Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability (NCT03421964), a randomized na study. The primary outcome is Number of Subjects Completing the Two Structured Outpatient Intervention Programs Resilience and Adjustment Intervention (RAI) vs. RAI With Follow-up Booster Sessions (RAI+) on Resilience.

2. Clinical Question

The study record describes an evaluation of RAI and RAI+ for resilience, emotional well-being, postinjury adjustment, and abilities such as problem solving, communication, and stress management. It also states an aim of examining whether demographic, lifestyle, injury, or treatment-response information can predict maintenance of gains. Those aims are broader than the primary outcome measure actually posted: a count of participants, rather than a direct resilience score or a comparative change in resilience.

The primary result therefore addresses a narrow question about completion, not the full set of aims. Secondary outcomes include measures of adaptability, psychological distress, and stress, recorded as change from baseline to follow-up. Those outcomes offer additional information about participant-reported measures but do not make the completion count a direct measure of resilience. The registry does not report a sponsor analysis for the posted outcomes, and its primary outcome description does not fully resolve whether the count refers to completing treatment sessions or completing an assessment.

3. Trial Design

The record identifies NCT03421964 as a completed study sponsored by Virginia Commonwealth University. It lists traumatic brain injury as the condition, enrollment of 184, a start date of 2018-02-16, and a primary completion date of 2023-05-25. The phase is listed as NA.

The allocation field says randomized, and the record lists two behavioral programs: Resilience/Adjustment Counseling and Resilience/Adjustment Counseling with Booster Sessions. Masking is listed as none. At the same time, the model field says single group. These entries do not form a fully clear account of the design: the record does not explain how the single-group model relates to the listed randomized allocation and two arms. The reader should therefore distinguish the registry’s stated design fields from any stronger characterization that would require clarification.

The RAI is described as a seven-session intervention, with two or three topics covered during each 60-minute session. Its stated approach includes skill-building, psychological support, and education. For RAI+, the registry describes three additional 60-minute virtual booster sessions, scheduled three months after completing the seven initial sessions.

The primary outcome timeframe is described as data collection after the seventh treatment session and at 3,4 and 9 months post-treatment. The secondary outcomes use a different stated timeframe: change from baseline to follow-up 11 months after baseline. The record does not report the randomization procedure, allocation concealment, participant flow, the number assigned to each arm, or a detailed account of the analysis populations. It also does not explain whether all listed time points were observed for every participant.

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: Number of participants who have completed the treatment sessions for each arm

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: Subjects enrolled

6. Primary Endpoint

The registry lists the primary outcome as Number of Subjects Completing the Two Structured Outpatient Intervention Programs Resilience and Adjustment Intervention (RAI) vs. RAI With Follow-up Booster Sessions (RAI+) on Resilience, measured over Data collection will be after the 7th treatment session and at 3,4 and 9 months post-treatment.

The primary endpoint is titled as a count of participants completing the two structured outpatient programs. Its unit is participants, and the registry description says it is quantitatively measured by the number of subjects who completed the assessment for each arm. The population description instead refers to participants who completed the treatment sessions. This leaves an important operational ambiguity: the registry does not make clear whether the posted count represents completion of treatment, completion of an assessment, or a relationship between those two events.

A completion count can describe participation or retention in a program. It does not, on its own, measure how much resilience changed, whether emotional well-being changed, or whether gains were maintained. The study’s stated aims include efficacy on resilience, but the primary outcome as posted is a count rather than a resilience score. That distinction matters when interpreting the result: the count can address how many participants met the recorded completion criterion, but it cannot establish the size of a change in resilience.

Completion outcomes may be useful alongside measures of participant status, especially when an intervention involves a sequence of sessions. However, the registry record does not explain why this count was selected as the primary endpoint or how completion was defined consistently across arms. Without that definition, the result should be read as the posted count comparison, with the endpoint-label ambiguity kept in view.

7. Results Posted in the Registry

• Resilience/Adjustment Counseling With Booster Sessions: 0.0% (0/16) versus 60.0% (12/20) on control; risk difference -60.0 percentage points (95% CI -81.5 to -38.5); unadjusted two-proportion z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Mayo Portland Adaptability Inventory-4 (MPAI-4)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Resilience/Adjustment Counseling With Booster Sessions: mean -4.42 versus -3.07 on control; difference -1.35 (95% CI -3.42 to 0.72), standardized effect d = -0.23; z-test p = 0.201.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Resilience/Adjustment Counseling With Booster Sessions and the control. The interval gives the range of effects that remain compatible with the data.

Brief Symptom Inventory-18 (BSI-18), 18-item Self-report Instrument Was Developed to Quantify Psychological Distress in the General Population

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Resilience/Adjustment Counseling With Booster Sessions: mean -7.72 versus -7.60 on control; difference -0.12 (95% CI -3.71 to 3.47), standardized effect d = -0.01; z-test p = 0.948.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Resilience/Adjustment Counseling With Booster Sessions and the control. The interval gives the range of effects that remain compatible with the data.

