Development and Validation of the Client Centered Occupational Therapy Service Model: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Development and Validation of the Client Centered Occupational Therapy Service Model (NCT04465422), a randomized na study. The primary outcome is Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores.

2. Clinical Question

3. Trial Design

This was a randomized, double-masked, parallel-group study sponsored by Taipei City Hospital. The registry lists an enrollment of 33 and a completed status. The recorded study start date is 2020-06-19, and the primary completion date is 2020-07-16. The phase is listed as NA. These registry entries describe the study record, not the delivery details of each participant’s care.

The two groups were the Intervention Group and Control Group. The intervention is described as occupational therapy based on MOHO theory, and the comparator as original occupational therapy. Both interventions are classified as behavioral. The registry’s arm descriptions state an intention to recruit 70 inpatients with schizophrenia, while the enrollment entry records 33. The record does not explain the difference between that recruitment statement and the recorded enrollment. The arm descriptions also end with incomplete text, so they do not supply a complete account of the study procedures.

Randomization indicates that assignment was intended to be determined by chance, but the sequence-generation method, allocation concealment, and implementation details are not reported in the registry record. Double masking is recorded, but the identities of the masked groups—such as participants, therapists, assessors, or analysts—and how masking was maintained are not reported. These details matter for judging the risk of bias, particularly for an occupational therapy intervention where participants and therapists may be aware of treatment content.

The primary outcome is OPHI-II total and subscale scores, assessed before and after in both groups, with a stated timeframe of 2 weeks. A secondary outcome is Occupational Therapy Evaluation Scales Measure. The registry lists two outcome measures and eight analyses, but does not supply enough detail to reconstruct the analysis plan or the results for a single primary comparison. The precise timing of assessments, follow-up beyond the stated timeframe, and participant flow are not reported in the registry record.

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: Individuals with schizophrenia were recruited from acute ward of the Psychiatric Department of Taipei City Hospital.

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 Occupational Performance History Interview-II (OPHI-II) Total and Subscale Scores, measured over 2 weeks.

The primary endpoint is the Occupational Performance History Interview-II (OPHI-II) total and subscale scores. The registry describes OPHI-II as a semi-structured interview that gathers information about a person’s life history. Its three subdomains are Occupational Identity, Occupational Competence, and Occupational Behavior Settings. The listed score ranges are 11 to 44 for Occupational Identity, 9 to 36 for Occupational Competence, and 9 to 36 for Occupational Behavior Settings. The total score ranges from 29 to 116, with higher scores indicating higher performance.

The description assigns four levels to the subdomains: 4 points indicate good performance, 3 points indicate good functions, 2 points indicate lack of certain functions, and 1 point indicates poor functions. The total is described as the sum of the three subdomain scores. OPHI-II is relevant to the stated aim because it captures occupational identity, competence, and settings, which are related to the occupational performance focus of the service model. The registry says the measure was administered before and after the intervention in both groups, and identifies a 2 weeks timeframe.

Means and standard deviations are the registered summary form for this continuous measure. These summaries can describe group scores, but a comparative interpretation also requires the reported analysis, its uncertainty, and clarity about which outcome and assessment occasion define the primary contrast. Those results are not reported in the registry record as one reduced comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry gives limited statistical detail. It describes OPHI-II as a continuous outcome summarized using a mean and standard deviation, and records random allocation, double masking, and a parallel-group model. It also lists eight analyses. The analysis methods used for the primary outcome, the specific comparison, and the treatment of multiple outcomes are not reported in the registry record. The concepts below explain how such methods are generally interpreted; they do not establish which methods were used in this study.

What does randomization contribute?

In general, randomization assigns participants to groups by chance. Its purpose is to make treatment assignment independent of participant characteristics on average, limiting systematic differences in measured and unmeasured factors. It does not guarantee that groups will be alike in a particular study, especially when the recorded enrollment is limited. Baseline data and a clearly specified analysis are still important for understanding the comparison. The record does not report how the random sequence was generated, whether assignments were concealed before enrollment, or whether any departures from assigned treatment occurred.

Masking can reduce the influence of expectations or knowledge of treatment assignment on behavior, outcome assessment, and analysis. The record labels the study double-masked but does not identify which parties were masked or explain how masking was maintained. Because the intervention involves occupational therapy, treatment providers may need to know what approach they are delivering; the registry does not clarify this practical issue. The label alone is not enough to assess whether outcome measurement was protected from knowledge of assignment.

What would a group comparison represent?

For a continuous outcome, a group mean describes the average score in that group, and the standard deviation describes the spread of individual scores around the mean. A between-group contrast is different from reporting a mean in each group: it directly quantifies the separation between groups under a stated analysis. If a measure is collected before and after treatment, a contrast might compare endpoint scores, compare changes, or use an adjusted model. These approaches answer related but not identical questions. The registry says OPHI-II was assessed before and after in both groups, but it does not report which contrast or model defines the primary analysis.

