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 Improving Treatment Outcomes for Suicidal Veterans With PTSD (NCT04690582), a randomized na study. The primary outcome is Change in Suicide Ideation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04690582 |
| Phase | NA |
| Condition | Suicidal Ideation, Suicide, Attempted, Ptsd |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 157 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ohio State University |
| Results posted | Yes |
2. Clinical Question
Population
Military veterans with PTSD receiving cognitive processing therapy (CPT). The study description distinguishes participants who are acutely suicidal from those who begin CPT without suicide ideation. The registry record does not report further eligibility details in the information available for this analysis.
Intervention
CPT combined with a collaborative crisis response plan (CRP). The description says the plan includes warning signs, self-management strategies, sources of social support, and crisis services.
Comparator
CPT combined with a self-guided safety plan, described in the registry record as treatment as usual. The available arm description says the safety plan is assigned during the first therapy session, but the remainder of that description is incomplete.
Primary question
Does adding a CRP to CPT lead to faster reductions in suicide ideation among acutely suicidal veterans, and prevent the development of suicide ideation among veterans who begin CPT without it? The registered primary outcome is change in suicide ideation over repeated assessments.
The comparison focuses on whether the two combinations of care are associated with different patterns of suicide ideation over time. The question is broader than whether the groups differ at one assessment: the study description emphasizes the pace of change among participants who are acutely suicidal and the development of ideation among those who begin treatment without it. Those are related but distinct clinical questions, and the registry record does not report separate numerical results for either one.
The registry lists a parallel randomized design, but does not report the number assigned to each arm, the criteria used to define acute suicidality, or subgroup definitions. Those details matter when interpreting which participants the results might describe. The registry record also does not report numerical estimates for the primary outcome, so the direction and size of any difference between the care combinations cannot be assessed from the posted results.
3. Trial Design
The registry record describes a randomized, triple-masked, parallel trial sponsored by Ohio State University. It lists enrollment of 157 and a status of completed. The record gives a start date of 2021-01-15 and a primary completion date of 2023-12-31. It lists the phase as NA. These details describe the registered design and status, but do not establish how many participants completed treatment or contributed data at each assessment.
Both groups received CPT for PTSD. One group combined CPT with a collaborative CRP; the other combined CPT with a self-guided safety plan and was labelled treatment as usual. The record describes the CRP as including warning signs, self-management strategies, sources of social support, and crisis services. It describes the comparison as CPT plus a safety plan. The full arm descriptions are not reported in the registry record available for this analysis, so additional differences in delivery, treatment exposure, or clinician contact cannot be characterized.
The primary outcome was assessed at baseline (pretreatment), 1 week, 2 weeks, 26 weeks, and 52 weeks. This repeated schedule is relevant to the stated aim of evaluating faster reductions as well as later patterns, but the record does not report the numerical outcome results at these time points. It also does not report arm-specific sample sizes, adherence, withdrawals, or the number assessed at each visit.
