Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder (NCT01409707), a randomized na study. The primary outcome is Impact of Event Scale-Revised.

2. Clinical Question

The trial concerns participants with alcohol dependence and posttraumatic stress disorder (PTSD). It examines whether trauma-focused exposure therapy, alone or preceded by motivational enhancement, is associated with different PTSD symptom scores than a healthy lifestyles intervention. The registry describes the study purpose as assessing whether prolonged exposure could be tolerated in alcohol-dependent patients with PTSD and whether it was associated with better treatment outcomes than an active control condition. The posted primary outcome is a symptom measure at 3-months posttreatment.

The clinical question has two parts: whether the trauma-focused approaches were feasible and tolerable in this population, and whether symptom outcomes differed across groups. The posted primary endpoint and reported comparisons address symptom scores. The registry record does not report a specific measure or analysis for tolerability, so the symptom results alone cannot answer that part of the study purpose.

3. Trial Design

The registry describes a randomized, single-masked, parallel-group study, with an enrollment of 126. The listed phase is NA. The sponsor is the University of Mississippi Medical Center. The study began in 2008-07, had primary completion in 2012-01, and is recorded as completed. The registry record does not report the details of who was masked or how masking was maintained.

Three behavioral interventions are listed: Healthy Lifestyles Sessions, Trauma-focused Exposure Therapy, and Motivational Enhancement + Trauma-focused Exposure Therapy. Healthy lifestyles sessions are described as a structured 9-12 session program with 50-60 minute sessions that addressed health-related topics. The trauma-focused intervention is described as cognitive-behavioral therapy using imaginal and in vivo exposure techniques. The combined intervention began with a one session, 90 min. motivational enhancement session before trauma-focused exposure therapy. Further details of the treatment descriptions are not fully reported in the registry record.

The outcome results list 41.0 participants for Healthy Lifestyles Sessions, 45.0 for Trauma-focused Exposure Therapy, and 40.0 for Motivational Enhancement + Trauma-focused Exposure Therapy. The primary outcome is a continuous measure, reported as a mean with standard error, at 3-months posttreatment. The record says all participants who started the study were included in the analyses and missing data were estimated using maximum likelihood estimation.

Random allocation helps make group comparisons less vulnerable to systematic differences at baseline, although it does not guarantee that all relevant characteristics are balanced. A parallel design compares the groups over the same trial period rather than having each participant receive every intervention. The registry record does not report the original sample-size assumptions, the allocation ratio, the details of the masking, or other protocol information needed to assess those design features further.

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: 222 assessed; 96 ineligible. 53 did not have current PTSD, 6 did not have current alcohol dependence (AD), and 2 did not have either current PTSD or AD. 35 participants were ineligible for other reasons (e.g., current mania, current psychosis, etc.).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.

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 Impact of Event Scale-Revised, measured over 3-months posttreatment.

The primary endpoint is the Impact of Event Scale-Revised (IES-R) at 3-months posttreatment. The registry describes the IES-R as a 22-item self-report measure of PTSD symptoms, with a total score ranging from 0 to 88. Lower scores represent less severe PTSD symptoms and higher scores represent more severe symptoms. The results are reported as group means in units on a scale, with standard errors as the measure of dispersion.

Using a defined symptom measure gives the trial a consistent outcome for comparing the groups at a specified follow-up point. A mean offers a summary of the group’s scores, while the standard error describes uncertainty around the estimated mean; it is not a description of the spread of individual participants’ scores. The scale’s direction matters when reading the results: a lower group mean corresponds to fewer reported symptoms on this measure. That interpretation is limited to the IES-R score and the recorded follow-up.

The registry identifies the population for analysis as all participants who started the study, using an intention-to-treat approach. Missing data were estimated using maximum likelihood estimation. The record does not describe the amount or pattern of missing outcome data, or provide additional detail on how the estimator was implemented. The endpoint therefore indicates a reported symptom outcome, but cannot on its own establish tolerability or represent every aspect of treatment outcome.

7. Results Posted in the Registry

• Trauma-focused Exposure Therapy: mean 19.10 versus 26.00 on control; difference -6.90 (95% CI -15.33 to 1.53), standardized effect d = -0.35; z-test p = 0.109.
• Motivational Enhancement + Trauma-focused Exposure Therapy: mean 14.11 versus 26.00 on control; difference -11.89 (95% CI -20.11 to -3.67), standardized effect d = -0.63; z-test p = 0.005.

