Functional Rehabilitation of Older Patients With Schizophrenia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Functional Rehabilitation of Older Patients With Schizophrenia (NCT00237796), a randomized na study. The primary outcome is Independent Living Skills Survey (ILSS).

2. Clinical Question

The study is described as evaluating a group intervention for older patients with schizophrenia, with social functioning and compensatory strategies as its focus. The record names the outcome and its assessment schedule, but does not report a treatment-effect estimate, confidence interval, or statistical test for the primary comparison. Consequently, the clinical question is identifiable, but the posted information does not establish the direction or magnitude of any between-group difference.

3. Trial Design

The registry describes a randomized, single-masked, parallel-group behavioral study. Participants were assigned to CBSST or supportive contact. The recorded enrollment is 116. The study status is completed; its recorded start is 2005-02 and primary completion is 2009-01. The phase is listed as NA.

The intervention description characterizes CBSST as group therapy that teaches social functioning skills and cognitive-behavioral compensatory aids. The comparator is described as Goal Focused Supportive Contact. Although the registry uses a supportive-care label in its adverse-event listing, it does not explain whether that wording is simply an alternate name for GFSC or represents a difference in intervention description.

Single masking indicates that the registry records some masking, but it does not identify who was masked. The record also does not describe the randomization sequence, allocation concealment, treatment-session schedule, intervention fidelity procedures, or the length and details of follow-up. These design details are therefore not reported in the registry record and should not be inferred from the randomized, single-masked, parallel-group labels.

The ILSS assessment schedule includes baseline, mid-treatment, end of treatment, mid-follow-up, and follow-up. The record does not give calendar timing for those visits or state which assessment occasion was used for a primary between-group contrast. It also lists secondary measures covering knowledge or skills, symptoms, and mood, but reports no analyses for them. Without outcome estimates or a defined analysis contrast, the design can be described, but comparative efficacy cannot be assessed from the posted results.

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: Baseline data were collected before randomization. N=116 participants enrolled in the study and N=79 started. Total of 37 excluded for reasons: n=20 lost interest; n=6 wrong diagnosis, n=3 not psychiatrically stable; n=3 not medically stable, and n=5 lost contact/moved.

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.

Population: Participants numbers reported include at least one baseline and at least 1 ILSS assesssment

6. Primary Endpoint

The registry lists the primary outcome as Independent Living Skills Survey (ILSS), measured over baseline, mid-treatment, end of treatment, mid-follow up, and follow up.

The primary endpoint is the Independent Living Skills Survey (ILSS), recorded as a mean measured in units on a scale. It is a self-report measure administered in an interview format and covers everyday functioning across ten domains: appearance and clothing, personal hygiene, care of personal possessions, food preparation and storage, health maintenance, money management, transportation, leisure, job seeking, and job maintenance. Subscales are averaged to produce a composite score.

The scale ranges from 0 to 1, and higher scores represent a higher level of functioning. A composite measure can provide a broad summary across practical activities rather than focusing on a single task. That breadth is relevant to the study’s stated focus on social functioning and disability in aging veterans with severe mental illness. It also means that the composite combines multiple domains, so an overall score does not by itself show which particular activities account for any difference.

The ILSS was scheduled at baseline, mid-treatment, end of treatment, mid-follow-up, and follow-up. Repeated measurement can describe functioning at different stages, but the registry record does not identify a single time point as the primary comparison or state how the occasions were combined. Numerical ILSS means, standard deviations, and between-group estimates are not reported in the registry record, so the endpoint’s observed results cannot be interpreted.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry classifies the primary measure as continuous and describes its summary as a mean with standard deviation. A mean represents the average score in a group. A standard deviation describes how spread out individual scores are around that average. These summaries can help readers understand both the group’s typical score and the variability among participants, but neither is reported for the ILSS in the posted results.

What would a between-group estimate mean?

General statistical explanation: A treatment-effect estimate for a continuous endpoint expresses the difference between the groups on the chosen scale and at the chosen assessment occasion, or according to a specified model across occasions. Its interpretation depends on how the contrast is defined. For example, an end-of-treatment comparison and a comparison of change from baseline answer different questions. The registry record lists several assessment occasions but does not identify the primary contrast or report an estimate, so neither the magnitude nor the direction of an effect can be described.

General statistical explanation: A confidence interval gives a range of estimates compatible with the data under the analysis assumptions. It conveys precision as well as direction and magnitude: a wide interval indicates less precision than a narrow interval. It is not a guarantee that the true effect lies within the interval, and it does not replace consideration of the endpoint’s meaning. No confidence interval for the primary ILSS outcome is reported in the registry record.

Why does the assessment schedule matter?

General statistical explanation: Repeated measurements on the same participants are related. Analyses that use multiple occasions need to account for that within-person relationship and specify how time enters the comparison. Different approaches can target a single visit, average across visits, or estimate a pattern over time. Those approaches can yield estimates with different interpretations. The registry gives the ILSS schedule but does not report the statistical model, the primary time point, or how measurements across occasions were handled.

