A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression (NCT01599585), a randomized na study. The primary outcome is Beck Hopelessness Scale (BHS).

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial with single masking. The registry lists the phase as NA and enrollment as 121. The study status is completed; the recorded start is 2012-05 and the primary completion is 2015-01. The sponsor was the National Center for Telehealth and Technology.

Both groups received Behavioral Activation, so the contrast concerns the delivery setting and mode rather than BA versus no BA. In the in-home group, treatment was delivered through a secure web-based video-conferencing system. In the in-person group, treatment took place in a clinic setting. Both intervention descriptions specify 8 sessions over approximately 8 weeks, although only the in-person description explicitly mentions allowance for rescheduling.

“Single” masking is recorded, but the registry record does not report who was masked or how masking was maintained. It also does not report the randomization procedure, allocation ratio as a planned design feature, recruitment sites, eligibility criteria beyond the population description, or the trial’s original sample-size justification. These details cannot be inferred from the number enrolled or from the later outcome counts.

The primary endpoint was the Beck Hopelessness Scale (BHS) mean at post-treatment, Week 8. The posted arm summaries include 45 participants in the in-home group and 42 in the in-person group. These endpoint counts are smaller than total enrollment; the reasons for the difference and the analysis population definition are not reported in the registry record. Baseline summaries use 62 participants in the in-home group and 59 in the in-person group, so the analysis counts are not identical across the posted time points.

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 Beck Hopelessness Scale (BHS), measured over Post treatment - Week 8.

The primary endpoint is the mean score on the Beck Hopelessness Scale (BHS) at post-treatment, Week 8. The registry describes the BHS as a 20-item measure of negative attitudes about the future. Each item uses a true/false response, and total scores range from 0-20, with higher scores indicating a greater degree of hopelessness.

A mean is a summary of the group’s average score. The standard deviation describes how spread out individual scores are around that average; it is not a measure of uncertainty in the mean itself. The posted results give each group’s mean and standard deviation, allowing readers to see both the average score and the variability among participants with recorded endpoint values.

Hopelessness is directly relevant to the study description, which names symptoms of hopelessness and depression as outcomes the intervention was intended to address. A continuous scale can retain information across the score range rather than reducing each participant to a binary category. The primary endpoint is specifically a Week 8 group comparison, however, and does not by itself describe changes over all follow-up times or establish what happened to participants whose Week 8 results are not included.

The registry record does not report a clinically important difference threshold for the BHS, nor does it explain how such a threshold would be used. Statistical differences in group means therefore should not be equated with a threshold for meaningful change.

7. Results Posted in the Registry

• In-Person: mean 4.43 versus 4.89 on control; difference -0.46 (95% CI -2.48 to 1.56), standardized effect d = -0.10; z-test p = 0.655.

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 Depression Inventory -II (BDI-II)

• 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:
  • In-Person: mean 29.71 versus 27.60 on control; difference 2.12 (95% CI -1.77 to 6.00), standardized effect d = 0.19; z-test p = 0.286.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between In-Person and the control. The interval gives the range of effects that remain compatible with the data.

Beck Hopelessness Scale (BHS)

• 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:
  • In-Person: mean 10.37 versus 9.00 on control; difference 1.37 (95% CI -0.65 to 3.39), standardized effect d = 0.24; z-test p = 0.182.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between In-Person and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists 17 outcome measures, with 16 secondary outcomes posted. The available secondary numerical summaries include baseline BDI-II and BHS measurements, along with adverse-event information. Baseline scores describe the groups before the post-treatment endpoint; they are not treatment effects and should not be presented as evidence of response. The registry record does not report numerical results for the other listed secondary measures in the available outcome information.

These baseline summaries provide context for the groups but do not alter the interpretation of the primary Week 8 BHS comparison. In particular, a difference between baseline group averages is not evidence that one delivery approach changed depression or hopelessness more than the other. To estimate change, the analysis would need to use follow-up and baseline information appropriately, and the registry record does not report a secondary change analysis for these scales.

