Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy (NCT05427201), a randomized na study. The primary outcome is PROMIS Pain Interference Change.

2. Clinical Question

This is therefore a question about an integrated treatment approach and a repeated measure of pain interference, not a direct comparison of ACT with no behavioral treatment. Since both groups receive ACT, any between-group contrast would concern the contribution of active rather than sham rTMS within this treatment context. The registry describes feasibility as the study’s purpose and identifies functional improvement as an overall goal; it does not establish that the trial was designed to provide a definitive efficacy estimate. The numerical primary-outcome results and a single prespecified between-group estimate are not reported in the registry record. Accordingly, the clinical question can be described from the study design, but its answer cannot be inferred from the registry information alone.

3. Trial Design

The registry describes a randomized, single-masked, parallel-group study listed as completed. Enrollment is recorded as 31. The study start date is 2023-05-22, and primary completion is recorded as 2025-05-30. The phase is listed as NA. The sponsor is the VA Office of Research and Development.

One arm received active DLPFC-rTMS with ACT; the other received sham rTMS with ACT. Both arms therefore include the behavioral intervention, while the stimulation condition differs. The masking designation is single, but which people were masked is not reported in the registry record. Details of the randomization procedure, allocation concealment, treatment delivery, and adherence are not reported in the registry record.

The primary measure is PROMIS Pain Interference Change, expressed as a T-score. The registry describes measurement at baseline, weekly during the ACT intervention, and at 9 weeks (post-treatment), for a total of 10 timepoints. The registry also lists Patient Health Questionnaire-9 Change and PROMIS Pain Intensity Change as secondary outcomes. It lists three outcome measures and six analyses, but does not give the details needed to identify the analysis populations or the model used for each outcome.

The registry’s summary frames the study as an examination of feasibility and as preparation for a future randomized efficacy trial. It also describes two cognitive control tasks with concurrent electroencephalography as exploratory measures of a potential objective indicator of treatment response. Specific feasibility criteria, task results, and analysis details for those measures are not reported in the registry record. Although the study is marked completed, completion status alone does not supply the numerical results or establish what conclusions the investigators drew.

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: Of the 31 participants that met initial screening criteria and completed informed consent procedures, 5 were excluded following the psychiatric diagnostic interview, 3 declined to participate, and 4 were lost to follow-up. This left a total of 19 participants that were randomized to treatment.

Overall Study

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 PROMIS Pain Interference Change, measured over Baseline, weekly during ACT intervention, 9 weeks (post-treatment) for total of 10 timepoints.

The primary endpoint is change in PROMIS Pain Interference, reported as a T-score. The questionnaire has 8 items covering the extent to which pain interferes with areas such as mobility, social activity, and mood. Item responses range from 1, “Not at all,” to 5, “Very much”; the registry describes a raw-score range of 8 - 40 that is transcribed to a standardized T-score. Higher scores indicate greater pain interference.

The registry describes PROMIS T-scores as standardized to a reference population mean of 50 and standard deviation of 10. It notes that a 10-point difference represents one standard deviation from the reference population mean. These reference values help interpret the scale; they are not trial results and do not indicate the amount of change observed in either study arm.

Pain interference captures the effect of pain on daily functioning rather than pain intensity alone. That makes it relevant to a study whose stated overall goal is to maximize functional improvement in veterans with chronic pain and depression. The registry specifies repeated assessments: baseline, weekly during ACT, and post-treatment at 9 weeks, for a total of 10 timepoints. Repeated measurements can describe the course of scores over the intervention, but a clear treatment comparison depends on how those measurements are analyzed. The registry record does not report a single primary comparison or numerical result for this outcome.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization assigns participants to treatment groups by chance according to a study procedure. As a general statistical principle, this approach aims to make the groups comparable at the start, including with respect to factors that may be difficult to measure. Its protection depends on implementation and follow-up; the registry identifies the study as randomized but does not report the sequence-generation method or allocation concealment. The groups differ in whether rTMS is active or sham, while both include ACT. Thus, the randomized contrast is active versus sham stimulation in the context of ACT.

What does a parallel-group design mean?

In a parallel-group design, participants are assigned to one group and receive that group’s intervention during the study, rather than switching between interventions as in a crossover design. This trial is recorded as parallel. A between-group comparison can therefore address differences in outcomes between the active DLPFC-rTMS plus ACT group and the sham-rTMS plus ACT group. It cannot, by itself, isolate the effect of ACT compared with receiving no ACT, because ACT is included in both arms.

How should repeated measurements be understood?

