Internet-delivered Psychotherapy for Depression: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Internet-delivered Psychotherapy for Depression (NCT02091856), a randomized na study. The primary outcome is Beck Depression Inventory-II (BDI-II).

2. Clinical Question

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. The study compared three groups: conventional CBT, religious CBT, and a wait-list control group. The listed intervention was behavioral CBT. The conventional approach included mindfulness-paradigm exercises, while the religious approach included exercises based on general Christian belief. The wait-list group served as the comparison condition.

The recorded enrollment is 79. The outcome summaries report 34 participants for C-CBT, 19 for R-CBT, and 26 for WLCG. These are the group sizes attached to the reported post-intervention results; the registry record does not explain how they relate to enrollment, participant flow, or the analysis population. Reasons for any difference between enrollment and the outcome group counts are not reported in the registry record.

The primary completion date is recorded as 2015-09, and the study status is terminated. The study start is recorded as 2014-03. Phase is listed as NA. The sponsor is West University of Timisoara. Further information about why the trial was terminated, its recruitment process, or the duration and delivery details of the intervention is not reported in the registry record.

The primary outcome was the BDI-II average score at 11 weeks after the intervention. The registry also reports three secondary outcomes: the Beck Anxiety Inventory (BAI), Quality of Life Inventory (QOLI), and Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR), each measured at the post-intervention assessment. Allocation concealment, masking procedures beyond the recorded absence of masking, and the original statistical analysis plan 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.

Active Intervention Interval

Follow-up Assessment

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 Beck Depression Inventory-II (BDI-II), measured over Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention).

The primary endpoint is the average score on the Beck Depression Inventory-II (BDI-II) at 11 weeks after the intervention. The registry describes the BDI-II as a unidimensional measure of depression level, with a total score ranging from 0 to 63. It states that lower scores are associated with lower levels of depression and higher scores with higher levels. The posted endpoint is an absolute post-intervention score, rather than a change from baseline.

A continuous score preserves information across the instrument’s range and can be summarized by a group mean and standard deviation. Comparing group averages can describe whether the observed score distributions are centered at different levels. The standard deviation gives context about how widely individual scores vary around each group average. These summaries do not, by themselves, describe every participant’s experience or the shape of the score distribution.

The endpoint is useful for a randomized group comparison because it applies the same named measure at a common post-intervention time point across the groups. However, interpretation depends on trial details that are not reported in the registry record, including baseline scores, the handling of missing assessments, and the prespecified analysis population. The registry’s wording refers to “Back Depression Inventory-II” in the timeframe and description, while the endpoint title identifies the measure as the Beck Depression Inventory-II.

7. Results Posted in the Registry

• Conventional-CBT (C-CBT): mean 11.45 versus 26.02 on control; difference -14.57 (95% CI -19.43 to -9.71), standardized effect d = -1.49; z-test p = <0.001.
• Religious CBT (R-CBT): mean 12.43 versus 26.02 on control; difference -13.59 (95% CI -21.14 to -6.04), standardized effect d = -1.15; z-test p = <0.001.

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.

Beck Anxiety Inventory (BAI)

• 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:
  • Conventional-CBT (C-CBT): mean 24.72 versus 27.27 on control; difference -2.55 (95% CI -9.13 to 4.03), standardized effect d = -0.20; z-test p = 0.448.
  • Religious CBT (R-CBT): mean 22.62 versus 27.27 on control; difference -4.65 (95% CI -12.49 to 3.19), standardized effect d = -0.36; z-test p = 0.245.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Conventional-CBT (C-CBT) and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Religious CBT (R-CBT) and the control. The interval gives the range of effects that remain compatible with the data.