Secondary outcomes can help describe different aspects of a trial, but interpreting many outcomes creates a multiplicity concern. If many hypotheses are examined, some apparently notable findings can arise by chance even when there is no corresponding underlying effect. The registry record does not report a multiplicity adjustment or a prespecified hierarchy for secondary outcomes. For that reason, secondary findings should carry less weight than the designated primary endpoint, particularly when the analysis plan and complete numerical results are not reported.

The adverse-event counts address safety reporting rather than symptom efficacy, and they should be interpreted separately from the BHS result. Taken together, the posted secondary information is not a substitute for a complete set of prespecified secondary analyses. Missing numerical results and unreported multiplicity procedures limit the strength of any broader claim about a consistent pattern across secondary outcomes.

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

• Adverse Events
• Beck Depression Inventory -II (BDI-II)
• Adverse Events
• Adverse Events
• Adverse Events
• Adverse Events
• Adverse Events
• Adverse Events

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant has a BHS score, and the group summaries are means with standard deviations. The posted recalculation compares the two independent group means. It is an unadjusted analysis based on the summary statistics, rather than a model that adjusts for baseline scores or other participant characteristics. The registry record does not report the method used for the sponsor’s full primary analysis beyond identifying its reported statistic as regression, Beta.

What does a mean difference represent?

A mean difference expresses the separation between two group averages in the original outcome units. Its sign depends on the order used for the contrast. For the recalculation, the in-person group is compared with the in-home group. A negative value therefore points toward a lower average BHS score in the in-person group; a positive value points toward a higher average in that group. Because higher BHS scores indicate greater hopelessness, the direction can be described in scale terms, but the estimate remains a group-level comparison rather than an individual outcome.

What does the confidence interval add?

A confidence interval gives a range of values compatible with the observed data under the assumptions of the analysis. It communicates precision as well as direction. An interval that crosses zero includes both a no-difference value and values on either side, so it does not establish the direction of the underlying difference. A wide interval also means that materially different differences remain compatible with the data. The primary recalculated interval spans both negative and positive values, and the p-value is 0.655. Neither quantity should be read as a direct probability that one treatment is better or that the null hypothesis is true.

What assumptions accompany this comparison?

The simple two-group mean comparison treats the observations as independent across participants and relies on the summary statistics as a suitable basis for estimating uncertainty. The posted calculation is not adjusted for baseline differences. It does not incorporate participant-level outcomes, repeated measurements, or any covariates. The registry record does not report whether the sponsor used these or other methods in its full analysis, nor does it specify how departures from model assumptions were assessed.

The standard deviation is important because it describes variation among participant scores. Greater spread relative to the difference between group means makes it harder to estimate a group contrast precisely. In general, if outcome variability is substantial, a larger study may be needed to estimate a given mean difference with the same precision. This is a general statistical principle, not a claim about the trial’s original planning.

How should the sponsor statistic be understood?

The registry reports a regression Beta of 0.40 with a 90% confidence interval from .12 to .68 and classifies the analysis as non-inferiority or equivalence. A regression coefficient is interpreted according to the model, outcome coding, reference group, and any adjustments used. Those details, along with the non-inferiority or equivalence margin, are not reported in the registry record. The coefficient should not be treated as if it were the unadjusted difference between the two posted means. Its confidence interval also has a different stated confidence level from the recalculated primary interval.

A non-inferiority analysis asks whether an intervention is not worse than a comparator by more than a specified margin; an equivalence analysis asks whether the difference falls within prespecified bounds in both directions. The margin is essential to either conclusion. Without it, the reader cannot determine what range the sponsor regarded as acceptably similar. A conventional difference test with a nonsignificant result does not substitute for that prespecified framework.

Why do planning illustrations depend on the assumed effect?

The sample-size planning illustrations use the observed effect as a reference and show scenarios based on detecting the full observed effect or a fraction of it. In general, smaller effects are harder to distinguish from random variation and require more participants for a target power, when other planning assumptions are held fixed. The resulting figures are planning illustrations, not a description of the trial’s design and not a measure of the study’s observed power.

Those illustrations assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The original design assumptions, including the intended effect and justification for the enrolled sample, are not reported in the registry record. A planning calculation based on an effect observed after a study has been conducted should not be used to imply that the trial was planned around that effect.

