Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD) (NCT00288860), a randomized na study. The primary outcome is Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms.

2. Clinical Question

The study’s stated aim was to test whether added telephone support after discharge improves patient outcomes and helps keep patients out of hospital longer. The registry identifies the primary outcome as scores on four measures, with higher scores indicating worse outcomes. It does not report numerical group results or a comparison for any of those measures, so the size and direction of the observed differences cannot be described from this record.

Depressive symptoms and subjective quality of life are listed as secondary outcomes. The registry record does not provide numerical results for those outcomes either. The study is marked completed, but completion status alone does not establish what the outcome findings were or whether the telephone intervention changed them.

3. Trial Design

This was a randomized, parallel-group trial with single masking. The registry does not specify who was masked, so the masking designation cannot establish whether participants, clinicians, outcome assessors, or another group were unaware of assignment. The study is marked completed. The registry lists enrollment as 837 and gives the phase as NA.

Participants were veterans with PTSD after discharge from residential treatment. The intervention was telephone monitoring: biweekly monitoring and support, up to 6 calls over 3 months, as an addition to usual mental health care. The comparison group received Treatment-As-Usual. That care could potentially include case management, pharmacotherapy, and individual and/or group psychotherapy. The registry does not establish which specific components each participant received.

The primary outcomes were assessed at 12 months post-discharge (8 months post intervention). This timing places the listed assessment after the intervention period; it does not, by itself, show whether outcomes changed during treatment or at other follow-up times. The record also lists depressive symptoms and subjective quality of life as secondary outcomes.

The registry lists the study start as 2006-10 and primary completion as 2011-04. It does not report further details about the randomization procedure, allocation concealment, masking procedures, recruitment sites, or the distribution of participants across arms beyond the safety denominators. The record does not give a protocol-based sample-size justification or a detailed statistical analysis plan. Those omissions limit assessment of how the trial was planned and how its outcome analyses were intended to be conducted.

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: 926 patients were initially consented into the study. 6 withdrew prior to randomization, and 83 met exclusion criteria after being consent (usually because they were discharged to another inpatient program, not to outpatient care). This left 837 subjects to be randomized.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Veterans entering residential treatment for posttraumatic stress disorder.

6. Primary Endpoint

The registry lists the primary outcome as Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms, measured over 12 months post-discharge (8 months post intervention).

The primary outcome is presented as scores on measures of aggressive behavior, alcohol problems, drug problems, and PTSD symptoms. The registry gives the assessment time as 12 months post-discharge (8 months post intervention). Each measure is described as a continuous score, with the mean and standard deviation identified as the relevant summary statistics. Higher scores represent worse outcomes on all four measures.

The aggressive behavior measure counts types of violent behavior in the past four months on a scale from 0-6 and is adapted from the conflict tactics scale. Alcohol problems and drug problems use the Addiction Severity Index alcohol and drug composites, each ranging from 0 to 1. PTSD symptoms are assessed with the DSM IV PTSD Checklist, ranging from 17 to 85. These measures cover different aspects of the clinical question; their scores are not interchangeable simply because all are interpreted in the same direction.

Using these measures allows the study to assess behavioral, substance-related, and PTSD symptom outcomes after telephone support ends. However, the registry record does not report group means, standard deviations, confidence intervals, or tests for these primary outcomes. It also does not reduce the several listed measures to a single comparison. The record therefore describes what was measured but does not establish the magnitude or precision of any group differences.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry classifies the primary outcome as continuous and identifies the mean and standard deviation as the summary measures. A mean describes the average score in a group, while a standard deviation describes how spread out individual scores are around that average. For clinical measures, both can be useful: the mean conveys the group’s typical score, and the standard deviation gives context about variation among participants. Neither summary is reported for the primary outcomes in this record.

What would a group comparison describe?

For a continuous measure, a group comparison would ordinarily describe the difference between the groups’ average scores, with an uncertainty estimate. The scale direction matters: because higher scores are identified as worse on all four primary measures, a lower average score would indicate a more favorable score on that measure, while a higher average would indicate a less favorable score. This is a general explanation of score interpretation, not a claim about the trial’s observed results.

A confidence interval is a range of values compatible with the data and the statistical model used to calculate it. It helps communicate precision: a narrower interval indicates a more precise estimate than a wider interval. A confidence interval also helps readers assess which effect sizes remain plausible. The registry record does not report confidence intervals for the primary outcomes, so the precision of any group comparison cannot be assessed from this information.

Why distinguish the four measures?

The primary outcome title combines four measures, but each addresses a different domain and uses its own score range. Aggressive behavior is assessed as types of violent behavior in the past four months on a scale from 0-6. Alcohol and drug problems use separate Addiction Severity Index composites ranging from 0 to 1. PTSD symptoms use the DSM IV PTSD Checklist, ranging from 17 to 85. These scales should be interpreted within their own definitions; raw score units from one measure do not have the same meaning as raw score units from another.