The registry lists four outcome measures and identifies change in PTSD symptoms as a secondary outcome. It records no analysis entries. Therefore, the statistical model, analysis population, adjustment variables, treatment of repeated observations, and planned contrasts are not reported in the registry record. Randomization helps define the intended comparison, but without a reported analysis and outcome estimates it is not possible to assess the observed between-group pattern or the precision of that pattern.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Safety Plan | Crisis Response Plan |
|---|---|---|
| STARTED | 81 | 76 |
| COMPLETED | 75 | 72 |
| NOT COMPLETED | 6 | 4 |
Reasons for not completing this period:
| Reason | Safety Plan | Crisis Response Plan |
|---|---|---|
| Withdrawal by Subject | 6 | 4 |
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 | Safety Plan | Crisis Response Plan | Total |
|---|---|---|---|---|
| Participants analysed | 81 | 76 | 157 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 76 | 66 | 142 |
| Age, Categorical: >=65 years | Participants | 5 | 10 | 15 |
| Age, Continuous | years | 45.9 (SD 13.0) | 48.3 (SD 12.1) | 47.0 (SD 12.6) |
| Sex: Female, Male: Female | Participants | 30 | 12 | 42 |
| Sex: Female, Male: Male | Participants | 51 | 64 | 115 |
| Race/Ethnicity, Customized: White | Participants | 63 | 58 | 121 |
| Race/Ethnicity, Customized: Black | Participants | 9 | 7 | 16 |
| Race/Ethnicity, Customized: Native American | Participants | 3 | 2 | 5 |
| Race/Ethnicity, Customized: Asian | Participants | 2 | 2 | 4 |
| Race/Ethnicity, Customized: Other | Participants | 4 | 7 | 11 |
| Race/Ethnicity, Customized: Latino/Hispanic | Participants | 3 | 10 | 13 |
| Region of Enrollment: United States | participants | 81 | 76 | 157 |
| Scale for Suicide Ideation | units on a scale | 5.91 (SD 7.79) | 6.86 (SD 7.56) | 6.37 (SD 7.67) |
| Number of Participants with Pre-Baseline Suicide Attempts | Participants | 62 | 63 | 125 |
| National Stressful Events Survey PTSD Short Scale | units on a scale | 27.01 (SD 7.09) | 25.93 (SD 7.38) | 26.49 (SD 7.23) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Suicide Ideation, measured over Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in suicide ideation, measured with the Scale for Suicide Ideation. The registry describes this as an empirically supported self-report scale assessing the intensity of suicide-related thoughts, urges, intentions, and behaviors. Scores range from 0 to 38, with higher scores indicating more severe suicide ideation. The registered measure is a continuous outcome summarized by its mean and standard deviation.
Assessments were scheduled at baseline (pretreatment), 1 week, 2 weeks, 26 weeks, and 52 weeks. Repeated assessment is suited to the study’s stated interest in the speed and persistence of change, rather than only a single endpoint. In general, comparing scores over time can describe whether groups follow different trajectories; a clear interpretation still depends on the analysis specifying how those repeated measurements are combined and compared.
The record does not report the observed means, standard deviations, changes, or between-group estimates at these time points. It also does not report a single primary contrast. The registry notes that the primary outcome has several time points and was not reduced to one comparison. Consequently, the endpoint definition and measurement schedule are available, but the magnitude and precision of the observed outcome are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies change in suicide ideation as the primary outcome and gives its measure, scale range, and assessment schedule. It does not report a numerical primary-outcome comparison. In particular, there are no posted group means, mean changes, standard deviations, confidence intervals, or p-values for the scheduled assessments in the information available for this analysis. The record also notes that the outcome has several time points and was not reduced to one comparison. As a result, there is no single reported estimate from which to describe the direction, magnitude, or precision of a group difference.
The stated aim distinguishes two patterns: faster reductions among acutely suicidal veterans and prevention of new ideation among those who begin CPT without suicide ideation. These aims would require outcome information that can be interpreted for the relevant baseline groups and over time. A pooled average change alone might not answer both questions, while separate subgroup estimates would require clear definitions and adequate data. The registry record does not report subgroup results or their analysis details, so neither aim can be evaluated numerically from the posted results.
The assessment schedule spans baseline (pretreatment), 1 week, 2 weeks, 26 weeks, and 52 weeks. Early assessments align with the question about speed of change, while later assessments allow the course of ideation to be examined at follow-up. However, an assessment schedule is not itself evidence of a change, and later observations can be affected by missing follow-up. The number of participants assessed at each time point and the handling of missing observations are not reported in the registry record.
The registry lists enrollment of 157, but does not give arm-specific enrollment or analysis counts. The overall enrollment figure therefore cannot show how many participants contributed to each outcome assessment or whether the randomized groups remained balanced in the analyzed data. The record lists four outcome measures and a secondary outcome of change in PTSD symptoms, but records no analysis entries. This leaves the planned or performed statistical procedures, including any adjustment for baseline scores or repeated measurements, unreported.
The posted safety counts record zero serious adverse events affecting participants and zero other adverse events affecting participants in each group, with zero deaths in each group. These are descriptive counts in the registry record; without fuller event definitions, follow-up details, and context, they should not be treated as a complete account of all possible harms or as proof that no event occurred outside the reported categories.
