This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands (NCT00122109), a randomized na study. The primary outcome is State-Trait Anger Inventory (STAXI-2) Anger Expression Index.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00122109 |
| Phase | NA |
| Condition | Posttraumatic Stress Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 125 |
| Arms in the primary outcome | 2 |
| Lead sponsor | US Department of Veterans Affairs |
| Results posted | Yes |
2. Clinical Question
Population
Veterans with posttraumatic stress disorder who resided in remote locations on the Hawaiian Islands were the target population described in the registry record. Enrollment was 125. The posted results include baseline measurements for 61 participants in the videoteleconferencing group and 64 in the face-to-face group. The registry record does not report further eligibility details or describe how participants were recruited.
Intervention
The intervention was Anger Management Therapy delivered in a group by videoteleconferencing. The registry describes the behavioral intervention as 12 sessions. The record characterizes AMT as a manual-guided, cognitive-behavioral, skills-based group intervention.
Comparator
The comparison group received the same named AMT intervention in a traditional face-to-face group format. The intended contrast was therefore the delivery modality, rather than AMT compared with no treatment or a different therapy.
Primary question
The primary outcome was the STAXI-2 Anger Expression Index, reported as a mean with a standard deviation. The posted timeframe is baseline. The registry record therefore describes baseline scores in the randomized groups, not a reported comparison of treatment-related change or a post-treatment endpoint. The statistical question that can be addressed from these results is how the baseline group means compare and how uncertain that difference is.
The study was designed to assess anger management therapy delivered by videoteleconferencing against traditional in-person delivery for veterans with PTSD in remote Hawaiian locations. That is an important distinction when interpreting the posted numbers: the trial question concerns treatment delivery, but the primary result available in the registry record is explicitly labelled baseline. It cannot, by itself, answer whether either modality changed anger expression, or whether changes differed between the groups. Results for later treatment or follow-up time points are not reported in the registry record.
3. Trial Design
The registry describes a randomized, parallel-group trial with no masking. One group received AMT through videoteleconferencing, and the other received AMT face to face. The registry record lists an enrollment of 125 and marks the study as completed. It lists the study start as 2005-08 and primary completion as 2008-10. The sponsor is the US Department of Veterans Affairs.
The trial compared two ways of delivering a group behavioral intervention. The registry describes AMT as a manual-guided, cognitive-behavioral, skills-based program and specifies 12 sessions. It also describes the videoteleconferencing format as the experimental arm and the face-to-face format as the control arm. These labels describe the study comparison; they do not imply that either group is a no-treatment control.
Random allocation can help make groups comparable at the start of a study, but the registry record does not report the randomization sequence method, allocation concealment, or whether any stratification was used. It does not report the number or location of treatment groups, the clinicians involved, or how adherence to the manual was assessed. Although masking is listed as none, further details about which people involved in the study knew the assigned modality are not reported in the registry record.
The posted primary outcome is a baseline measurement, and the listed secondary outcome is also described at baseline. The registry record does not report later outcome time points in the results available for this analysis. This limits what can be learned from the posted results about the intervention period or subsequent follow-up. The reported group counts for the primary outcome are 61 and 64; the record does not explain whether these counts represent all randomized participants, all participants measured at baseline, or another analysis population.
The registry lists 10 outcome measures, but the number of reported analyses is zero, and the reported analyses list is empty. The posted summary statistics and comparisons do not come with a registry-listed analysis description. Details such as the original analysis plan, sample-size justification, handling of missing observations, and the originally intended analysis population are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Of the 125 veterans who entered treatment, 112 attended at least 9 of 12 treatment sessions and were included in our completer sample (NP = 57 and VTC = 55).
Overall Study
| Stage | Videoteleconferencing AMT | Face to Face AMT |
|---|---|---|
| STARTED | 61 | 64 |
| COMPLETED | 55 | 57 |
| NOT COMPLETED | 6 | 7 |
Reasons for not completing this period:
| Reason | Videoteleconferencing AMT | Face to Face AMT |
|---|---|---|
| Did not meet criteria | 6 | 7 |
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.
