Transdiagnostic Brain-Behavior Profiling to Enhance Cognitive Behavioral Therapy Response: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Transdiagnostic Brain-Behavior Profiling to Enhance Cognitive Behavioral Therapy Response (NCT03175068), a randomized na study. The primary outcome is Changes in Symptom Severity From Baseline to Week 12 Between Treatment Arms.

2. Clinical Question

3. Trial Design

The registry describes a randomized, single-masked, parallel study, marked completed. Enrollment is listed as 203. The study dates recorded are a start date of 2017-07-05 and a primary completion date of 2022-03-01. The phase is listed as NA. The registry record does not describe the randomization procedure, the allocation ratio, or which people were masked.

Patients were randomized to CBT or ST. Both interventions were delivered over a 12-week period by a clinical psychologist. CBT was manualized and tailored to the diagnosis; the listed strategies include psychoeducation, cognitive intervention, and behavioral changes. The ST description identifies supportive psychotherapy principles and reflective listening, but the registry text available for the description is incomplete. Details beyond those stated are not reported in the registry record.

Healthy control participants did not receive treatment, but completed the same assessments at the same time points as patients. They are listed as a Control group in the adverse-event results. The primary outcome description focuses on the comparison between treatment arms; it does not specify that healthy controls belong in that treatment-effect comparison.

The primary outcome population included only participants who completed the entire study and had data at baseline and week 12. This means the stated analysis population is based on completion and availability of both assessments, rather than all randomized participants. The registry record does not report the numbers included in the primary outcome analysis by arm, reasons for missing assessments, or an analysis of participants who did not complete the study.

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: 35 participants consented to the study (included in protocol enrollment) but were not randomized due to study ineligibility or early withdrawal from the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Only participants who completed the entire study (with data at baseline and week 12) were included.

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: The number of all participants for whom baseline characteristics were measured, in each arm/group and in the entire study population (total).

6. Primary Endpoint

The registry lists the primary outcome as Changes in Symptom Severity From Baseline to Week 12 Between Treatment Arms, measured over baseline and week 12.

The primary endpoint represents symptom severity using a composite score based on the Liebowitz Social Anxiety Scale (LSAS) and Hamilton Depression Rating Scale (HDRS). The registry describes both instruments as interviewer-based standard clinical measures. It says the composite was constructed using proportion of maximum scaling (POMS) to represent symptom severity. Its scale runs from 0 to 1, and higher scores mean worse outcomes.

The endpoint concerns change from baseline to week 12 and compares that change between CBT and ST. Using a composite was intended to represent symptom severity across the two disorders rather than treating either scale as the sole primary measure. The posted description does not give the component weights or further construction details, so the precise contribution of each scale to the composite is not reported in the registry record.

The registry identifies the outcome as continuous and specifies a mean with standard deviation. In general, a mean describes the average score in a group, while a standard deviation describes how spread out individual scores are around that average. A change-based endpoint focuses on the movement in scores over the stated assessment period; a between-arm comparison asks whether that movement differs between treatment groups. The record does not report numerical means, standard deviations, or a numerical between-arm result for this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean and standard deviation describe?

The primary outcome is marked continuous, with the mean and standard deviation as its summary measures. In general, the mean is an average that locates the center of a group’s scores. The standard deviation describes the spread of scores around that average. Reporting both can help readers distinguish a group with a particular average from one in which individual scores are tightly or widely distributed. Neither statistic alone describes the full shape of the data.

For this trial, the measured score combines LSAS and HDRS using proportion of maximum scaling. The registry gives the score’s scale limits and direction, but does not report the score distributions or the group summaries. The record also does not describe whether the treatment comparison used a model, a direct comparison of change scores, or another method. The analysis method is not reported in the registry record.

What does a change comparison ask?

The primary outcome is framed as change from baseline to week 12 between treatment arms. In general, a change comparison asks whether the movement from an initial assessment to a later assessment differs between groups. This differs from considering only the final scores, because initial scores may also be relevant to how the final contrast is interpreted. The registry specifies the assessment times and the treatment-arm comparison, but does not provide numerical change estimates or details of the statistical model used to compare them.

Random allocation is intended, in general, to make treatment groups comparable at the start of a study on average. It does not ensure that every characteristic is balanced, nor does it resolve missing follow-up data by itself. The record states that the study was randomized, but does not describe sequence generation, concealment, stratification, or other allocation details. The term single-masked is recorded, but the identity of the masked party is not reported.

How should a confidence interval be understood?

