Depression Therapy to Improve Cardiovascular Risk in HIV: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Depression Therapy to Improve Cardiovascular Risk in HIV (NCT02309372), a randomized na study. The primary outcome is Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12.

2. Clinical Question

3. Trial Design

The registry describes a randomized, controlled pilot trial with parallel groups and single masking. Participants were assigned to computerized cognitive behavioral therapy or usual care. The record does not identify who was masked, so the masking designation alone cannot establish whether participants, clinicians, outcome assessors, or another group were unaware of assignments. The phase is listed as NA.

The trial title and summary place the work in the context of depression treatment and cardiovascular risk among adults with HIV already receiving HIV treatment. The stated enrollment is 54. Primary completion is listed as 2019-04, the start as 2015-04, and the overall status as completed. The primary endpoint compares change in brachial artery flow-mediated dilation from baseline to week 12.

The cognitive behavioral therapy arm received the computerized Beating the Blues intervention. The usual-care arm did not receive study-provided depression care, but care outside the study remained possible at a caregiver’s discretion. That distinction matters when interpreting the contrast: the comparator was not described as a prohibition on depression treatment outside the trial.

Results for the primary endpoint report 24 participants in the cognitive behavioral therapy arm and 25 in usual care. The secondary endpoint results report 23 and 24, respectively. These endpoint-specific counts should not be assumed to explain why counts differ from the enrollment figure; reasons for the differences are not reported in the registry record. Details of randomization procedures, allocation concealment, adherence, participant flow, and the trial’s original analysis plan are also 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

Reasons for not completing this period:

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 Brachial Artery Flow-mediated Dilation From Baseline to Week 12, measured over Baseline and Week 12 of participation.

The primary endpoint is change in brachial artery flow-mediated dilation from baseline to week 12. The registry defines the change as the FMD value at week 12 minus the FMD value at baseline, and gives the unit as absolute percent change. The reported measure is a mean with standard deviation in each arm.

Flow-mediated dilation is a measure of how an artery responds to increased blood flow. In general, it is used as a physiological measure related to vascular endothelial function. The trial’s official title identifies endothelial function and inflammation as areas of interest, while the brief summary frames the broader question around cardiovascular risk in people with HIV. These descriptions explain the endpoint’s place in the trial’s rationale; they do not establish that a change in this measure directly predicts a clinical event or a person’s future health.

Using change from baseline focuses the comparison on how the measure shifted over the stated follow-up interval, rather than on the final value alone. A negative change means the week 12 value was lower than baseline; a positive change means it was higher. The between-arm mean difference compares the average changes, with the contrast reported as cognitive behavioral therapy relative to usual care. The registry record does not report a minimally important difference or a threshold for interpreting the magnitude as clinically important.

7. Results Posted in the Registry

• Cognitive Behavioral Therapy (CBT): mean -0.47 versus 0.29 on control; difference -0.76 (95% CI -2.32 to 0.80), standardized effect d = -0.27; z-test p = 0.341.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Changes in Circulating IL-6 From Baseline to Week 12

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Cognitive Behavioral Therapy (CBT): mean 2.38 versus 1.24 on control; difference 1.14 (95% CI -2.79 to 5.07), standardized effect d = 0.17; z-test p = 0.570.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Cognitive Behavioral Therapy (CBT) and the control. The interval gives the range of effects that remain compatible with the data.

Change in hsCRP From Baseline to Week 12

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Cognitive Behavioral Therapy (CBT): mean 1.22 versus 1.06 on control; difference 0.16 (95% CI -2.31 to 2.63), standardized effect d = 0.04; z-test p = 0.899.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Cognitive Behavioral Therapy (CBT) and the control. The interval gives the range of effects that remain compatible with the data.

Change in D-dimer From Baseline to Week 12

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Cognitive Behavioral Therapy (CBT): mean 3.69 versus -10.26 on control; difference 13.95 (95% CI -308.70 to 336.60), standardized effect d = 0.02; z-test p = 0.932.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Cognitive Behavioral Therapy (CBT) and the control. The interval gives the range of effects that remain compatible with the data.

The three secondary outcomes cover circulating IL-6, hsCRP, and D-dimer changes from baseline to week 12. Across these measures, the recalculated contrasts do not form a uniform directional pattern, and each confidence interval includes zero. Their estimates therefore add context but do not provide a precise or consistent signal that changes the main reading of the primary comparison.

