A Randomized Controlled Trial of an Exposure-Based Treatment for Perfectionism: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Randomized Controlled Trial of an Exposure-Based Treatment for Perfectionism (NCT05351710), a randomized na study. The primary outcome is Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale.

2. Clinical Question

This question concerns a self-reported dimension of perfectionism: concern over mistakes. The trial compares two behavioral conditions rather than comparing treatment with no study activity. The stress-management condition therefore provides an active comparator with its own computerized content and repeated sessions. Any interpretation of a group difference would need to consider the contrast between these particular conditions, the outcome measure, and the time points assessed.

The registry identifies the study as randomized, with parallel groups and no masking. It reports 43 participants at risk for adverse events in the exposure-based arm and 42 in the stress-management arm. Those figures describe the safety groups, not necessarily the number with primary-outcome data at every assessment. The registry says primary-outcome counts differed over time because of dropout. It does not report outcome estimates, group-specific changes, uncertainty intervals, or a statistical test. Consequently, the clinical question is identifiable, but its answer cannot be inferred from the registry record.

3. Trial Design

The registry describes a randomized, parallel-group behavioral trial sponsored by Florida State University. The study is marked completed. The listed start date is 2022-08-30 and the primary completion date is 2022-12-01. Enrollment is recorded as 85. The phase is listed as NA, and masking is listed as none. Further details about the randomization procedure, allocation concealment, or the reason masking was not used are not reported in the registry record.

One group received the Exposure-Based Treatment for Perfectionism. The description characterizes it as a computerized intervention delivered at home over 2 weeks, with treatment sessions every 2 days and 8 sessions total. The other group received the Stress Management Condition, also computerized and home-based over 2 weeks, with 8 sessions every 2 days. Its videos addressed health habits, including nutrition, exercise, and sleep, alongside relaxation videos. These descriptions identify the intended activities; adherence and the amount of intervention actually received by each participant are not reported in the registry record.

The primary outcome was the Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale. The listed assessment schedule was baseline, post treatment at 2 weeks, and follow-up at 6 weeks. The subscale is described as a self-report questionnaire with 9 items and scores ranging from 9 to 45; higher scores signify higher levels of perfectionism. The registry notes that the number of participants differed at each time point because of dropout.

Five secondary outcomes are named: the Center for Epidemiological Studies Depression Scale (CES-D), Generalized Anxiety Disorder-7, Social Phobia Inventory (SPIN), ED-15, and Irrational Procrastination Scale. The record lists 6 outcome measures in total. It reports no outcome analyses. Details of the planned statistical model, the primary contrast, handling of repeated measurements, and analysis populations are not reported in the registry record. The record also does not describe whether follow-up assessments were completed by all participants or how missing assessments were handled.

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

Analysis population for the primary outcome, as defined in the registry: Number of participants differed at each time point due to drop out.

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.

6. Primary Endpoint

The registry lists the primary outcome as Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale, measured over Baseline, post treatment (2 weeks), and follow-up (6 weeks).

The primary endpoint is the Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale. It is a self-report measure intended to assess levels of perfectionism, focusing on concern over mistakes. The subscale contains 9 items, and the registry describes scores ranging from 9 to 45, with higher scores signifying higher levels of perfectionism.

A continuous score retains more information about a participant’s reported level than a simple category such as improved or not improved. In general, a scale like this can be used to compare average scores between randomized groups or to examine how average scores change across assessments. The registry identifies the outcome parameter as a mean and its dispersion as a standard deviation. Those are descriptions of the planned or reported form of the measure, not trial results: no group means, standard deviations, changes, or comparative estimates are reported in the registry record.

The recorded assessment times are baseline, post treatment at 2 weeks, and follow-up at 6 weeks. Repeated assessment can describe scores at the end of treatment and at a later follow-up, but interpretation depends on the analysis and on how many participants contributed data at each time. The registry explicitly notes that the number of participants differed at each time point because of dropout. It does not report the count with outcome data at each assessment or the way missing measurements were addressed.