In general, a confidence interval expresses uncertainty around an estimated contrast. A narrower interval indicates greater precision under the method used; a wider interval indicates less precision. It can help show which effect sizes remain compatible with the observed data, rather than presenting only a single estimate. It does not remove uncertainty or establish that an effect is clinically important. The registry record does not report a confidence interval for the primary comparison, so its precision cannot be assessed.

A p-value is also a method-dependent summary. In general, it measures how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the model assumptions held. It does not show the probability that the null hypothesis is true, nor does it quantify the size of an effect. A p-value for the primary comparison is not reported in the registry record, and the analysis assumptions are not described there.

Why does the analysis population matter?

The registry says that only participants who completed the entire study and had baseline and week 12 data were included in the primary outcome population. In general, restricting an analysis to people with complete measurements can make the analyzed group differ from the randomized group if completion is related to symptoms, treatment experience, or other factors. This does not show that such a difference occurred in this trial; it identifies a possible consideration when interpreting a completer analysis. The record does not report reasons for non-completion or compare completers with non-completers.

Other approaches to missing data may use assumptions or models to incorporate incomplete records. Which approaches were used, and whether any sensitivity analyses were conducted, are not reported in the registry record. It is therefore not possible to assess the robustness of the primary outcome analysis to missing data from the posted information.

What does the planning illustration represent?

The planning illustration is described as based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers an effect to detect expressed as a fraction of the observed effect. These are planning assumptions, not evidence about the trial’s actual design or its observed statistical power. The registry record does not report the trial’s sample-size justification or statistical plan. The posted information does not give numerical planning results in the registry record for this explanation, so no participant requirement can be stated.

In general, a sample-size calculation estimates how many participants would be needed under specified assumptions to have a chosen probability of detecting an effect of a stated size, using a stated significance threshold and analysis. It depends on assumptions about the effect and variability, among other design choices. A planning calculation is not the same as an observed result, and a calculation using an observed effect does not establish the probability that the trial detected a real effect. No sample-size illustration should be read as observed power.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and four analyses. The primary outcome description combines LSAS and HDRS into a composite, and the posted record indicates that the primary outcome has several categories or time points and was not reduced to one comparison. This makes it important to know which comparisons were planned as primary and how results across outcomes or time points were handled. The statistical plan and any multiplicity adjustment are not reported in the registry record.

In general, when several outcomes or comparisons are examined, the chance of at least one apparently notable result can increase if each is assessed separately without adjustment. Methods for addressing this may define a hierarchy of outcomes, adjust the testing procedure, or emphasize estimation and uncertainty rather than a collection of isolated tests. None of these approaches can be attributed to this study from the registry information. The number of outcomes and analyses alone does not establish whether multiplicity was addressed.

For missing data, the registry states that the primary outcome population included participants who completed the entire study with data at baseline and week 12. It does not report the number missing by arm, reasons for missingness, methods for handling incomplete observations, or sensitivity analyses. In general, the consequences of missing data depend in part on why measurements are missing and on the assumptions used in the analysis. The available record is insufficient to assess those assumptions.

The study is described as randomized, but the record does not specify whether analyses followed assignment regardless of treatment received, or whether other analysis populations were used. Such details are not reported in the registry record and should not be inferred from the stated completer population.

11. 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 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists serious adverse events as affecting 0 participants in CBT, 0 in ST, and 0 in Control. Deaths are listed as 0 for each group. The numbers at risk for serious adverse events are 61 in CBT, 57 in ST, and 50 in Control. No serious adverse-event terms are listed.

For other adverse events, the registry lists 32 affected in CBT, 25 in ST, and 4 in Control. The corresponding numbers at risk are 61, 57, and 50. These are the registry’s affected figures; the record does not provide event descriptions or further detail about severity, timing, or relation to treatment in the information.

In general, adverse-event counts describe what was recorded under the registry’s definitions and reporting process. A zero serious-event figure does not establish that no adverse experiences occurred, and the presence of other adverse events does not by itself establish a cause. The Control group did not receive treatment, according to the primary outcome description, so its figures should not be read as a randomized psychotherapy arm. Safety figures also do not substitute for the missing numerical primary outcome results.

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

The registry record identifies a randomized comparison of CBT and ST and defines a symptom-severity composite based on LSAS and HDRS. It also identifies the assessment interval, the scale direction, and the completer population used for the primary outcome. These details clarify what the study set out to measure, but they are not numerical evidence of the treatment comparison.

The primary outcome estimates and their uncertainty are not reported in the registry record. As a result, the posted information does not show whether symptom severity changed differently between CBT and ST, how large any difference was, or how precisely it was estimated. It also does not permit an assessment of whether any observed difference would be clinically important. No conclusion about the comparative effect of the therapies follows from the endpoint description alone.

