Development of a Mobile System for Self-management of Schizophrenia (SOS): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Development of a Mobile System for Self-management of Schizophrenia (SOS) (NCT01969500), a randomized na study. The primary outcome is Change in Severity of Psychotic Symptoms.

2. Clinical Question

In practical terms, the clinical question was whether assignment to a mobile self-management system, rather than treatment as usual, was associated with a different course of symptoms or social functioning during the trial. Randomization is intended to support a fair comparison by assigning participants to study arms through a chance-based process. It does not by itself establish that the groups were similar in every respect, nor does it tell readers the size or precision of an outcome difference. Those judgments require the outcome data and analysis results, which are not reported in the registry record.

3. Trial Design

This was a randomized, single-masked, parallel, two-arm trial. The registry lists the study as completed, with enrollment of 51. Its stated purpose was to pilot the SOS mobile system and compare it with treatment as usual. The study is recorded as phase NA. The trial began in 2015-11, and primary completion was recorded as 2017-02. These dates describe the registry record; they do not provide details about the timing of individual participants’ follow-up.

In a parallel design, participants are assigned to one study arm and followed in that arm rather than switching between interventions. Random allocation can reduce systematic differences between groups at the point of assignment, on average, but the record does not describe the sequence-generation method, concealment of allocation, or whether assignment used any stratification. It also does not specify what was masked. The label single masking indicates that masking was recorded, but the identity of the masked people is not reported in the registry record.

The mobile application arm received a system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. The treatment-as-usual description includes outpatient case management, linkage to services, and medication monitoring. The registry record does not report whether participants in either arm could receive additional services, how adherence to the assigned approach was measured, or how consistently the intervention was used.

The registry lists secondary outcomes concerning system use, usability, and satisfaction. It records four outcome measures and two analyses, but those counts do not establish which analyses were prespecified or how the outcomes were handled statistically. A detailed protocol, analysis plan, sample-size justification, interim-analysis plan, and participant-flow account are not reported in the registry record. The study’s pilot designation is useful context: its record describes an early evaluation of a mobile system, but does not establish that the study was designed or powered to provide a definitive estimate of clinical effects.

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: N=3 enrolled participants were not assigned because N=1 did not pass a competency screener, N=1 did not meet Recovery Assessment Scale inclusion criteria, and N= 1 was no longer interested prior to completing baseline.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.

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 Severity of Psychotic Symptoms, measured over Baseline, week 12.

The primary endpoint was change in severity of psychotic symptoms, measured with the Psychotic Symptom Rating Scales. The registry describes PSYRATS as a 17-item assessment covering dimensions of hallucinations and delusions. Each item is rated from 0 (absent) to 4 (severe). The auditory hallucinations subscale has 11 items, and the delusions subscale has 6 items. The two subscale scores are added to form a total score ranging from 0-68; higher scores indicate worse symptoms.

The stated timeframe is baseline and week 12. Measuring at baseline and follow-up allows investigators to describe symptom status at each assessment and to assess change over time. A change score can be useful because it expresses how an outcome moved from a participant’s starting assessment, though its interpretation depends on the scoring and analysis choices. The registry record does not report the exact change-score definition, the arm-specific means, the estimated between-arm contrast, or its uncertainty.

PSYRATS is used to quantify symptom severity across hallucinations and delusions rather than to record only whether a symptom is present. A total score can condense information across the listed dimensions, while the subscales retain distinctions between symptom domains. The record does not state whether the primary analysis used the total score, separate subscale scores, or more than one category or time point. It explicitly notes that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, the endpoint description identifies what was assessed, but the registry record does not provide a single result to interpret.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design is described as randomized and parallel. In general, randomization assigns participants to study arms through a chance-based procedure. Its purpose is to reduce the risk that treatment assignment is systematically linked to participant characteristics. Randomization does not guarantee that every characteristic will be balanced in a particular trial, especially when enrollment is limited, and it does not remove the need to report baseline information and outcome analyses. Details of the randomization procedure are not reported in the registry record.

What does a parallel design mean?

In a parallel trial, participants remain in their assigned arm for the comparison rather than receiving each study approach in sequence. The registry describes one mobile application arm and one treatment-as-usual arm. It does not report whether analyses followed assignment regardless of actual system use, how crossovers or departures from the assigned approach were handled, or the definition of the analysis population. Those choices can affect the meaning of an estimate, so they should not be presumed from the design label alone.

What does the reported mean represent?

The outcome type is identified as continuous, and the reported parameter is a mean. In general, a mean is an average that summarizes measurements on a numeric scale. For a change outcome, the meaning depends on how change was defined and which observations entered the calculation. The registry record identifies baseline and week 12 but does not report the analysis formula or the arm-level means. The direction of a score’s meaning is available: higher PSYRATS totals indicate worse symptoms. The direction of a change contrast would still depend on how the subtraction was defined.

How should standard error be understood?