When several outcomes are examined, multiplicity becomes a statistical consideration. If many comparisons are tested, the chance of finding at least one apparently notable result by chance can increase. Researchers may address this through a prespecified primary comparison, adjustment procedures, or a careful emphasis on estimation and uncertainty. The registry record does not report a multiplicity strategy. Because it lists several primary measures and secondary outcomes, the absence of that information matters when judging how a set of results should be interpreted. It does not establish that any particular adjustment was or was not used outside the registry record.

What does the planning information mean?

The sample-size description characterizes its calculations as planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. Such calculations explore how many participants per arm might be needed under those assumptions. They are planning illustrations, not observed power and not evidence that the trial had a particular probability of detecting an effect. The numerical illustration values are not reported in the registry record used for this analysis, and the record does not report the trial’s own sample-size justification.

Equal allocation is an assumption in the described planning approach; it should not be taken as evidence that the enrolled or analyzed groups had equal sizes. Likewise, a normal approximation is a modeling choice for the calculation, not a description of every feature of the observed outcome data. The registry record does not provide the underlying primary outcome summaries needed to evaluate those assumptions against the data.

How should uncertainty and safety summaries be read?

Statistical estimates are most informative when paired with their uncertainty and with clear definitions of the analysis population. For example, an intention-to-treat analysis generally compares participants according to randomized assignment, while a per-protocol analysis focuses on participants meeting specified adherence criteria. These are general concepts. The registry record does not state which analysis population was used for primary outcomes, and it does not report a numerical primary analysis to interpret.

Serious event counts are descriptive safety summaries. They may be useful for understanding what was recorded, but counts alone do not show whether an intervention caused an event or whether groups differ beyond what could occur by chance. A formal comparison would need a specified method and sufficient detail about event definitions, follow-up, and attribution. Such a method is not reported in the registry record.

Over-dispersion is a general issue when observed variability exceeds what a statistical model assumes; if ignored, uncertainty estimates can be too small and inference too confident. That concept is relevant to some types of outcome models, but the registry’s continuous-outcome description does not identify a specific model for the primary scores. It would be inappropriate to claim that over-dispersion was present or addressed in this trial. The record does not report model diagnostics or other details that would permit such an assessment.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists four measures within the primary outcome title: aggressive behavior, alcohol misuse, drug misuse, and PTSD symptoms. It also lists depressive symptoms and subjective quality of life as secondary outcomes. The primary outcome measures span distinct domains and scales, so their results would ordinarily need to be interpreted separately unless a prespecified combined approach were described. The record does not report such a combined measure or a single primary comparison; it notes that the primary outcome has several categories or time points and is not reduced to one comparison.

When investigators assess multiple outcomes, multiplicity can affect how much weight to place on apparently notable findings. A prespecified hierarchy or adjustment method can help define how evidence across outcomes is evaluated. The registry record does not report a multiplicity plan, so it is not possible to determine from this record how the trial intended to handle the set of primary and secondary outcomes.

The record does not report a missing-data strategy, the amount or pattern of missing outcome data, or the analysis population for the primary outcomes. These details matter because an analysis based on observed follow-up scores can differ in meaning from an analysis that accounts for participants with unavailable measurements. The record also does not report whether an intention-to-treat, per-protocol, or other population was used.

The registry lists 0 analyses and gives no numerical primary outcome comparisons. It therefore does not permit evaluation of adjustment methods, model specifications, sensitivity analyses, interim analyses, or the handling of missing values. These items are not reported in the registry record; their absence from this record should not be taken as proof that they were absent from all trial documents.

11. Safety Results

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

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: psychiatric hospitalization (2.4%), death doe to causes not known (1.0%), hospitalization for overdose (0.5%), hospitalization for cardiology or chest pain (0.5%), arrest or incarceration (0.5%).

The registry reports serious adverse events for the two groups. For Telephone Monitoring, 16 participants were affected among 412 at risk. For Treatment-As-Usual, 12 participants were affected among 425 at risk. These are the reported group counts; they should not be converted into a causal conclusion from the registry information alone. The record does not report an adjusted comparison or uncertainty estimate for these figures.

For other adverse events, the record lists 1 affected participant among 412 at risk in Telephone Monitoring, and 0 affected among 0 at risk in Treatment-As-Usual. The different at-risk denominator means the latter entry cannot be read as a direct comparison of other adverse events between groups. The record does not explain the reason for that denominator.

The listed serious event terms include Psychiatric Hospitalization (2.4%), Death doe to causes not known (1.0%), Hospitalization for overdose (0.5%), Hospitalization for cardiology or chest pain (0.5%), Arrest or incarceration (0.5%), and Scheduled laminotomy (0.2%). These are listed terms and percentages; the record does not specify their denominators or whether terms can overlap. Death counts are not reported in the registry record. The event listing should therefore be read as safety reporting, not as proof that the intervention caused or prevented any event.