Overall, the registry record describes the trial question, design, outcome measure, follow-up schedule, and selected safety counts. It does not report numerical primary-outcome results or an inferential analysis. Statistical conclusions about whether the groups differed, how large any difference was, or how uncertain an estimate might be are therefore not available from the posted results.
9. Statistical Methods Explained
What does the registered endpoint measure?
The Scale for Suicide Ideation is described as a self-report measure of the intensity of suicide-related thoughts, urges, intentions, and behaviors. The registered score range is 0 to 38; higher scores indicate more severe suicide ideation. The primary outcome is continuous and is specified as a mean with standard deviation. A mean describes the group’s average score, while a standard deviation describes the spread of scores around that mean. Neither statistic is reported for the scheduled assessments in the registry record available for this analysis.
Because scores were scheduled repeatedly, a statistical analysis could describe change across assessments and compare the groups’ trajectories. In general, a repeated-measures analysis needs to account for the fact that observations from the same participant are related rather than independent. Different models can make different assumptions about that relationship and about participants with incomplete follow-up. The registry record does not report which model, covariance structure, or missing-data approach was used, so none can be attributed to this trial.
How would a group comparison be interpreted?
In general, a between-group estimate describes the contrast in outcome between the randomized strategies, either at a specified assessment or across a specified time pattern. The estimate’s meaning depends on the chosen contrast: a difference at one follow-up does not answer exactly the same question as a difference in change from baseline or a difference in trajectories over all assessments. The registry record does not report a chosen contrast or an estimate. It would therefore be inappropriate to infer a treatment difference from the trial’s stated aim or its completion status.
A confidence interval, in general, expresses the statistical uncertainty around an estimated effect under the analysis assumptions. A narrower interval indicates greater precision than a wider interval, but does not by itself establish clinical importance. A p-value, in general, describes how compatible the observed data are with a specified null model; it does not measure the size or importance of an effect. No confidence interval or p-value for the primary outcome is reported in the registry record, so the precision and statistical evidence for a group difference cannot be assessed.
Why does the schedule matter?
The registered assessments—baseline (pretreatment), 1 week, 2 weeks, 26 weeks, and 52 weeks—reflect the question about both early change and later course. A pattern in early measurements could differ from a pattern at later follow-up. Repeated assessment also creates several possible comparisons and raises the question of which time points or summary measures should carry the primary interpretation. The registry record does not report how this was handled, nor does it report an analysis that combines the time points.
For participants who begin without suicide ideation, the study description asks whether ideation develops during or soon after CPT. That question concerns the occurrence of new ideation, whereas the registered primary outcome is described as change in a continuous scale score. In general, a study can use different outcome definitions or analyses to address these questions, but their methods and results must be reported to distinguish them. The registry record does not report a separate numerical analysis for development of ideation.
What can be said about planning estimates?
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that the effect to detect is a specified fraction of the observed effect. Such planning estimates are hypothetical participant requirements under assumptions; they are not observed trial results and are not observed power. The registry record does not report a numerical planning estimate in the information available for this analysis. No planning value should be interpreted as the actual number randomized or analyzed.
General sample-size calculations depend on assumptions about the target effect, variability, allocation, significance threshold, and analysis. If those assumptions differ from the trial’s actual design or data, the resulting planning illustration may not describe the study’s achieved precision. The record does not report the trial’s original sample-size justification, so the rationale for the enrollment target of 157 is not reported in the registry record.
Why is over-dispersion relevant in general?
Over-dispersion is a general concern when outcome variability exceeds what a statistical model assumes. If a model underestimates variability, its uncertainty estimates can be too small and statistical evidence can appear stronger than warranted. This is a general methodological consideration, not a claim that over-dispersion occurred in this trial. The primary endpoint is a continuous scale score, and the registry record does not report a model or diagnostic assessment from which over-dispersion or another variance issue could be evaluated.