| Characteristic | Unit | Videoteleconferencing AMT | Face to Face AMT | Total |
|---|---|---|---|---|
| Participants analysed | 61 | 64 | 125 | |
| Age, Continuous | years | 54.8 (24 to 80) | 54.6 (22 to 75) | 54.7 (22 to 80) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 61 | 64 | 125 |
| Region of Enrollment: United States | participants | 61 | 64 | 125 |
6. Primary Endpoint
The registry lists the primary outcome as State-Trait Anger Inventory (STAXI-2) Anger Expression Index, measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the State-Trait Anger Inventory, Second Edition, Anger Expression Index, abbreviated STAXI-2 Anger Expression Index. It is reported as a mean in units on a scale, with standard deviations. The measure is described as a 32-item index with a range of 0 - 96. It is intended to provide a general measure of anger expression, including a person's experience of anger, expression of anger, and efforts to control it. Higher scores indicate more problematic levels of anger and its expression.
The registry record describes the STAXI-2 subscales as having robust psychometric properties, including high internal consistency, external validity, and construct validity. A measure with these properties can offer a consistent and meaningful way to quantify a study outcome, although those properties do not establish that the measure captures every aspect of anger or that an observed group difference is caused by treatment.
The posted timeframe for this endpoint is baseline. Thus, these results describe the groups' initial scores as recorded, rather than the amount of change following AMT. For a treatment-delivery comparison, measurements after the intervention or comparisons of change could address a different question; such results are not reported in the registry record. The baseline measure can describe the starting outcome distribution, but it cannot establish whether either modality improved or worsened anger expression.
7. Results Posted in the Registry
- Face to Face AMT: mean 55.00 versus 56.70 on control; difference -1.70 (95% CI -5.63 to 2.23), standardized effect d = -0.15; z-test p = 0.396.
Mean difference: Face to Face AMT
95% CI: -5.63 to 2.23
Recalculated from the posted summary statistics
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.
| Secondary outcome | Type | Effect measure | Estimate (95% CI) | Planning size, 80% power |
|---|---|---|---|---|
| PTSD Checklist-military Version (PCL-M) | Continuous Endpoint | Mean difference | 1.30 (-2.63 to 5.23) | 1,165 per arm |
PTSD Checklist-military Version (PCL-M)
- 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:
- Face to Face AMT: mean 65.80 versus 64.50 on control; difference 1.30 (95% CI -2.63 to 5.23), standardized effect d = 0.12; z-test p = 0.517.
- Interpretation:
- The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Face to Face AMT and the control. The interval gives the range of effects that remain compatible with the data.
The registry lists the PTSD Checklist-military Version as a secondary outcome and describes its posted measurement time as baseline. The listed secondary outcome names repeat the same measure, while the posted secondary results are a baseline comparison. This gives some context about the groups' starting symptom scores, but it does not add a treatment-period result or demonstrate a pattern of change across multiple follow-up times.
The secondary result is related to the primary result in that both are baseline measures from the randomized groups. Neither can establish the effect of videoteleconferencing versus face-to-face delivery on outcomes after AMT. Reading the secondary data alongside the primary baseline comparison can help describe initial group status, but it cannot turn the baseline contrasts into evidence about treatment response.
The registry lists 10 outcome measures, but it reports zero analyses, and the reported-analyses list is empty. The available secondary information therefore does not include a registry-reported set of inferential analyses across outcomes. No multiplicity adjustment is reported. When several outcomes are examined, unadjusted findings can carry less weight because multiple opportunities to find an apparently notable result can increase the chance of misleading evidence. That general concern is especially relevant when the analysis plan and outcome-selection process are not described.
Secondary results are commonly useful for describing other aspects of a study question, but their interpretation depends on whether they were prespecified, how they were analyzed, and how many comparisons were considered. Those details are not reported in the registry record. The secondary results should therefore be treated as descriptive posted information, rather than as a confirmatory basis for a separate treatment conclusion. Their baseline timing is the central limitation: later PCL-M outcomes and comparisons are not reported in the registry record.
Secondary outcomes registered for this trial, for reference (only those above were recalculated):
- PTSD Checklist-military Version (PCL-M)
- PTSD Checklist-military Version (PCL-M)
9. Statistical Interpretation
At baseline, the mean STAXI-2 Anger Expression Index was 56.7 in the videoteleconferencing AMT group and 55.0 in the face-to-face AMT group. The posted mean difference, defined as face to face compared with videoteleconferencing, is -1.7 units. The interval accompanying that difference extends from -5.629 to 2.229, and the unadjusted p-value is 0.396. The interval includes zero, so the posted results are compatible with a range of possible baseline differences in either direction. They do not establish a clear baseline separation between the groups.