13 Item Stress Test

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Resilience/Adjustment Counseling With Booster Sessions: mean -1.90 versus -1.47 on control; difference -0.43 (95% CI -1.38 to 0.52), standardized effect d = -0.17; z-test p = 0.376.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Resilience/Adjustment Counseling With Booster Sessions and the control. The interval gives the range of effects that remain compatible with the data.

Across the secondary measures, the registry reports mean changes from baseline to follow-up 11 months after baseline. The booster arm’s mean change is numerically more negative for each of the three measures, but the record does not state how the direction of change should be interpreted for each scale. A more negative change therefore cannot automatically be described as improvement or worsening. The comparison intervals all include zero, and the unadjusted p-values do not provide clear evidence of an arm difference on these outcomes.

These secondary results add a different perspective to the primary completion count, rather than confirming or contradicting it directly. Completion is a count-based outcome, whereas the secondary measures concern average change in adaptability, psychological distress, and stress. A difference in one kind of outcome does not establish a corresponding difference in another. The timeframes also differ: the primary outcome description refers to post-session and post-treatment collection points, while the secondary outcomes refer to follow-up 11 months after baseline.

The secondary comparisons are unadjusted, and the registry lists no sponsor-reported analyses for them. When multiple outcomes are examined, the chance of obtaining at least one apparently notable result can increase if each is tested separately without accounting for multiplicity. This is a general concern, not a claim that any particular finding is false. The record does not report whether the secondary outcomes were prespecified in a hierarchy, whether multiplicity adjustments were used, or how these outcomes were intended to support the primary question.

For these reasons, the secondary findings are best treated as exploratory context rather than independent confirmation of the primary result. Their intervals and estimates show uncertainty, and the registry does not provide enough information to establish how missing observations, repeated measurements, or multiple comparisons were handled.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Mayo Portland Adaptability Inventory-4 (MPAI-4)
• Brief Symptom Inventory-18 (BSI-18), 18-item Self-report Instrument Was Developed to Quantify Psychological Distress in the General Population
• 13 Item Stress Test

9. Statistical Interpretation

10. Statistical Methods Explained

What does the primary risk difference represent?

A risk difference compares the observed proportions with the recorded outcome in two groups by subtracting one group’s proportion from the other’s. In this record, the comparison is expressed for RAI+ relative to RAI, so the negative estimate indicates a lower observed proportion for the recorded primary event in RAI+ than in RAI. The estimate is -0.6. A risk difference is an absolute contrast on the proportion scale; it is not a relative risk, an odds ratio, or a count difference.

This is a simple unadjusted comparison based on the posted group counts. It does not control for other participant characteristics or account for any features of the study design beyond the arm labels. The record does not report an adjusted model or a sponsor analysis for this primary outcome. Because the endpoint wording is not fully consistent, the statistical contrast can be described precisely, while the substantive meaning of the event remains qualified by the registry’s definitions.

How should a confidence interval be read?

A confidence interval gives a range of effect estimates that are compatible with the observed data under the method used to construct it. It conveys uncertainty as well as the direction and scale of an estimate. A narrower interval indicates greater precision under that method; a wider interval indicates less precision. An interval that crosses zero for a difference does not establish that the true difference is zero. It means that zero is among the values not ruled out by that interval.

The primary comparison’s reported interval is entirely negative, while the intervals for the secondary mean differences cross zero. This distinction is consistent with the primary unadjusted p-value below 0.001 and the secondary unadjusted p-values of 0.201, 0.948, and 0.376. These p-values describe how compatible the observed comparisons are with a null difference under their respective unadjusted tests; they do not measure the probability that a treatment is effective or that the null hypothesis is true.

What do the secondary mean differences measure?

The secondary outcomes report mean change from baseline to follow-up. A mean difference compares the average change in RAI+ with the average change in RAI. The registry’s summary statistics include the mean change and standard deviation for each arm, as well as an unadjusted mean difference and its interval. Standard deviations describe variability among observations within an arm; they are not confidence intervals for the mean.

The posted mean differences are calculated from the summary statistics and are unadjusted. They do not incorporate covariate adjustment, repeated-measures modeling, or other methods unless such methods are explicitly reported. No sponsor-reported analyses are listed for the secondary outcomes. In addition, the record does not describe how the change scores were handled if a participant had a baseline or follow-up measure missing.

Why can over-dispersion matter for counts?

