Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial (NCT04471207), a randomized phase 1 study. The primary outcome is Post Traumatic Stress Disorder Symptom Severity - Clinician Rated.

2. Clinical Question

The study concerns prolonged exposure (PE) for people with PTSD and compares two ways of using a BioWare device alongside therapy. In one group, therapists use biometric and subjective information during in vivo exposures to adjust assignments. In the other, the device passively records information for later offline analyses. The registry describes the study as evaluating whether the technology system can improve PE for veterans with PTSD.

This is therefore a comparison of two approaches to incorporating biometrics into PE, not a comparison of PE with no treatment. The record does not establish that any observed difference in group summaries was caused by the way device information was used. It also does not report an analysis of the full randomized population for the primary endpoint. The statistical interpretation depends on the distinction between the randomized design and the smaller, selected groups contributing to the posted endpoint summaries.

3. Trial Design

The registry describes a randomized, parallel-group, phase 1 trial with no masking. Its status is completed. The enrollment listed in the record is 40. The recorded start date is 2020-06-08, and the primary completion date is 2022-02-03. These details describe the trial record; they do not establish that every enrolled or randomized participant contributed to the primary outcome summaries.

Participants were assigned to therapist-guided PE with the BioWare device or record-only PE with the device. In the therapist-guided group, therapists use biometric and subjective information during in vivo exposures to modify assignments. The record identifies galvanic skin response, heart rate and subjective units of distress as information used in that approach. In the record-only group, biometric and behavioral data are collected and stored for future offline analyses. The record says participants receive at least 10 PE sessions.

The primary endpoint is assessed at end of treatment, described as after 10-12 PE sessions. Participants had 24 weeks to complete treatment. The posted endpoint population is narrower than a general description of everyone enrolled: it includes treatment completers who completed at least eight sessions and used the device at least one time. The group summaries include 18 participants in the therapist-guided arm and 5 in the record-only arm. The registry does not report the randomized allocation counts by arm or explain how participants who did not meet the endpoint population definition were handled.

The registry lists two outcome measures but reports no posted secondary outcome measures. It lists zero analyses. The randomization procedure, allocation concealment, protocol details and planned statistical methods are not reported in the registry record. Because masking is listed as none, the record does not indicate masking; whether any particular outcome assessor was masked is not reported. A completed status indicates the trial is recorded as completed, but does not by itself establish that every planned analysis or outcome is available in the record.

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: A total of 40 participants were randomized in a 3:1 fashion (Guided, n = 29; Non-Guided, n = 11). One participant was removed from the Non-Guided group due to a medical contraindication, and thus the intent-to-treat (ITT) sample consisted of N = 39 individuals. A total of n = 23 individuals completed at least eight sessions of prolonged exposure therapy and used the BioWare system at least one time and represents the treatment completers or per protocol (PP) sample.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Analysis on treatment completers (completion of at least eight sessions of prolonged exposure and use of BioWare device at least one time.

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: 18 years of age or older Able to comprehend English Met diagnostic criteria for current posttraumtic stress disorder (PTSD) Stabilized on any psychotropic medications for at least four weeks prior to study initiation Not at risk for imminent suicidal or homicidal ideation or intent requiring a higher level of care, enrolled in any other evidence based PTSD treatment or implanted with any electronic device (pacemaker, electron pump)

6. Primary Endpoint

The registry lists the primary outcome as Post Traumatic Stress Disorder Symptom Severity - Clinician Rated, measured over End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment..

The primary endpoint is clinician-rated PTSD symptom severity at end of treatment, measured with the Clinician Administered Posttraumatic Stress Disorder Scale, CAPS-5. The record describes CAPS-5 as a clinician-administered assessment covering 20 PTSD symptoms through 30 items. Scores range from 0-80, with lower scores representing fewer and less severe symptoms. The endpoint is reported as a mean with a standard deviation, making it a continuous measure rather than an event count.

The assessment is administered at baseline, mid treatment and end of treatment. The stated primary timeframe is end of treatment after 10-12 PE sessions, with 24 weeks allowed for treatment completion. The primary analysis population is treatment completers: participants who completed at least eight PE sessions and used the BioWare device at least one time. Thus, the posted endpoint summary describes symptom scores for that defined group, rather than necessarily describing everyone assigned at random.