The dispersion is reported as standard error. In general, a standard error describes the statistical uncertainty in an estimated quantity, such as a mean, under an analysis model. It is not the same as the spread of individual participants’ measurements. A standard error is used in inferential calculations, including the construction of confidence intervals, but interpretation requires the estimate, the relevant model, and any degrees-of-freedom or distributional assumptions. The registry record does not give the primary means or standard errors, so no interval can be reconstructed from the record.

A standard deviation, by contrast, describes variability among individual measurements. Confusing standard error with standard deviation can make an outcome appear more or less variable than it is. The distinction is especially relevant when a report presents means with uncertainty: the uncertainty around an estimated mean does not describe the range of scores among participants. The registry identifies standard error for the primary outcome, but does not provide enough numerical information to assess participant-level variability.

What can be learned from an unreported comparison?

A statistical comparison usually combines an estimated difference with a measure of uncertainty and may include a hypothesis test. The estimate addresses the size and direction of the contrast; the uncertainty indicates how precisely it was estimated. Statistical significance alone, if reported, would not establish the practical importance of a difference. Here, the registry does not report a single primary comparison. It is therefore not possible to assess either its estimated size or precision from the registry record.

The record says the primary outcome had several categories or time points and was not reduced to one comparison. Multiple outcome versions or assessment points can create multiple opportunities for analysis. In general, when many comparisons are made, the chance of at least one apparently unusual result can increase if each is treated as though it were the only test. Methods for addressing this issue depend on the planned estimand and analysis strategy. The multiplicity approach is not reported in the registry record, so it would be inappropriate to assume that a correction was or was not used.

How should planning calculations be read?

The registry’s planning assumptions describe illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. In general, sample-size planning asks how many participants would be needed under specified assumptions to have a chosen chance of detecting an effect of a stated size, while controlling a chosen error criterion. The output depends on those assumptions and is not a finding about what the trial actually demonstrated.

A calculation based on an observed effect should be treated cautiously as a planning illustration. Estimates from a pilot can be uncertain, and a future-study calculation can change when the assumed effect or other design inputs change. It is not observed power, nor does it establish that the completed trial had adequate power. The registry record does not report the trial’s own sample-size justification or the assumed effect used when the study was designed.

What is not established by the design labels?

Single masking does not identify who was masked; that detail is not reported in the registry record. Randomized allocation does not establish how the sequence was generated or concealed. The parallel model does not tell readers how missing observations were handled. A completed status does not mean that every planned analysis or outcome is available in the registry. These design labels provide context, but they cannot substitute for a statistical analysis plan and outcome estimates.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is described as having several categories or time points, and the registry states that it was not reduced to one comparison. The timeframe lists baseline and week 12, while the PSYRATS description includes a total score formed from two subscales. The record does not identify a single primary contrast among possible score components or time points. Nor does it report whether a multiplicity adjustment was planned or used. Without that information, a reader cannot determine how the analysis distinguished a principal test from other possible comparisons.

The registry lists four outcome measures and two analyses. These counts do not reveal how many models were fitted, which outcomes were included in each analysis, or whether the analyses were prespecified. Details about the statistical plan, covariate adjustment, model form, and handling of repeated measurements are not reported in the registry record. It is therefore not possible to establish whether the analyses followed a particular protocol or how any analytic choices were made.

Missing-data information is limited. The record states that N=1 participant in the mobile application arm did not complete the baseline assessment and was excluded from analyses for all measures except ISI. It does not report the amount or pattern of missing follow-up data, the treatment of missing observations beyond that baseline exclusion, or whether any imputation or sensitivity analysis was used. The number analyzed for the primary endpoint is not reported in the registry record.

Analysis populations also require care. A randomized trial may define populations based on assignment, treatment received, or availability of outcome measurements, but the registry record does not state which definition was used for the reported analyses. The baseline exclusion note is a specific exception, not a complete account of the analysis population. Without participant flow and endpoint-specific denominators, the relationship between enrollment and the primary outcome analysis cannot be fully assessed.

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 registry reports no serious adverse events among the 25 participants at risk in the treatment-as-usual arm and none among the 26 participants at risk in the mobile application arm. It also reports zero other adverse events in each arm. These are reported counts, not a complete description of how safety was monitored or how events were defined. The event-collection period and any rules for attributing events to an intervention are not reported in the registry record.

The death count is 0 in the treatment-as-usual arm and 1 in the mobile application arm. The registry record does not report the circumstances of the death or whether it was considered related to the intervention. A death recorded in an arm is not, by itself, evidence that the assigned intervention caused it. Conversely, the absence of reported serious adverse events does not establish that no other harms occurred or that the approaches have no risks.

These safety figures should be read as the registry’s reported counts within the listed arms. They do not replace a fuller account of event definitions, timing, severity, or relatedness. The counts also do not answer the primary question about symptom change. No rates or comparative safety estimates are needed to interpret the reported figures, and the available record does not provide a basis for drawing a broader safety conclusion.

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

The record documents a completed randomized pilot of a mobile self-management system for schizophrenia, with treatment as usual as the comparator. It identifies symptom severity measured by PSYRATS as the primary outcome and gives baseline and week 12 as assessment points. It also describes social functioning as an outcome of interest and lists system use, usability, and satisfaction among secondary outcomes.