As a general statistical point, a count model may rely on assumptions about how variable counts are relative to their mean. If the observed variability exceeds what a model assumes, standard errors can be too small and confidence intervals too narrow unless the analysis accounts for that over-dispersion. That issue is relevant to some count outcomes, but the posted primary result is a count of participants with the recorded event and is presented as a risk difference. The registry does not report a count-regression model or an over-dispersion assessment, so there is no basis to infer that either was used.

How should the planning illustrations be used?

The record includes planning illustrations based on observed secondary effects, with assumptions of a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The calculations use stated fractions of the observed effect, and the reported planning quantities are participants per arm for 80% power or participants per arm for 90% power. These are illustrations for planning, not the trial’s own design justification, not observed power, and not evidence that the study was planned around those effects.

Planning calculations based on an observed effect are especially sensitive to uncertainty in that estimate. A small observed difference can imply a large planning requirement, while a larger observed difference can imply a smaller one. The illustrations do not resolve the design inconsistencies or missing analysis details in the registry. The sample-size justification and any prospective power calculation for this study are not reported in the registry record.

11. Confidence Intervals and Precision

The primary risk-difference estimate is -0.6, and the reported confidence interval lies entirely below zero. This makes the direction of the posted unadjusted comparison clear within the interval’s range: the observed completion event was less frequent in RAI+ than in RAI. The interval does not remove the endpoint-definition issue, however. Precision in estimating a count contrast cannot clarify whether the event was treatment completion or assessment completion when the registry uses both descriptions.

The secondary mean-difference intervals are wider in relation to their estimates and include zero. For the MPAI-4 comparison, the interval runs from -3.418 to 0.718. For BSI-18, it runs from -3.711 to 3.471. For the 13 Item Stress Test, the interval includes zero, with the posted upper endpoint recorded as 0.521; that endpoint is not repeated because it exceeds the permitted displayed precision. These intervals indicate uncertainty about the direction and magnitude of the arm differences, rather than evidence that the groups had identical changes.

Precision depends in part on the amount of information contributing to each estimate and on the variability of the outcome. The secondary summaries have different arm counts and standard deviations, and the registry does not report adjusted estimates that might account for baseline or other participant characteristics. The outcome counts also differ across summaries, but the record does not explain why, whether follow-up availability differed, or how missing measurements were handled.

Confidence intervals are not guarantees about the true effect, and their interpretation depends on the statistical method and data assumptions. The registry does not describe the methods used for sponsor analyses, and no reported sponsor analyses are listed. The intervals and p-values should therefore be read as unadjusted comparisons derived from posted summary statistics, rather than as a complete account of the analysis plan.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, including the primary outcome and three posted secondary outcomes. It does not report a multiplicity strategy, such as a hierarchy of outcomes or an adjustment for testing multiple hypotheses. Without such information, the unadjusted secondary p-values should be interpreted cautiously: they do not account for the possibility of chance findings across a set of outcomes. This general issue does not change the numerical estimates, but it affects how strongly separate nominal test results can be treated as confirmatory.

Missing-data methods are not reported in the registry record. The record does not say how participants with no follow-up measurement were handled, whether the analysis used available observations only, or whether any imputation or sensitivity analysis was performed. Counts contributing to the posted outcomes vary, but no explanation is given for the differences in contributing observations. It is therefore not possible to determine from the record whether missingness was related to arm, outcome, or participant characteristics.

Analysis populations are also not reported. The record does not specify whether the primary comparison included all randomized participants, only participants who started treatment, or a subset defined by completing an assessment or treatment sessions. The difference between the stated enrollment and the arm-specific primary outcome counts is not explained. Nor does the record describe whether secondary analyses used the same population or different available-case samples.

The randomized allocation field may suggest an intended comparison by assigned arm, but the model field says single group and the record does not resolve this discrepancy. Without a clear analysis population, participant flow, missing-data approach, and multiplicity plan, readers cannot fully assess whether the posted comparisons preserve the intended design or how robust the results are to analytic choices. These items are not reported in the registry record.

13. 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 no serious adverse events among the participants at risk in either group: 0 affected among 22 at risk for RAI and 0 affected among 26 at risk for RAI+. It also lists no other adverse events among the participants at risk in either group, with 0 affected among 22 at risk for RAI and 0 affected among 26 at risk for RAI+. Deaths are listed as 0 in both groups.

These figures describe what was recorded for the groups and risk counts stated in the registry. They should not be interpreted as proof that no adverse events occurred outside the record’s definitions, reporting period, or recorded group. The record does not list serious adverse-event terms, and it does not explain how adverse events were collected, classified, or followed over time. The safety figures are separate from the primary completion counts and should not be used to infer the number of participants included in other outcome analyses.

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

The posted primary result describes a marked difference in the recorded completion event between the two arms: 12.0 of 20.0 in RAI and 0.0 of 16.0 in RAI+. The unadjusted risk difference is -0.6, with p < 0.001 and a confidence interval entirely below zero. This is a statistical comparison of the event as recorded. Because the registry describes that event both as assessment completion and treatment-session completion, the result cannot be assigned a more specific interpretation without clarification.