In sum, the registry record establishes the endpoint, its scale, its schedule, and the randomized comparison. It does not report the statistical model, its assumptions, a primary contrast, or numerical results. General statistical concepts can explain what such an analysis would need to address, but cannot substitute for the unreported analysis details or outcome estimates.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study assesses multiple outcomes, time points, subgroups, or contrasts. In general, making many statistical comparisons can increase the chance of at least one apparently notable result even when no true difference exists. This trial’s primary measure was scheduled at baseline (pretreatment), 1 week, 2 weeks, 26 weeks, and 52 weeks, and the registry lists four outcome measures. Change in PTSD symptoms is listed as a secondary outcome. The registry record does not report a multiplicity strategy, such as a hierarchy of tests or an adjustment across comparisons.
The registry record notes that the primary outcome has several time points and was not reduced to one comparison. It also records no analysis entries. Thus, the primary contrast and any rules for interpreting multiple assessments are not reported in the registry record. Without those details, it is not possible to determine which comparison was intended to carry the main statistical conclusion or how other tests should be interpreted.
Missing-data handling is also not reported. The number assessed at each time point, reasons for missed visits, withdrawals, and any imputation or model-based treatment of missing scores are not reported in the registry record. In general, incomplete follow-up can affect an estimate if participants with missing scores differ from those observed, especially when missingness relates to the outcome. This is a general concern, not evidence that missingness biased this trial.
The analysis population is not reported in the registry record. It is therefore unclear whether the analysis included all randomized participants, participants who began treatment, or another defined group. Randomization describes assignment, but the population used for an outcome analysis must be stated to understand the comparison. No specific analysis population or missing-data assumption can be inferred from the completed status or overall enrollment.
11. 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 |
|---|---|---|---|
| Safety Plan | 0 | 81 | 0.0% |
| Crisis Response Plan | 0 | 76 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Safety Plan | 0 of 81 |
| Crisis Response Plan | 0 of 76 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Safety Plan | 0 of 81 |
| Crisis Response Plan | 0 of 76 |
The registry reports safety counts for two groups. For the Safety Plan group, 81 participants are listed as at risk; serious adverse events affected 0, other adverse events affected 0, and deaths numbered 0. For the Crisis Response Plan group, 76 participants are listed as at risk; serious adverse events affected 0, other adverse events affected 0, and deaths numbered 0. No serious adverse-event terms are listed.
These are the counts recorded in the registry, not a detailed event-level account. The record does not provide further event definitions, timing, severity breakdowns, follow-up duration for safety, or descriptions of how events were collected. The at-risk counts should not be mistaken for the number enrolled in each arm or for the number contributing to the primary outcome; arm-specific enrollment and analysis counts are not reported in the registry record.
Zero affected participants in the reported categories means that the registry lists no affected participants for those categories. It does not establish that every possible adverse experience was assessed or that no unreported event occurred. These counts are descriptive and do not by themselves establish a causal safety comparison between the randomized strategies.
12. What the Result Does, and Does Not, Mean
The record supports a description of the intended comparison: CPT combined with a collaborative CRP versus CPT combined with a self-guided safety plan. It also identifies a randomized, triple-masked, parallel design, overall enrollment of 157, a continuous primary measure of suicide ideation, and assessments from baseline through 52 weeks. The status is completed. Those details describe the design and registered outcome, but they do not reveal the observed effect.
The posted results do not give a numerical primary-outcome estimate, group summaries, confidence interval, or p-value. Therefore, they do not establish whether suicide ideation changed differently between groups, whether change was faster in either group, or how precisely a difference was estimated. The study’s stated aims are questions to be tested, not findings. Completion of a trial is not evidence that either strategy produced a particular outcome.
The registry record also does not report separate results for participants who were acutely suicidal or for those who began CPT without suicide ideation. It is not possible to determine whether the two aims were analyzed separately, how those groups were defined, or what their observed patterns were. The listed secondary outcome of change in PTSD symptoms likewise has no numerical result in the record available for this analysis.
The safety counts report zero serious adverse events affecting participants, zero other adverse events affecting participants, and zero deaths in both groups. These counts are limited to the recorded categories and do not replace a complete account of event ascertainment or follow-up. They should not be interpreted as proof of no risk or as evidence that one strategy is safer.