Finally, a reported p-value is conditional on the analysis model and assumptions. It does not measure the size or clinical importance of an effect, and it does not account automatically for multiple outcomes or multiple analyses. The record does not report a multiplicity strategy for the trial’s outcome measures. That absence limits how strongly isolated secondary findings can be interpreted.

11. Confidence Intervals and Precision

For the primary Week 8 comparison, the recalculated 95% confidence interval runs from -2.478 to 1.557 BHS units. It includes zero and extends to values favoring either group in the direction of the mean contrast. This is a key precision finding: the observed means are close, but the interval does not rule out a range of differences on either side. The data therefore do not pin down the direction or size of the underlying mean contrast with high precision.

A confidence interval is not a range containing 95% of individual participant scores. It concerns uncertainty about the estimated group contrast under the analysis assumptions. Individual scores are more variable, as reflected by the group standard deviations of 4.643 in the in-home arm and 4.939 in the in-person arm.

The unadjusted p-value is 0.655. This does not quantify the probability that the null hypothesis is true. It describes how unusual a result at least as incompatible with the null would be under the null model and its assumptions. A nonsignificant p-value is not evidence of equivalence, especially without a reported equivalence margin and an analysis designed to assess that margin.

The sponsor’s reported 90% confidence interval, .12 to .68, applies to its regression Beta of 0.40, not to the recalculated mean difference. Because the statistic and confidence level differ, the two intervals answer different analytical questions and should not be compared as if they were estimates on a common scale. The model details and margin needed to interpret the sponsor analysis fully are not reported in the registry record.

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 illustrations give the number of participants per arm, not the total across both arms. They use the observed effect as a starting point and show planning scenarios for detecting 100%, 75%, or 50% of that effect. For the primary comparison, planning for 100% of the observed effect gives 1,699 participants per arm for 80% power and 2,274 participants per arm for 90% power. The other rows apply the same interpretation to smaller fractions of the observed effect.

The 80% power column describes a planning target: under the stated assumptions, a study of the listed size would have an 80% chance of detecting the assumed effect at the specified significance level. The 90% column uses a higher chance of detection as its target. These are design probabilities conditional on the assumed effect, analysis, and other planning conditions; they do not describe the probability that the trial result is correct.

The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. For this continuous outcome, the figures count participants per arm; the convention for time-to-event outcomes, if present, is total events, but this primary result is not a time-to-event outcome.

Smaller effects require more participants to detect with the same power, all else being equal. Thus, the scenarios using 75% and 50% of the observed effect require larger per-arm counts than planning around the full observed effect. These are planning illustrations, not observed power. They are not the trial’s original sample-size calculation: the trial’s own design assumptions and sample-size justification are 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 = -0.460; pooled standard deviation σ = 4.788.
2. n = 2 × (1.96 + 0.842)² × 4.788² / -0.460² = 1,698.5, rounded up to 1,699 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 <- -0.460318                      # observed difference in means
sigma <- 4.78813476774568                     # 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(1599585)
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 = 1,699 (80% power), 2,274 (90% power)
 75% of observed effect: n per arm = 3,020 (80% power), 4,043 (90% power)
 50% of observed effect: n per arm = 6,794 (80% power), 9,096 (90% power)
power.t.test: 1699.4 
Simulated power at n = 1,699 per arm: 0.799 (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 a sponsor analysis for the primary comparison as regression, Beta, with an estimate of 0.40 and a 90% confidence interval from .12 to .68. It is classified in the record as a non-inferiority or equivalence analysis. The registry does not include a p-value for this analysis.

The separate recalculation uses the posted group means and standard deviations to estimate an unadjusted difference in means. It gives a 95% confidence interval from -2.478 to 1.557 and p = 0.655. The discrepancy flag is false, but that does not make the analyses interchangeable: they report different statistics, at different confidence levels, and the sponsor’s model specification is not reported. The registry record also does not state the coding or reference group for the regression coefficient.

