Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma (NCT05723328), a randomized na study. The primary outcome is Change in the Internalized Stigma of Mental Illness Inventory (ISMI) Score Between Pre and Post MTAR.

2. Clinical Question

3. Trial Design

The study was registered as randomized, parallel-group, and unmasked. Its title identifies a group music therapy advocacy recording intervention for internalized stigma among adult psychiatric inpatients in acute care. The listed sponsor is Hackensack Meridian Health. The study phase is recorded as NA.

The planned intervention consisted of five group songwriting and recording sessions, one per day. The control condition was access to standard-of-care programming, including multiple groups focused on coping skills, mindfulness, journaling, creative arts, wellness recovery, and recreation, as well as at least one music therapy group. Thus, the planned contrast was between a specific sequence of advocacy recording sessions and the listed standard services, which themselves included music therapy.

Enrollment was 7. The record does not report the allocation ratio, the number assigned to each arm, or the reason for termination. Study start is recorded as 2023-04-25, and primary completion as 2023-04-26. The status is terminated. Most importantly for interpreting the design, the primary outcome population field states that study interventions never took place. The randomized designation describes the registered design, not evidence that participants received the planned intervention or comparator.

The planned outcome schedule included baseline assessment within 3 days of admission, posttest at ten days, and follow-up at 3 weeks from baseline. The primary outcome timeframe is given as post-MTAR intervention (day 8-10). The registry record does not report whether any assessments were collected, why the study was terminated, or whether any part of the intended procedures was started.

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: Study interventions never took place

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 in the Internalized Stigma of Mental Illness Inventory (ISMI) Score Between Pre and Post MTAR, measured over Post MTAR intervention (day 8-10).

The planned primary endpoint was change in the Internalized Stigma of Mental Illness Inventory score between pretest and posttest after MTAR. The ISMI is described as a 29 item questionnaire. Each item is scored on a 1-4 scale, and the total scale score is calculated by summing answered items and dividing by the number of items answered. The measure is intended to quantify internalized stigma, the outcome named in the study title and objective.

A pretest and posttest comparison can describe whether a participant's measured score changes across an intervention period. Here, however, the primary outcome was to be reported only for the treatment arm, rather than as a between-arm contrast. That distinction matters: an observed within-arm change alone would not isolate the intervention's effect from changes over time or other influences. A randomized comparison between arms can address a different question, but the registry record does not specify a primary between-arm endpoint.

No ISMI score, change estimate, dispersion measure, or analysis result is reported. The registry record states that the interventions never took place, so the planned endpoint cannot be interpreted as an observed treatment outcome. It also does not report how unanswered questionnaire items would be handled in an analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry design labels are useful for understanding what was intended, but they do not establish that the design was carried out. RANDOMIZED indicates a planned allocation by chance; PARALLEL indicates that the intended arms were to proceed as separate groups; and NONE indicates that masking was not planned. In general, random allocation can reduce systematic differences between groups at the start of a study. It does not guarantee balance in a small sample, and it cannot produce a treatment comparison when interventions and outcome measurements are absent. The record does not report the allocation procedure, allocation ratio, or arm-specific enrollment.

What would a randomized comparison estimate?

In general, a between-arm analysis compares outcomes in participants allocated to the intervention with outcomes in participants allocated to the comparator. When allocation and follow-up are conducted as planned, that contrast can help distinguish the intervention's effect from changes that might occur under standard care or over time. Here, the primary outcome description instead specifies pretest-to-posttest change in the treatment arm only. The record does not provide a completed between-arm analysis, an estimate of within-arm change, or participant-level data. No treatment effect can therefore be calculated or interpreted from this entry.

What does the ISMI score represent?

The registry describes the ISMI as a 29 item questionnaire. Items use a 1-4 scoring scale, and the total is calculated as the sum of answered items divided by the total number answered. In general, a questionnaire score reduces responses to a measure that can be compared across assessment times or groups. Interpretation depends on consistent administration, a clearly defined scoring procedure, and a suitable analysis of the resulting measurements. The registry record does not report an observed score, a baseline distribution, or the handling of incomplete questionnaires.

The planned assessments were within 3 days of admission, at ten days, and at 3 weeks from baseline. The primary outcome timeframe is stated as post-MTAR intervention (day 8-10). These are intended time points, not evidence that measurements were collected. The registry record does not report how the planned follow-up was to be incorporated into the primary analysis or whether the follow-up measurement was itself a confirmatory outcome.