Quality of Life Inventory (QOLI)

• 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:
  • Conventional-CBT (C-CBT): mean 0.74 versus -0.92 on control; difference 1.66 (95% CI 0.69 to 2.63), standardized effect d = 0.86; z-test p = <0.001.
  • Religious CBT (R-CBT): mean 0.39 versus -0.92 on control; difference 1.31 (95% CI 0.31 to 2.31), standardized effect d = 0.76; z-test p = 0.010.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Conventional-CBT (C-CBT) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Religious CBT (R-CBT) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

• 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:
  • Conventional-CBT (C-CBT): mean 10.47 versus 14.90 on control; difference -4.43 (95% CI -6.94 to -1.92), standardized effect d = -0.87; z-test p = <0.001.
  • Religious CBT (R-CBT): mean 10.27 versus 14.90 on control; difference -4.63 (95% CI -7.85 to -1.41), standardized effect d = -0.90; z-test p = 0.005.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Conventional-CBT (C-CBT) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Religious CBT (R-CBT) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Across the secondary outcomes, the broad descriptive pattern is that average BAI and QIDS-SR scores are lower in both therapy groups than in the wait-list group, while average QOLI scores are higher in both therapy groups. The registry reports an overall ANOVA result for each of these measures. This pattern points in a direction broadly aligned with the primary BDI-II summaries for depressive symptoms, while also adding anxiety and quality-of-life measures to the outcome picture.

The secondary findings do not carry the same weight as the primary outcome. The registry record does not report whether these outcomes, comparisons, or analysis methods were prespecified, nor whether any adjustment was made for testing multiple outcomes or contrasts. When many outcomes are examined, the chance of seeing apparently notable results by chance can increase. In general, multiplicity procedures are used to manage that issue, but no such procedure is reported in the registry record.

These secondary results should therefore be read as supportive or exploratory context rather than as independent confirmation of the primary finding. The posted summaries do not establish that one therapy format is better than the other, and the record does not report a direct active-arm contrast for the secondary endpoints. Missing baseline values, analysis-population details, and missing-data methods also limit interpretation of the post-intervention averages. The overall pattern is informative, but it cannot resolve these design and analysis uncertainties.

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

• Beck Anxiety Inventory (BAI)
• Quality of Life Inventory (QOLI)
• Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

9. Statistical Interpretation

10. Statistical Methods Explained

The registry reports an analysis of variance (ANOVA) across the three groups for the primary outcome. In general, ANOVA tests whether there is evidence that group means are not all the same. An overall result does not tell which specific pairs differ; pairwise estimates are needed to describe particular group contrasts. The reported overall primary result is p < 0.001. The registry record does not report the ANOVA’s test statistic, degrees of freedom, model details, or an interval for the omnibus comparison.

What do the recalculated mean differences represent?

The posted recalculations compare each therapy group’s mean with the wait-list group’s mean using the posted summary statistics. The C-CBT contrast is -14.57 and the R-CBT contrast is -13.59. The negative signs indicate that the therapy-group average is below the wait-list average under the comparison’s direction. These are unadjusted, two-group summaries, not adjusted estimates from a model that accounts for baseline scores or other covariates. Such adjustment is not reported in the registry record.

Each recalculated contrast is accompanied by an interval estimate and an unadjusted p-value. An interval conveys a range of estimates compatible with the data under the assumptions of the calculation; it also makes the estimate’s uncertainty visible. The interval level and the method used to construct it are not reported in the registry record, so the interval should not be assigned an unstated confidence level. A p-value describes how incompatible the observed data are with a specified null model, conditional on the analysis assumptions. It is not the probability that a hypothesis is true, nor a measure of the clinical importance of a difference.

Why compare means and standard deviations?

The primary endpoint is continuous, and the registry reports group means and standard deviations. The mean describes the center of a group’s scores, while the standard deviation describes variation around that center. A mean difference expresses the contrast in the original scale units, which is directly interpretable against the BDI-II score scale. The standardized effect-size summaries are another way to express a difference relative to variability, but they should be treated as descriptive summaries of these data rather than as universal measures of importance.

In general, the standard error reflects the expected variability of an estimate across repeated samples under the statistical model. It tends to be smaller when estimates are based on more information and when the observations are less variable. Unequal group sizes and different group standard deviations can affect the uncertainty of comparisons. The registry’s detailed original model assumptions are not reported, so the recalculated estimates should be understood as simple, unadjusted comparisons based on posted summary statistics.