The result does not by itself establish a difference in resilience, emotional well-being, postinjury adjustment, problem solving, communication, or stress management. Those are among the study’s stated aims, but the primary endpoint is a count. The secondary outcomes measure changes on different scales, and their unadjusted comparisons do not show clear between-arm differences. The record does not explain how a change in each scale should be interpreted, so the direction of the reported mean changes should not be translated into a claim of benefit or harm.

A statistically small p-value does not describe the size, practical importance, or cause of an effect. The unadjusted comparison also does not account for possible differences in participant characteristics, missing follow-up, or other analysis choices. Randomized allocation is listed, but the model field says single group, and the record does not clarify that conflict. Sponsor-reported analyses and the analysis population are not reported.

Nor does the result show that one program is generally suitable or unsuitable, or that the observed pattern would occur in other settings. The registry record supplies a limited statistical account, with incomplete endpoint and analysis details. The most defensible conclusion is specific: the posted completion counts differ between the listed arms, while the meaning of that completion event and its relation to the broader resilience aims remain uncertain.

15. Why This Trial Matters Statistically

This study is statistically interesting because its registry record juxtaposes a clear unadjusted primary comparison with less conclusive secondary comparisons, while leaving key aspects of the design and endpoint definition unresolved. The contrast highlights why a statistically distinct count outcome should not be treated as a stand-in for a broader clinical or behavioral construct. Completion, resilience, distress, adaptability, and stress are different kinds of outcomes, even when they appear within one study’s aims.

The record also illustrates the importance of alignment between research question, outcome definition, and analysis. The stated primary aim concerns resilience, but the posted primary measure is a participant count whose description alternates between assessment completion and treatment completion. That ambiguity affects what the estimate means before any statistical test is considered. A precise comparison cannot repair an unclear endpoint definition.

There is also a design-reporting issue: randomized allocation is recorded, but the model is listed as single group, and two arms are reported. Clear reporting of allocation, participant flow, analysis populations, missing-data handling, and model choice would help readers evaluate whether the comparison follows the intended design. The absence of reported sponsor analyses makes it important to distinguish posted summary-statistic comparisons from a fuller prespecified analysis.

Finally, the secondary outcome pattern underscores why confidence intervals and multiplicity matter. Intervals that include zero leave uncertainty about the size and direction of differences, while multiple unadjusted comparisons can make isolated results harder to interpret. The registry does not report how those issues were handled. These limitations do not erase the posted findings; they define what conclusions the available record can support.

16. 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.

Several limitations are specific to the information recorded for this study. First, the primary outcome description is internally ambiguous: the measure is described as the number completing an assessment, while the population description refers to completing treatment sessions. The record does not give a precise operational definition or explain whether the two descriptions refer to the same event.

Second, the enrollment figure and the group counts attached to the primary result are not reconciled. The registry does not provide participant flow showing how many were assigned, began treatment, completed each stage, or contributed to each analysis. Counts contributing to secondary outcomes also differ, without an explanation of the reasons.

Third, the design fields are difficult to reconcile. Allocation is listed as randomized, but the model is listed as single group, while results are given for two programs. The record does not explain the randomization procedure or clarify the model designation. Masking is listed as none, but no further account of who knew assignment or how outcomes were assessed is reported.

Fourth, the record does not report the statistical analysis plan, sponsor analyses, analysis populations, missing-data methods, or multiplicity strategy. It does not state how the direction of change should be interpreted for the secondary scales. The primary and secondary outcome timeframes are also described differently, and the record does not explain how the measurements align with the intervention schedule. These limitations restrict interpretation of the posted estimates and make it difficult to assess their robustness.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability — NCT03421964.
• Registry record last updated 2025-03-27; status last verified 2025-03.
• Results first posted 2025-03-27.
• 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.

20. Record Summary

NCT03421964 is listed as a completed behavioral study sponsored by Virginia Commonwealth University, with traumatic brain injury as its condition and enrollment of 184. The registry lists randomized allocation, no masking, and a single-group model, but does not explain how those design fields relate to the two reported program arms.

The primary outcome is a participant count comparing Resilience/Adjustment Counseling with the same program plus booster sessions. The posted counts are 12.0 of 20.0 and 0.0 of 16.0, respectively, with an unadjusted risk difference of -0.6 and p < 0.001. The endpoint description is ambiguous about whether completion means treatment sessions or an assessment.

Three secondary measures report change from baseline to follow-up 11 months after baseline. Their unadjusted comparisons do not show clear between-arm differences. Sponsor analyses, missing-data methods, analysis populations, and multiplicity procedures are not reported in the registry record.