Reward Processes and Rehearsal in Exposure Therapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Reward Processes and Rehearsal in Exposure Therapy (NCT06132425), a randomized na study. The primary outcome is Change in Public Speaking Anxiety.

2. Clinical Question

3. Trial Design

The registry record describes a randomized, single-masked, parallel-group behavioral study. The listed interventions are exposure and rehearsal. Participants engaged in short public-speaking exposures over two sessions. After every two exposures, they completed either a positive or neutral rehearsal exercise. The study description says rehearsal involved recalling aspects of the exposures; the full exercise instructions for each arm are not reported in the registry record.

The enrollment is 88, and the adverse-event information lists 44 participants at risk in each rehearsal group. These figures describe the registered trial and safety record; they do not establish how many participants contributed data to each outcome or analysis. The primary-outcome description says 42 participants in each group completed baseline measures and reports post-exposure measure counts, but its population text is incomplete.

The primary completion date is 2023-12-12, the start date is 2023-04-18, and the status is completed. The phase is listed as NA. The sponsor is the University of California, Los Angeles. Who was masked is not reported in the registry record, so single masking cannot be assigned to participants, investigators, assessors, or another role.

Random allocation is intended to make groups comparable on average, while a parallel design assigns participants to one group rather than having each participant receive both rehearsal conditions. These are general design principles; the registry record does not report the sequence-generation method, allocation concealment, or implementation details. The planned sample-size justification and the detailed statistical analysis plan are not reported in the registry 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 42 participants from each group completed baseline measures. 38 participants in the positive group and 40 in the neutral group completed post-exposure measures (6 lost to follow-up, withdrew from the study, or did not follow study instructions). 38 participants in the positive group and 37 in the neutral group completed follow-up measures (3 lost to follow-up). Additionally, 2 participants in the positive group partially completed follow-up measures.

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: We report on baseline measures for participants who at least completed Visit 1 of the study and therefore engaged in at least one session of exposure and rehearsal exercises (n=84).

6. Primary Endpoint

The registry lists the primary outcome as Change in Public Speaking Anxiety, measured over Baseline through study completion, an average of 3 weeks..

The primary endpoint is change in public-speaking anxiety from baseline through study completion, over an average timeframe of 3 weeks. It combines responses to two self-reported questions about public-speaking anxiety and avoidance, each scored from 0-8, with responses to the Personal Report of Public Speaking Anxiety. The PRPSA is scored from 34-170. For both measures, higher scores indicate greater public-speaking anxiety or avoidance, or greater symptom severity, as applicable.

Change is used to describe how a measured outcome differs between the baseline assessment and the later assessment. In general, studying change can focus attention on movement over the study period rather than on a single endpoint score. The registry record does not specify how the separate questions and PRPSA scores were combined, whether each score was analyzed separately, or what method was used to handle their different score ranges. Those details are not reported in the registry record.

Numeric baseline and follow-up summaries, a measure of variability, and a comparison between rehearsal groups are not reported in the registry record. Without those results, the direction and precision of any observed change cannot be evaluated from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design and endpoint description permit some general statistical context, but the registry record does not provide numerical primary-outcome results or a detailed analysis plan. The distinctions below explain what the relevant methods would mean in general; they do not imply that a particular model or procedure was used in this trial.

What does randomization contribute?

In general, random allocation is used to reduce systematic differences between groups at the start of a study. It does not guarantee identical groups, especially on every measured or unmeasured characteristic. The randomized comparison is most informative when participants are analyzed according to their assigned group and outcome data are collected and handled consistently. The registry record says the study was randomized, but does not report the allocation sequence, concealment procedures, or analysis population used.

What does a mean represent?

The primary outcome is described as a mean of a continuous measure. In general, a mean summarizes the average observed score in a group. It does not show how scores are distributed or whether participants' responses are tightly clustered or widely spread. The standard deviation describes the spread of observations around the mean, but does not itself show the uncertainty in the estimated mean or group contrast. The registry record names standard deviation as the dispersion measure, but reports no primary-outcome means or standard deviations.

Why does the outcome definition matter?

The primary description includes two self-reported questions scored from 0-8 and the PRPSA scored from 34-170. Higher scores reflect greater public-speaking anxiety and avoidance or greater symptom severity. Because the scales have different ranges, an analysis needs a clear definition of whether each is reported separately, combined, transformed, or otherwise summarized. The registry record does not report that definition. It also says the primary outcome has several categories or time points and is not reduced to one comparison. This prevents a reader from identifying a single reported endpoint contrast from the record.