Because the ILSS is a bounded composite with a stated scale range of 0 to 1, an analysis would also need to respect the meaning and behavior of that score. General statistical explanation: A mean-based approach can be useful for continuous outcomes, while distributional features such as clustering near a scale boundary or unusual skew can affect how well model assumptions fit. The registry does not report the ILSS score distributions or diagnostic checks, so no judgment about those features is possible.

What can a significance test establish?

General statistical explanation: A p-value measures how incompatible the observed data are with a specified null model, conditional on the analysis assumptions. It does not measure the probability that a treatment is effective, the size of an effect, or its practical importance. A small p-value alone would not describe precision or the relevance of an estimate; a non-small p-value would not demonstrate equivalence. The registry record reports no primary-outcome p-value, so statistical significance cannot be assessed from the posted results.

The planning assumptions describe illustrative calculations using a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as fractions of an observed effect. Such illustrations are planning aids, not observed trial outcomes and not observed power. They do not replace estimates and uncertainty from the trial itself. The numerical planning results are not reported in the registry record, and no observed ILSS effect is available in the posted results for interpretation.

How should variability be considered?

General statistical explanation: Standard deviations describe variability between participants. If the variability is large relative to a group difference, that difference will generally be estimated less precisely than it would be with less variability, all else being equal. In some kinds of data, variability may also increase as the mean increases; this is called over-dispersion when variation exceeds what a model expects. Over-dispersion matters because a model that understates variability can produce intervals that are too narrow and tests that appear too decisive. This is general guidance, not a claim about the ILSS data: the registry does not report observed means, standard deviations, or model diagnostics.

The registry record does not describe the analysis model, covariate adjustment, handling of baseline scores, assumptions checks, or methods for missing observations. These details are not reported in the registry record. Without them, readers cannot determine whether the intended estimate was adjusted or unadjusted, or assess the assumptions behind a particular result. Since no numerical primary analysis is posted, these are limits on what can be evaluated, rather than grounds for favoring one unreported analytical approach.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome, the ILSS, assessed at baseline, mid-treatment, end of treatment, mid-follow-up, and follow-up. It also names six secondary measures: the Comprehensive Module Test, the PANSS Positive Subscale, two SANS measures, the Beck Depression Inventory-II, and the Beck Anxiety Inventory. Across a set of outcomes and assessment occasions, multiple statistical comparisons may arise. General statistical explanation: The more comparisons considered, the greater the chance of at least one apparently unusual result if all null hypotheses are true. A prespecified hierarchy or multiplicity adjustment can address that concern, but the registry does not report such a strategy.

The record indicates zero analyses and does not reduce the primary outcome’s several time points to a single comparison. Consequently, no primary or secondary outcome estimates are available to interpret, and it is not possible to determine which comparisons were planned as primary, secondary, exploratory, or not performed. A statistical analysis plan, outcome hierarchy, and multiplicity procedures are not reported in the registry record.

Missing-data handling is also not reported in the registry record. The record does not state how many participants completed each ILSS assessment, why any measurements were missing, or whether an analysis used all randomized participants or a subset. It does not report imputation, likelihood-based methods, sensitivity analyses, or assumptions about missingness. Those omissions limit assessment of potential bias from incomplete follow-up.

Analysis populations are not described. The registry does not say whether results were intended to follow randomized assignment regardless of participation, or to include only participants meeting a treatment or follow-up criterion. These distinctions can affect interpretation, particularly when adherence or missing assessments differ by group. No analysis population can be inferred from the enrollment figure alone.

11. Safety Results

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

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: hospitalization (23.7%).

The adverse-event listing reports serious adverse events for the CBSST group with 41 participants at risk and 4 affected. For the group labelled “Goal Directed Supportive Care,” it reports 38 participants at risk and 11 affected. The other-adverse-event entries list 41 at risk and 0 affected for CBSST, and 38 at risk and 0 affected for the supportive-care-labelled group. These are the figures recorded; they do not by themselves identify the event types beyond the listed serious-event term or establish why an event occurred.

Hospitalization is listed as a top serious-event term at 23.7%. The registry record does not define the denominator for that percentage in the adverse-event summary, so it should not be interpreted as a percentage of participants without further information. The death entries are null; death counts are therefore not reported in the registry record and should not be read as zero.

Adverse-event counts are descriptive. They do not establish causation or provide a complete comparison of risks without details about ascertainment, follow-up, event definitions, and exposure. Those details are not reported in the registry record. The supportive group’s differing label in the adverse-event listing also makes it important not to assume that the wording has been reconciled elsewhere in the record.

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

The record establishes that the study was designed as a randomized, parallel-group comparison of CBSST and supportive contact, with the ILSS as its primary outcome. It describes the intervention’s intended focus, the comparator, the ILSS domains and scale direction, and the assessment schedule. It also gives enrollment and adverse-event counts. These registry entries are useful for understanding the trial’s structure and what it set out to measure.