What does the omnibus test add?

The registry’s ANOVA assesses the three groups together, whereas the recalculated mean differences isolate each therapy arm versus WLCG. These answer related but different questions. An omnibus result can indicate that group means vary overall, without specifying which contrast accounts for that result. The pairwise recalculations provide the direction and magnitude for the two therapy-versus-wait-list comparisons, but their p-values are unadjusted. The record does not report a multiplicity procedure for these or the other outcomes.

Why can over-dispersion matter?

For continuous outcomes, larger variation relative to the mean difference makes it harder to estimate a group contrast precisely. In general, this is because individual scores are more spread out, so the group averages carry more sampling uncertainty. The group standard deviations vary across arms and outcomes in this trial. Whether the original analysis assessed distributional assumptions, unequal variances, or influential observations is not reported in the registry record. That missing detail limits how specifically the posted results can be evaluated against the assumptions of the analyses.

The registry record gives no baseline-adjusted estimates, model diagnostics, covariate list, missing-data method, or analysis-population definition. These omissions do not invalidate the posted summaries, but they mean the estimates cannot be read as fully adjusted results from a documented statistical plan. In general, randomization supports causal comparisons when allocation and follow-up are handled appropriately; the record does not contain enough detail to assess those processes fully.

11. Confidence Intervals and Precision

The recalculated primary-outcome contrasts are accompanied by intervals that show the range of estimates compatible with the calculation, given its assumptions. For C-CBT versus WLCG, the mean difference is -14.57 and the interval runs from -19.43 to -9.707. For R-CBT versus WLCG, the mean difference is -13.59 and the interval runs from -21.14 to -6.039. Both intervals lie below zero, consistent with lower average BDI-II scores in the therapy groups in these unadjusted comparisons.

The R-CBT interval is wider than the C-CBT interval. In general, wider intervals indicate less precision, often because there is less information or more variability. The R-CBT outcome group size is 19, compared with 34 for C-CBT and 26 for WLCG, and the reported standard deviation for R-CBT is 15.04, compared with 10.46 for C-CBT and 8.74 for WLCG. These features help describe why the estimates have different precision; they do not identify the full cause of uncertainty.

The registry does not report the confidence level or construction method for the intervals associated with the recalculated contrasts. The interval endpoints should therefore be read as posted, without attributing an unreported level. Intervals address sampling uncertainty under a calculation’s assumptions, but do not account for every concern, such as missing outcomes, selection, measurement, or unreported analysis choices.

The overall ANOVA result is reported as a p-value without an estimate or interval. It therefore gives evidence about an overall group difference but does not quantify its precision in the same way as the pairwise estimates. The record also does not provide intervals for the sponsor’s ANOVA result or a direct interval for the contrast between the two therapy approaches.

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 sample-size illustrations report participants per arm for the continuous-outcome comparisons. They use two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. The assumed effect to detect is a stated fraction of the observed effect. The original trial’s own sample-size assumptions and justification are not reported in the registry record.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the specified effect under those assumptions, if that effect and the other assumptions held. The 90% power column uses a higher target chance of detecting that same specified effect. These are design-planning quantities, not guarantees about what a future study would find.

Rows for smaller fractions of the observed effect require more participants per arm than rows for larger fractions. That pattern reflects a general statistical principle: smaller differences are harder to distinguish from random variation, so more information is needed to detect them at a given power target. The figures based on the observed effect should be treated cautiously because an effect estimated from a trial can be unstable, especially when group sizes are limited.

This is not observed power. It is a planning illustration based on the posted effect estimates and stated calculation assumptions, not a measure of how much power the completed trial actually had. The registry does not report the assumptions used when the trial was originally designed, so these illustrations should not be mistaken for the study’s original sample-size calculation.

