Mantram Repetition to Manage PTSD in Veterans: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mantram Repetition to Manage PTSD in Veterans (NCT00120627), a randomized na study. The primary outcome is Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR.

2. Clinical Question

The record describes a randomized, parallel-group study sponsored by the US Department of Veterans Affairs. It lists enrollment of 146, but does not report how participants were distributed between arms or the analysis-specific sample sizes. The registered primary measure is a mean CAPS score with standard deviation, and the stated timeframe is pre-treatment and post-treatment.

The registry lists additional outcomes covering mental health-related quality of life, spiritual well-being, mindfulness, quality of life enjoyment and satisfaction, and symptoms of depression, anxiety, and somatization. The clinical question is therefore broader than a single symptom score, but the primary endpoint specified in the record is CAPS. Whether MRP changed that endpoint, by how much, and with what precision cannot be determined from the outcome information in this record.

3. Trial Design

The registry identifies this as a randomized, single-masked, parallel-group study. It lists phase as NA and enrollment as 146. The identity of the people who were masked, the allocation ratio, the method used to generate the random sequence, and the method used to conceal assignments are not reported in the registry record. The record also does not describe the setting or detailed eligibility criteria.

Participants assigned to the intervention arm were offered the Mantram Repetition Program as an addition to usual care. The program was described as a 6-week intervention with 90-minute weekly sessions. Usual care consisted of medication and case management. The comparator arm received usual care for 6 weeks, with medication and case management as needed and no group meetings. The record does not report adherence, attendance, treatment fidelity, or use of other services during the study.

The study was listed as starting in 2005-11, with primary completion in 2009-02, and its status is completed. The sponsor was the US Department of Veterans Affairs. These registry entries describe the study’s design and conduct, but do not establish what happened to participants’ outcomes.

The primary endpoint was CAPS, recorded as a mean with standard deviation and measured pre-treatment and post-treatment. The record describes an intent-to-treat analysis using an Expectation-Maximization algorithm in SPSS to handle missing data. It does not report the statistical test or model used for the primary comparison, a prespecified contrast between time points, an analysis hierarchy, or whether any analyses were adjusted for baseline values or other covariates. Those details are not reported in the registry record and should not be inferred from the design label alone.

The record lists 10 outcome measures and 14 analyses. It does not provide enough detail to determine how outcomes and analyses were grouped, whether all analyses were prespecified, or how the multiplicity of analyses was handled. The registered timeframe includes pre-treatment and post-treatment observations, but a single primary comparison has not been reduced from the available categories or time points in the posted results.

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: There were 4 subjects who dropped after random assignment and before entering the interventions. Two had scheduling conflicts and could not attend the groups at the time they were offered. One was too ill. The other did not have a reason.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS for missing data; this is a maximum-likelihood method based on group assignment, demographic variables and clinical variables.

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 Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR, measured over Pre-treatment and post-treatment.

The primary endpoint is the Clinician Administered PTSD Scale (CAPS), a clinician-administered measure of PTSD symptom severity and the presence or absence of a PTSD diagnosis. The registry describes a total score formed by summing frequency and intensity ratings for 17 items. Each item uses a 5-point scale: frequency ranges from 0, “never,” to 4, “daily or almost everyday,” and intensity ranges from 0, “none,” to 4, “extreme.” The total score ranges from 0-136, with higher scores indicating greater symptom severity. The record states that total scores >45 indicate the presence of a PTSD diagnosis.

CAPS also includes Criterion B for re-experiencing, Criterion C for avoidance, and Criterion D for hyper-arousal. Their score ranges are 0 to 40, 0 to 56, and 0 - 40, respectively; higher scores indicate worse symptoms. The registry names the total CAPS measure as the primary outcome, but does not report results for the total score or its subscales.

Using a continuous symptom score can describe severity across a range, rather than only whether a diagnostic threshold is met. The registered summary is a mean with standard deviation, and the stated timeframe is pre-treatment and post-treatment. The record does not report the observed means, the variation around them, or a single numerical contrast between arms. Consequently, the endpoint definition is available, but its comparative result and precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study is described as randomized and parallel-group. In general, random allocation is used to make treatment assignment independent of participants’ measured and unmeasured characteristics at the point of assignment, on average. This can support a fair comparison between arms, although randomization does not guarantee that groups will be identical. The registry does not report the allocation sequence method, concealment procedures, or allocation ratio, so those features cannot be assessed from this record.

What does a parallel-group design mean?

In a parallel-group design, participants are assigned to an intervention strategy or a comparison strategy and followed within that assignment. Here the strategies were MRP plus usual care and usual care alone. The intervention was described as a 6-week program with 90-minute weekly sessions, while the comparison was medication and case management as needed, without group meetings. A parallel design compares outcomes across assigned arms; it is not the same as having each participant receive both strategies. The registry labels the study single-masked, but does not say who was masked or how masking was maintained.