What the record does not establish is whether the mobile application arm had a greater, smaller, or similar change in psychotic symptom severity compared with treatment as usual. The primary outcome values and a direct between-arm estimate are not reported in the registry record. No conclusion about the direction or size of the primary outcome should be drawn from the trial title, design, enrollment, or intervention description.

In general, an estimated difference should be interpreted alongside its uncertainty, the endpoint definition, the analysis population, and the prespecified comparison. A result can be imprecise even if its point estimate appears notable, and a precisely estimated difference may still require context to judge its importance. Those elements are not available for the primary comparison in this registry record. It therefore cannot support a conclusion about the statistical or practical importance of a difference.

The registry’s planning assumptions do not fill this gap. A planning illustration based on an observed effect is not evidence that the trial detected an effect and is not observed power. Similarly, the absence of reported serious adverse events does not demonstrate the absence of harm, and the recorded death does not establish a causal relationship. The safety counts and the efficacy question address different aspects of the study.

The most defensible interpretation is descriptive: the trial enrolled participants, randomized them to the mobile application or treatment-as-usual arm, and specified outcomes relevant to symptom severity and social functioning. The posted record does not provide the results needed to determine what the primary comparison showed. Any stronger claim would go beyond what is reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it brings a mobile self-management intervention into a randomized clinical comparison while focusing on outcomes that are not captured by a single binary event. Psychotic symptom severity was measured on a multi-item scale, and the trial also considered social functioning, system use, usability, and satisfaction. Such studies make clear why a registry entry needs to pair an outcome definition with the analysis result and its uncertainty.

The design labels provide a useful starting point: randomized allocation, single masking, and a parallel model. Each label describes a design feature, but none is a substitute for details about implementation or analysis. Readers need to know who was masked, how randomization was conducted, how missing observations were handled, and how the primary comparison was selected. Those details are not reported in the registry record, illustrating the distinction between a design summary and a complete statistical account.

The primary outcome’s several categories or time points also highlight the importance of a clearly specified estimand and analysis. When a measure has subscales and repeated assessment points, a report should make clear which score and contrast answer the principal question. Otherwise, it can be difficult to distinguish a confirmatory result from exploratory findings. The registry explicitly notes that the outcome was not reduced to one comparison, but does not report the chosen analysis or a multiplicity strategy.

Finally, the study’s pilot designation and its recorded enrollment provide context, not an effect estimate. A pilot can inform the development and evaluation of an intervention, but a registry record needs reported outcome results to support an assessment of statistical evidence. The missing primary comparison is the central limitation for interpreting this trial statistically.

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 trial-specific limitation for interpretation is that the registry record does not report a numerical result for the primary outcome or a direct comparison between arms. It therefore gives no estimate of symptom change by arm, no uncertainty interval, and no test result for a single primary contrast. The note that the endpoint had several categories or time points and was not reduced to one comparison further limits the ability to identify which result would answer the principal question.

The outcome timeframe is identified as baseline and week 12, but the record does not report the detailed analysis method or the number of participants contributing data at each assessment. It notes a baseline assessment exclusion for N=1 participant in the mobile application arm, except for ISI, but does not provide a complete account of missing follow-up data or the handling of missing values. This limits assessment of the analysis population and the possibility that missingness affected the results.

Important design and analysis details are also not reported in the registry record. These include the identity of the masked party, randomization and allocation-concealment procedures, a detailed protocol, a sample-size justification, an interim-analysis plan, and the prespecified approach to multiplicity. The record also does not describe intervention exposure or variation in usual care in enough detail to assess implementation.

The safety entry gives event counts but not event definitions, monitoring details, timing, or the circumstances and relationship of the recorded death. Accordingly, the safety record is limited to those counts. Together, these omissions mean the entry is useful for identifying the trial and its stated outcomes, but does not permit a full appraisal of its primary statistical result or safety context.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Development of a Mobile System for Self-management of Schizophrenia (SOS) — NCT01969500.
• Registry record last updated 2019-05-13; status last verified 2019-02.
• Results first posted 2019-05-13.
• 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

NCT01969500 is a completed randomized, single-masked, parallel pilot with enrollment of 51. It compared a mobile application system designed to support self-management of schizophrenia with treatment as usual, described as outpatient case management, linkage to services, and medication monitoring. The listed conditions are schizophrenia and schizoaffective disorder.

The primary outcome was change in psychotic symptom severity on PSYRATS, assessed at baseline and week 12. Higher PSYRATS totals indicate worse symptoms. The record says that N=1 participant in the mobile application arm did not complete baseline and was excluded from analyses for all measures except ISI. It does not report a single primary comparison or its numerical result.

The safety counts show no reported serious or other adverse events in either arm and one death in the mobile application arm. The circumstances and relationship of the death are not reported in the registry record. The outcome and analysis details available in the record are insufficient to determine the direction or precision of the primary between-arm result.