The sponsor analysis is the trial’s reported analysis, while the recalculation is a simple unadjusted analysis of the posted summaries. The non-inferiority or equivalence label alone is not enough to establish the conclusion: the margin, hypothesis details, and analysis population are not reported in the registry record. The mean-difference recalculation should likewise not be used as a replacement for a prespecified model or margin-based analysis.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists 17 outcome measures and 16 posted secondary outcomes, in addition to the primary BHS endpoint. It does not report a multiplicity plan, such as a hierarchy of hypotheses, an adjustment to significance thresholds, or a distinction between confirmatory and exploratory secondary analyses. Without this information, a reader cannot determine how the trial intended to control the chance of false-positive findings across multiple tests.

Multiplicity matters because the more statistical questions examined, the greater the opportunity for one result to appear unusual by chance. This general concern does not mean that any particular result is false; it means that isolated secondary results require caution when the full testing strategy is unknown. The posted primary comparison is itself unadjusted in the recalculation, and the registry record does not say whether or how the sponsor addressed multiplicity in its model-based analyses.

The registry record also does not report the handling of missing outcome data, the reasons participants lack a Week 8 value, or whether imputation or other missing-data methods were used. Nor does it identify whether the reported endpoint analysis follows an intention-to-treat, per-protocol, or other population definition. The primary endpoint counts are 45 in the in-home group and 42 in the in-person group, whereas baseline summaries use 62 and 59. These differences in posted counts do not establish why data are absent or whether missingness could bias the comparison.

Information about withdrawals, adherence, protocol deviations, and the relationship between missingness and outcomes is not reported in the registry record. These details are important because an analysis limited to participants with recorded endpoint values may not represent all randomized participants if the availability of an outcome is related to the outcome itself or to group assignment.

The registry record does not report an interim analysis plan, stopping rules, or the original sample-size justification. These omissions should be treated as unknowns, rather than filled in by assumptions about common trial practice. As a result, the posted estimates can be described, but a full assessment of the prespecified analysis strategy is not possible.

16. Safety Results

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

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: severe chest pain (1.7%), exacerbation of asthma symptoms requiring hospitalization (1.6%), hospitalization for high fever and chills (1.6%), exacerbation of baseline suicidality (1.6%).

The registry reports serious adverse events in 3 of 62 participants at risk in the in-home group and 1 of 59 at risk in the in-person group. For other adverse events, it also reports 3 affected among 62 at risk in the in-home group and 1 among 59 at risk in the in-person group. These are the registry’s counts; they do not establish that the events were caused by treatment, and they should not be treated as a comparison adjusted for follow-up time or participant characteristics.

The registry lists serious-event terms including severe chest pain (1.7%), exacerbation of asthma symptoms requiring hospitalization (1.6%), hospitalization for high fever and chills (1.6%), and exacerbation of baseline suicidality (1.6%). The record does not provide enough detail alongside these terms to infer event-specific comparative risks. Death counts are not reported in the registry record.

Small event counts provide limited information about uncommon harms. The safety figures should be read as descriptive reports from the registry, not as proof that one delivery setting is safer or riskier than the other.

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

The primary result is a comparison of average BHS scores at Week 8 among participants with posted endpoint values. The group means are 4.889 for in-home BA and 4.429 for in-person BA. The unadjusted recalculated interval includes zero and plausible differences in either direction, so the estimate is not precise enough to identify a clear direction of the underlying mean contrast.

This result does not demonstrate that the two delivery approaches are equivalent. Equivalence requires prespecified bounds defining what differences are small enough to count as similar, along with an appropriate analysis. Although the sponsor analysis is labeled as non-inferiority or equivalence, the registry record does not report the margin or enough model details to assess that conclusion. A nonsignificant unadjusted test is not a substitute for those requirements.

The result also does not establish whether either group improved from baseline. Baseline and Week 8 summaries involve different posted counts, and no participant-level change estimate or longitudinal model is reported. Group means at two time points cannot be connected into a within-person change result without additional information about the analysis and participants represented at each time.

Nor does the primary endpoint alone answer all questions about depression symptoms, safety, engagement, or feasibility. The BHS measures hopelessness, and its mean does not stand in for every secondary outcome. The registry record does not report complete numerical results for all listed secondary measures or the full analysis plan.