The primary outcome is measured from baseline through weekly assessments during ACT and at post-treatment. Repeated observations can show how scores evolve over time and can use information from more than a single assessment. As a general statistical matter, measurements from the same participant are correlated; they are not independent observations. An analysis should account for this within-participant structure. The registry record does not report the model used, whether the primary comparison focused on a particular time point or an overall trajectory, or how changes from baseline were defined.

A mean is a summary of the central value of a continuous outcome. The registry identifies the primary outcome as a mean-based continuous measure and names standard deviation as its dispersion measure. Standard deviation describes how spread out individual scores are around the mean; it is not the same as a standard error or a confidence interval. A confidence interval, as a general concept, expresses uncertainty around an estimated quantity under the assumptions of the analysis. The registry does not report a primary effect estimate or confidence interval, so its precision cannot be assessed.

What does the T-score scale contribute?

PROMIS T-scores place the questionnaire results on a standardized scale. The registry describes a population reference mean of 50 and standard deviation of 10, with higher scores indicating greater pain interference. Standardization facilitates interpretation relative to that reference, but it does not replace a comparison between randomized groups. The reference mean is not the trial’s baseline mean, and the reference standard deviation is not the observed spread in this study. The registry does not report the trial’s group means or standard deviations for the primary outcome.

Why might over-dispersion matter?

As a general concept, over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model understates variability, uncertainty estimates can be too narrow and tests can appear more decisive than the data justify. The registry record does not report whether over-dispersion was assessed or whether a particular model was used for the primary endpoint. This is therefore a general consideration, not a claim about the trial’s analysis.

How should a planning calculation be read?

The sample-size assumptions described for the planning illustration use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. These are planning assumptions, not evidence about the trial’s observed efficacy and not a report of observed power. Any sample-size estimate based on an observed effect is an illustration for planning under those assumptions; it does not show how likely the trial was to detect an effect that truly existed. The numerical planning outputs and the exact fractions are not reported in the registry record. The registry also does not report the trial’s own sample-size justification or statistical plan.

The record lists six analyses, but a count does not describe their methods. It does not identify which comparisons were prespecified, how repeated measurements were handled, or whether estimates were adjusted for other variables. Those details, along with model diagnostics, missing-data methods, and analysis populations, are not reported in the registry record. Without them, the intended statistical procedure and the assumptions underlying any result cannot be evaluated.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six analyses and multiple outcomes, including a primary repeated measure and secondary measures. When researchers examine several outcomes, time points, or comparisons, the chance of obtaining at least one apparently unusual result can increase. As a general statistical principle, a prespecified analysis plan and an appropriate multiplicity strategy can help readers distinguish a primary confirmatory test from exploratory analyses. The registry record does not report whether any adjustment for multiplicity was planned or used, or which analysis was designated as the primary statistical test.

The primary outcome is recorded across 10 timepoints, and the registry notes that it is not reduced to one comparison. This leaves unclear whether the intended primary inference concerned a particular time point, a pattern over time, or another summary. The numerical estimates and uncertainty measures needed to evaluate those possibilities are not reported in the registry record.

Missing data can affect repeated-measures analyses if measurements are unavailable, particularly when missingness is related to participants’ outcomes or treatment experience. General methods make different assumptions about why data are missing; those assumptions can influence estimates. The registry record does not report the amount or pattern of missing outcome data, the method used to address it, or sensitivity analyses.

The analysis population is also not reported in the registry record. It is therefore not possible to determine whether analyses followed randomized assignment, included only participants who completed treatment, or used another population definition. These omissions limit assessment of how the planned comparisons were implemented and how robust their interpretation would be.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse-event and other adverse-event counts separately for the two arms. In the DLPFC-rTMS + ACT group, 0 serious adverse events are recorded among 10 at risk, and 6 other adverse events are recorded among 10 at risk. In the Sham-rTMS + ACT group, 0 serious adverse events are recorded among 9 at risk, and 7 other adverse events are recorded among 9 at risk. Deaths are recorded as 0 in each group.

These are posted counts, not estimates of comparative risk. They should be read in relation to the reported at-risk group sizes and the registry’s event categories. The record does not provide descriptions of the other adverse events, their severity, timing, duration, or whether an individual could contribute more than one event. It also does not report an assessment attributing events to either rTMS condition or to ACT. The absence of a listed serious adverse event or death in these counts does not establish that an intervention is free of risk, nor can the counts alone establish a difference in safety between groups.

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

The registry record describes a completed randomized study of active versus sham rTMS, with ACT in both groups, among veterans with chronic pain and depression. Its primary outcome is PROMIS Pain Interference Change, a standardized measure intended to capture how pain affects functioning. The planned repeated assessments make the course of pain interference relevant, not only a single post-treatment score.