8. Statistical Interpretation

9. Statistical Methods Explained

Continuous outcomes, such as the IES-R score, can be summarized with a mean and a measure of uncertainty. The mean describes the central level of the group’s observed or estimated scores. The standard error describes the precision of the estimated mean: smaller standard errors generally correspond to more precise estimates, while larger standard errors indicate greater uncertainty. Standard error is not the same as the standard deviation, which describes variation among individual scores. The registry reports means and standard errors but does not report standard deviations for the individual arms.

What does a mean difference represent?

A mean difference subtracts one group’s mean from another group’s mean in a stated comparison. In the recalculations, the healthy lifestyles group is the reference, and the difference is the mean for the trauma-focused group minus the healthy lifestyles mean. A negative estimate therefore corresponds to a lower mean score in the trauma-focused group. Since lower IES-R scores indicate less severe symptoms, the direction is interpretable on this scale. The estimate remains a group-level contrast; it does not describe the score or experience of every participant.

The recalculated comparisons are explicitly unadjusted. They use the posted summary statistics and do not represent the sponsor’s mixed models analysis. An unadjusted comparison does not account for covariates or other model structure unless those are part of the calculation; the registry record does not specify that such adjustments were made for these recalculations. The reported sponsor analysis uses mixed models, but the model specification and its estimates are not reported. General statistical context: mixed models can represent relationships among measurements or groups while accounting for modeled structure in the data. The name alone does not reveal which terms, assumptions, or covariance structure were used in this trial.

How should p-values be read?

A p-value describes how compatible the observed data are with a specified null model, under the assumptions of the analysis. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. The reported mixed models p-value is p = .068. The unadjusted recalculated comparisons report p = 0.109 and p = 0.005. These values belong to different analyses, so they should not be treated as interchangeable evidence from one model. The registry record does not report a prespecified threshold or the sponsor’s interpretation of the p-value.

General statistical context: a confidence interval presents a range of values compatible with the data and analysis procedure at a stated confidence level. If an interval for a mean difference includes zero, values with no group difference are among those compatible with that interval. If the interval lies entirely on one side of zero, its compatible values indicate a difference in that direction under the specified comparison. These statements concern statistical uncertainty, not a guarantee about the true value or the practical importance of the difference.

What does randomization contribute?

Random allocation is intended to reduce systematic differences between groups at the start of a trial. It supports a comparison of outcomes by assigned intervention, subject to the trial’s conduct, missing data, and analysis choices. It does not make outcome estimates exact, eliminate chance imbalances, or answer questions that were not measured. The record says analyses included all participants who started the study and that missing data were estimated using maximum likelihood estimation, but it does not report details about adherence, treatment discontinuation, or missingness patterns.

Intention-to-treat analysis generally aims to retain participants in the groups to which they were assigned, regardless of later treatment participation. The record’s description refers to all participants who started the study as included in analyses, but it does not provide a fuller account of assignment-based analysis procedures. Maximum likelihood estimation can use the observed data under assumptions about the missing-data process and the fitted model. General statistical context: if those assumptions do not fit the actual reasons or pattern of missingness, estimates can be affected. The registry record does not report enough information to assess those assumptions.

Why can the reported and recalculated results differ?

The sponsor-reported analysis is a mixed models analysis across all three groups, whereas the recalculations are simple pairwise comparisons based on posted means and standard errors. The analyses may differ in model structure, handling of missing observations, and the question being tested. The registry record does not report the model details or the pairwise contrasts from the mixed model, so the reason for the discrepancy is not reported in the registry record. In accordance with the registry’s flagged discrepancy, the sponsor’s own analysis takes precedence over the recalculations.

General statistical context: over-dispersion occurs when the variability in data is greater than a model expects. If relevant, accounting for it can affect standard errors and confidence intervals. The registry record does not report evidence of over-dispersion or a model adjustment for it, so this issue cannot be assessed as a feature of this trial.

10. Confidence Intervals and Precision

Precision concerns how narrowly an estimate is determined by the data and analysis. The recalculated Trauma-focused Exposure Therapy comparison has a mean difference of -6.9, with a 95% confidence interval from -15.33 to 1.528. The interval spans zero, so the data are compatible with a range that includes no difference as well as values on either side. This interval indicates uncertainty around the unadjusted estimate; it is not a range containing a guaranteed proportion of individual participant scores.