A clinician-rated symptom scale is relevant to the study question because the intervention strategies aim to inform how PE assignments are delivered, while the endpoint captures PTSD symptom severity at treatment completion. The score is an outcome measure, not a direct measure of whether the biometric system was used as intended or whether any particular assignment changed. Information about assessor training, reliability procedures or blinding is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: each participant has a CAPS-5 score, and the record reports group means and standard deviations. A mean describes the average score in the participants contributing to that group summary. A standard deviation describes how spread out participants’ scores are around that group mean. These two statistics answer different questions. The mean locates the group average, while the standard deviation describes variation among individual scores. Neither alone provides a confidence interval for a treatment contrast.

What does the mean summarize?

The mean is an appropriate descriptive summary for a continuous scale when the aim is to characterize average symptom severity. Here, the interpretation follows the scale direction stated in the record: lower CAPS-5 scores represent fewer and less severe PTSD symptoms. A group mean does not imply that every participant had a score near that value, and it can conceal variation in individual outcomes. The standard deviations help convey that variation, but do not reveal the full distribution, such as whether scores cluster evenly or include extreme values.

What would a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimate, such as a group mean or a difference between group means. It is not a range containing every participant’s score. For a comparison, an interval would help show which effects are compatible with the data under the analysis assumptions, and how precisely the effect is estimated. The registry record does not report confidence intervals for the group means or an interval for a two-arm contrast. No interval should be inferred from the posted means and standard deviations alone without choosing and applying an analysis method.

Why is the group comparison not interpreted as a calculated effect?

The registry marks values as missing or not estimable for a two-arm comparison of this continuous endpoint. It also lists zero analyses. The arm summaries therefore support a descriptive account, but they do not provide a sponsor-reported inferential contrast. A simple unadjusted recalculation would be a separate analysis rather than the trial’s own reported result; the record does not present such a recalculated estimate. The record indicates no discrepancy between sponsor and recalculated results, but that does not create an estimate when a comparison is not reported as estimable.

In general, a two-group comparison needs an explicit estimate and an uncertainty measure to distinguish the observed contrast from sampling variability. Its interpretation also depends on the target population, outcome timing, handling of missing outcomes and whether the analysis respects random assignment. Those elements are not all described in the registry record. The registry entries available do not support assigning a p-value, stating statistical significance, or asserting that a difference is clinically important.

What does the completer population imply?

The posted endpoint population consists of treatment completers, defined as people who completed at least eight PE sessions and used the BioWare device at least one time. This criterion selects participants based on events occurring after assignment. In general, excluding participants who do not meet a post-assignment criterion can weaken the protection randomization offers for comparing groups, particularly if completion or device use is related to prognosis or outcome. The record does not report whether those factors were related to CAPS-5 scores, so the extent or direction of any selection effect cannot be determined.

The endpoint description also says treatment is completed after 10-12 sessions, while the analysis population definition requires at least eight sessions. These statements describe different thresholds in the registry record. The record does not explain how participants who completed a different number of sessions were treated in the analysis beyond the stated completer definition. The treatment window is described as 24 weeks, but no further outcome timing or missing-data rules are reported.

How should the planning illustrations be understood?

In general, sample-size planning asks how many participants would be needed under specified assumptions to detect a target effect with a chosen error rate and power. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation, a normal approximation and effects expressed as fractions of the observed effect. These are planning assumptions, not a report of the trial’s original design justification or its achieved power. The record does not report the protocol’s sample-size justification, and no planning estimate should be mistaken for an observed trial result.

Sample-size illustrations are conditional on assumptions about the effect to detect and the analysis. They do not measure the probability that the observed study result is true, nor do they repair limitations in the observed data. They are also distinct from power calculated after observing results, which is not an informative substitute for an interval around an effect. The posted record does not report a trial-specific statistical plan, planned interim analyses or a justification for enrollment. Those matters are not reported in the registry record.