More broadly, registry information can document trial design and registered outcomes, while a statistical conclusion requires reported analyses and estimates. Important details—including analysis populations, missing-data methods, outcome contrasts, and precision—are not reported in the registry record. The appropriate interpretation is therefore limited to what was registered and counted; no conclusion about comparative benefit, lack of benefit, or causal effect can be drawn from the information available.
13. Why This Trial Matters Statistically
The statistical question is not only whether suicide ideation changes, but whether its pattern over time differs between two treatment combinations. The registered assessments include early and later follow-up, matching the stated interest in faster reductions as well as subsequent course. Repeated measurements can make the estimand—the precise quantity being compared—important: a single-time-point difference, average change, and trajectory contrast answer different questions.
The trial also describes two participant situations: veterans who are acutely suicidal and veterans who begin CPT without suicide ideation. The first aim concerns reducing existing ideation; the second concerns preventing new ideation. These aims may call for distinct summaries, and a single overall average could obscure different patterns. The registry record does not report subgroup estimates or analyses that clarify how these questions were handled.
Random allocation is an important design feature because it is intended to support a fair comparison between the assigned strategies. But randomization alone does not provide an effect estimate. Interpretation also depends on the analysis population, follow-up completeness, the statistical model, and the uncertainty around estimates. Those details and the primary outcome results are not reported in the registry record.
The trial is therefore statistically relevant as a registered design addressing a time-dependent outcome and more than one clinical aim, while its available record leaves the comparative evidence unquantified. Enrollment and completion describe trial conduct at a broad level; they do not substitute for group-specific results. Readers need the estimates and their precision, as well as clear definitions of the contrasts, to judge what the data indicate.
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.
A central limitation for interpretation is that the registry record does not report numerical results for the primary outcome. Means, standard deviations, changes, between-group estimates, confidence intervals, and p-values are not reported in the registry record. The outcome has multiple scheduled time points and is not reduced to a single comparison, so the direction and size of any effect cannot be inferred.
Further limits arise from unreported analysis details. The record does not report arm-specific enrollment, analysis populations, the number observed at each visit, missing-data handling, model specification, or covariate adjustment. It also does not report the trial’s sample-size justification, interim analyses, or statistical plan. These omissions prevent assessment of whether the analysis matched the design, how incomplete follow-up was handled, and what precision was intended.
The study description includes distinct aims for participants who are acutely suicidal and those who begin CPT without suicide ideation, but subgroup definitions and separate outcome results are not reported in the registry record. The record also does not report a distinct numerical result for the secondary outcome of change in PTSD symptoms. Consequently, neither the subgroup-specific questions nor the secondary outcome can be evaluated from the posted results.
The available safety information is limited to counts of affected participants and deaths, without fuller event descriptions or ascertainment details. The overall enrollment of 157 does not indicate the number who completed treatment or were measured at each assessment. Finally, the record’s completed status does not by itself indicate the quality, completeness, or direction of the outcome evidence. These limitations are specific to what is reported and do not establish that the unreported analyses were not performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Improving Treatment Outcomes for Suicidal Veterans With PTSD — NCT04690582.
- Registry record last updated 2024-12-20; status last verified 2024-11.
- Results first posted 2024-12-20.
- 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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18. Record Summary
NCT04690582, titled “Improving Treatment Outcomes for Suicidal Veterans With PTSD,” is listed as a completed randomized, triple-masked, parallel trial sponsored by Ohio State University. The registry gives enrollment of 157, a start date of 2021-01-15, and a primary completion date of 2023-12-31. The comparison is CPT plus a collaborative CRP versus CPT plus a self-guided safety plan.
The primary outcome is change in suicide ideation measured with the Scale for Suicide Ideation at baseline (pretreatment), 1 week, 2 weeks, 26 weeks, and 52 weeks. Change in PTSD symptoms is listed as a secondary outcome. Numerical primary-outcome results and analysis details are not reported in the registry record. Safety counts list zero serious adverse events affecting participants, zero other adverse events affecting participants, and zero deaths in both groups.