The key qualification is the timing: this primary result is labelled baseline. It is not an estimate of the effect of videoteleconferencing versus face-to-face AMT after treatment, nor an estimate of change from baseline. A baseline comparison can be useful for describing the randomized groups, but it does not address whether treatment delivery affected the endpoint. A treatment-effect conclusion would require relevant outcome data over the intervention period or at a later time point, and those results are not reported in the registry record.
The registry also posts a baseline comparison for the PTSD Checklist-military Version. Its reported mean difference and interval likewise describe a baseline contrast, not a treatment response. The secondary results should therefore be read as descriptive information about starting measurements. They do not supply an independent demonstration of how the primary endpoint changed.
The record identifies the study as randomized, which is relevant to the intended comparison, but the posted result does not document how randomization was implemented or how the reported analysis handled missing data. Nor does the registry provide a named analysis in its reported analyses list. The summary statistics allow readers to see the observed group means and the uncertainty attached to the unadjusted comparison; they do not reveal the full analysis process or resolve questions about outcome availability and analysis populations.
The registry lists no serious or other adverse events as affecting participants in either group in the posted adverse-event fields. Those counts are useful as a description of what was entered in the record, but they do not establish that no events occurred outside the recorded information or during unreported periods. The record does not report death counts.
Overall, the posted results support a narrow statistical reading: the randomized groups had broadly similar baseline mean scores in the listed measures, with uncertainty around the estimated differences. The results available in the registry do not establish the relative effects of the two delivery modalities, because treatment-period or follow-up comparisons are not reported. This is a statement about the content and precision of the registry results, not a recommendation about care.
10. Statistical Methods Explained
The posted outcomes are continuous measures summarized by group means and standard deviations. A mean describes the average score in a group, while a standard deviation describes the spread of individual scores around that average. These summaries give a compact account of the outcome distribution, but they do not show every participant's score or indicate how scores are distributed across the full scale. The primary outcome is the STAXI-2 Anger Expression Index; the secondary measure is the PTSD Checklist-military Version.
What does the mean difference represent?
The primary comparison is expressed as the face-to-face group mean minus the videoteleconferencing group mean. Under that direction, a negative estimate means the face-to-face group mean is lower at the recorded time point; a positive estimate would mean it is higher. The reported estimate is -1.7 units. This direction is a property of how the contrast is defined, not a judgment about which group did better. The scale description says that higher scores indicate more problematic anger expression, but the comparison is at baseline and is not a treatment-effect estimate.
The same general approach applies to a continuous outcome such as the PCL-M: group averages are compared, and the difference is accompanied by an interval. An unadjusted comparison uses the posted group summaries without adjustment for other variables. The registry record does not report an adjusted analysis or identify covariates used in a model. The word unadjusted describes the posted p-value; it should not be taken to imply that a particular full statistical model was used.
How should the interval be understood?
A confidence interval expresses uncertainty about an estimated quantity. In general, it gives a range of values reasonably compatible with the data and the method used to calculate the interval. A narrower interval indicates greater precision, while a wider interval indicates more uncertainty. If an interval includes zero for a difference, the data do not distinguish the estimate from no difference at the interval's stated confidence level. The confidence level itself is not reported in the registry record, so it should not be assumed from the numeric endpoints alone.
The primary interval runs from -5.629 to 2.229. Its span across zero indicates that the posted summary does not pin down a single direction for the baseline group difference. The p-value of 0.396 is labelled unadjusted. In general, a p-value measures how unusual data at least as incompatible with a specified null hypothesis would be under the assumptions of a test. It is not the probability that the null hypothesis is true, and it does not measure clinical importance. The test details and any adjustments are not reported in the registry record.
What does randomization contribute?
In general, random allocation is intended to reduce systematic differences between study groups at the outset, so that later differences can be interpreted in light of the assigned intervention. It does not guarantee that every baseline characteristic will be identical, and it does not by itself ensure that later outcome data are complete or analyzed as planned. The registry labels the allocation randomized but does not describe the sequence generation or concealment procedures. Since the posted outcomes are baseline measurements, their comparison is not an estimate of the effect of randomized treatment assignment.
What is not described about the analysis?
