Effect of Telehealth Mindfulness on Sleep and Anxiety in Acquired Brain Injury Population: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of Telehealth Mindfulness on Sleep and Anxiety in Acquired Brain Injury Population (NCT06717399), a na na study. The primary outcome is Pittsburgh Sleep Quality Index (PSQI).

2. Clinical Question

The study description also names anxiety as a question of interest, measured with the PROMIS Anxiety Short Form. The registry record does not report the results for that measure. The primary outcome is a within-person pre- and post-program question: whether PSQI scores differ across the two assessment times among participants in the single group. That question is distinct from whether the program caused any observed change. Without a separate comparator group, changes across time cannot be distinguished from changes that might have occurred for other reasons, including the passage of time or other experiences during the study period.

3. Trial Design

This is a completed pilot study of mindfulness meditation delivered by telehealth to people with acquired brain injury. The registry record identifies a single-group model, enrollment of 12, and no allocation scheme. It describes one intervention: mindfulness meditation. No separate control group is listed, and the record notes that the arms are not a like-for-like control comparison. The study is therefore not a randomized comparison.

The intervention description plans eight mindfulness meditation sessions over 4 to 5 weeks, with two sessions each week. Each session is described as 30 minutes, made up of an introduction, guided meditation, and educational discussion. Participants were also expected to complete two additional sessions for pre- and post-test measurements. The record describes baseline assessment before the intervention and a post-test after completion of the sessions, up to 5 weeks.

The primary outcome is the PSQI, reported as a mean on a scale. The study description also identifies anxiety, assessed with the PROMIS Anxiety Short Form, as a question of interest. The registry record lists three outcome measures and two analyses, but does not report enough detail to identify the full analysis set or statistical procedures. The phase is listed as not applicable. The registry status is completed; that status does not establish that every enrolled participant completed all intervention sessions or assessments. Completion and adherence details are not reported in the registry record.

The study began on 2025-01-13, and primary completion is listed as 2025-05-02. The sponsor is Saint Joseph's University, Philadelphia. Those administrative details describe the trial record, not the outcome evidence. Because the design has one group and no concurrent control, the central statistical evidence would be the observed pattern of paired measurements, together with its uncertainty and the number of participants contributing data. Those outcome values 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.

Before assignment: Participants were only included in the study if they met the inclusion criteria. They were eligible for this study if they had a known diagnosis of acquired brain injury, scored 19 or below on the SOMCT, were 18 years or older, could speak and comprehend English, and had access to an internet connection and an electronic device. Participants were excluded from the study if they had a diagnosis of aphasia.

Overall Study

Reasons for not completing this period:

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 Pittsburgh Sleep Quality Index (PSQI), measured over Pre-test Before the start of the intervention (baseline) and Post test after the completion of 8 sessions of mindfulness meditation, up to 5 weeks.

The primary endpoint is the Pittsburgh Sleep Quality Index (PSQI), a self-rated questionnaire used to assess sleep disturbances and sleep quality. Its 19 questions contribute to seven subcategories. Responses use a scale from 0 to 3, and the total score ranges from 0 to 21. A score higher than 5 is described in the registry record as indicating poor sleep quality.

The endpoint is assessed before the intervention and after completion of the eight mindfulness meditation sessions, up to 5 weeks. The registry record specifies a mean as the summary measure and standard deviation as the measure of dispersion. The mean describes the group’s average score, while the standard deviation describes the spread of scores around that average. Together, these summaries can describe the group’s measured sleep quality at each assessment, but they do not by themselves show how individual participants changed.

A pre- and post-intervention measure is relevant to the study question because it captures sleep scores at both times in the same study group. However, the registry record does not report the actual PSQI means, standard deviations, participant-level changes, or an estimated pre-post effect. It therefore does not establish the direction or magnitude of any change. Nor can the single-group endpoint alone establish that any change was caused by the mindfulness program.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the primary measure as a continuous score summarized by a mean and standard deviation. It does not report the statistical test, model, confidence interval, or other inferential method used for the PSQI analysis. The explanations below describe general statistical concepts relevant to this kind of pre- and post-intervention question; they do not identify methods used in this trial.

What does a mean describe?

In general, a mean is the arithmetic average of a set of measurements. For a continuous questionnaire score, it offers a compact description of the group’s central level at an assessment time. A mean alone does not describe how scores are distributed, whether most participants had similar scores, or whether a few scores were unusually high or low. The standard deviation gives a general sense of how dispersed observations are around the mean. It is not the same as the uncertainty around the mean, and it does not describe the pattern of changes within individuals.