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

The record establishes that a randomized, parallel-group study compared telephone monitoring added to usual mental health care with Treatment-As-Usual for veterans with PTSD after residential treatment. It identifies an intervention schedule, a follow-up time, four primary score measures, and two secondary outcomes. It also reports selected serious adverse event information. These details help define what the study was designed to examine.

The record does not report numerical results for aggressive behavior, alcohol problems, drug problems, or PTSD symptoms. It therefore cannot show whether the groups’ average scores differed, whether any difference favored one group, or how precisely an effect was estimated. The same limitation applies to the listed secondary outcomes. No claim that telephone monitoring improved, worsened, or had no effect on these outcomes follows from the information in this record.

The stated study purpose includes keeping patients out of hospital longer, but the record does not provide a numerical time-to-hospitalization analysis. A serious event term that includes psychiatric hospitalization does not answer that separate outcome question. Nor do the safety counts alone establish whether events were related to the intervention.

More complete interpretation would require reported outcome estimates and their uncertainty, along with definitions of the analysis population, handling of missing data, and methods for addressing multiple outcomes. Those details are not reported in the registry record. A completed status indicates the study is marked completed; it does not supply the missing results or determine their meaning.

The distinction is between a study question and an answer supported by reported data. The registry describes the question and some features of the design, but the primary statistical comparison is not available in this record. Conclusions should be limited accordingly, without treating absence of numerical results as evidence for either benefit or no effect.

13. Why This Trial Matters Statistically

This trial is statistically notable for the structure of its primary outcome: the registry groups several clinically distinct score measures under one primary outcome title. Aggressive behavior, alcohol problems, drug problems, and PTSD symptoms each represent a different domain and use a different scale. Clear reporting of each estimate and its uncertainty would be important for understanding whether patterns were consistent or differed across outcomes.

The measures also differ in their score ranges, while sharing the interpretation that higher scores are worse. That common direction is helpful for reading each scale, but it does not make their numerical units comparable. A raw score change on the PTSD checklist cannot be directly equated with a change on an Addiction Severity Index composite or the aggressive behavior scale.

The trial’s intervention is an addition to usual care rather than a replacement for it. The comparator could include several forms of mental health care, which makes the treatment contrast one of added telephone monitoring against usual care as delivered. The record does not describe the specific care received by individual participants, so the degree of variation in usual care cannot be assessed from this registry information.

Finally, the record illustrates why design details and results must be read separately. Randomization and a completed status describe important features of the study, but neither supplies the outcome estimates needed to evaluate an effect. With no reported primary numerical comparison, the registry supports a careful account of what was measured and how the groups were assigned, while leaving the central statistical conclusion unresolved.

14. 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 available record gives limited detail about who qualified for the trial, where recruitment took place, and which participants were included in each outcome analysis. It identifies veterans with PTSD after residential treatment as the population of interest, but does not report more specific eligibility criteria or participant characteristics. Applicability beyond that described population cannot be assessed from this record alone.

The telephone intervention is described as biweekly support for up to 6 calls over 3 months. The registry does not report call completion, intervention adherence, or how consistently monitoring was delivered. Treatment-As-Usual could include case management, pharmacotherapy, and individual and/or group psychotherapy, but the record does not say which components participants received. This makes it difficult to characterize the care contrast beyond the assigned intervention and comparator descriptions.

The single-masking designation is not accompanied by an explanation of who was masked or how masking was maintained. The randomization procedure and allocation concealment are also not described in this record. These omissions limit assessment of potential sources of bias, although they do not establish that such protections were absent.

The primary outcomes comprise several distinct measures, and the registry does not report numerical estimates, confidence intervals, missing-data handling, analysis populations, or a multiplicity strategy. The stated primary assessment is at 12 months post-discharge (8 months post intervention), but the record does not provide outcome information at other times. The safety information is similarly limited by missing details about event definitions, attribution, denominator conventions, and whether event categories overlap.

These limitations are specific to the information recorded. Further trial documentation could contain additional methods or results, but those are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD) — NCT00288860.
• Registry record last updated 2016-04-25; status last verified 2016-03.
• Results first posted 2016-04-25.
• 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.

18. Record Summary

The registry identifies NCT00288860 as a completed, randomized, parallel-group trial with single masking. It lists enrollment as 837 and phase as NA. The study examined telephone monitoring added to usual mental health care for veterans with PTSD after discharge from residential treatment, compared with Treatment-As-Usual.

The primary outcome consists of scores for aggressive behavior, alcohol problems, drug problems, and PTSD symptoms at 12 months post-discharge (8 months post intervention). Higher scores are described as worse on all four measures. Depressive symptoms and subjective quality of life are listed as secondary outcomes.

The record includes serious adverse event counts and selected event terms, but lists 0 analyses and does not report numerical primary outcome comparisons. It therefore describes the trial’s design, measures, and some safety reporting without resolving the central outcome question.