The record lists zero reported analyses and an empty reported-analyses list. It does post summary statistics and an unadjusted comparison for the primary result, but it does not identify a statistical analysis plan, a model, or the population used for analysis. It also does not report how missing measurements were handled, whether participants were analyzed according to their assigned group, or whether there were deviations from the planned treatment. These details matter because different analysis choices can change the estimate or its uncertainty, especially when observations are missing or groups have different amounts of follow-up.
The posted outcomes are continuous means, not counts or event rates. The statistical summaries therefore concern differences in average scale scores. General statistical methods for count outcomes, time-to-event outcomes, or binary outcomes are not needed to interpret these particular posted comparisons. Nor does the registry record describe a repeated-measures model that would estimate trajectories over time.
Why does outcome timing matter?
For a trial comparing delivery modalities, a baseline measure records the outcome before the treatment comparison could produce a treatment-related change. A later value, a change score, or an analysis that compares changes could address treatment response, subject to the study's design and analysis assumptions. The registry results do not include such a treatment-period contrast. Without those results, interpreting the baseline mean difference as an intervention effect would confuse starting status with response.
For general context, statistical significance and effect size answer different questions. A p-value describes evidence against a specified null model under test assumptions; the estimated difference describes the direction and scale of the observed contrast; and the interval describes its precision. None of these alone resolves whether a difference matters in practice. The registry record does not report a threshold for a meaningful change on the STAXI-2, and such a threshold should not be inferred from the observed baseline estimates.
11. Confidence Intervals and Precision
The primary baseline mean difference is -1.7 units, with a reported interval from -5.629 to 2.229. The interval extends on both sides of zero. In general, that means the posted data are compatible with a lower face-to-face mean, little or no baseline difference, or a higher face-to-face mean, within the range represented by the interval and its calculation method. The exact confidence level is not reported in the registry record.
The width of an interval matters alongside its midpoint. A point estimate alone can appear definite even when the data allow a broad range of values. Here, the endpoints show that the estimated baseline contrast is not highly precise: its direction is not fixed by the interval. This is not evidence that the groups are exactly alike. Rather, it means the posted comparison does not sharply distinguish among several possible baseline differences.
The reported group standard deviations are 12.0 for videoteleconferencing and 10.3 for face to face. Standard deviations describe participant-level spread, whereas an interval for the mean difference describes uncertainty in the group contrast. They answer related but different questions. The registry also reports group counts of 61 and 64 for this primary measure, but does not report how the counts relate to the full randomized population or whether any data were missing.
The p-value is 0.396 and is labelled unadjusted. It does not replace the interval: a p-value gives a test-based measure under a null model, while the interval shows a range for the estimated difference. Neither establishes a treatment effect because the outcome time point is baseline. Later outcome estimates and their precision 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.
| Effect to detect | Participants per arm, 80% power | Participants per arm, 90% power |
|---|---|---|
| 100% of the observed effect | 677 | 906 |
| 75% of the observed effect | 1,204 | 1,611 |
| 50% of the observed effect | 2,707 | 3,624 |
The sample-size figures are planning illustrations based on the observed effect, not a report of the trial's original design assumptions. For these continuous outcomes, the entries are participants per arm, not total events. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set as the stated fraction of the observed effect. The registry record does not report the original sample-size justification or the assumptions used when the trial was planned.
The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the specified effect under the stated planning assumptions, if that effect and those assumptions were correct. The 90% power column gives the corresponding per-arm figure for a design with a 90% chance under those assumptions. These are design calculations, not descriptions of what happened in this completed study.
The rows that use smaller fractions of the observed effect require more participants per arm in the planning illustration. In general, smaller effects are harder to distinguish from random variation, so greater sample sizes are needed to achieve the same target power when other assumptions remain fixed. The curve should be read in that planning context: it represents how the required sample size changes with the effect size assumed for a future design.
This is not observed power. It should not be used to judge the probability that the trial found a result, to infer that the trial was adequately or inadequately designed, or to replace an analysis of its estimates and intervals. Because the illustration is anchored to the observed effect, it is sensitive to that estimate and is not an independent validation of the effect's size.
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 z1−α/2 = 1.960) and the desired power (z1−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
- Observed difference Δ = -1.700; pooled standard deviation σ = 11.162.
