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 Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder (NCT04293341), a randomized na study. The primary outcome is PTSD Checklist for DSM-5 (PCL-5).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04293341 |
| Phase | NA |
| Condition | Major Depressive Disorder, Posttraumatic Stress Disorder, Panic Disorder and Agoraphobia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 304 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Veterans with major depressive disorder, posttraumatic stress disorder, or panic disorder and agoraphobia. The registry record reports an enrollment of 304 and notes that numbers varied across assessment times because of missing data and participant discontinuation of psychotherapy.
Intervention
Transdiagnostic Behavior Therapy (TBT), a behavioral therapy described as addressing transdiagnostic avoidance through exposure techniques. The record lists situational or in-vivo, physical or interoceptive, thought or imaginal, and positive emotional or behavioral activation approaches.
Comparator
Disorder-specific therapies (DSTs): Cognitive Processing Therapy for PTSD, Cognitive Behavioral Therapy for MDD, or Cognitive Behavioral Therapy for panic disorder. The record describes matching a DST to the participant’s most severe diagnosis.
Primary question
How do PTSD symptom scores on the PTSD Checklist for DSM-5 change from baseline through week 6, week 12, and 6-month follow-up in the randomized treatment groups? The registry record does not report the outcome results or a statistical comparison of the groups.
The trial’s stated aim is to evaluate TBT against existing disorder-specific therapies in Veterans with depressive and anxiety disorders, including PTSD. The primary outcome focuses on PTSD symptoms, while the broader study description also identifies psychiatric symptomatology, related impairment, and process variables as areas of interest. The clinical question is therefore about the pattern of symptom scores over time, not simply a single endpoint at one visit.
The comparison is between a therapy intended to address avoidance across diagnoses and therapies selected for a participant’s most severe diagnosis. Because the registry record does not report outcome estimates or analyses, it cannot establish from the posted results whether the groups differed, how large any difference was, or how precisely such a difference was estimated.
3. Trial Design
This is a randomized, parallel-group trial with single masking, listed as completed in the registry record. The record gives an enrollment of 304. It identifies the sponsor as the VA Office of Research and Development and lists the trial start as 2020-10-01 and primary completion as 2025-01-01. The phase is listed as NA.
The two treatment groups are TBT and DST. The DST category includes Cognitive Processing Therapy for PTSD, Cognitive Behavioral Therapy for MDD, and Cognitive Behavioral Therapy for panic disorder. The registry description says the disorder-specific therapy is matched to the participant’s most severe diagnosis, based on average ADIS interference and distress scores. If those scores are equivalent for two or more diagnoses, the description says participants will be asked to list their most distressing disorder. The registry record does not report further details about the allocation procedure or the masking procedures.
Assessments are described as occurring before treatment, midway through treatment, after treatment, and at 6-month follow-up. For the primary outcome, the specified timeframe is change from baseline to week 6, week 12, and 6-month follow-up. The record notes that numbers differed across time points because of missing data and participant discontinuation of psychotherapy.
The registry lists three outcome measures, but no statistical analyses are listed. It does not report the number randomized to each group as an analysis population, the numbers completing each assessment, or whether participants were analyzed according to their original assignment. Those details are needed to understand how the randomized design was carried through to the analysis.
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 | Transdiagnostic Behavior Therapy | Disorder Specific Therapies |
|---|---|---|
| STARTED | 153 | 151 |
| COMPLETED | 90 | 87 |
| NOT COMPLETED | 63 | 64 |
Analysis population for the primary outcome, as defined in the registry: Numbers varied across time points due to missing data and participant discontinuation of psychotherapy
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 | Transdiagnostic Behavior Therapy | Disorder Specific Therapies | Total |
|---|---|---|---|---|
| Participants analysed | 153 | 151 | 304 | |
| Age, Continuous | years | 46.03 (SD 14.34) | 42.57 (SD 12.72) | 44.31 (SD 13.65) |
| Sex: Female, Male: Female | Participants | 46 | 108 | 154 |
| Sex: Female, Male: Male | Participants | 107 | 43 | 150 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 53 | 62 | 115 |
| Race (NIH/OMB): White | Participants | 89 | 82 | 171 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 7 | 5 | 12 |
6. Primary Endpoint
The registry lists the primary outcome as PTSD Checklist for DSM-5 (PCL-5), measured over change from baseline to week 6 to week 12 to 6-month followup.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome is the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure assessing PTSD symptoms defined by DSM-5 criteria. Each item is scored from 0, not at all, to 4, extremely. The total score ranges from 0 to 80, with higher scores indicating more severe symptomatology.