The primary outcome and the secondary measures address different aspects of the trial’s stated interest in cardiovascular risk, inflammation, and endothelial function. Similar uncertainty across the secondary comparisons is not independent confirmation of the primary result. The measures are distinct outcomes from the same trial, and the registry record does not report a multiplicity adjustment, a hierarchy among secondary endpoints, or an analysis plan that would establish how they should jointly inform a conclusion.

Unadjusted secondary results generally carry less evidential weight when several outcomes are examined, because repeated testing can make chance findings more likely. This is a general statistical concern, not evidence that any particular posted result is spurious. The record identifies three secondary outcomes and reports one analysis for each, but does not state whether the outcomes were prespecified in a formal testing sequence or whether any correction was applied. They are best treated as descriptive and supportive rather than as separate confirmatory tests.

The secondary pattern does not resolve the primary endpoint’s uncertainty. Nor does it demonstrate that the intervention had no effect on the secondary measures: the intervals remain compatible with a range of differences. Interpretation should remain focused on the observed estimates and their precision, without elevating isolated secondary findings above the primary comparison.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Changes in Circulating IL-6 From Baseline to Week 12
• Change in hsCRP From Baseline to Week 12
• Change in D-dimer From Baseline to Week 12

9. Statistical Interpretation

10. Statistical Methods Explained

The main comparison concerns a continuous outcome: change in flow-mediated dilation from baseline to week 12. The registry reports an arm-specific mean and standard deviation, and a mean difference between cognitive behavioral therapy and usual care. A difference in means keeps the endpoint in its original unit, absolute percent change. The recalculated contrast is unadjusted and uses the posted summary statistics; it is not an adjusted model estimate.

What does the mean difference express?

The arm means are -0.47 for cognitive behavioral therapy and 0.29 for usual care. The reported contrast is -0.76, calculated in the direction of cognitive behavioral therapy minus usual care. A negative contrast therefore indicates that the average change was lower in the cognitive behavioral therapy arm. This sign describes the direction of the observed comparison; by itself, it does not indicate whether the size of the difference is important to patients or clinically meaningful.

In general, a mean difference is most directly interpretable when the outcome scale and direction are understood. The outcome is defined as a follow-up value minus a baseline value, so negative and positive values have a specific change-score interpretation. The record does not provide a threshold for judging clinical importance, and no such threshold should be inferred from the sign or magnitude alone.

How should a confidence interval be read?

In general, a confidence interval gives a range of values compatible with the observed data under the assumptions of the analysis. It conveys uncertainty around an estimate rather than a range in which the true value is guaranteed to fall. The recalculated 95% interval for the primary mean difference runs from -2.323 to 0.803. Because this range includes zero, the posted summary statistics do not rule out no average difference. The range also includes values on both sides of zero, so the direction of the underlying contrast is not determined precisely.

A confidence interval and a p-value are related but answer different practical questions. The interval shows the range and direction of plausible contrasts under the method; the p-value measures how unusual data at least this discrepant would be under a specified null model. The recalculated unadjusted p-value is 0.341. It is not a measure of the probability that the null hypothesis is true, nor a direct measure of the size or importance of an effect.

What does the two-sided t-test mean?

The sponsor reports a two-sided t-test for the mean difference. In general, a two-sided test considers departures in either direction rather than testing only whether one named arm is higher. A t-test compares means while accounting for variability and the amount of information in the groups. The sponsor’s reported result is a mean difference of -0.76 with a 95% confidence interval from -2.28 to 0.77 and p = 0.32. The record does not report enough detail to reconstruct every feature of the sponsor’s analysis, such as any covariate adjustment or missing-data handling.

The recalculation uses the posted arm means, standard deviations, and group counts to obtain a simple unadjusted comparison. It gives a 95% interval from -2.323 to 0.803 and p = 0.341. These values are close to the sponsor’s reported results and support a similar qualitative interpretation. They are not a substitute for the sponsor’s analysis, which is the analysis reported by the trial.

Why does variability matter?