- n = 2 × (1.96 + 0.842)2 × 11.1622 / -1.7002 = 676.7, rounded up to 677 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 <- -1.7 # observed difference in means
sigma <- 11.161661297801 # 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(122109)
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 = 677 (80% power), 906 (90% power)
75% of observed effect: n per arm = 1,204 (80% power), 1,611 (90% power)
50% of observed effect: n per arm = 2,707 (80% power), 3,624 (90% power)
power.t.test: 677.7
Simulated power at n = 677 per arm: 0.801 (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. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study examines several outcomes, time points, subgroups, or statistical comparisons. In general, the more opportunities there are to observe a seemingly unusual result, the greater the risk that at least one result will appear noteworthy by chance. Prespecified outcome hierarchies or statistical adjustments can help manage that issue, but the registry record does not report whether such procedures were planned or used.
The registry lists 10 outcome measures and names the STAXI-2 Anger Expression Index as the primary outcome. It lists the PCL-M among secondary outcomes, with the same title repeated in the outcome list. However, it reports zero analyses and provides no reported-analyses list. The record does not describe how many analyses were conducted, whether all listed outcomes were assessed, whether multiplicity was considered, or whether any secondary findings were designated exploratory. The unadjusted p-values should consequently be interpreted as unadjusted comparisons, not as evidence that a family of outcomes was controlled for multiple testing.
Missing data are another important issue. The primary result includes 61 participants in the videoteleconferencing group and 64 in the face-to-face group, but the registry record does not explain whether these are all randomized participants, whether there were unavailable measurements, or how missing observations were handled. The record does not report reasons for missingness, imputation methods, sensitivity analyses, or a participant flow by analysis population. Without these details, it is not possible to assess whether missing outcome data could have affected the comparisons.
The analysis population is also not specified. The record does not say whether analyses followed assignment regardless of treatment received, included only participants completing treatment, or used another rule. The study is labelled randomized, but that label alone does not identify the population included in each posted result. Treatment attendance, adherence, crossover, and deviations from assigned modality are not reported in the registry record.
These gaps do not show that the study handled multiplicity or missing observations poorly; they mean the record does not provide the information needed to evaluate those choices. A careful reading distinguishes the numerical summaries that are posted from the analysis procedures and safeguards that are not described.
15. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Videoteleconferencing AMT | 0 | 61 | 0.0% |
| Face to Face AMT | 0 | 64 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Videoteleconferencing AMT | 0 of 61 |
| Face to Face AMT | 0 of 64 |
The posted adverse-event fields list 61 participants at risk in the videoteleconferencing AMT group and 64 at risk in the face-to-face AMT group. The number affected by serious adverse events is recorded as 0 in each group. The number affected by other adverse events is also recorded as 0 in each group. No serious adverse-event terms are listed.
These figures describe the counts entered in the registry record, not a detailed account of every possible event. The record does not report an adverse-event collection timeframe, definitions, severity criteria, or methods for soliciting and verifying events. Death counts are not reported in the registry record. Thus, the zero entries should be read as zero events recorded in these fields, rather than as proof that no events occurred in any circumstance or period.
The counts also do not permit a detailed comparison of event types or timing, because no event terms are listed and no further safety analysis is reported. They are a concise record of posted safety counts, with the limitations of the reporting information available.
16. What the Result Does, and Does Not, Mean
The posted primary result describes baseline anger-expression scores in two randomized groups assigned to different delivery formats for AMT. The group means were close in the scale's units, and the estimated baseline difference has an interval that includes zero. This is a description of the data available in the registry record. It is not a finding about whether either treatment modality changes anger expression.
The intended clinical question was whether group AMT delivered by videoteleconferencing could be compared with traditional face-to-face delivery for veterans with PTSD in remote Hawaiian locations. The treatment itself was offered in both groups, so the comparison concerns delivery modality. But the posted endpoint is baseline, and the record does not report outcome results after the 12 sessions or at later follow-up. The central treatment question therefore remains unanswered by these posted numbers.
The baseline results also do not establish equivalence between the delivery formats. An interval spanning zero does not demonstrate that any true difference is absent or small enough to be unimportant. An equivalence or noninferiority conclusion requires a suitable design, a prespecified margin, and an analysis addressing that question; such details are not reported in the registry record. The observed means and interval should not be recast as proof of equal outcomes.
Likewise, the p-value does not measure the probability that one modality is better, the size of a treatment benefit, or the importance of a difference to participants. The scale's direction is described, but the registry does not report a threshold for a clinically meaningful change. The posted estimates provide statistical description, not a basis for medical advice.