Overall, the available statistical information supports reading the endpoint summaries as means and standard deviations for the defined completer groups. It does not support a precise inferential comparison, a claim about the randomized population, or a causal conclusion. General statistical concepts explain what additional analyses could contribute, but do not fill gaps in the trial record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Intelligent Biometrics - Prolonged Exposure (Thera", "Intelligent Biometrics - Prolonged Exposure (Recor")
n   <- c(18, 5)
m   <- c(25.71, 32)
sp  <- c(14.65, 11.64)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Intelligent Biometrics - Prolonged Exposure (Thera  18  25.710  14.650  18.425  32.995
CARM  Intelligent Biometrics - Prolonged Exposure (Recor  5  32.000  11.640  17.547  46.453

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures, but reports no posted secondary outcome measures and zero analyses. The record does not describe a multiplicity adjustment, a prespecified hierarchy of outcomes, or rules for choosing among several statistical tests. Multiplicity concerns arise when many outcomes or comparisons are examined, because repeated testing can increase the chance of apparently notable findings. Whether that issue affected this study cannot be determined from the registry record.

The primary endpoint summary is restricted to treatment completers, defined as completing at least eight PE sessions and using the BioWare device at least one time. The record does not report how many participants were excluded from that endpoint population, reasons for non-completion, or the distribution of missing CAPS-5 measurements. It does not state whether missing values were imputed, whether any sensitivity analyses were conducted, or whether outcomes were analyzed according to randomized assignment. These procedures are not reported in the registry record.

In general, missing data can affect an estimate when the probability of having an observed outcome is related to the outcome itself or to factors associated with it. An analysis limited to available completer outcomes can describe those observed participants, but does not automatically represent participants without posted outcomes. No direction or magnitude of missing-data bias can be inferred from this record.

Randomization is listed, but the method of sequence generation and allocation concealment is not reported. The record lists no masking. It does not report an intention-to-treat analysis or another prespecified analysis population beyond the completer definition. Consequently, the posted summaries should be interpreted as descriptive results for the stated endpoint population, with no reported multiplicity or missing-data strategy to support broader inference.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: intestinal lymphangiectasia (9.1%), transient ischemic (9.1%), spinal injury (3.4%).

The adverse-event record lists serious adverse events and other adverse events separately for the two groups. In the therapist-guided group, 29 participants are listed as at risk for serious adverse events, with 1 affected; 29 are listed as at risk for other adverse events, with 10 affected. In the record-only group, 11 are listed as at risk for serious adverse events, with 2 affected; 11 are listed as at risk for other adverse events, with 3 affected. Deaths are listed as 0 in each group.

These are registry counts, not an adjusted comparison of safety between strategies. The record does not provide a statistical comparison, confidence intervals, exposure-adjusted rates, or enough detail to determine whether the events were judged related to the device, PE or another cause. “At risk” counts are the denominators recorded for these adverse-event summaries and should not be assumed to match the primary endpoint populations.

The record lists Intestinal Lymphangiectasia at 9.1%, Transient Ischemic at 9.1%, and Spinal Injury at 3.4% among the top serious terms. The registry wording does not provide further context for interpreting these terms or their relationship to study procedures. Counts and listed terms describe what was entered in the record; they do not establish causation or permit a claim that an event was or was not caused by an intervention.

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

The primary results describe end-of-treatment CAPS-5 scores among treatment completers in two device-supported PE approaches. The therapist-guided group has a reported mean of 25.71 and standard deviation of 14.65 among 18 participants. The record-only group has a mean of 32.0 and standard deviation of 11.64 among 5 participants. Because lower CAPS-5 scores indicate fewer and less severe symptoms, the means describe different observed group averages in the stated direction of the scale.

Those summaries do not establish that therapist guidance caused a difference in symptoms. The registry does not report an estimable two-arm comparison, its uncertainty, or an analysis of all randomized participants. The unequal numbers contributing to the endpoint, and the completer definition applied after assignment, limit interpretation as a comparison of the randomized groups. A descriptive contrast is not equivalent to evidence of a treatment effect.

The record also does not answer whether therapist use of biometric information changes treatment delivery, whether the record-only data predict later outcomes, or how well either approach would perform in a different population or setting. The description of the record-only arm says its data are stored for future offline analyses; the posted primary endpoint summaries alone do not establish predictive performance.

The findings should not be treated as a comparison of PE with no therapy, since both listed groups receive PE with a BioWare device. Nor do the registry summaries establish that either approach improves symptoms relative to baseline: baseline endpoint values and a reported change analysis are not included in the posted results. The record gives the end-of-treatment means, but no inferential estimate that quantifies a between-group effect.