In general, the standard deviation describes how dispersed individual observations are around an arm’s mean. More variability makes a mean harder to estimate precisely when the amount of information is held fixed. The primary standard deviations are 2.65 for cognitive behavioral therapy and 2.93 for usual care. These values provide context for the broad uncertainty around the comparison. They do not describe the uncertainty of the mean difference by themselves; the group counts also matter.

The assumptions behind a simple mean comparison include a suitable scale for the outcome and a reasonable model for the sampling distribution of the estimate. The registry record does not report diagnostic checks, transformations, covariate adjustments, or a prespecified robust analysis. There is no basis in the record to claim that such procedures were or were not used beyond the analysis description that is posted.

All recalculated tests described in this material are unadjusted. That means they do not account for testing multiple outcomes or multiple comparisons. General statistical practice recognizes that examining many outcomes can increase the chance of finding an apparently notable result by chance, so multiplicity plans and outcome hierarchies can affect interpretation. The record does not report such a plan. The primary endpoint remains the main registered comparison, while the secondary outcomes are best read as exploratory or supportive unless a stronger analysis plan is documented.

11. Confidence Intervals and Precision

The primary mean difference is -0.76, with a recalculated 95% confidence interval from -2.323 to 0.803. The interval crosses zero, extending from a negative contrast to a positive one. This means the posted data are consistent with more than one direction of the underlying average difference. The estimate is therefore not precise enough to settle whether the average change was lower or higher in the cognitive behavioral therapy arm in the population represented by the trial.

The interval is also wide relative to the point estimate. In general, a wider confidence interval indicates less precision: a range of materially different contrasts remains compatible with the observed data and the calculation method. The interval should not be read as a guarantee that the true value lies within those endpoints, nor as a statement that every value inside the interval is equally plausible.

The sponsor’s 95% confidence interval, from -2.28 to 0.77, also includes zero and has the same broad implication. The difference between the sponsor’s interval and the simple recalculation is small in practical interpretation; both leave substantial uncertainty about the contrast. The sponsor’s result should be used as the reported trial analysis, while the recalculation provides a transparent unadjusted comparison from the posted group summaries.

Precision depends on the amount of information and the variability in the outcome. The primary endpoint has reported group counts of 24 and 25, with standard deviations of 2.65 and 2.93. The registry record does not report a target precision, a clinically important margin, or an interval-based decision criterion. Without such a benchmark, the interval can be described statistically but not classified as sufficiently precise for a particular clinical decision.

12. 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 figures are participants per arm, not total event counts. The sample-size illustration assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It uses the observed effect as a reference and considers planning for 100%, 75%, or 50% of that observed effect. The trial’s original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column represents the illustrative number of participants per arm needed to have an 80% chance of detecting the specified effect under those assumptions, if that effect were the true one and the assumptions held. The 90% column uses a higher chance of detection and therefore requires more participants per arm. These are planning calculations, not a statement about what the completed trial’s power was. This is not observed power.

For the primary endpoint, the planning values rise as the assumed effect becomes a smaller fraction of the observed effect. The same general pattern appears for the secondary outcomes: smaller effects require more participants to detect reliably, all else being equal. These figures are especially sensitive to the observed effect estimate and variability in a pilot study, so they should not be treated as fixed design recommendations or as evidence that an effect is established.

The curve is a visual representation of how the illustrative participant requirement changes with the effect size being targeted. Moving toward a smaller target effect increases the required number of participants per arm. The values support planning discussions under the stated assumptions; they do not reconstruct the trial’s original planning process, which is not reported in the registry record.

13. 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 = -0.760; pooled standard deviation σ = 2.796.
2. n = 2 × (1.96 + 0.842)² × 2.796² / -0.760² = 212.5, rounded up to 213 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 <- -0.76                      # observed difference in means
sigma <- 2.79648373436996                     # 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(2309372)
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 = 213 (80% power), 285 (90% power)
 75% of observed effect: n per arm = 378 (80% power), 506 (90% power)
 50% of observed effect: n per arm = 851 (80% power), 1,139 (90% power)
power.t.test: 213.5 
Simulated power at n = 213 per arm: 0.803 (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.