The registry record describes the PCL-5 as a way to assess PTSD symptoms and notes that the measure has been incorporated into standard PTSD assessment at the VA. It also states that previous versions of the PCL have shown excellent internal consistency and test-retest reliability in Veterans. These are general measurement properties cited in the record; they do not establish the reliability of scores in this particular trial.
The primary outcome is defined as a mean score, with standard deviation as the measure of dispersion. It is assessed over a sequence of time points: baseline, week 6, week 12, and 6-month follow-up. Repeated assessment can describe both the level of symptoms and how scores change during and after treatment. However, the registry record does not report the mean scores, standard deviations, change estimates, or between-group comparisons at these times.
The record does not specify a single summary contrast, such as a particular time point or an overall treatment-by-time comparison, as the reported primary analysis. Its stated timeframe covers change across several assessments.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of TBT with disorder-specific therapies and identifies PCL-5 scores as the primary outcome. However, it lists no statistical analyses and does not report primary outcome estimates. Consequently, the posted results do not show whether mean symptom scores changed, whether changes differed between treatment groups, or how precisely any group difference was estimated.
This distinction matters because an outcome definition is not itself a result. The PCL-5 score has a stated range of 0 to 80, and higher scores correspond to more severe symptomatology. To interpret the comparison, readers would need the group-specific scores or changes at the relevant time points, along with an estimate of the between-group contrast and its uncertainty. These are not reported in the registry record.
The record gives an enrollment of 304 but does not report how many participants contributed PCL-5 data at each assessment or how many were included in any primary analysis. It explicitly notes that numbers varied over time because of missing data and discontinuation of psychotherapy. Without assessment-specific denominators and an account of missing-data handling, the amount and possible impact of missing information cannot be assessed from the registry entry.
Safety information is presented separately from the symptom outcome. The record reports serious adverse events in both groups, including psychiatric hospitalization and an EMS call or emergency visit among the listed serious-event terms. These descriptive counts do not answer the primary symptom question and, by themselves, do not establish a causal difference in safety between treatments.
The registry lists the trial as completed, but completion status does not supply the missing outcome analysis. A completed study may have collected the planned assessments, yet without posted estimates and methods, the treatment comparison remains statistically unevaluable from this record. The appropriate interpretation is that the design and outcome are described, while the primary efficacy results and their precision are not reported in the registry record.
No conclusion about the magnitude or direction of a treatment contrast can be drawn from the enrollment count, outcome definition, or safety counts. Likewise, the absence of an analysis in the registry entry should not be interpreted as evidence that the treatments produced the same results. It indicates only that the necessary statistical results are not reported there.
9. Statistical Methods Explained
The registry record identifies randomization, a parallel-group comparison, a continuous primary outcome, and repeated assessment over time. It does not report the statistical model, the treatment contrast, an inferential procedure, or the handling of missing outcome data. The explanations below distinguish the general statistical ideas from methods documented for this trial.
What does a mean and standard deviation describe?
General: A mean summarizes the average score in a group. A standard deviation describes the spread of individual scores around that mean. Together they give a basic account of the outcome distribution, but they do not by themselves quantify the uncertainty in a difference between groups. That uncertainty depends on factors including the number of observations contributing to the estimate and the analysis used.
For this trial, the primary measure is the PCL-5 total score, and the registry specifies a mean and standard deviation. The score range is 0 to 80, with higher scores indicating more severe symptomatology. The actual group means and standard deviations are not reported in the registry record.
Why does randomization matter?
General: Random assignment is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics at the point of assignment. It supports a treatment comparison when participants are analyzed in a way that preserves the randomized groups and when the analysis and follow-up are adequately described. Randomization does not ensure that every follow-up assessment is complete, nor does it remove uncertainty from an estimate.
The record states that allocation was randomized and that the study used a parallel model. It does not report the allocation sequence, concealment procedures, or the analysis population. Those details are not reported in the registry record.
What does repeated measurement add?
General: Repeated measures allow investigators to examine outcomes at multiple times and to describe whether group patterns change during follow-up. Analyses can account for the fact that measurements from the same participant are related. A model might estimate a difference at a selected time, an average difference across times, or a difference in trajectories. These are distinct questions and can yield different estimates.
The PCL-5 timeframe names baseline, week 6, week 12, and 6-month follow-up. The registry record does not report which repeated-measures model was used or which specific contrast was selected for inference. It does not report estimated trajectories, group-by-time contrasts, confidence intervals, or p-values.
Why is uncertainty important?
General: An estimate describes the observed size and direction of a contrast, while a confidence interval describes the statistical uncertainty around that estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval. A p-value addresses compatibility of the data with a specified null hypothesis under an analysis model; it does not describe the size or clinical importance of an effect. Interpreting a treatment comparison generally requires the estimate, its uncertainty, and a clear definition of the contrast.