This outcome is relevant to the trial’s stated focus because it measures concern over mistakes, a dimension of perfectionism. It does not, by itself, describe every aspect of perfectionism or broader mental health. The registry lists several secondary measures, but does not report their results either.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical interpretation of this trial begins with the distinction between a study design and a study result. The registry describes randomization, two parallel behavioral groups, a continuous primary outcome, and repeated assessment times. It does not report the statistical analyses or outcome estimates. As a result, general statistical concepts can explain what an analysis could mean, but they cannot fill in the missing trial findings.

What does a mean describe?

For a continuous measure, the mean describes the average score in a group. The registry identifies the primary outcome parameter as a mean and its dispersion as a standard deviation. In general, a standard deviation describes how spread out individual scores are around their group mean. Means and standard deviations would help readers understand both the central score and the variation among participants. Neither is reported for the primary outcome in the registry record.

A comparison could focus on the difference in average scores between the randomized groups at a particular assessment, or on changes over time. These are not interchangeable descriptions. A baseline-adjusted comparison, a comparison of change scores, and a model of measurements across time can target different quantities and rely on different analysis choices. The planned approach and primary contrast are not reported in the registry record, so the intended estimand—the precise treatment effect the analysis was meant to estimate—cannot be identified from the record.

Why does a confidence interval matter?

In general, a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the statistical method. It gives a range of values compatible with the data and method, rather than a guarantee that the true effect lies in that range. A narrow interval indicates more precision than a wide interval, while an interval that includes values pointing in different directions may leave the direction uncertain. No confidence interval for this trial’s primary outcome is reported, so neither the estimate nor its precision can be assessed.

A p-value, when reported, describes how unusual the observed data would be under a specified null hypothesis and analysis model. It does not measure the size or practical importance of an effect. The registry record reports no p-value or other test result. It also does not report the statistical plan needed to determine which hypothesis or model a test would have addressed.

How should repeated assessments be understood?

The primary measure was listed for baseline, post treatment at 2 weeks, and follow-up at 6 weeks. In general, repeated measurements can be analyzed with methods that account for the fact that observations from the same participant are related. Such methods can estimate patterns over time and compare groups while representing within-person correlation. Other approaches may compare groups separately at each assessment or use change from baseline. The choice affects the question being answered and how uncertainty is calculated. The registry does not report which method, if any, was planned or used.

Different numbers of participants contributed at different time points because of dropout. In general, missing observations can reduce precision and can also introduce bias if the probability of missingness is related to participants’ outcomes or characteristics. Methods for missing data rely on assumptions; they do not make dropout irrelevant. The record does not report the number assessed at each time point, reasons for dropout, or any imputation or sensitivity analysis. The consequences of missing data therefore cannot be quantified from the registry record.

Why does over-dispersion matter?

Over-dispersion is a general issue for count outcomes when their variability exceeds what a simple count model assumes. It can make standard errors too small if ignored, leading to confidence intervals that are too narrow and tests that appear more conclusive than warranted. The primary outcome in this trial is described as a continuous scale score, not a count outcome, so over-dispersion is not the central issue for that endpoint. This general concept does not establish which methods were used in the trial.

For a continuous score, other modeling considerations may matter, including the distribution of scores, the relation between baseline and follow-up scores, and the handling of repeated observations. The registry record does not report diagnostic checks, model specifications, or analytic decisions on these matters. No particular model should be inferred from the outcome’s being continuous.

What can sample-size illustrations say?

In general, a sample-size calculation estimates how many participants a future study might need under assumptions about the effect to detect, variability, allocation, significance level, and desired power. Such a calculation is a planning illustration, not a measure of the power actually achieved in a completed trial. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation, and a normal approximation, with target effects expressed as fractions of the observed effect. The assumptions also distinguish participants per arm from total events for time-to-event outcomes. The primary endpoint in this trial is continuous.

The planning assumptions do not substitute for a reported treatment effect or an analysis. No outcome effect estimate is reported in the registry record, and no trial-specific sample-size justification is reported there. Planning illustrations based on an observed effect should not be read as observed power or as evidence that the trial was adequately powered. Without the underlying outcome estimates and interval estimates, the precision of the trial’s comparison cannot be judged.

What does randomization contribute?