The posted record does not establish the comparative effect on everyday functioning. It contains no ILSS group summaries, treatment-effect estimate, confidence interval, or p-value, and reports zero analyses. It therefore cannot show whether functioning differed between the groups, how large a difference might have been, or how precise an estimate would be. The missing result is not evidence of no difference and should not be interpreted as a null finding.

The trial’s stated purpose and intervention rationale are not outcomes. Describing CBSST as targeting social functioning skills and compensatory aids does not demonstrate that the intervention changed functioning. Similarly, a randomized design can support a comparative interpretation when results and analysis details are reported, but randomization alone does not supply an effect estimate.

The secondary measures and safety counts add context but do not fill the primary-outcome gap. No secondary analyses are reported, and the adverse-event entries do not answer the functioning question. The record also does not give enough information about missing data, assessment completion, or analysis populations to assess the completeness and comparability of outcome data.

A careful reading therefore separates what is documented from what remains unknown. The design and measurement plan are documented; the numerical results and analytical details needed to assess the primary comparison are not reported in the registry record. No conclusion about the relative results of the interventions can be drawn from those missing outcome statistics.

13. Why This Trial Matters Statistically

This trial illustrates the distinction between a well-defined research question and a reported statistical result. The registry identifies a randomized comparison, a named primary measure, its scale direction, and several assessment occasions. Those details make the intended topic of evaluation understandable. Yet a result requires more than a study status, an enrollment figure, or a measurement schedule: it requires group outcome data and an analysis that connects those data to a defined comparison.

The ILSS combines scores across ten practical domains. A composite endpoint can align with a multidimensional research question, but it can also conceal variation among domains. If a composite difference were reported, readers would still need to distinguish the overall score from any domain-specific pattern. The registry lists the component domains but does not report results for the composite or its components.

The multiple assessment occasions make the estimand especially important. A difference at end of treatment, a difference at follow-up, and a trajectory across visits are not interchangeable statistical questions. Naming the occasions without specifying the primary contrast leaves uncertainty about what result would represent the main comparison. The absence of a reported analysis prevents readers from resolving that issue.

The record also offers a useful reminder about safety summaries: counts at risk and affected, event terminology, and a percentage need clear denominators and consistent group labels to support interpretation. Here, the adverse-event comparator wording differs from the intervention name, and the hospitalization percentage’s denominator is not stated. Statistical reporting is strongest when such definitions are explicit.

These features matter for biostatistical reading because they separate design information from evidence about outcomes. A trial can have a relevant question and a specified scale while still leaving the effect, uncertainty, and analysis choices unavailable to readers. In this record, the absence of those elements sharply limits statistical interpretation.

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 of the registry record for interpreting this trial is the absence of numerical results for the primary ILSS endpoint. Group means, standard deviations, a between-group estimate, an interval estimate, and a statistical test are not reported. The record also lists no analyses. Without those results, the direction, magnitude, and precision of any primary-outcome difference cannot be evaluated.

The primary outcome is scheduled at multiple occasions, but the record does not specify which occasion or across-time contrast was intended as the primary comparison. The analysis model and handling of baseline scores are not reported. Participant numbers contributing outcome data at each occasion, missing-data procedures, and analysis populations are also not reported in the registry record. These gaps prevent assessment of attrition and the assumptions supporting any analysis.

The registry names several secondary measures but does not report their analyses or a strategy for handling multiple comparisons. Eligibility details, participant characteristics, masking roles, allocation concealment, intervention dose, adherence, and fidelity procedures are not described in the record. Their absence limits assessment of how the trial was conducted and to whom its results might apply.

The safety summary has additional interpretive constraints. The comparator label differs between the intervention description and adverse-event listing, the hospitalization percentage’s denominator is not identified, and the death entries are null. The record does not describe event ascertainment or attribution. These limitations do not establish that the study was conducted poorly; they mark what cannot be evaluated from the registry information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Functional Rehabilitation of Older Patients With Schizophrenia — NCT00237796.
• Registry record last updated 2015-04-06; status last verified 2015-03.
• Results first posted 2015-04-06.
• 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

The registry describes a completed, randomized, single-masked, parallel-group behavioral study with enrollment of 116. It compares Cognitive Behavioral Social Skills Training with Goal Focused Supportive Contact in a study focused on older patients with schizophrenia and related listed conditions. The primary endpoint is the ILSS, a mean composite score for everyday functioning, assessed at baseline, mid-treatment, end of treatment, mid-follow-up, and follow-up.

The record lists six secondary measures and provides adverse-event counts. It does not report analyses or numerical primary-outcome results. The statistical plan, missing-data methods, analysis populations, and multiplicity approach are not reported in the registry record. The available information therefore describes the trial question and design, but does not permit evaluation of the comparative ILSS outcome.