Active and Passive Music Therapy Interventions: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Active and Passive Music Therapy Interventions (NCT03362944), a randomized na study. The primary outcome is Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude.

2. Clinical Question

The stated purpose was to assess the feasibility of using a structured music therapy intervention in later research focused on MDD. Investigators planned to measure heart-rate variability (HRV) and saliva markers before and after each condition, and anticipated greater physiological changes after active music-making than after passive listening. That expectation is a stated research hypothesis, not a reported finding.

The distinction between the study population and its longer-term motivation matters. The registered participants were healthy controls; the record does not describe this as a trial testing music therapy in people with MDD. Its stated aim was to use estimated treatment effects and variance components to inform sample-size choices for a subsequent grant-funded MT-MDD clinical trial. The registry record does not report those estimates or establish whether that later study proceeded.

3. Trial Design

NCT03362944, titled “Active and Passive Music Therapy Interventions,” is listed as a completed, randomized, unmasked crossover study. It was sponsored by the University of North Carolina, Chapel Hill. The recorded start date is 2017-11-20, and the primary completion date is 2017-12-18. The phase is listed as not applicable.

A crossover design means that each participant is intended to receive both study conditions in separate sessions. This allows the comparison to be made within participants, rather than relying only on comparisons between separate groups. The registry describes the design as within participants and identifies passive listening as the control condition. It does not report the order in which participants received the conditions, the method used to generate or conceal the randomized sequence, the interval between sessions, or whether any procedures were used to address possible carryover effects.

The enrollment is 16. The participant description specifies healthy controls aged 18 to 34 years, both male and female, who speak English and have no history of cardiovascular or neurological diseases. The registry’s condition entries include autonomic nervous system imbalance and hypothalamic pituitary adrenal axis suppression, but the participant description is of healthy controls. The record does not provide additional eligibility criteria or report how many participants completed both sessions or contributed data to each measure.

Neither participants nor study personnel were masked, according to the registry. The intervention entries identify active music therapy and passive music therapy as behavioral interventions, but their arm descriptions are blank. Further information about intervention content, session procedures, treatment fidelity, and allocation concealment is not reported in the registry record. The record lists six outcome measures, but no statistical analyses. It also does not report a protocol-level sample-size justification, interim analyses, or a detailed statistical analysis plan.

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: No participants were excluded from the study prior to assignment to groups.

First Intervention

Single Week Washout Period

Second Intervention

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 Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude, measured over Before and after 40-minute intervention.

The primary outcome is change from baseline to after the intervention in HF power amplitude and LF/HF power amplitude ratio, measured in decibels. The stated timeframe is before and after a 40-minute intervention. The registry describes five minute HRV recordings before and after each intervention session, collected using two electrodes placed on the participant’s right collarbone and left rib cage.

HRV describes variation in the time between heartbeats. The registry says the HF and LF/HF components correspond with parasympathetic and sympathetic autonomic nervous system activity. These measures were chosen to capture physiological correlates of the two music conditions, rather than to measure a clinical outcome such as symptoms or functioning. The record’s brief summary also describes saliva sampling before and after each session, and secondary outcomes include post-intervention cortisol and A-amylase. Those saliva measures are distinct from the stated primary HRV outcome.

For a crossover comparison, the central question is whether the within-participant change differs between active music-making and passive listening. A change measured within each condition is not, by itself, the comparative treatment effect; the comparison must account for both conditions. The record gives the primary outcome title and measurement procedures, but does not report numerical values for either condition, the difference between conditions, or uncertainty around that difference. It therefore does not establish the direction or size of any observed HRV contrast.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registered design is randomized and crossover. Randomization concerns how participants are assigned to condition order; crossover means the same participants are expected to receive both conditions. In general, a within-participant comparison can reduce the influence of stable between-person differences, because each participant contributes information under each condition. This advantage does not remove the need to consider session order, changes over time, or possible carryover between conditions. The registry record does not describe the randomization sequence or the statistical handling of these design features.

What does a change score represent?

The primary outcome is framed as change from before to after each intervention. In general, a change score describes how a measurement differs from its own pre-intervention value. The comparative question is whether that change differs between active music-making and passive listening. Looking only at a post-intervention value, or only at change under one condition, would not by itself answer the registered comparison. No change estimates or between-condition contrasts are reported in the registry record.

Why do the outcome components matter?