For Motivational Enhancement + Trauma-focused Exposure Therapy versus Healthy Lifestyles Sessions, the recalculated mean difference is -11.89, with a 95% confidence interval from -20.11 to -3.671. This interval lies below zero, indicating that the compatible values for this unadjusted comparison are lower mean scores in the combined-treatment group, according to the sign convention used. The interval’s location does not establish clinical importance, and its interpretation is specific to the recalculation rather than the sponsor’s mixed models analysis.

The group means have reported standard errors of 2.98 for Healthy Lifestyles Sessions, 3.1 for Trauma-focused Exposure Therapy, and 2.95 for Motivational Enhancement + Trauma-focused Exposure Therapy. These standard errors characterize precision of the means, not the full participant-level variability. The registry record does not report confidence intervals for the individual group means or for the sponsor’s mixed models result. The reported 95% designation applies to the registry’s mixed models analysis, but its interval limits are not reported.

Confidence intervals and p-values should be considered together with the analysis that generated them. The pairwise recalculations do not incorporate the unreported details of the mixed model or any unreported multiplicity adjustment. Since the record flags a discrepancy, the sponsor’s own analysis takes precedence. The absence of its estimate and interval limits how precisely the registry’s primary group analysis can be interpreted.

11. Planning a Similar Trial: Sample Size

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

The planning figures are participants per arm for 80% power and participants per arm for 90% power. They are not total events: the event-count convention applies to time-to-event outcomes, and this endpoint is continuous. The planning illustration uses a two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. It sets the effect to detect as the stated fraction of the observed effect. The registry record does not report the trial’s own original design assumptions, so these illustrations should not be confused with the rationale for the trial’s enrollment.

For each comparison, the row based on 100% of the observed effect uses the full recalculated effect as the planning target. The 75% and 50% rows plan for smaller effects than the observed estimate. The columns describe how many participants per arm the illustration estimates would be needed to have an 80% or 90% chance of detecting the chosen effect under the listed assumptions, if that effect and those assumptions were appropriate. The 90% power column represents a higher chance of detecting the target effect than the 80% column, and therefore has larger planning figures.

Smaller effects are harder to distinguish from random variation, so the planning figures increase as the target moves from the full observed effect to smaller fractions. The figures are planning illustrations derived from the observed effect, not observed power. They do not establish what the trial was designed to detect, whether its enrollment was sufficient for its original aims, or how likely the findings are to replicate. The sponsor-reported mixed models analysis remains the primary reported analysis where it differs from these unadjusted calculations.

12. How the Sample Size Is Derived

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

Formula

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

Worked calculation for this trial

1. Observed difference Δ = -6.900; pooled standard deviation σ = 19.998.
2. n = 2 × (1.96 + 0.842)² × 19.998² / -6.900² = 131.9, rounded up to 132 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 <- -6.9                      # observed difference in means
sigma <- 19.9975165124739                     # 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(1409707)
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 = 132 (80% power), 177 (90% power)
 75% of observed effect: n per arm = 235 (80% power), 314 (90% power)
 50% of observed effect: n per arm = 528 (80% power), 707 (90% power)
power.t.test: 132.8 
Simulated power at n = 132 per arm: 0.797 (20000 replicates)

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

13. Analyses Reported by the Sponsor

The registry reports a sponsor analysis using mixed models across Healthy Lifestyles Sessions, Trauma-focused Exposure Therapy, and Motivational Enhancement + Trauma-focused Exposure Therapy. The reported p-value is p = .068. The registry does not report the model’s estimated group effect, confidence interval limits, or the details needed to reconstruct the analysis from the record.

The pairwise estimates and p-values are unadjusted recalculations from posted summary statistics. For Trauma-focused Exposure Therapy versus Healthy Lifestyles Sessions, the recalculated mean difference is -6.9 and p = 0.109. For Motivational Enhancement + Trauma-focused Exposure Therapy versus Healthy Lifestyles Sessions, the recalculated mean difference is -11.89 and p = 0.005. These are not substitutes for the sponsor’s mixed models result: they use a different analytical approach and do not supply the missing model details.