Why does pairing matter?

When the same participants are assessed before and after an intervention, the observations are paired: each participant’s later score is linked to that participant’s earlier score. An analysis that uses this pairing focuses on within-person change. In general, pairing can account for the fact that repeated observations from one person are related. Comparing only group means at the two times does not reveal how many participants improved, worsened, or had unchanged scores. The registry record does not report participant-level PSQI changes or state whether the reported analyses used a paired method.

What does a confidence interval tell readers?

In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the statistical method. It communicates uncertainty about the estimated quantity, rather than a range containing a specified proportion of individual participant scores. A narrow interval indicates greater precision than a wide interval, all else being comparable. A confidence interval is not reported for the primary outcome in the registry record, so the precision of any pre-post estimate cannot be evaluated.

How should a test result be interpreted?

In general, a statistical test evaluates how compatible observed data are with a specified null hypothesis, given the method’s assumptions. A p-value is not the probability that the null hypothesis is true, and it does not quantify the size or practical importance of an effect. It should be read alongside an effect estimate and its uncertainty. The registry record does not report a p-value or the test used for the primary outcome; no test-based conclusion can therefore be drawn from the recorded information.

Why does the single-group design matter?

A before-and-after comparison can describe whether measurements changed over time in the participants who were assessed. In general, it cannot separate the intervention from other explanations for that change, because there is no concurrent comparison group to represent the same period without the intervention. This limits causal interpretation even if a precise pre-post estimate were available. The design information in the registry record identifies a single group and no like-for-like control comparison.

What is over-dispersion?

Over-dispersion is a general concern for certain types of statistical data when the observed variability is greater than a model assumes. It is most often relevant to count or binary outcomes, rather than being a default issue for a continuous questionnaire score. If a model fails to account for extra variability, its uncertainty estimates may be too small. The registry record does not identify a model or report a dispersion assessment for the PSQI; it would be inappropriate to claim that over-dispersion was tested or found in this study.

What can planning calculations say?

In general, sample-size calculations are planning tools that describe how many participants might be needed under specified assumptions about an effect and analysis. They do not measure the reliability of an observed result, and they are not observed power. The registry record says that its planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Those are illustration assumptions, not evidence that the study itself had two arms or used that design. The actual study is recorded as single-group, and no numerical planning results are reported in the registry record.

Since the primary outcome estimates and analysis details are not reported, readers cannot check the model assumptions, reproduce an analysis, or judge whether uncertainty was estimated appropriately. General statistical principles help explain what such information would mean, but they cannot replace the missing trial-specific results.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study examines more than one outcome, comparison, time point, or statistical test. In general, as the number of inferential tests increases, the chance of at least one apparently notable result can also increase if no adjustment or prespecified interpretation strategy is used. This is a reason to distinguish a clearly identified primary outcome from other questions and to report how multiple analyses are handled.

The primary outcome named in the registry record is the PSQI. The study description also raises anxiety measured with the PROMIS Anxiety Short Form. The record lists three outcome measures and two analyses, but does not explain the analysis plan, identify all outcome results, or report whether any multiplicity strategy was used. The handling of multiplicity is therefore not reported in the registry record. No inference about selective emphasis or adjustment can be made from that omission alone.

Missing-data information is also not reported in the registry record. The enrollment is 12, but the number with both baseline and post-intervention PSQI measurements is not stated. The record does not describe reasons for missing assessments, how missing values were handled, or whether analyses used all enrolled participants or a subset. These details matter because the observed pre-post estimate can depend on which participants contribute data, particularly if missingness is related to scores or study participation.

The analysis populations are not reported in the registry record. It is therefore unclear which participants were included in each analysis, whether participants who did not complete every session were retained in outcome analyses, and whether the reported assessment schedule was achieved. These are unanswered reporting questions, not evidence that data were missing or that any particular analysis population was used.

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.

For the listed mindfulness meditation group, the registry record gives 12 participants at risk for serious adverse events and 0 affected. It also gives 12 participants at risk for other adverse events and 0 affected. The record separately lists 1 death. These are the safety figures recorded for the group.

The counts describe what is recorded, not whether an event was caused by the intervention. The registry record does not report an attribution assessment or explain the circumstances of the death. A death count should not be assumed to be intervention-related or unrelated without that information. The record also does not provide additional serious adverse event terms.

Zero affected in the listed adverse event categories does not establish that no unrecorded events occurred or that the intervention is free of risk. The figures should be read alongside the number at risk, the scope of events being reported, and the limits of a small pilot. These registry entries do not provide enough detail to assess event timing, duration, severity beyond the listed serious category, or causal relationship.