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 = -14.570; pooled standard deviation σ = 9.756.
2. n = 2 × (1.96 + 0.842)² × 9.756² / -14.570² = 7.0, rounded up to 8 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 <- -14.57                      # observed difference in means
sigma <- 9.7558760365935                     # 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(2091856)
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 = 8 (80% power), 10 (90% power)
 75% of observed effect: n per arm = 13 (80% power), 17 (90% power)
 50% of observed effect: n per arm = 29 (80% power), 38 (90% power)
power.t.test: 8.1 
Simulated power at n = 8 per arm: 0.787 (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 registry reports the sponsor’s primary-outcome analysis as an ANOVA across the three groups, with p < 0.001. That is an overall test: it indicates evidence of differences among the groups under the reported analysis, but it does not provide a group-specific estimate or identify which pairwise contrasts account for the result. No omnibus effect estimate or interval is reported in the registry record.

The recalculated comparisons use the posted means, standard deviations, and group sizes to estimate unadjusted differences between each therapy arm and WLCG. They give a direction, magnitude, interval, and unadjusted p-value for each of those two contrasts. These calculations are complementary to, not replacements for, the sponsor’s reported ANOVA. The primary-outcome overall result and the two pairwise recalculations are consistent in indicating that the observed group scores were not all alike, but they answer different statistical questions.

The recalculations do not reproduce a documented sponsor model, since the registry does not report model specifications or adjustment details. They also do not establish a direct comparison between C-CBT and R-CBT. The registry record does not report whether the sponsor conducted such a comparison or adjusted for multiple testing.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary endpoint and three secondary outcomes, with an overall ANOVA reported for each. It does not report how many outcomes or comparisons were planned in the original protocol, whether the secondary analyses were prespecified, or whether any family-wise error or false-discovery procedure was used. The recalculated pairwise p-values are explicitly unadjusted. Accordingly, the secondary p-values and pairwise results should not be treated as if they were protected from the increased chance of false-positive findings that can arise when multiple hypotheses are tested.

Details about missing outcome data are not reported in the registry record. Although the endpoint summaries include group sizes, the record does not state how many randomized participants lacked post-intervention assessments, why data might be missing, or how missing scores were handled. It also does not describe imputation, sensitivity analyses, or whether the reported analyses followed intention-to-treat principles.

The analysis population is not defined. The record does not clarify whether the reported participants represent everyone randomized, those who began treatment, those who completed treatment, or another subset. The relationship between the recorded enrollment and the outcome group counts is not explained. Baseline outcome values and changes from baseline are not reported, and the registry does not specify whether the primary comparison was adjusted for baseline or other variables.

Interim analyses, stopping rules, protocol deviations, and the original statistical analysis plan are not reported in the registry record. The study status is terminated, but the reason for termination is also not reported. These omissions make it difficult to determine the complete testing context or assess whether choices made during conduct or analysis could have influenced the posted results.

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

The posted primary-outcome averages show lower BDI-II scores at post-intervention in both therapy groups than in the wait-list group. The registry’s overall ANOVA result is p < 0.001, and the unadjusted recalculations estimate lower mean scores for each therapy arm relative to WLCG. The BDI-II is described as a measure for which lower scores are associated with lower levels of depression. These findings describe the recorded post-intervention data and the analyses reported for them.

They do not, on their own, establish what caused the differences. The registry record does not report baseline scores, participant flow, missing-data handling, or the analysis population, all of which matter when assessing how a randomized comparison was carried out. The recalculated contrasts are unadjusted and do not reproduce an undocumented sponsor model. The registry also does not report a direct comparison between the two active approaches, so the results do not support a conclusion that conventional CBT and religious CBT differ from one another.

The reported p-values are not measures of effect size, clinical importance, or the probability that a result is true. The interval estimates convey uncertainty under their calculation assumptions, but their level and method are not reported in the registry record. The outcome summaries also do not describe individual responses or longer-term outcomes; the reported assessment is at 11 weeks after the intervention.