How should uncertainty be assessed?

In general, an effect estimate gives the size and direction of a measured contrast, while a confidence interval conveys uncertainty around that estimate. A p-value, when used, summarizes how compatible the observed data are with a specified null hypothesis under the analysis assumptions; it does not give the probability that a treatment works. None of these quantities is reported for the primary endpoint in this record. Without an outcome estimate and its uncertainty, it is not possible to assess precision, distinguish a potentially meaningful change from random variation, or evaluate statistical evidence for a contrast.

Over-dispersion is a general concern when variability in observed data is greater than a model assumes. If present, an analysis that fails to account for it can understate uncertainty. That issue cannot be assessed for this study because no outcome observations or model results are reported. Similarly, general choices such as adjusted versus unadjusted analysis, repeated-measures modeling, and covariate adjustment cannot be attributed to the study: the statistical analysis plan is not reported in the registry record.

What does the planning illustration mean?

The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; its target effect is described as a fraction of the observed effect. The record characterizes these calculations as planning illustrations rather than the trial's own design. For non-time-to-event outcomes, such illustrations are expressed as participants per arm. In general, a sample-size illustration describes a hypothetical design under chosen assumptions; it is not an observed result and is not observed power. Since the trial record reports no outcome effect from which to assess a real contrast, the illustration should not be interpreted as evidence about the intervention.

The record lists 0 analyses. It does not report an analysis method, a prespecified model, an interim-analysis plan, or a sample-size justification for the trial itself. Those omissions mean that statistical choices beyond the descriptive endpoint and planning assumptions cannot be reconstructed from the registry entry.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists two outcome measures: the primary ISMI change outcome and a secondary outcome concerning change in ISMI score based on diagnostic category. It does not report a plan for controlling multiplicity, such as a hierarchy of tests or an adjustment for examining multiple outcomes. In general, when several hypotheses are tested, the chance of at least one apparently notable result can increase unless the analysis plan accounts for that multiplicity. No outcome analyses are reported, so there are no statistical findings for which a multiplicity adjustment can be evaluated.

Missing-data handling is also not reported in the registry record. The ISMI scoring description uses answered items in calculating the scale score, but that does not establish how missing questionnaire responses, missing visits, or participants without posttest observations would be handled in a trial analysis. The planned follow-up at 3 weeks from baseline is not accompanied by a reported completion rate or missingness analysis.

The record does not specify an analysis population, such as whether participants would be analyzed according to randomized assignment or according to intervention received. Nor does it report numbers randomized, treated, or included in an endpoint analysis by arm. Enrollment was 7, and the primary outcome population field states that study interventions never took place. Without participant flow and outcome data, it is not possible to assess attrition, adherence, or whether any analysis population was assembled.

The statistical analysis plan, any interim analyses, and the rationale for the trial's sample size are not reported in the registry record. These unknowns are distinct from the stated planning illustration, which is not the trial's own design justification.

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 record lists 7 consented patients at risk and reports 0 serious adverse events, 0 other adverse events, and 0 deaths. These figures describe the registry's adverse-event entry for the listed group; they should not be treated as a complete safety assessment of the planned intervention.

The primary outcome population field states that study interventions never took place. The record therefore does not establish that participants were exposed to MTAR or that adverse events were systematically assessed during intervention. Zero reported events in this entry does not demonstrate that the intervention is free of risk, nor does it support a comparison of safety between the intervention and control arms. The record does not provide arm-specific safety counts, event definitions, observation time, or a detailed adverse-event monitoring method.

In general, adverse-event counts are interpretable only in the context of who was observed, what exposure occurred, and how events were collected. Those details are not reported in the registry record. The event figures should be read as the registry's reported counts for consented patients, alongside the explicit statement that the interventions never took place.

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

This record documents a planned randomized study of a group music therapy advocacy recording intervention for internalized stigma among adult psychiatric inpatients. It describes the intended intervention, standard-of-care comparator, questionnaire, and assessment schedule. It also reports enrollment of 7 and a terminated status. These are relevant details about the study's registration and conduct status.

It does not report a measured change in ISMI score, a treatment-versus-control effect, a confidence interval, a p-value, or any other primary outcome analysis. The interventions never took place according to the primary outcome population field. Therefore, the record cannot establish whether scores changed, whether groups differed, or how precisely any effect was estimated. It also cannot support a conclusion that the intervention is beneficial, ineffective, harmful, or safe.