For the primary outcome, none of these inferential results is reported in the registry record. There is therefore no posted estimate or interval with which to discuss precision, and no posted p-value with which to assess evidence against a null hypothesis.
What are the planning illustrations?
General: A sample-size calculation asks how many observations might be needed to detect a specified effect under chosen assumptions. It is a planning exercise, not a measurement of what a completed trial found. A calculation based on an observed effect is especially dependent on that estimate and should not be described as observed power.
The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. The record distinguishes participants per arm for outcomes other than time-to-event outcomes; time-to-event calculations instead refer to a total number of events. These illustrations are not the trial’s own design justification, and the registry record does not report the trial’s sample-size justification. They do not show the probability that this completed trial detected an effect.
Why can over-dispersion matter?
General: Over-dispersion means that observed variability is greater than a statistical model assumes. When a model understates variability, uncertainty estimates can be too small and statistical evidence can appear stronger than warranted. For a continuous measure such as a score, the spread of observations and the model’s assumptions about that spread affect precision. The registry record does not report an over-dispersion assessment or a model for the PCL-5 outcome, so no trial-specific judgment about this issue can be made.
In sum, the registry describes the outcome scale and assessment schedule, but not the analysis used to turn repeated observations into a treatment estimate. The statistical model, uncertainty estimates, hypothesis tests, and analysis population are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is assessed at multiple times: baseline, week 6, week 12, and 6-month follow-up. Each time point could support a separate comparison, while an overall repeated-measures analysis could address a different question. When multiple comparisons are considered, the chance of finding at least one apparently notable result can increase. General approaches to this issue include defining a primary contrast in advance or adjusting inference across a family of comparisons. The registry record does not report a multiplicity strategy or identify a single primary time-point contrast.
The registry record lists no statistical analyses, and does not report p-values or confidence intervals for the primary outcome. It therefore does not establish whether multiplicity was addressed, whether interim analyses were conducted, or what statistical plan governed the comparisons. These matters are not reported in the registry record.
Missingness is a further concern because the record says numbers varied across time points due to missing data and participant discontinuation of psychotherapy. The amount of missing outcome data at each time, the reasons for missingness, and the statistical method used to handle it are not reported in the registry record. General missing-data methods rely on assumptions about how the probability of missingness relates to observed and unobserved outcomes. Because the trial-specific method and assumptions are not stated, their plausibility cannot be assessed.
The record also does not report analysis populations, such as whether participants were analyzed according to randomized assignment or only when outcome data were available. It does not provide the number assessed at each time point. These omissions limit interpretation of both the treatment comparison and its precision.
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 |
|---|---|---|---|
| Transdiagnostic Behavior Therapy | 1 | 153 | 0.7% |
| Disorder Specific Therapies | 2 | 151 | 1.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Transdiagnostic Behavior Therapy | 0 of 153 |
| Disorder Specific Therapies | 0 of 151 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Transdiagnostic Behavior Therapy | 13 of 153 |
| Disorder Specific Therapies | 8 of 151 |
Most frequent serious adverse event terms
| Event term | Organ system | Transdiagnostic Behavior Therapy | Disorder Specific Therapies |
|---|---|---|---|
| psychiatric hospitalization | Psychiatric disorders | 0 of 153 | 2 of 151 |
| EMS call - Emergency Visit | Psychiatric disorders | 1 of 153 | 0 of 151 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Transdiagnostic Behavior Therapy | Disorder Specific Therapies |
|---|---|---|---|
| Patient cancelled appt due to minor physical health complaints (e.g., stomach virus) | Psychiatric disorders | 13 of 153 | 8 of 151 |
Serious events with the highest arm-level rate: psychiatric hospitalization (1.3%), ems call - emergency visit (0.7%).
The registry record reports serious adverse events separately for TBT and DST. For TBT, 153 participants were at risk, 1 had a serious adverse event, 13 had another adverse event, and 0 deaths were reported. For DST, 151 participants were at risk, 2 had a serious adverse event, 8 had another adverse event, and 0 deaths were reported.
The listed serious-event terms include psychiatric hospitalization, reported as 1.3%, and EMS call - Emergency Visit, reported as 0.7%. The registry record does not provide further detail about event timing, severity beyond the serious-event classification, or the relationship of each event to treatment. The listed terms and percentages are descriptive; they do not establish whether the events were caused by a therapy.
These figures should be read as counts and listed terms, not as a formal comparative safety analysis. The record does not report a statistical comparison of adverse events, uncertainty intervals, or an adjustment for differences in follow-up. A count alone does not show how precisely a group difference is estimated. The adverse-event information also does not answer the primary question about change in PCL-5 scores.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized comparison was conducted between TBT and disorder-specific therapies for Veterans with major depressive disorder, PTSD, or panic disorder and agoraphobia. It identifies a repeated-measures PTSD symptom score as the primary outcome and gives the score’s range and direction. It also reports serious and other adverse-event counts by treatment group.