What would an estimated contrast say?

In general, a between-group contrast compares outcomes for the randomized conditions. For a change endpoint, the analysis must clarify whether it compares mean changes, compares follow-up values while accounting for baseline, or uses another approach. These methods can answer related but not identical questions, and their interpretation depends on the specified model and data. The registry record does not report which approach was used, nor does it report an estimate for the contrast.

A confidence interval communicates statistical uncertainty around an estimate. A narrow interval indicates greater precision under the model assumptions; a wide interval indicates less precision. It is not a guarantee that the true effect lies inside the interval, and it does not replace consideration of the endpoint's meaning or study limitations. No confidence interval is reported for the primary comparison in the registry record. No p-value or other inferential result is reported there either.

Why can missing outcomes affect interpretation?

When outcome measurements are unavailable for some participants, the analysis may represent a different set of participants from the group initially randomized. The implications depend on why data are missing, how many observations are missing for each outcome, and the method used to address missingness. In general, complete-case analysis uses participants with the required measurements, while other methods may use additional assumptions or information. The registry record mentions participants who were lost to follow-up, withdrew, or did not follow study instructions, but does not report the analysis method or a complete accounting by endpoint.

What do planning illustrations mean?

In general, a sample-size illustration describes how many participants per arm might be needed under stated assumptions about the effect, significance level, allocation, and model. It is a planning calculation, not an estimate of the trial's observed power and not a substitute for the observed effect and its uncertainty. The record's planning description says the illustration uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and a fraction of the observed effect. Those assumptions describe an illustration rather than the trial's own design justification. The sample-size justification is not reported in the registry record.

Over-dispersion is a general issue for count outcomes when variability exceeds what a simple model assumes; accounting for it can prevent uncertainty from being understated. The primary endpoint is described as continuous, and the registry record does not report that an over-dispersed count model was used. More broadly, model choice should follow the outcome type, data structure, and prespecified question. The statistical plan, model diagnostics, covariate adjustment, and interim-analysis procedures are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists six outcome measures and names learning rate, relief rate, change in positive affect, and change in reward sensitivity among the secondary outcomes. Change in reward sensitivity appears twice in the listed secondary outcomes. The record does not explain whether the repeated label reflects separate measures, separate time points, or a duplicate entry. It also does not report a multiplicity adjustment or a hierarchy specifying which secondary analyses should be treated as confirmatory. Without such information, multiple outcome tests could increase the chance of at least one apparently notable result by chance; that is a general statistical concern, not a claim about this trial's findings.

The record lists zero analysis entries. A detailed statistical analysis plan, including how the primary outcome's several categories or time points were handled, is not reported in the registry record. No analysis population, covariate set, or method for handling repeated observations is specified there.

The primary-outcome population description says 42 participants in each group completed baseline measures. It then reports post-exposure measures for 38 participants in the positive group and 40 in the neutral group, followed by a note that 6 were lost to follow-up, withdrew, or did not follow study instructions. The description is incomplete and does not fully explain the relation among these statements. It also mentions 38 participants in the positive group and 37 in the neutral group in a further incomplete statement. The outcome or analysis to which those latter counts refer is not clear from the registry record.

Reasons for missing data, outcome-specific missingness, and the method used to address missing observations are not reported in the registry record. These omissions limit assessment of whether the analyzed participants represent the randomized groups and how sensitive the results might be to missing-data assumptions.

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.

The adverse-event record lists 44 participants at risk in the Positive Rehearsal group and 44 in the Neutral Rehearsal group. For each group, the registry record reports zero serious adverse events, zero other adverse events, and zero deaths. These are the posted counts for the categories recorded; they should not be read as a comparison of the rehearsal strategies' effects on the primary anxiety outcome.

Zero recorded events means no events were entered in those categories in the registry record. It does not show how events were defined, how actively they were collected, or how long participants were monitored for safety. The event-collection timeframe, definitions, and further safety details are not reported in the registry record. The figures therefore describe the safety reporting available in the record, rather than establishing that no other unwanted experiences occurred.

The at-risk counts are reported by group and should not be used to infer outcome-completion counts. The primary-outcome description gives different assessment counts and is incomplete. Safety counts and endpoint-analysis populations answer different questions, and the registry record does not provide enough detail to reconcile them.

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

The record supports a description of the study question and its design: a randomized, parallel-group behavioral comparison of positive and neutral rehearsal after public-speaking exposures. It also identifies change in public-speaking anxiety as the primary outcome and names several secondary outcomes concerning relief, learning, positive affect, and reward sensitivity.