What do the CAPS mean and standard deviation describe?

The registered primary measure is a continuous score summarized by its mean and standard deviation. In general, a mean is an average across observations, while a standard deviation describes how dispersed individual scores are around that average. A standard deviation is not the uncertainty in the estimated mean or the uncertainty in a treatment contrast. Those questions are typically addressed through an inferential estimate and its confidence interval. No CAPS means, standard deviations, treatment contrast, or confidence interval are reported in the registry record.

CAPS assesses symptom frequency and intensity, with higher total scores indicating greater symptom severity. The record describes a total score range of 0-136 and notes that total scores >45 indicate the presence of a PTSD diagnosis. A continuous score and a diagnostic classification are different summaries: the score represents severity along a scale, while classification uses a threshold. The registry provides the scale description, but does not report either comparative mean scores or diagnostic classifications by arm.

How is missing outcome information addressed?

The primary outcome population is described as an intent-to-treat analysis using an Expectation-Maximization (EM) algorithm in SPSS for missing data. The stated method is maximum likelihood based on group assignment, demographic variables, and clinical variables. In general, maximum-likelihood methods use the observed data and a specified model to estimate parameters while accounting for incomplete observations. EM is an iterative procedure used in some settings to find those estimates when data are missing.

Such methods rely on assumptions about the data and the model. They do not make missing observations equivalent to directly observed outcomes, nor do they remove the need to understand how much data are missing and why. The record does not report the amount or pattern of missing CAPS data, the variables included beyond the broad categories named, the details of the model, or sensitivity analyses assessing different missing-data assumptions. The use of an EM algorithm is documented; the robustness of the resulting estimates cannot be evaluated from the registry record.

What can be inferred from the planning assumptions?

The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustration is expressed as participants per arm; time-to-event illustrations would instead concern total events. These are planning assumptions, not evidence about the trial’s actual design rationale or observed results.

In general, a sample-size illustration estimates the amount of information that might be needed under its assumptions to detect a chosen effect at a specified error threshold. It is conditional on the effect size and statistical model used. It is not observed power, does not establish that the original study was adequately powered, and cannot replace a confidence interval for the observed effect. The registry does not report the trial’s own sample-size justification or enough outcome estimates in this record to evaluate any illustration numerically.

The registry does not report the primary inferential test, the model used to compare groups, an adjustment strategy for baseline CAPS, or a plan for interpreting repeated measurements. No statistical procedure beyond the stated missing-data method should be attributed to the trial on the basis of the available record. General statistical explanations describe how such methods work; they are not claims about unreported analyses in this study.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures and 14 analyses. It names the primary CAPS outcome and several secondary measures, including mental health-related quality of life, spiritual well-being, mindfulness, quality of life enjoyment and satisfaction, and symptoms of depression, anxiety, and somatization. Multiple outcomes and analyses can create multiple opportunities to observe apparently noteworthy results. In general, multiplicity procedures can control the chance of false-positive conclusions across a defined family of tests, but they may also affect the precision or interpretation of individual comparisons.

The registry record does not report whether the analyses were grouped into families, whether a multiplicity adjustment was used, or how results were prioritized across outcomes and time points. The total number of listed analyses alone does not reveal how many were confirmatory or whether the analyses were planned before examining the data. Those details are not reported in the registry record. The primary outcome is described at pre-treatment and post-treatment, while the posted results have not been reduced to a single comparison across the listed categories or time points.

For missing outcome data, the record specifies an intent-to-treat analysis using an Expectation-Maximization algorithm in SPSS. It characterizes the method as maximum likelihood based on group assignment, demographic variables, and clinical variables. This describes an approach to missingness, but the record does not give the amount of missing data, reasons for missingness, or results of sensitivity analyses. Consequently, readers cannot assess from this record whether missingness differed between arms or how alternative assumptions might affect the estimates.

The registry identifies an intent-to-treat population, but does not report the number included in each outcome analysis or whether additional analysis populations were used. It also does not describe how participants with incomplete follow-up were handled beyond the EM method. These omissions limit assessment of the analysis population, missing-data assumptions, and the implications of examining multiple outcomes.

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

The record establishes that this study compared MRP plus usual care with usual care alone in a randomized, parallel-group design and identified CAPS as its primary outcome. It also defines the score, its direction, its diagnostic threshold, and the intended approach to missing data. These details clarify what the trial set out to measure and how the primary endpoint was described.

They do not establish the observed effect. The record does not report group-level CAPS results, a between-arm estimate, or an interval describing the precision of that estimate. Without those results, the size and direction of any difference cannot be assessed. It is also not possible to determine whether the result was compatible with little difference, a potentially important difference, or a range of possibilities, because no comparative estimate or uncertainty measure is reported.