What it does not establish is whether the treatments differed in PTSD symptom change. The registry record lists no statistical analyses and reports no primary outcome scores, changes, treatment contrasts, confidence intervals, or p-values. Without those results, neither the direction nor the size of any difference can be described, and its precision cannot be assessed.
The absence of a posted analysis is not evidence that the therapies had identical outcomes. Equally, a completed status, the randomized design, or the existence of multiple assessment times cannot be taken as evidence that one approach produced a greater change. Those conclusions require reported estimates and an analysis that makes the treatment contrast clear.
The record’s safety counts are also limited in what they can establish. They identify reported events in each group, but do not provide a formal comparison or establish causation. Further, outcome numbers varied over time because of missing data and psychotherapy discontinuation. Without assessment-specific denominators and missing-data methods, the impact of incomplete follow-up cannot be determined from the registry entry.
Accordingly, the record supports a description of the trial question, design, outcome measure, and reported adverse-event counts. It does not support a conclusion about comparative efficacy or a precise comparison of safety. The primary results and the methods used to analyze them are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial addresses a statistical comparison between a transdiagnostic treatment strategy and disorder-specific therapies selected according to a participant’s most severe diagnosis. That design raises a meaningful question about how treatment groups can be compared when the comparator is tailored to different diagnoses, while the primary outcome is a PTSD symptom score. The registry record specifies the treatment categories and the PCL-5 assessment schedule, but does not report results that answer the question.
The repeated assessment schedule makes the definition of the treatment effect especially important. A contrast at week 12, a difference in change over the full follow-up, and a pattern of scores across all assessments are not interchangeable statistical summaries. Clear reporting of the chosen contrast, its estimate, and its uncertainty would allow readers to understand what the randomized comparison shows. Those details are not reported in the registry record.
Missing assessments also matter to the interpretation of a longitudinal trial. The record notes variation in participant numbers over time due to missing data and discontinuation of psychotherapy. Reporting how many observations contribute at each time, how missingness was handled, and which participants were included in the analysis would help readers judge the robustness of the comparison.
Finally, the separation between a planning calculation and a trial result is important. The record describes sample-size illustrations using assumptions about significance level, allocation, and effect size, but those illustrations are not the trial’s own design justification and are not observed power. A completed trial’s evidential value is assessed through its estimated treatment contrast and uncertainty, neither of which is reported for the primary outcome.
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 main limitation for statistical interpretation is that the registry record lists no analyses and reports no primary outcome results. There are no PCL-5 group summaries, changes, between-group estimates, confidence intervals, or p-values from which to judge the size, direction, or precision of the comparison.
The primary outcome covers several time points, but the record does not identify a single inferential contrast or explain how conclusions across the assessments were handled. A multiplicity strategy is not reported. The statistical model and any assumptions used for repeated measurements are also not reported in the registry record.
Participant numbers varied across assessment times because of missing data and discontinuation of psychotherapy. The record does not give time-specific denominators, detail the extent or reasons for missingness, describe missing-data methods, or identify the analysis population. As a result, the influence of incomplete follow-up on the estimated treatment comparison cannot be evaluated.
The registry describes single masking but does not report who was masked or how masking was maintained. It also does not report allocation concealment procedures or a statistical analysis plan. The sample-size illustrations are explicitly described as planning exercises based on an observed effect, not the trial’s own design justification. The registry record does not report the underlying justification for the enrollment target.
These limitations concern what can be assessed from the registry entry; they do not establish that the study lacked procedures or analyses that may have been conducted but are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder — NCT04293341.
- Registry record last updated 2025-11-06; status last verified 2025-10.
- Results first posted 2025-11-06.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT04293341 is listed as a completed randomized, single-masked, parallel-group trial with an enrollment of 304. It compares Transdiagnostic Behavior Therapy with disorder-specific therapies for Veterans with major depressive disorder, PTSD, or panic disorder and agoraphobia. The registry record lists Cognitive Processing Therapy for PTSD, Cognitive Behavioral Therapy for MDD, and Cognitive Behavioral Therapy for panic disorder as the disorder-specific options.
The primary outcome is mean PCL-5 score, with standard deviation, assessed from baseline through week 6, week 12, and 6-month follow-up. Higher scores indicate more severe PTSD symptomatology. The record notes that participant numbers varied over time due to missing data and discontinuation of psychotherapy.
Serious and other adverse-event counts are reported for both treatment groups, along with two listed serious-event terms. No statistical analyses or primary outcome results are reported in the registry record, so the comparative symptom findings and their precision cannot be assessed.