The primary outcome names both HF power amplitude and the LF/HF power-amplitude ratio, and the described measurements occur before and after the sessions. These are multiple components of the physiological assessment, not a single scalar outcome that can be interpreted without specifying which component and contrast is being discussed. The record does not identify a single numerical contrast or report results for either component. It lists six outcome measures overall, including secondary post-intervention measures for cortisol and A-amylase.

In general, when a study examines multiple outcomes or contrasts, the chance of finding at least one apparently notable result can increase if each is assessed independently without an appropriate plan. Multiplicity methods can define which comparisons are primary, adjust inference, or otherwise explain how a family of results is interpreted. The registry record does not report a multiplicity strategy or statistical analysis plan. This absence does not show that no such procedures were used; it means they are not described in the registry record.

What would an estimate and its uncertainty tell the reader?

In general, an effect estimate describes the direction and magnitude of a contrast, while a confidence interval expresses the range of values compatible with the data and the estimation procedure. A narrow interval indicates greater precision than a wide interval, but neither an interval nor a point estimate is reported for the primary comparison. The registry therefore does not support an assessment of precision, and no p-value or other inferential result is reported.

Why can over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a model’s assumptions allow. If variability is understated, uncertainty estimates may be too small and inferential conclusions may be overly confident. This is a general statistical consideration, not a reported feature of this study. The primary endpoint is continuous and described using a mean and standard deviation; the registry does not report observed variability or a fitted model from which over-dispersion could be assessed.

What does the preparation for a later study imply?

The brief summary says model-based estimation of treatment effects and variance components was intended to inform sample-size selection for a later grant-funded MT-MDD clinical trial. In general, treatment-effect estimates describe the contrast a study seeks to estimate, while variance components describe sources of variability relevant to precision and design. These preparatory estimates are not reported in the registry record. A sample-size calculation based on an observed effect, if available elsewhere, would be a planning illustration rather than observed power for the completed study. No such calculation or effect estimate is reported in this record.

Enrollment should also be distinguished from the analysis population. In general, participants enrolled, participants completing every session, and participants included in a particular outcome analysis need not be the same set. The registry lists enrollment of 16, but does not report the number contributing data to each outcome, missing-data methods, or analysis populations. These omissions limit the ability to evaluate how the planned crossover comparison was carried out.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures, including the primary HRV measure and secondary outcomes involving post-intervention HF and LF/HF power amplitude, cortisol, and A-amylase. It reports zero analyses. Thus, numerical analyses and results for these outcomes are not reported in the registry record.

In general, examining several outcomes can create multiplicity: the more comparisons considered, the more important it is to explain how the primary question was distinguished from secondary or exploratory questions. The registry record does not report a multiplicity adjustment, a hierarchy of comparisons, or an analysis plan explaining how multiple measures were to be interpreted. It is not possible to infer from the outcome list whether a formal adjustment was planned or used.

The record does not state how missing measurements were handled, why any data may have been missing, or how many participants contributed to each outcome. Although enrollment is listed as 16, that number does not establish the analysis population for each measure. The record also does not describe an intention-to-treat, per-protocol, or other analysis population. These details are important for understanding whether and how the randomized crossover comparison was retained in the outcome analysis.

For a crossover study, analysis populations and missing sessions can affect the paired comparison because data from both conditions may be needed for a participant-level contrast. This is a general design consideration; the registry record does not say whether any participant lacked a session or how such a case would have been addressed.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The adverse-event entries list Active Music Therapy and Passive Music Therapy, with 16 participants at risk in each condition. For each entry, the registry reports zero serious adverse events, zero other adverse events, and zero deaths. These are the counts recorded for the two intervention categories.

Because the study is a crossover, participants were intended to experience both conditions. The 16 listed under each condition should not be added to infer a total number of distinct participants exposed. The registry reports the same at-risk count for both conditions but does not provide additional information about adverse-event collection, monitoring procedures, or how events were attributed across sessions.

Zero recorded events means no events are entered in those categories in the registry record. It does not establish that all possible events were captured, nor does it provide information about how adverse events were defined or assessed. No further safety narrative or event terms are reported in the registry record. The figures should therefore be read as the registry’s recorded counts, not as a complete account of every aspect of safety monitoring.

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

The record establishes that a randomized crossover study was completed, with healthy controls intended to receive active music therapy and passive listening in separate sessions. It identifies the primary physiological measures, the before-and-after measurement approach, and the investigators’ expectation that active music-making would produce greater physiological changes. It also records an enrollment of 16 and zero entered adverse events in the listed categories.