The planned primary endpoint was a within-treatment-arm pretest-to-posttest change, whereas the design also describes a control arm. Those are distinct statistical questions. A within-arm change can reflect influences other than the intervention; a randomized between-arm contrast addresses a comparison with the control condition. No result for either question is reported.

The comparator description matters when interpreting the study question. Standard care included several group services and at least one music therapy group, so the intended contrast was not music therapy against no music therapy. The specific MTAR sequence was to be compared with the described standard services.

The registry record does not report why the study was terminated, whether data were collected before termination, or whether analyses were conducted outside the reported entry. These absences leave the reasons for non-completion and any possible partial observations unknown. The most defensible conclusion is limited: the registry describes an intended study but provides no outcome evidence with which to estimate the planned intervention effect.

13. Why This Trial Matters Statistically

This trial illustrates why a registered design and a completed statistical comparison are not the same thing. The record identifies randomization, parallel groups, a named intervention, an active standard-of-care comparator, and a specified patient-reported outcome. Those details allow readers to understand the research question that was intended. But the record also says the interventions never took place and lists 0 analyses, so the design description cannot be mistaken for completed efficacy evidence.

It also highlights the value of distinguishing within-arm change from a between-arm effect. The primary outcome was framed as change from pretest to posttest in the treatment arm only. A change in one group, even if it had been measured, would not by itself show that the intervention caused that change. The planned control condition provides a possible comparative framework, but the registry does not report a completed contrast.

The endpoint details demonstrate that measurement rules matter. The ISMI is described as a 29 item scale with a stated method for averaging answered items. Yet even a defined questionnaire and assessment schedule cannot answer a statistical question without collected observations, transparent analysis methods, and an account of missing data.

Finally, the entry shows why adverse-event counts require context. The registry lists zero events among 7 consented patients, but also states that study interventions never took place. Without evidence of exposure and a described monitoring period, those counts cannot establish safety of the planned intervention. Together, these features make the record useful for understanding what was intended and what remains unanswerable.

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 limitation is that the study interventions never took place, as stated in the primary outcome population field. No primary or secondary outcome results are reported, and the record lists 0 analyses. Consequently, the planned endpoint cannot be used to estimate a change in stigma or a comparative intervention effect.

Enrollment was 7, but the record does not report how participants were distributed between arms, how many were randomized, or whether any outcome assessments were completed. Participant flow, intervention exposure, adherence, and analysis populations are not reported. These omissions prevent assessment of recruitment and retention as well as any potential imbalance between groups.

The record does not report the reason for termination. It also does not report the trial's statistical analysis plan, sample-size justification, interim analyses, missing-data procedures, or approach to multiplicity. The stated planning illustration assumptions do not supply these trial-specific design details.

The primary outcome was planned as treatment-arm pretest-to-posttest change, not explicitly as a between-arm contrast. The registry record does not describe how any observed change would be separated from time effects or other influences. The intended control group also had access to standard services that included at least one music therapy group, so the planned comparison was between MTAR and a package of usual services rather than between music therapy and no music therapy.

The adverse-event entry lists no reported events for 7 consented patients, but does not provide arm-specific counts, event-monitoring details, or evidence of intervention exposure. This limits safety interpretation. Finally, the record's condition categories are listed, but subgroup sizes and diagnostic-category outcome results are not reported.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma — NCT05723328.
• Registry record last updated 2024-07-05; status last verified 2024-06.
• Results first posted 2024-07-05.
• 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

NCT05723328 is a terminated, randomized, unmasked, parallel-group study sponsored by Hackensack Meridian Health. It was designed to examine a group music therapy advocacy recording intervention for internalized stigma among adult psychiatric inpatients in acute care. Enrollment was 7. The planned MTAR intervention involved five songwriting and recording groups, one per day, with standard-of-care services as the control condition.

The primary outcome was planned as pretest-to-posttest change in the Internalized Stigma of Mental Illness Inventory score in the treatment arm. The registry describes the ISMI as a 29 item questionnaire scored on a 1-4 scale, with the total calculated from answered items. It also lists a secondary outcome concerning change by diagnostic category.

The record states that study interventions never took place, reports 0 analyses, and gives no outcome estimates. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 7 consented patients; these counts do not establish safety of an intervention that was not carried out. The reason for termination is not reported in the registry record.