The registry flags a discrepancy between the recalculation and reported analysis. In that situation, the sponsor’s own analysis takes precedence. The recalculated comparisons can be useful as transparent, simple contrasts of the posted means, but the record does not permit a full reconciliation of why their results differ. The sponsor-reported p-value also cannot be read as the effect estimate or as evidence of the size of a difference.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and two analyses, but identifies no posted secondary outcome results. The primary endpoint is the IES-R score at 3-months posttreatment. The record does not report a prespecified statistical analysis plan, the hierarchy of outcomes, or whether the primary outcome was the only confirmatory endpoint. It also does not report how multiplicity was handled across outcomes, groups, or comparisons.

Multiplicity arises when several outcomes or statistical comparisons are considered. General statistical context: as the number of tests increases, the chance of at least one apparently unusual result can increase if each test is interpreted separately. Adjustment procedures or a prespecified hierarchy can address that issue, but the registry record does not report whether any were used. The pairwise recalculations should therefore be understood as unadjusted comparisons, not as evidence that a multiplicity strategy was part of the trial’s analysis.

The analysis population is described as all participants who started the study, with missing data estimated using maximum likelihood estimation. This is identified as an intention-to-treat approach in the record. The amount of missing primary outcome data, reasons for missingness, and sensitivity analyses are not reported in the registry record. General statistical context: likelihood-based methods rely on assumptions about the data and missingness process; without details on missingness and model specification, the robustness of the analysis cannot be evaluated from the registry entry.

The registry reports a mixed models analysis and a p-value, but does not provide the model coefficients, group contrasts, confidence interval limits, covariates, or handling of repeated measurements. The endpoint is measured at 3-months posttreatment, and the record does not describe additional follow-up outcome analyses. The registry record also does not report interim analyses, stopping rules, or sample-size justification. These gaps limit assessment of whether the analysis followed a prespecified plan and how fully the reported result represents the intended analysis.

15. 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 5% reporting threshold.

The serious adverse event record lists Healthy Lifestyles Sessions with 38 at risk and 0 serious adverse events, and Trauma-focused Exposure Therapy with 82 at risk and 0 serious adverse events. These are the figures recorded for those listed groups. Deaths are not reported in the registry record. Serious adverse event terms are also not reported in the registry record.

The safety figures do not include a listed serious-adverse-event group for Motivational Enhancement + Trauma-focused Exposure Therapy. The registry record does not explain why that group is absent from this adverse-event listing, or how the at-risk counts relate to the outcome arm counts. They should not be assumed to cover every participant or every intervention group.

Zero recorded serious adverse events in the listed groups means no such events are recorded for those group entries; it does not show that no other adverse experiences occurred. The record lists 0 other adverse events for Healthy Lifestyles Sessions and 0 for Trauma-focused Exposure Therapy, with 38 and 82 at risk respectively. The categories and reporting coverage should be interpreted as recorded, not as a complete account of all possible harms or tolerability.

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

The posted IES-R means at 3-months posttreatment are lower for both trauma-focused groups than for Healthy Lifestyles Sessions. The unadjusted recalculation for Trauma-focused Exposure Therapy has a confidence interval that includes zero. The unadjusted recalculation for Motivational Enhancement + Trauma-focused Exposure Therapy has an interval below zero. These contrasts describe the posted symptom scores and their statistical uncertainty; they do not establish a broad conclusion about the interventions.

The registry’s sponsor-reported mixed models analysis across the three groups gives p = .068, without a reported estimate or confidence interval limits. Because the record flags a discrepancy, the sponsor’s own analysis takes precedence over the simple recalculations. The record lacks enough model detail to reconcile the group-level result with the unadjusted comparisons. This means the recalculated pairwise findings should not be presented as though they were the sponsor’s final analysis.

The outcome is a self-reported PTSD symptom scale at a specific posttreatment follow-up. It does not, by itself, measure every aspect of treatment outcome or establish tolerability. Although tolerability is part of the stated study purpose, the available serious adverse event information is incomplete across the listed groups and does not describe all adverse experiences. The registry record does not report a separate tolerability result.

The findings also have limits in scope. They concern participants with alcohol dependence and PTSD in this randomized study and should not be assumed to apply to people outside that population or to other settings. The registry record does not report the original sample-size justification, detailed analysis plan, or amount of missing outcome data. Those omissions limit interpretation of the design’s intended precision, the analysis choices, and the sensitivity of the findings to missing data.