The secondary outcomes show a broadly aligned pattern in the posted averages, but their multiplicity status is unknown. They should be interpreted cautiously and do not remove the limitations of the primary analysis. The registry record supports a statistical description of the reported groups, not a complete account of treatment effectiveness, acceptability, durability, or safety. The brief summary names acceptability as an aim, but no acceptability outcome is reported in the posted outcome results.

17. Why This Trial Matters Statistically

This trial offers a useful example of why an overall group test and pairwise contrasts should be distinguished. The sponsor’s ANOVA addresses whether the three groups differ overall, while the recalculated comparisons quantify the two therapy-versus-wait-list contrasts. Neither approach alone answers every possible question: in particular, a direct comparison between the active approaches is not reported.

The outcome summaries also illustrate the importance of considering uncertainty alongside the point estimate. The primary contrasts are accompanied by intervals, and their widths differ across comparisons. Group sizes and outcome variability provide context for that precision. Looking only at p-values would leave out the magnitude, direction, and uncertainty of the estimated differences.

Another statistical lesson is that a broad pattern across multiple secondary measures does not automatically amount to confirmatory evidence. Without reported prespecification and multiplicity handling, those findings require cautious interpretation. Similarly, a sample-size illustration based on observed effects is not a substitute for the original design rationale and cannot establish the completed trial’s observed power.

For clinical researchers, the record demonstrates the value of reporting the analysis population, missing-data approach, baseline measures, model specifications, confidence-interval methods, and multiplicity plan. Those details allow readers to understand what the analyses estimate and how robustly the results can be interpreted. Here, the posted summaries are informative, but key analysis details are not reported in the registry record.

18. 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 gives limited detail about participant characteristics and eligibility beyond the condition description “Mild - Major Depression.” It does not describe recruitment, diagnostic procedures, baseline severity, or other characteristics that would help assess how closely the outcome groups resemble the intended study population. Generalizability therefore cannot be evaluated from the record alone.

The trial is recorded as terminated, but the reason is not reported. The enrollment is recorded as 79, while the outcome summaries report group sizes of 34, 19, and 26. The registry does not explain participant flow or the relationship between these numbers. Missing assessments, attrition, adherence, and treatment completion are not described. The reported results are post-intervention averages, without baseline values or change-from-baseline estimates.

The record describes no masking, and it does not report allocation concealment or assessment blinding. For a behavioral intervention, participants and providers may know which condition is assigned; however, how that could affect outcome measurement or reporting cannot be assessed from the registry entries. The registry also does not report treatment fidelity, intervention duration beyond the assessment timeframe, or acceptability results, despite acceptability being named as a project aim.

Only three secondary outcomes are listed in the posted results, although the record gives an outcome-measure count of 5. The identities and results of any additional outcome measures are not described in the listed outcome summaries. The registry does not report long-term follow-up, direct active-arm comparisons, or the original analysis plan. These gaps limit assessment of completeness, robustness, and the scope of conclusions that can be drawn.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Internet-delivered Psychotherapy for Depression — NCT02091856.
• Registry record last updated 2018-06-28; status last verified 2016-02.
• Results first posted 2016-03-28.
• 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.

22. Record Summary

NCT02091856 is a randomized, parallel-group, unmasked study of internet-delivered CBT for depression, sponsored by West University of Timisoara. The registry records enrollment of 79, a start of 2014-03, primary completion at 2015-09, and status as terminated. The comparison involved conventional CBT, religious CBT, and a wait-list group.

The primary outcome was the BDI-II average score at 11 weeks after intervention. The registry reports an overall ANOVA result of p < 0.001. Posted summaries and unadjusted recalculations show lower average BDI-II scores in each therapy group than in the wait-list group. A direct comparison between the two therapy approaches is not reported. Secondary outcomes cover anxiety, quality of life, and depressive symptoms.

Important details about participant flow, missing data, analysis populations, multiplicity, and the original statistical plan are not reported in the registry record. The results therefore provide a statistical account of the posted summaries, with important limits on interpretation.