The record describes healthy controls who completed assessments without treatment, but does not provide a numerical primary outcome comparison involving that group. Their assessment role should not be confused with the randomized treatment contrast. Similarly, the reported adverse-event figures describe recorded events; they do not answer the primary symptom-severity question.

In general, a trial’s interpretation depends on its estimated effects, uncertainty, analysis population, and design. Randomization is relevant to how a treatment comparison may be interpreted, while completion-based analysis can affect which participants contribute to the outcome. Here, key details about allocation procedures, analysis methods, missing data, and multiplicity are not reported in the registry record. These gaps limit assessment of the strength and robustness of any treatment comparison, beyond the more fundamental absence of numerical primary outcome results.

The findings should therefore be read as a description of the study question and its registered outcome framework, not as evidence for or against either therapy. The registry record does not provide the results needed to make that comparison.

13. Why This Trial Matters Statistically

This trial is statistically notable for linking two diagnostic groups with a shared symptom-severity outcome. The registry describes major depressive disorder and generalized social anxiety disorder, and combines scores from LSAS and HDRS using proportion of maximum scaling. A composite can represent more than one measured domain in a single outcome, but its interpretation depends on how the component measures are combined. The registry gives the intended role and direction of the composite, while further construction details are not reported.

The study also includes healthy controls who completed assessments without treatment, alongside the randomized CBT and ST treatment arms. Keeping these roles distinct matters: the primary question is framed as a comparison between therapies, while control participants provide assessments without treatment. The record does not report a numerical result for the randomized comparison or for comparisons involving controls.

From a statistical perspective, the stated restriction to study completers with baseline and week 12 data is important. It defines who contributed to the primary outcome and makes the analysis population narrower than the general randomized population may be. The registry does not give arm-specific analysis counts or missing-data methods, so the potential effect of incomplete follow-up cannot be evaluated.

The record lists multiple outcome measures and analyses, and indicates that the primary outcome involved several categories or time points rather than one reduced comparison. Without the statistical plan, readers cannot determine how the analyses were prioritized or whether multiplicity was addressed. These considerations illustrate why outcome definitions, analysis populations, and reporting of estimates with uncertainty are essential parts of interpreting a clinical trial—not merely details accompanying a result.

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 of the registry information is that numerical results for the primary outcome comparison are not reported. The record therefore does not show arm-level outcome summaries, a between-arm estimate, or its uncertainty. The direction, magnitude, and precision of the treatment comparison cannot be evaluated.

The primary outcome is a composite of LSAS and HDRS using proportion of maximum scaling, but the component-level results and further details of the composite construction are not reported. Without component results, the posted information cannot show whether the two measures followed similar patterns or contributed differently to the composite.

The stated primary outcome population includes only participants who completed the entire study and had both baseline and week 12 data. Arm-specific analysis counts, reasons for missing assessments, and missing-data methods are not reported in the registry record. This limits assessment of how the completer restriction may affect interpretation.

The record identifies the study as randomized, single-masked, and parallel, but does not report the randomization method, allocation ratio, or who was masked. The statistical analysis plan, multiplicity procedures, and sample-size justification are also not reported. Although a planning illustration is described, its assumptions should not be mistaken for the trial’s original design or for observed power.

The supportive therapy description is incomplete in the registry text, limiting detail about the comparator’s delivery beyond the stated supportive psychotherapy principles and reflective listening. The registry’s adverse-event figures give affected counts and numbers at risk, but the available information does not describe event timing, severity beyond the serious-versus-other categories, or attribution. These limits affect interpretation of the posted record and do not establish that unreported procedures or results were absent from the conduct of the study.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Transdiagnostic Brain-Behavior Profiling to Enhance Cognitive Behavioral Therapy Response — NCT03175068.
• Registry record last updated 2026-06-23; status last verified 2026-05.
• Results first posted 2026-06-23.
• 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 describes a completed randomized, single-masked, parallel study of CBT and supportive therapy for major depressive disorder and social anxiety disorder. The interventions lasted 12 weeks. Healthy controls completed assessments without treatment. Enrollment is listed as 203.

The primary outcome is change in symptom severity from baseline to week 12, measured by a composite of LSAS and HDRS using proportion of maximum scaling. Higher scores indicate worse outcomes, and the scale ranges from 0 to 1. The stated outcome population includes participants who completed the study and had both assessments.

Numerical primary outcome results, analysis details, and missing-data methods are not reported in the registry record. Serious adverse events and deaths are listed as 0 in each group; other adverse-event affected counts are listed as 32 for CBT, 25 for ST, and 4 for Control.