14. Analyses Reported by the Sponsor

The sponsor reports a two-sided t-test for the primary comparison. Its mean difference is -0.76, with a 95% confidence interval from -2.28 to 0.77 and p = 0.32. The registry record’s recalculated unadjusted comparison gives the same mean difference, a 95% confidence interval from -2.323 to 0.803, and p = 0.341. The reported discrepancy flag is false.

The two analyses lead to the same broad statistical reading: the estimated contrast is negative, the interval includes zero, and the result remains uncertain. Minor differences in the interval endpoints and p-value can arise from differences in calculation details or rounding. The record does not specify enough detail to identify a particular cause, so none should be assumed.

The sponsor’s own analysis takes precedence as the trial’s reported analysis. The recalculation is useful as a simple check based on the posted group means, standard deviations, and counts, but it is not a replacement for the sponsor’s statistical procedure. Neither result should be interpreted as proof of no difference, and neither establishes a clinically meaningful effect.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome and three secondary outcomes. It reports a single analysis for the primary endpoint and posted comparisons for the secondary measures. It does not report a multiplicity adjustment, a formal testing hierarchy, or a rule for deciding which secondary results would be considered confirmatory. Without that information, unadjusted secondary p-values should not be interpreted as if they came from a single prespecified test.

In general, multiplicity arises when several hypotheses or outcomes are examined. Testing more outcomes can increase the chance of at least one apparently unusual result even if there is no true effect on any outcome. Adjustments and prespecified ordering can help control that issue, but the choice depends on the aims and design. Since the record does not report such choices, it is not possible to determine whether the posted secondary analyses were adjusted or whether other analyses were planned.

Missing-data methods and analysis populations are also not reported in the registry record. The record gives endpoint-specific group counts, but does not explain why those counts differ from enrollment or whether missing endpoint data occurred. It does not identify an intention-to-treat, per-protocol, or other analysis population, and it does not describe imputation, likelihood-based methods, or sensitivity analyses. No assumption about how missing observations were handled can be made from the posted counts alone.

These omissions limit assessment of the robustness of the estimates. In general, missingness can affect a comparison if the availability of outcome measurements is related to assignment or outcome values. That is a methodological consideration, not a claim that such a pattern occurred in this trial. Details about the randomization process, allocation concealment, adherence, and protocol deviations are likewise not reported in the registry record. The available statistics support a description of the posted results, while leaving these design and analysis questions unresolved.

16. 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.

Most frequent non-serious adverse event terms

The registry records zero serious adverse events among 27 participants at risk in the cognitive behavioral therapy arm and zero among 27 at risk in usual care. Deaths are recorded as zero in both arms. No serious adverse event terms are listed. These figures describe the registry’s reported safety counts; they do not establish that the intervention caused or prevented any event.

For other adverse events, the record lists 5 affected participants in the cognitive behavioral therapy arm and 1 in usual care, with 27 at risk in each arm. The record does not provide descriptions of those other events, their severity, timing, relatedness to the intervention, or the method used to collect and classify them. The counts should therefore be read as recorded events, not as a comparative safety conclusion.

Zero reported serious events in these groups does not rule out uncommon harms, and the counts do not by themselves show whether the groups differ in risk. The registry record does not report further detail needed to evaluate event definitions, follow-up completeness, or causality.

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

The posted primary results describe a randomized comparison of computerized cognitive behavioral therapy with usual care in a pilot trial of depressed, virologically suppressed, antiretroviral-treated adults with HIV. The average change in flow-mediated dilation was -0.47 in the cognitive behavioral therapy arm and 0.29 in usual care. The estimated between-arm difference was -0.76, with uncertainty spanning both negative and positive values.

These data do not establish that the intervention improved or worsened the endpoint, and they do not establish equivalence between the arms. An interval that includes zero is compatible with no average difference, but it is also compatible with effects in either direction. The estimate should be read together with its confidence interval rather than reduced to a yes-or-no conclusion based on a p-value.

The outcome is a physiological measure, not a clinical event. The registry record does not provide evidence that the observed change predicts cardiovascular events or establishes a patient-important benefit or harm. The secondary measures likewise do not provide a precise, consistent pattern that resolves the primary uncertainty. No inference about other outcomes, longer-term effects, or groups beyond the trial population should be drawn from these results.