What the posted information does not show is the numerical primary-outcome comparison. The registry explicitly indicates that the primary outcome has several time points and is not reduced to one comparison. Without group-level results, an effect estimate, or a measure of uncertainty, it is not possible to say from this record whether scores differed, in which direction, or how precisely any difference was estimated. The secondary outcome names are listed, but their results are not reported in the registry record.

The study’s description identifies feasibility and preparation for a future randomized efficacy trial as its purpose. This context cautions against treating the record as a definitive evaluation of efficacy. Feasibility findings would need to be interpreted using defined criteria and results; those criteria and results are not reported in the registry record. The record also describes exploratory cognitive control tasks with electroencephalography, but does not report their findings.

The adverse-event counts provide limited descriptive safety information. They list no serious adverse events or deaths in either arm, alongside other adverse-event counts, but do not establish causation or comparative safety. More generally, registry status and intervention descriptions cannot substitute for outcome estimates and their uncertainty. The information supports understanding what was studied and how the main measure was defined; it does not establish whether the integrated treatment approach improved outcomes.

13. Why This Trial Matters Statistically

This trial is statistically notable for the structure of its treatment comparison. Both arms include ACT, while active versus sham DLPFC-rTMS is the randomized distinction. That design can address the stimulation contrast within an ACT context, but it does not separately estimate the effect of ACT versus no ACT. Keeping this distinction clear is essential when interpreting any eventual group difference.

The primary measure reflects pain interference with daily life, including mobility, social activity, and mood. Its repeated assessment is relevant to a feasibility-oriented study because an intervention’s course may matter alongside a post-treatment score. Repeated data also require analysis that accounts for observations from the same participant being related. The registry specifies the timepoint schedule but does not report the analysis model or a single primary comparison.

The study is framed as a first step toward a future randomized efficacy trial. Statistical interpretation therefore depends not only on whether outcomes were measured, but also on whether feasibility criteria were met and whether the effect estimates are sufficiently precise to inform later research. The registry record does not report those feasibility results or a primary effect estimate. The completed status does not fill that gap.

The record also highlights the importance of transparent reporting. A clear account of analysis populations, missing data, multiplicity, and uncertainty would allow readers to assess how the repeated outcome was handled and how much confidence to place in the estimated comparison. Those details are not reported in the registry record. The study design and outcome definition can be understood, but the statistical evidence needed to evaluate comparative change is not available in the posted results.

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 this trial from the registry record is the absence of a single numerical primary-outcome comparison. The endpoint is repeated over 10 timepoints, and the registry notes that it is not reduced to one comparison. Group-specific estimates, an effect estimate, and its uncertainty are not reported in the registry record. Consequently, the direction, magnitude, and precision of comparative change cannot be evaluated.

The registry’s feasibility framing is not accompanied by reported feasibility criteria or results. Details of the randomization procedure and allocation concealment are also not reported. Although masking is designated as single, the record does not specify who was masked. These gaps prevent fuller assessment of how the study was conducted and how its design might affect interpretation.

Analysis details are limited. The registry does not report the model for repeated measurements, the analysis population, how missing data were handled, whether analyses adjusted for other factors, or whether multiplicity was addressed. It lists secondary outcomes and exploratory cognitive control tasks with electroencephalography, but their numerical results are not reported in the registry record.

The safety information is also limited to counts. Descriptions, severity, timing, and treatment attribution for other adverse events are not reported. These omissions do not show that problems occurred or that an intervention was unsafe; they mean that the registry information does not support a detailed safety comparison. Finally, the record describes a study of veterans with chronic pain and depression, but does not provide further participant characteristics needed to judge how well the enrolled group represents other populations.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy — NCT05427201.
• Registry record last updated 2026-07-17; status last verified 2026-07.
• Results first posted 2026-07-17.
• 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

NCT05427201 is a completed, randomized, single-masked, parallel-group study sponsored by the VA Office of Research and Development. Registry enrollment is 31. It compares active DLPFC-rTMS plus ACT with sham rTMS plus ACT in veterans with chronic pain and depression. The primary outcome is PROMIS Pain Interference Change, measured at baseline, weekly during ACT, and at post-treatment at 9 weeks, for a total of 10 timepoints. Secondary outcomes include Patient Health Questionnaire-9 Change and PROMIS Pain Intensity Change.

The registry describes feasibility and preparation for a future randomized efficacy trial as the study’s purpose. The primary outcome is not reduced to one comparison, and numerical primary and secondary outcome results are not reported in the registry record. Posted safety counts list 0 serious adverse events and 0 deaths in each arm, along with other adverse-event counts. Analysis details, missing-data methods, and the identity of the masked parties are not reported in the registry record.