The adverse-event fields record zero affected participants in both groups, but incomplete details about event collection and timeframes limit what those entries can establish. The trial's completed status and enrollment count describe the registry record, yet the available results do not disclose all aspects of participant flow or analysis. The appropriate conclusion is bounded: the record contains baseline outcome summaries and adverse-event counts, while treatment-related outcome comparisons and key analytic details are not reported.
17. Why This Trial Matters Statistically
This trial addresses a design question with practical relevance to research delivery: whether a group behavioral intervention can be studied in a remote setting using videoteleconferencing rather than relying only on face-to-face groups. For statistical interpretation, it is important that the study's randomized comparison and its posted outcome timing are kept distinct. Randomization describes how the treatment groups were assigned; the baseline means describe the groups before treatment response can be evaluated.
The case illustrates why outcome timing is not a minor reporting detail. A numerical contrast between randomized groups may look like a treatment comparison at a glance, but its meaning depends on when the outcome was measured. Here the primary and secondary measures are labelled baseline. Interpreting them as evidence about response would confuse starting scores with changes attributable to the intervention.
It also illustrates the complementary roles of an estimate, an interval, and a p-value. The point estimate gives the observed direction and scale of the baseline contrast. The interval conveys uncertainty around that estimate, while the unadjusted p-value summarizes evidence under a test framework. None can replace a clear account of the endpoint timing, analysis population, missing data, or planned comparisons.
Finally, sample-size illustrations are often easy to misread as retrospective judgments about a completed trial. The figures in this record are planning calculations anchored to the observed effect under stated assumptions; they are not observed power and do not recover the original study design. Keeping planning illustrations separate from trial results is important when evaluating the strength and precision of clinical evidence.
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.
A major trial-specific limitation of the results available in the registry record is that the primary and secondary outcome timeframes are labelled baseline. The treatment comparison concerns two AMT delivery modalities, but outcome comparisons after treatment or during follow-up are not reported. As a result, the posted measures cannot estimate treatment-related change or a difference in response between the modalities.
The analysis description is limited. The registry reports zero analyses and an empty reported-analyses list, while the posted results include group summaries and comparisons. It does not report a statistical analysis plan, the original sample-size justification, the randomization procedure, or allocation concealment. It also does not identify the analysis population or explain whether the posted outcome counts include every randomized participant.
Information about missing data is not reported in the registry record. The record does not describe participant flow, missing measurement patterns, reasons for missingness, or any method used to address missing values. Treatment attendance and adherence, treatment fidelity, and deviations from assigned delivery modality are also not described. These omissions make it difficult to assess how representative the analyzed measurements are of the enrolled population and how closely the intervention was delivered as intended.
The registry lists 10 outcome measures, but the available analysis information does not say how outcomes were selected, whether multiple comparisons were addressed, or which analyses were prespecified. The PCL-M title is repeated among the secondary outcome names. The record does not explain that repetition or provide a broader set of reported secondary analyses. The confidence-interval level is not reported in the registry record, and no threshold for a meaningful STAXI-2 change is given.
Safety reporting is also brief: adverse-event fields show zero affected participants, but event collection methods and timeframes are not described, and death counts are not reported. These are limitations of the available registry information; they do not establish that unreported procedures or events were absent.
19. Related Tutorials
20. Related Statistical Calculators
21. Sources
- ClinicalTrials.gov: Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands — NCT00122109.
- Registry record last updated 2015-04-28; status last verified 2014-08.
- Results first posted 2014-10-16.
- 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.
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22. Record Summary
The registry record describes a completed randomized, parallel-group study with no masking, sponsored by the US Department of Veterans Affairs. Enrollment was 125. Veterans with PTSD were assigned to group AMT delivered by videoteleconferencing or face to face; the intervention is described as 12 sessions.
The primary outcome was the STAXI-2 Anger Expression Index, and the posted timeframe was baseline. The secondary measure was the PTSD Checklist-military Version, also listed at baseline. The reported analyses list is empty. The posted results therefore describe baseline group measurements, not treatment-related changes. Serious and other adverse events are recorded as affecting 0 participants in each group; death counts are not reported in the registry record.
The registry lists the study start as 2005-08, primary completion as 2008-10, and status as completed. Key details about the original analysis plan, sample-size justification, missing data, and analysis populations are not reported in the registry record.