The trial’s usual-care arm allowed caregivers to provide depression treatment outside the study. As a result, the randomized contrast is between assignment to the computerized intervention and assignment to usual care as described, not necessarily between receiving depression treatment and receiving none. The record does not report what outside care participants received, nor does it provide adherence or treatment-exposure details.

Overall, the result is an estimate with substantial uncertainty from a completed pilot trial. It can inform understanding of the posted data and the scale of uncertainty, but it does not by itself settle whether a meaningful difference exists or how the intervention would perform in a different study.

18. Why This Trial Matters Statistically

This trial is statistically useful because it puts a numerical estimate and its uncertainty beside a randomized comparison of a behavioral intervention with usual care. The mean difference and confidence interval show why the point estimate alone is insufficient: the observed contrast has a direction, but the interval remains compatible with a range of possibilities that includes zero.

The pilot designation and enrollment of 54 provide important context for the amount of information in the trial. The endpoint-specific group counts and standard deviations help explain why an estimate may remain imprecise even when a numerical mean difference can be calculated. The illustrative planning values also show how strongly required sample size can depend on the effect size targeted, while not revealing the assumptions used when the original trial was designed.

The trial also illustrates the value of distinguishing a sponsor-reported analysis from a simple recalculation. Here the reported and recalculated primary comparisons are close and have the same broad interpretation. Such agreement supports confidence that the basic summary contrast has been represented consistently, while leaving the limitations of unadjusted summary-statistic calculations intact.

Finally, the distinction between primary and secondary outcomes matters. The secondary measures contribute context about inflammatory and coagulation markers, but multiple unadjusted comparisons do not carry the same confirmatory weight as a prespecified primary analysis. Missing-data procedures, analysis populations, multiplicity plans, and the original sample-size justification are not reported, so the record is a useful case for separating visible estimates from questions that remain unanswered.

19. 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 describes a pilot trial and reports enrollment of 54. The primary endpoint has reported group counts of 24 and 25, while the secondary outcomes have counts of 23 and 24. The record does not explain the differences between enrollment and these endpoint-specific counts, so their cause and potential implications cannot be assessed.

The intervention was a computerized cognitive behavioral therapy program, while usual care did not include study-provided depression care. The usual-care description allows caregivers to provide depression treatment outside the trial. The record does not report what care was received in either arm, intervention adherence, treatment completion, or exposure to other relevant care. This makes it difficult to characterize the treatment contrast beyond the assigned study conditions.

Single masking is listed, but the identity of the masked group is not reported. Randomization procedures and allocation concealment are also not described in the registry record. These missing design details limit assessment of potential bias. The record does not describe outcome assessor procedures or whether the endpoint was collected consistently across groups.

The primary endpoint is a change in a physiological measure over the baseline-to-week-12 interval. The record does not report a clinically important difference threshold or a longer-term outcome. It therefore supports interpretation of the short-term measure, but not a direct conclusion about later cardiovascular events or patient-important effects.

The registry does not report the original sample-size calculation, missing-data methods, analysis populations, multiplicity approach, or a detailed statistical analysis plan. These limitations are specific to what can be assessed from the record and should not be mistaken for evidence that any particular method was or was not used.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Depression Therapy to Improve Cardiovascular Risk in HIV — NCT02309372.
• Registry record last updated 2020-07-14; status last verified 2020-07.
• Results first posted 2020-07-14.
• 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.

23. Record Summary

NCT02309372, titled “Depression Therapy to Improve Cardiovascular Risk in HIV,” is a completed randomized, controlled pilot trial with parallel groups and single masking. It compares computerized Beating the Blues cognitive behavioral therapy with usual care among depressed, virologically suppressed, antiretroviral-treated adults with HIV. Enrollment is listed as 54.

The primary outcome is mean change in brachial artery flow-mediated dilation from baseline to week 12. The posted means were -0.47 for cognitive behavioral therapy and 0.29 for usual care; the sponsor reported a mean difference of -0.76 with a 95% confidence interval from -2.28 to 0.77 and p = 0.32. The interval includes zero, leaving substantial uncertainty about the comparison.

Three secondary outcomes address IL-6, hsCRP, and D-dimer. The registry record does not report the original sample-size justification, multiplicity plan, missing-data methods, or analysis populations. Safety records show zero serious adverse events and zero deaths in both arms, with other adverse events recorded in each arm.