In general, random allocation aims to make the groups comparable in expectation, including with respect to characteristics that are measured and those that are not. It supports causal interpretation when allocation is implemented as intended and when outcome measurement, follow-up, and analysis are handled appropriately. Randomization does not guarantee identical groups in a particular trial, prevent differential dropout, or correct errors in measurement. The record states that allocation was randomized but does not detail sequence generation or concealment, and it does not report a baseline comparison or an outcome analysis.

The record’s lack of masking is also relevant to interpretation. In general, awareness of assignment can influence behavior, expectations, and self-reported responses. That possibility is not evidence that bias occurred; it is a design consideration. The record does not describe whether outcome assessors were masked or whether any other safeguards were used. No statistical method can be assumed from these design labels alone.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and five secondary outcomes, for 6 outcome measures in total. The secondary measures address depression, generalized anxiety, social phobia, ED-15, and irrational procrastination. The record does not report a multiplicity plan, such as whether one outcome was designated as the sole confirmatory test, whether secondary outcomes were exploratory, or whether any adjustment for multiple comparisons was planned. It also reports zero analyses, so there are no posted tests from which to assess how multiple outcomes were handled.

In general, testing many outcomes or time points can increase the chance of at least one apparently notable result when all are treated as separate tests. A prespecified hierarchy or multiplicity adjustment can help define how evidence should be interpreted. These are general statistical considerations; no specific procedure can be attributed to this trial from the registry record. The presence of multiple outcomes alone does not indicate that an adjustment was or was not necessary.

Missing outcome data are a separate concern. The registry states that the number of participants differed at each primary-outcome time point because of dropout. It does not report counts with observed scores at each time, reasons for missingness, the extent of dropout by group, or the analysis population. It also does not describe whether analyses followed randomized assignment, included only participants with observed data, or used another population definition.

In general, complete-case analysis, imputation, and likelihood-based repeated-measures methods can make different assumptions about missing data. Sensitivity analyses can examine whether conclusions depend on those assumptions. None of these approaches or checks is reported in the registry record. The stated variation in participant counts therefore matters, but its statistical effect cannot be determined without the missing-data details and outcome results. No conclusion about the robustness of a treatment comparison can be drawn from the posted record.

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 registry lists 43 participants at risk for serious adverse events in the Exposure-Based Treatment for Perfectionism group and 42 in the Stress Management Condition group. It records zero serious adverse events in each group. The corresponding other-adverse-event counts are also zero in both groups, and the death count is zero in both groups. No serious adverse event terms are listed.

These figures are counts as recorded in the registry. They do not describe the method or period used to collect events, the event definitions, the process for deciding whether events were related to an intervention, or the completeness of reporting. Those details are not reported in the registry record. The figures should not be interpreted as proof that no adverse experiences occurred; they indicate that none were reported in these categories in the posted record.

The at-risk counts are the denominators associated with the registry’s safety entries. They should not be substituted for the number of participants contributing primary-outcome data at each time point, because the registry notes that outcome counts varied over time due to dropout. The record does not report additional safety analyses or a detailed account of non-serious events.

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

The record establishes that a randomized parallel-group trial compared a computerized exposure-based intervention for perfectionism with a computerized stress-management condition. It identifies the Concern Over Mistakes subscale as the primary outcome and lists baseline, post-treatment at 2 weeks, and follow-up at 6 weeks as assessment times. It also describes the basic content and schedule of both interventions and reports the study as completed.

Those design details do not establish what happened to participants’ scores. The registry record does not report primary-outcome means, group differences, changes, confidence intervals, or statistical tests. It also does not report results for the secondary outcomes. The absence of posted analyses is not evidence that the interventions had identical outcomes, nor is it evidence of a difference. It means the comparative result cannot be assessed from this record.

Even if an estimate were available, its meaning would depend on the measure and comparison. The primary scale concerns mistakes and is self-reported; it does not cover every aspect of perfectionism or mental health. The comparator is an active stress-management program, so the relevant contrast would be between those two conditions as delivered, not between the exposure-based treatment and no activity. Outcomes at post-treatment and follow-up would answer questions about different assessment times.

The registry notes dropout and varying participant counts at outcome time points. Missing observations can affect both the amount of information and the interpretation of a comparison, depending on why data are missing and how analysis handles them. Those details are not reported. The record also lists no masking. These are considerations when evaluating a future report of results, but they do not establish that any particular bias occurred.