In short, the posted numbers characterize symptom scores for the defined completer groups. The absence of a reported comparative estimate means the precision and statistical compatibility of possible group differences are not available from the registry record. The results do not justify a causal conclusion or a broader claim about effectiveness.

14. Why This Trial Matters Statistically

This trial raises a statistical question that is important in studies of technology-assisted behavioral treatment: whether information collected during treatment is used to guide care or stored for later analysis. Those are distinct strategies, and a randomized comparison can be useful for assessing them when the outcome analysis is clearly defined and reported. Here, both arms receive PE with the BioWare device, while the way data are used differs.

The endpoint is a clinician-rated symptom score, and the record supplies group means and standard deviations. That makes clear what was observed among participants meeting the completer definition, while also exposing the limits of descriptive summaries. A trial can have a randomized design yet still leave readers without a precise treatment contrast when the available endpoint results are restricted to completers and no inferential comparison is reported.

The different numbers contributing to the two endpoint summaries underscore why the analysis population and missing-data approach matter. A comparison based on participants who complete a threshold number of sessions and use the device may not preserve the original randomized balance. Reporting the flow into the endpoint population, outcomes for those not included, and an analysis aligned with assignment would help readers judge how well the findings address the randomized question. Those details are not reported in the registry record.

The study also illustrates why safety counts and symptom outcomes should be read separately. Adverse-event entries describe recorded events, while CAPS-5 scores describe symptoms at end of treatment. Neither type of summary by itself establishes why an outcome occurred. Transparent reporting of outcome definitions, timing, analysis populations and uncertainty would help distinguish what the observed data show from what remains uncertain.

The statistical importance is therefore not a claim about which approach is superior. It is the need to align the trial’s question, the population analyzed and the reported estimate. The record identifies a randomized comparison, but its posted primary results are descriptive and do not quantify a comparative effect.

15. 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 primary endpoint is reported only for treatment completers, defined as completing at least eight PE sessions and using the BioWare device at least one time. Because this is a post-assignment criterion, the resulting summaries may not preserve the balance created by randomization. The record does not describe outcomes for participants outside that analysis population or explain their exclusion.

The endpoint groups differ in size: the therapist-guided summary includes 18 participants and the record-only summary includes 5. The registry does not report an estimable two-arm comparison, confidence interval or p-value. This prevents assessment of the precision of a group contrast and limits interpretation to descriptive summaries.

The endpoint timeframe is described as after 10-12 sessions, while the completer population requires at least eight sessions. The record does not explain the relationship between those statements in the analysis. Participants had 24 weeks to complete treatment, but further information on treatment exposure, missed assessments and outcome timing is not reported in the registry record.

The registry lists no masking. It does not report whether the clinician assessing CAPS-5 was masked, or how the randomized sequence was generated and concealed. It also does not report the statistical analysis plan, missing-data methods, multiplicity procedures, interim analyses, or the trial’s sample-size justification. These omissions make it difficult to assess how closely the posted results follow planned methods.

The adverse-event summaries provide counts and selected terms but no comparative analysis or attribution detail. The registry also lists two outcome measures while reporting no secondary outcome results. These limitations leave important questions about completeness, analysis choices and interpretation unresolved; they do not establish that any particular bias or error occurred.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial — NCT04471207.
• Registry record last updated 2023-10-31; status last verified 2023-10.
• Results first posted 2023-10-31.
• 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.

19. Record Summary

NCT04471207 is a completed, randomized, parallel-group phase 1 trial with no masking, sponsored by the Medical University of South Carolina. The registry lists enrollment of 40 and compares therapist-guided PE with a BioWare device against record-only PE with the device. The record states that participants receive at least 10 PE sessions.

The primary outcome is clinician-rated PTSD symptom severity at end of treatment, measured with CAPS-5. The posted means and standard deviations apply to treatment completers who completed at least eight sessions and used the device at least one time. The record reports 18 participants in the therapist-guided endpoint group and 5 in the record-only endpoint group.

The registry does not report an estimable two-arm comparison for the primary endpoint and lists zero analyses. It provides adverse-event counts, but no comparative safety analysis or attribution details. Methods for missing outcomes, multiplicity, randomization procedures and the statistical plan are not reported in the registry record.