and lower depressive avoidance, the reported group contrast is in that direction. This is a statistical description of the endpoint, not a claim that the intervention works or that participants experienced a particular personal benefit.

The result does not establish the size of an effect for every participant. Group means and standard deviations conceal individual variation, and no individual change data are posted. The record does not report a clinically important difference threshold, so statistical evidence for a group contrast cannot be translated directly into a judgment about how meaningful the difference would be to participants.

The comparison is also limited to the listed groups and endpoint assessment. The registry does not report follow-up results beyond week 10, so the persistence of any difference is unknown. Secondary results are not posted, and effects on outcomes other than BADS cannot be inferred. The study population and setting described in the record do not establish how the result would generalize to other populations or settings.

Random allocation is reported, but the record does not give key details about implementation, missing data, or the analysis population. Enrollment is 84, whereas the primary endpoint summaries include 37 control participants and 36 intervention participants; the reasons are not reported. Such information is relevant to interpreting the comparison and its precision. The result is therefore best read as the posted week 10 estimate, with its stated uncertainty and the limitations of the registry entries in mind.

16. Why This Trial Matters Statistically

This trial is statistically informative because it illustrates how a continuous behavioral measure can be compared between randomized groups. The posted mean difference retains the BADS scale units, while the confidence interval communicates uncertainty around that contrast. Considering both helps distinguish the estimated magnitude from the precision with which it is known.

The record also illustrates why a nominally small p-value is only one part of interpretation. The unadjusted p-value is 0.009, but the record does not report a multiplicity plan, the exact test, or a prespecified clinically important score difference. Statistical evidence, uncertainty, clinical meaning, and completeness of reporting are different questions. A result may be statistically distinguishable from a null comparison without the registry providing enough context to judge its practical importance.

Enrollment and analysis denominators deserve attention as well. The listed enrollment is 84; primary endpoint summaries include 37 participants in control and 36 in the intervention group, while safety summaries list 42 at risk in each arm. These figures represent different parts of the record, and no participant flow or explanation for the different denominators is reported. Clear accounting is important for assessing how much information contributes to each result and whether missingness could affect interpretation.

Finally, the planning illustrations demonstrate the dependence of sample-size requirements on the target effect and chosen power. Estimates based on a smaller effect are larger under the stated assumptions. Because the original design rationale is not reported, those illustrations should not be mistaken for the trial's prospective sample-size plan. Together, these statistical considerations show why a result is interpreted using design, endpoint, uncertainty, denominator, and reporting details—not a single p-value.

17. 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 does not describe the randomization sequence or allocation concealment, and the trial is listed as having no masking. The record does not establish whether outcome assessors were masked or how the self-report measure was administered. These details are relevant when considering how group assignment and knowledge of assignment might influence assessment or reporting.

The participant flow is not described. Enrollment is 84, while primary endpoint summaries contain 37 participants in control and 36 in the VR intervention group. Safety summaries instead list 42 participants at risk per group. The reasons for the differing counts and any missing outcome data are not reported in the registry record. Baseline BADS scores and other baseline characteristics are also not reported in the posted results, limiting assessment of group comparability at the endpoint.

The registry record gives limited information about the intervention. It states that the VR intervention involved 10 sessions of 30 minutes each and use of a VR headset with a smartphone running the Sites in VR app, but fuller session content, adherence, and fidelity details are not reported. The control description says participants received weekly check-in calls; details about call duration, consistency, and any additional care are not reported.

Only the primary outcome result is posted, despite four outcome measures being listed. The analysis plan, test specification, missing-data approach, multiplicity handling, original sample-size justification, and follow-up beyond week 10 are not reported. These limitations constrain assessment of the result and its generalizability; they do not negate the posted comparison, but they leave important questions unresolved.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador — NCT06219642.
• Registry record last updated 2026-08-21; status last verified 2026-08.
• Results first posted 2026-08-21.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

21. Record Summary

This completed randomized, parallel-group trial studied a VR mindfulness intervention in older adults with symptoms of anxiety and depression in Quito, Ecuador. The registry lists Universidad San Francisco de Quito as sponsor, enrollment of 84, and no masking. The intervention description specifies 10 sessions of 30 minutes each; the control group received weekly phone check-in calls.

The primary outcome was the BADS score at week 10. The intervention-group mean was 89.9 and the control-group mean was 77.0, with a posted mean difference of 12.9 points and a 95% confidence interval from 3.239 to 22.56. The unadjusted p-value was 0.009. Higher BADS scores indicate greater behavioral activation and lower depressive avoidance.

Secondary outcome results, participant flow, analysis details, and the original sample-size justification are not reported in the registry record. Safety fields list zero serious adverse events, zero other reported adverse events, and zero deaths in both groups, with 42 participants at risk per group.