The safety entries list no serious adverse events, other adverse events, or deaths in either group. They should be read as registry-reported counts with the limitations of the safety information described in the record. Taken together, the posted information permits a description of the study question and design, but not a conclusion about the size, direction, precision, or clinical importance of comparative outcomes.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it combines random allocation with a repeated, continuous self-report outcome. That design raises familiar questions about what comparison is being estimated, how scores are modeled across time, and how uncertainty should be represented. The registry identifies the groups and assessment schedule, allowing those questions to be framed, but does not report the analysis that would answer them.

The primary outcome is measured at baseline, post treatment, and follow-up. In general, repeated measures can provide information about both the level of scores and their pattern over time. They also require attention to the relationship between measurements from the same participant and to missing observations. Here, the registry explicitly notes dropout and varying numbers of participants across time points, making follow-up completeness an important part of any interpretation.

The comparison is between two computerized behavioral conditions, both delivered at home on a repeated schedule. This matters statistically because the contrast is specific to these intervention packages. It is not a comparison against no treatment, and results—if reported—would need to be interpreted in terms of the difference between the assigned conditions.

The record also illustrates the difference between planning assumptions and trial findings. A sample-size illustration can describe what a calculation would imply under stated assumptions, but it is not observed power and does not replace an effect estimate with uncertainty. The registry gives assumptions for such planning calculations but does not provide outcome analyses or a trial-specific sample-size justification.

Finally, the lack of posted results is itself consequential for statistical interpretation. Without estimates and uncertainty intervals, readers cannot judge whether the data are compatible with a small or large difference, or how precisely the groups were compared. The design is described, but the inferential evidence remains unavailable in 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 most direct limitation is that the registry record reports no outcome analyses. It does not include the primary endpoint results or secondary outcome results, so comparative effects and their precision cannot be assessed. The absence of results also prevents checking whether the reported findings, if any, align with the stated primary measure and assessment schedule.

The record notes that primary-outcome participant counts differed at each time point due to dropout, but does not give the counts at each assessment, reasons for dropout, or the distribution of missingness by group. Without those details, it is not possible to evaluate how much information was available for each comparison or how missing data might have affected estimates.

The primary endpoint is self-reported, and the trial is listed as having no masking. The registry does not explain whether outcome assessors were masked or describe procedures to reduce expectation effects. This combination is a potential interpretive consideration, not proof that reporting bias occurred.

Intervention descriptions give the intended schedule and broad content, but adherence, intervention fidelity, and participant engagement are not reported in the registry record. Eligibility criteria, participant demographics, baseline outcome summaries, and the basis for the enrollment target are also not reported. These omissions limit assessment of who was studied, how similar the groups were at baseline, and how the results might apply to other settings or populations.

The record does not report the statistical plan, analysis population, model for repeated measurements, multiplicity approach, or missing-data methods. It also does not describe adverse-event collection procedures or definitions. These omissions limit appraisal of both the intended analysis and the completeness of safety reporting. The listed registry status is completed, but completion status alone does not provide the missing outcome evidence.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Randomized Controlled Trial of an Exposure-Based Treatment for Perfectionism — NCT05351710.
• Registry record last updated 2024-08-07; status last verified 2024-07.
• Results first posted 2024-07-15.
• 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 NCT05351710, a completed randomized, parallel-group trial sponsored by Florida State University. Enrollment is recorded as 85. The study compared a 2-week computerized exposure-based treatment for perfectionism with a 2-week computerized stress-management condition; both involved 8 at-home sessions completed every 2 days. Masking is listed as none.

The primary outcome was the FMPS Concern Over Mistakes subscale, assessed at baseline, post treatment at 2 weeks, and follow-up at 6 weeks. The record notes that participant counts varied by time point because of dropout. Five secondary outcomes are listed. No analyses or outcome results are reported in the registry record.

The safety entries list zero serious adverse events, zero other adverse events, and zero deaths in both groups. The record does not report the statistical plan, missing-data methods, or multiplicity approach. It therefore describes the trial’s design and endpoints but does not permit assessment of comparative outcome estimates or their precision.