In general, a statistically significant result would not by itself establish that a difference is large or important, and a non-significant result would not establish that the groups are equivalent. Those interpretations require the estimate, its uncertainty, the analysis context, and a reasoned definition of importance. No such conclusion can be drawn from the endpoint description alone. The record does not report a clinically meaningful difference threshold.

The CAPS diagnostic threshold is part of the measure’s description, not a reported finding. The record does not state how many participants in either arm had scores above that threshold or how diagnostic status changed over time. Likewise, the listed secondary outcomes do not show whether quality of life, spiritual well-being, mindfulness, or other symptoms differed between groups; their comparative results are not reported in the registry record.

The missing-data method and planning assumptions also have limited interpretive scope. The EM method describes an approach to incomplete observations but does not show how much data were missing or whether conclusions were sensitive to assumptions. Planning illustrations based on an observed effect are not trial results and are not observed power. Overall, the available record supports a careful account of design and measurement, but not a claim about whether MRP changed PTSD symptoms or about the magnitude or certainty of any effect.

12. Why This Trial Matters Statistically

This trial illustrates why a detailed endpoint description and a reported treatment estimate serve different purposes. The registry explains what CAPS measures, the direction of its score, and how the score is summarized. Those details help define the question, but they cannot substitute for arm-specific results and a comparative estimate. Without those estimates, readers cannot judge the direction, magnitude, or precision of the primary finding.

It also highlights the importance of specifying what comparison a repeated-measures outcome is intended to support. The record names pre-treatment and post-treatment measurement, but does not report a single primary contrast or the model used to compare arms. In general, choosing a contrast in advance helps readers distinguish the main research question from other possible analyses of the same observations. That distinction is especially relevant when a record lists multiple outcomes and analyses.

The missing-data description is another useful statistical feature to examine. The registry identifies an EM maximum-likelihood approach based on assignment, demographic variables, and clinical variables. Naming a method makes the intended approach clearer, while information on missingness and sensitivity analyses is needed to assess how dependent the estimates may be on assumptions. Those additional details are not reported in the registry record.

Finally, the listed outcomes and analyses make multiplicity relevant to interpretation, even though the record does not say whether adjustment was performed. The study is therefore a useful example of the difference between a registered design, a statistical method description, and the evidence needed to interpret results. Clear reporting of the comparison, estimate, uncertainty, missing-data profile, and multiplicity plan would allow a more complete statistical assessment.

13. 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 main limitation for interpreting this trial from the registry record is that comparative outcome results are not reported. The CAPS means, standard deviations, treatment estimate, and uncertainty are unavailable, preventing assessment of the primary result’s direction, size, or precision. The posted information therefore does not support a conclusion about the observed effect on PTSD symptom severity.

The registry describes pre-treatment and post-treatment measurement but does not specify a single primary contrast or the statistical model used for the comparison. It is not reported whether analyses adjusted for baseline CAPS, whether the main comparison used post-treatment values or change over time, or how repeated observations were handled. The record also does not identify who was masked, and provides no information on allocation concealment, adherence, attendance, or treatment fidelity.

Participant eligibility criteria and baseline characteristics are not reported in the registry record, limiting assessment of how the enrolled participants relate to the broader population of veterans with PTSD. The record lists enrollment but not arm-specific enrollment or outcome-analysis counts. It also does not report missingness by arm, reasons for missing observations, or sensitivity analyses for the EM approach.

The record lists multiple outcome measures and analyses, but does not report a hierarchy beyond naming CAPS as primary or explain whether multiplicity was addressed. It does not provide results for secondary outcomes or a threshold for a clinically meaningful CAPS difference. These are limitations of what can be assessed from the registry information; they do not establish that the study itself lacked additional analyses or documentation outside the registry record.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Mantram Repetition to Manage PTSD in Veterans — NCT00120627.
• Registry record last updated 2015-04-28; status last verified 2014-08.
• Results first posted 2014-11-27.
• 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.

17. Record Summary

NCT00120627, titled “Mantram Repetition to Manage PTSD in Veterans,” is a completed, randomized, single-masked, parallel-group study sponsored by the US Department of Veterans Affairs. Enrollment is listed as 146, and phase is listed as NA. The study started in 2005-11 and had primary completion in 2009-02.

The intervention was the Mantram Repetition Program plus usual care, described as a 6-week program with 90-minute weekly sessions. The comparator was usual care consisting of medication and case management as needed, without group meetings. The primary measure was the mean Clinician Administered PTSD Scale score, with standard deviation, at pre-treatment and post-treatment. The registry describes an intent-to-treat analysis with an EM maximum-likelihood method for missing data.

The record lists 10 outcome measures and 14 analyses, but does not report comparative outcome estimates or their precision. It therefore describes the trial design and endpoint without providing the results needed to assess the effect of MRP on CAPS.