The appropriate interpretation is therefore bounded: the posted Week 8 BHS summaries show similar group averages, but the unadjusted estimate has substantial uncertainty, and the registry record leaves important details about the sponsor’s margin-based analysis, missing data, and outcome analysis populations unspecified. No individual treatment recommendation follows from these group-level registry results.

18. Why This Trial Matters Statistically

This trial raises an important statistical design question: when the treatment content is shared but the delivery setting differs, what evidence is needed to compare the delivery approaches? A trial designed to show that two approaches are similar must define in advance how much difference would still count as acceptable. A conventional test that does not detect a difference cannot, by itself, answer that question.

The record makes the distinction visible by reporting both a sponsor analysis classified as non-inferiority or equivalence and an unadjusted recalculation of the Week 8 mean difference. The sponsor statistic is a regression Beta with a 90% interval; the recalculation is a mean contrast with a 95% interval. Keeping the estimands and methods distinct is essential. Similar-looking summaries are not necessarily estimates of the same quantity, and a non-inferiority label is not interpretable without the margin and model details.

The result also illustrates why precision matters. Group means can be close while the confidence interval remains broad enough to include differences in either direction. Statistical interpretation should consider the full interval, not simply whether a p-value crosses a conventional threshold. This is particularly important when the scientific question concerns similarity rather than superiority.

Finally, the record demonstrates the importance of complete reporting: the original sample-size rationale, missing-data approach, analysis populations, multiplicity strategy, and details of the sponsor’s margin-based analysis are not reported. Those elements influence what conclusions can be supported, even when the outcome summaries themselves are clear. A careful statistical reading distinguishes what the data describe from what remains unknown.

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 primary recalculation is unadjusted and based on posted group summary statistics. It cannot account for participant-level covariates, baseline score adjustment, repeated measures, or correlations among measurements. The registry record does not report enough information to determine whether the sponsor’s full analysis addressed these features.

Primary endpoint counts are 45 in the in-home group and 42 in the in-person group, while enrollment was 121. The record does not explain the differences in counts, identify the analysis population, or describe the handling of missing outcomes. Baseline summaries contain 62 and 59 participants, but the reason those counts differ from the endpoint counts is not reported. It is therefore not possible to determine from the registry whether selection into the endpoint analysis could affect the result.

The sponsor’s analysis is labeled non-inferiority or equivalence, but the margin, model specification, coefficient coding, and analysis population are not reported in the registry record. Without the margin, the substantive meaning of the sponsor confidence interval cannot be assessed. The unadjusted mean-difference analysis does not resolve those missing details.

The record does not report the original sample-size justification, prespecified multiplicity procedure, interim-analysis plan, or missing-data methods. Further, numerical results for many listed secondary measures are not reported in the registry record. These gaps limit assessment of the trial’s full analysis strategy and the consistency of findings beyond the primary endpoint.

The population description identifies Soldiers and Veterans with Major and Minor Depressive Disorder, but further eligibility and participant-characteristic details are not reported in the registry record. The results should therefore be understood as applying to the posted trial population, without assuming broader representativeness. Safety counts are descriptive and small; the record does not support a detailed comparative safety assessment.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression — NCT01599585.
• Registry record last updated 2017-06-16; status last verified 2017-03.
• Results first posted 2017-06-16.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

The registry describes a completed randomized, single-masked, parallel-group trial sponsored by the National Center for Telehealth and Technology, with enrollment of 121. It compared 8-session Behavioral Activation delivered in the home by secure web-based video with in-person Behavioral Activation in a clinic.

The primary endpoint was mean Beck Hopelessness Scale score at post-treatment, Week 8. The posted means were 4.889 for in-home treatment and 4.429 for in-person treatment. The unadjusted recalculation has a 95% confidence interval from -2.478 to 1.557 and p = 0.655, leaving uncertainty about the direction and size of the mean difference.

The registry also reports a regression Beta of 0.40 with a 90% confidence interval from .12 to .68, classified as a non-inferiority or equivalence analysis. Its margin and model details are not reported in the registry record. Missing-data methods, analysis populations, multiplicity procedures, and the original sample-size justification are also not reported.