The record does not report numerical results for the primary endpoint. It gives no group means, standard deviations, between-group estimate, confidence interval, or inferential test for the primary comparison. Therefore, the record does not show whether anxiety scores changed in either group, how the groups compared, or how precise any difference was. This is a limitation of the posted results, not evidence that the groups were the same or that one condition was better.

The listed zero counts for serious adverse events, other adverse events, and deaths are safety-reporting figures. They do not answer the efficacy question, and the record does not provide enough detail to make broader claims about safety monitoring or unrecorded events.

A completed status is a trial-record status, not a statistical conclusion. Likewise, enrollment and group at-risk counts do not establish the number of participants included in a particular outcome analysis. The incomplete participant-flow description and absence of the analysis plan leave important questions about missing data and analysis populations unresolved.

The registry record can identify the planned comparison, the measured constructs, and the available safety counts. It cannot support a numerical conclusion about the primary outcome or the secondary questions. Any interpretation of benefit, lack of benefit, or practical importance would require outcome estimates and their uncertainty, neither of which is reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it separates exposure from what participants do immediately after exposure. The randomized comparison concerns positive-focused versus neutral rehearsal in the setting of public-speaking exposures. That design raises a focused question about whether the nature of rehearsal is associated with outcomes, while the broader study description also emphasizes relief, reward sensitivity, positive affect, and learning.

The measurement strategy spans different constructs. Public-speaking anxiety is assessed with two self-reported questions and the PRPSA, while the secondary outcomes include learning rate, relief rate, positive affect, and reward sensitivity. Keeping these constructs distinct matters: an association between relief and learning, for example, is not the same estimand as a randomized contrast in anxiety change. The registry record does not report the analyses needed to distinguish or quantify those questions.

The record also illustrates why a clear endpoint definition and analysis plan are central to interpretation. The primary outcome includes several measures or time points but is not reduced to one comparison. Without knowing how scores and time points were handled, readers cannot identify a single primary estimate or assess its uncertainty. The incomplete missing-data description adds another layer of uncertainty about which observations contributed to the endpoint results.

Finally, the separation between trial completion and result interpretability is important. The record lists the study as completed, but does not report the primary numerical findings or a statistical analysis. This means the design can be described while the central comparative result remains unassessable from the registry record.

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 interpreting the primary question is the absence of numerical outcome results. The registry record does not report the primary group summaries, a between-group estimate, its uncertainty, or an inferential result. It also states that the primary outcome has several categories or time points and is not reduced to one comparison, leaving the target contrast unclear.

The outcome description combines self-reported questions scored from 0-8 with the PRPSA, scored from 34-170, but does not report whether these measures were analyzed separately or combined. The record does not specify the statistical model, baseline handling, covariate adjustment, or approach to repeated measurements. The detailed analysis plan and sample-size justification are not reported in the registry record.

Participant-flow information is incomplete. The record reports baseline and post-exposure assessment counts and mentions loss to follow-up, withdrawal, or failure to follow study instructions, but does not fully connect these counts to specific analyses. It also includes a further pair of group counts in an incomplete population statement. Reasons for missing measurements and methods for handling missingness are not reported.

The arm descriptions are incomplete, and the record does not say who was masked. It does not report allocation concealment or the randomization implementation. The sample-size description is a planning illustration based on a fraction of the observed effect, not the trial's design justification. These limitations make it difficult to assess the reproducibility of the intervention procedures, the analysis, and the precision of any comparison.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Reward Processes and Rehearsal in Exposure Therapy — NCT06132425.
• Registry record last updated 2025-06-13; status last verified 2025-05.
• Results first posted 2025-06-13.
• 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

NCT06132425 is a completed, randomized, single-masked, parallel-group behavioral trial titled Reward Processes and Rehearsal in Exposure Therapy. The sponsor is the University of California, Los Angeles. The record lists Anxiety Disorders and Public Speaking Fear, with an enrollment of 88 and phase NA.

Participants completed public-speaking exposures over two sessions and were assigned to positive or neutral rehearsal after exposures. The primary outcome is change in public-speaking anxiety from baseline through study completion, over an average of 3 weeks. Secondary outcomes include learning rate, relief rate, change in positive affect, and change in reward sensitivity.

The primary numerical results, statistical analysis plan, and full missing-data methods are not reported in the registry record. The adverse-event record lists zero serious adverse events, zero other adverse events, and zero deaths in each group.