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

The registry record establishes that this was a completed pilot study of a telehealth mindfulness meditation program for people with acquired brain injury, with enrollment of 12 and a single-group design. It defines a primary sleep-quality measure and a pre- and post-intervention assessment schedule. It also identifies anxiety as a question of interest. These details clarify what the study set out to examine, but they are not outcome evidence.

The PSQI results are not reported in the registry record. The available information therefore cannot show whether sleep scores changed, how large any change was, how variable it was, or how precise an estimate might be. The PROMIS Anxiety results are also not reported. The study’s completed status does not supply these missing statistical results, and enrollment alone cannot indicate a treatment effect.

Even if a pre-post change were reported, a single-group design would describe change over time without establishing that the program caused it. A concurrent comparator would be needed to help distinguish intervention-associated change from changes that could occur for other reasons. This does not erase the descriptive value of repeated measurements, but it limits causal claims.

The appropriate interpretation is therefore restrained: the registry record documents a pilot intended to examine changes in sleep quality and anxiety following a telehealth mindfulness program, but it does not report the estimates needed to judge the observed changes. It cannot support a conclusion about the direction, magnitude, precision, or cause of any outcome change. The safety entries should also be interpreted as recorded counts, without inferring causal attribution.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of how a pilot study and a clinical question must be distinguished from evidence of an outcome. Its single-group pre-post structure can be useful for describing measurements over time and for examining whether a planned assessment approach was feasible, but the registry record does not report feasibility or adherence results. A pilot label does not itself explain the study’s intended statistical role or establish how its results should be used.

The design also makes clear why an outcome estimate and its uncertainty are essential. Enrollment of 12 identifies the recorded study size, but does not say how many participants posted paired measurements or how variable those measurements were. Without the primary estimate and a measure of precision, the magnitude and stability of a possible change cannot be evaluated.

The contrast between a pre-post question and a causal treatment question is particularly important. Repeated assessments can describe what happened in the group during the study period. A single group cannot, by itself, show what would have happened to similar participants over that same period in the absence of the intervention. This limits interpretation even if the endpoint had been fully reported.

The registry record also illustrates the value of complete reporting. Outcome estimates, analysis methods, missing-data handling, participant flow, and safety attribution each answer distinct questions. Where these details are not reported, statistical interpretation should remain focused on what is documented rather than filling gaps with assumptions. The record describes a relevant research question and an intervention schedule; the reported information is insufficient to assess outcome change or make a causal comparison.

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 principal trial-specific limitation is the absence of reported outcome estimates. The registry record does not report the PSQI means, standard deviations, pre-post estimate, or uncertainty. It also does not report the PROMIS Anxiety results. As a result, the direction and magnitude of any observed change cannot be evaluated.

The single-group design has no separate control group and is not a randomized comparison. Any measured change over time could not be separated from other influences using this design alone. The registry record also does not report whether participants completed the planned eight sessions or how many contributed data at both assessments. Although enrollment is 12, the number included in each outcome analysis is not reported.

Further limitations in interpretation arise because the analysis method, handling of missing data, analysis populations, and approach to multiple outcomes are not reported in the registry record. There is no information about the distribution of scores or individual changes. The safety record lists 1 death but does not report its circumstances or relationship to the intervention; causal attribution should not be inferred.

The intervention is described as telehealth mindfulness meditation delivered over 4 to 5 weeks, but the record does not establish the degree to which the planned schedule was achieved. These reporting gaps constrain both the descriptive account of participant outcomes and any assessment of the intervention’s effects. They do not establish that the study was conducted improperly; they identify information not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Effect of Telehealth Mindfulness on Sleep and Anxiety in Acquired Brain Injury Population — NCT06717399.
• Registry record last updated 2025-08-13; status last verified 2025-08.
• Results first posted 2025-08-13.
• 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

NCT06717399 is a completed, single-group pilot study sponsored by Saint Joseph's University, Philadelphia. It enrolled 12 people with acquired brain injury and examined a telehealth mindfulness meditation program planned as eight sessions over 4 to 5 weeks.

The primary outcome is the PSQI, assessed before and after the program and summarized as a mean with standard deviation. The study description also names anxiety measured by the PROMIS Anxiety Short Form. The registry record does not report the outcome results, analysis methods, missing-data handling, or analysis populations.

The listed safety entries include 0 participants affected by serious adverse events, 0 affected by other adverse events, and 1 death. The record does not report attribution details for the death. The single-group design does not provide a concurrent control comparison, so causal interpretation is limited.