Statistical evidence about group averages is not a guarantee about an individual’s outcome, and a p-value is not a measure of clinical importance. The results should be read as estimates for the recorded endpoint, with the uncertainty and reporting limitations, rather than as a general treatment recommendation.

17. Why This Trial Matters Statistically

This trial illustrates how conclusions can depend on the analysis being described. The registry reports a mixed models analysis across three groups, while the simple recalculations compare each trauma-focused group with healthy lifestyles sessions using posted group means and standard errors. The recalculated comparisons are not equivalent to the sponsor’s reported model. The discrepancy makes it important to distinguish a transparent summary-statistic calculation from the trial’s own analysis.

It also demonstrates why effect estimates and confidence intervals matter alongside p-values. A p-value alone does not convey the size or precision of a group contrast. The unadjusted mean differences and intervals give a directional estimate and a range of compatible values, while the registry’s reported mixed models p-value has no accompanying estimate or interval limits. That difference in reporting constrains what can be assessed from the record.

The endpoint’s direction is essential for interpretation: lower IES-R scores indicate less severe PTSD symptoms. A numerical decrease in the score is not automatically a causal or clinically important effect; it must be interpreted within the randomized comparison, analysis method, uncertainty, and follow-up. The stated study purpose also included tolerability, illustrating that a symptom endpoint cannot answer every question a trial sets out to consider.

Finally, this record shows the value of making analysis plans, missing-data information, and group-specific safety reporting available. The registry contains useful intervention and endpoint descriptions, but the original design assumptions and key analysis details are not reported. Clear reporting of these elements would make it easier to distinguish planned analyses from exploratory calculations and to evaluate how much confidence to place in each result.

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 does not report the original sample-size justification, the intended effect size, or the trial’s design assumptions. The available planning illustrations are recalculated from observed effects and cannot establish what the study was originally powered to detect. The allocation ratio and details of masking are also not reported in the registry record.

The sponsor-reported mixed models analysis is not accompanied by an effect estimate, confidence interval limits, or model specification. The registry flags a discrepancy with the unadjusted recalculations but does not explain it. This limits independent appraisal of the primary analysis and makes it important not to substitute the pairwise recalculations for the sponsor’s result.

The record states that missing data were estimated using maximum likelihood estimation, but does not report the amount of missing outcome data, reasons for missingness, assumptions, or sensitivity analyses. It identifies an intention-to-treat population as all participants who started the study, but does not give additional detail on treatment adherence or discontinuation. The registered outcome is a self-report measure, and only the specified 3-months posttreatment score is described in the primary results.

The adverse-event listing includes only Healthy Lifestyles Sessions and Trauma-focused Exposure Therapy, with no listed serious-adverse-event group for the combined intervention. Deaths are not reported in the registry record, and no serious event terms are listed. The record does not explain the safety reporting coverage, so these entries should not be taken as a complete account across all interventions.

The intervention descriptions are not fully reported in the registry record. The record also does not report details of allocation concealment, the masking procedures, multiplicity handling, or the prespecified statistical analysis plan. These limitations do not negate the posted results, but they narrow the conclusions that can be drawn from them.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder — NCT01409707.
• Registry record last updated 2014-03-10; status last verified 2014-01.
• Results first posted 2014-03-10.
• 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

NCT01409707 is a completed randomized, single-masked, parallel-group study sponsored by the University of Mississippi Medical Center. It enrolled 126 participants with alcohol dependence and posttraumatic stress disorder. The interventions were Healthy Lifestyles Sessions, Trauma-focused Exposure Therapy, and Motivational Enhancement + Trauma-focused Exposure Therapy.

The primary endpoint was the Impact of Event Scale-Revised at 3-months posttreatment, reported as a mean with standard error. Lower scores indicate less severe PTSD symptoms. The registry reports a mixed models analysis across all three groups with p = .068. Unadjusted recalculations give a mean difference of -6.9 for Trauma-focused Exposure Therapy versus Healthy Lifestyles Sessions and -11.89 for Motivational Enhancement + Trauma-focused Exposure Therapy versus Healthy Lifestyles Sessions. The registry flags a discrepancy, so the sponsor’s own analysis takes precedence.

The record states that all participants who started the study were included in analyses and missing data were estimated using maximum likelihood estimation. The original sample-size assumptions, detailed analysis plan, and full model results are not reported in the registry record. Safety entries list serious adverse event counts for two groups only.