It does not establish whether active music-making produced a larger change than passive listening. No numerical outcome estimates, comparisons, confidence intervals, or inferential results are reported. The expectation in the brief summary should not be mistaken for a finding. Without the outcome data, the direction, magnitude, and precision of any between-condition difference remain unknown from the registry record.

The registered population also defines the scope of interpretation. Participants were healthy controls aged 18 to 34 years, not a population described as having MDD. The study’s stated connection to MDD was preparatory: its estimates were intended to inform a subsequent clinical trial. The registry record does not show that physiological findings in this sample predict clinical outcomes or apply to people with MDD.

The design offers a within-participant structure, but important analytic details are not reported, including condition order, missing-data handling, the analysis population, and the statistical plan. Those gaps prevent a detailed assessment of how the randomized crossover comparison was analyzed. The appropriate conclusion is limited to what the registry records: the study’s planned question and procedures are described, but its comparative efficacy results are not reported.

13. Why This Trial Matters Statistically

This study is statistically notable for its preparatory purpose and crossover structure. Rather than describing a trial designed to establish a clinical treatment effect in people with MDD, the registry frames the work as an assessment of physiological correlates intended to inform a later MT-MDD study. It specifically states that model-based estimates of treatment effects and variance components were meant to help select a future sample size.

The within-participant design is relevant to that aim because it can support comparisons of conditions within the same person. Such a design can be useful when stable individual differences contribute to measurement variability. At the same time, crossover data require attention to condition order, session timing, and possible carryover. Those details are not reported in the registry record, so the design’s potential statistical advantages cannot be evaluated alongside its implementation.

The planned pairing of pre- and post-session HRV measurements also highlights the distinction between measuring change and comparing changes. The primary question concerns the contrast between changes under active music-making and passive listening, not simply whether a measurement changed after either session. No results are reported to quantify that contrast.

The record’s lack of outcome analyses is especially relevant because the stated goal was to produce estimates for later planning. Without reported effect estimates or variance components, readers cannot assess what planning information this study yielded. The record communicates a rationale and design, but not the numerical evidence needed to judge precision or to understand how the findings informed subsequent research.

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 registry record does not report numerical results for the primary HRV outcome or the secondary outcomes. It gives no effect estimates, confidence intervals, or test results, and lists zero analyses. This is the central limitation for statistical interpretation: the comparative question is stated, but its observed answer cannot be evaluated from the record.

Details needed to evaluate a randomized crossover implementation are also absent. The record does not describe condition order, session spacing, allocation concealment, or how possible period and carryover effects were handled. It gives no intervention descriptions beyond the labels active music therapy and passive music therapy, and the arm descriptions are blank. The registry record does not report intervention fidelity or additional procedural detail.

The enrolled sample is listed as 16, but the number completing both sessions and the number contributing data to each outcome are not reported. Missing-data reasons and methods, analysis populations, and the statistical analysis plan are also not reported. The registry lists six outcome measures without describing a multiplicity strategy, so the intended handling of multiple outcomes and contrasts cannot be assessed.

The participant description concerns healthy controls aged 18 to 34 years. The study’s preparatory aim may inform later research, but the registry record does not establish that its findings apply to people with MDD. Finally, the registry does not report the effect or variance estimates intended to inform future sample-size selection, so the success of that statistical objective cannot be judged from this record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Active and Passive Music Therapy Interventions — NCT03362944.
• Registry record last updated 2019-06-05; status last verified 2018-03.
• Results first posted 2019-06-05.
• 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

NCT03362944 is listed as a completed, randomized, unmasked crossover study sponsored by the University of North Carolina, Chapel Hill. Enrollment was 16. Participants were described as healthy controls aged 18 to 34 years who were male or female, English speakers, and had no history of cardiovascular or neurological diseases.

The study compared active music therapy with passive music therapy, described as active music-making and passive listening. The primary outcome concerned pre-to-post changes in HF power amplitude and LF/HF power-amplitude ratio, measured in decibels before and after a 40-minute intervention. The registry also lists saliva-related secondary outcomes.

The stated purpose was preparatory, with estimates intended to inform a later MT-MDD clinical trial. The registry lists six outcome measures and zero analyses. Numerical efficacy results, detailed analysis methods, missing-data handling, and estimates for future sample-size planning are not reported in the registry record.