In general, a confidence interval expresses uncertainty around an estimated contrast. Its width reflects both variability in the data and the amount of information available under the analysis. A narrow interval indicates greater precision than a wide one, but precision is not the same as clinical importance. A p-value addresses how compatible the observed data are with a specified null hypothesis under model assumptions; it does not quantify the size of an effect or establish that an effect is meaningful. The registry record does not report a primary contrast, confidence interval, or p-value, so those aspects cannot be assessed.

Why can over-dispersion matter?

General explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. It can make standard errors too small if the model fails to account for the extra variation, which can make uncertainty look lower than it is. The relevance depends on the outcome scale and the chosen model. The listed primary endpoint is a continuous score summarized by a mean and standard deviation; the record does not state that an over-dispersion model was used or that over-dispersion was assessed. This concept should not be taken as a description of an observed problem in this trial.

How should sample-size illustrations be read?

The registry’s sample-size assumptions describe a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The assumed effect to detect is described as a stated fraction of the observed effect. The record does not report a numeric planning estimate or the specific fraction in this information. Such planning values are hypothetical estimates of participants per arm under selected assumptions, not observed study outcomes and not observed power. They cannot resolve the absence of a reported treatment-effect estimate. The record does not report the trial’s own sample-size justification or the assumptions used when it was designed.

What is needed to assess the analysis?

Interpretation would require the outcome values or a comparative estimate, the definition of the primary contrast, and a description of the analysis population and handling of missing measurements. It would also help to know how the eight analyses relate to the registered outcomes and whether any adjustment or hierarchy was prespecified. These details are not reported in the registry record. Without them, a reader cannot check whether analyses followed the intended plan, reproduce the primary comparison, or judge how sensitive the conclusion might be to alternative reasonable methods.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and eight analyses. The primary outcome includes OPHI-II total and subscale scores, and the description refers to assessment before and after treatment in both groups. The registry’s note indicates that the primary outcome has several categories or time points and is not reduced to one comparison. This creates more than one potential result to interpret, but the record does not identify a single primary contrast among them.

Multiplicity refers generally to the increased chance of a misleading finding when several outcomes, time points, or comparisons are examined. Researchers may address this through prespecification, an adjustment to inference, or a hierarchy of outcomes; the appropriate method depends on the analysis plan. Whether any of these approaches was used is not reported in the registry record. The eight analyses are listed without enough detail to determine their relationship to each other or whether they were planned in advance.

Missing-data methods and the number of participants contributing to each outcome analysis are not reported in the registry record. The record does not describe withdrawals, incomplete interviews, exclusions from analyses, or imputation. It also does not specify whether analyses followed randomized assignment or another population definition. These omissions prevent assessment of whether missing measurements could have influenced the estimated comparison.

The record therefore does not support a judgment about multiplicity control, the completeness of outcome data, or the analysis population. The registered enrollment and arm-specific adverse-event counts do not establish how many participants contributed to the primary outcome analysis.

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 serious adverse events, other adverse events, and deaths by group. For the Intervention Group, the listed at-risk count is 17 for serious events and 17 for other events; the corresponding affected counts are 0 and 0, and deaths are 0. For the Control Group, the listed at-risk count is 16 for serious events and 16 for other events; the corresponding affected counts are 0 and 0, and deaths are 0. No serious-event terms are listed.

These entries mean that the registry recorded zero affected participants in each group for the reported adverse-event categories. They should not be read as proof that no symptoms, burdens, or other unwanted experiences occurred. The record does not provide event definitions, collection procedures, observation duration, severity grading beyond the serious-event category, or information about how events were attributed. It also does not describe whether these counts cover the same period as the primary outcome assessment.

Safety counts are descriptive and depend on how consistently events were sought and recorded. With the information in the registry record, the frequency and nature of unlisted experiences cannot be evaluated. The listed zero counts do not establish a comparative safety advantage or imply that risks are absent.

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

The record describes a randomized, double-masked, parallel-group study comparing occupational therapy based on MOHO theory with the original occupational therapy model. It identifies people with schizophrenia recruited from the acute ward of the Psychiatric Department of Taipei City Hospital as the population of interest. The primary outcome is OPHI-II total and subscale scores, with a stated timeframe of 2 weeks. These features define the question the study intended to address.

The registry record does not report numerical OPHI-II outcomes or one reduced comparison between groups. It therefore does not establish the direction or size of a difference, the precision of an estimate, or whether any observed difference would be compatible with chance variation under a specified statistical model. The absence of a reported comparison should not be interpreted as showing that the approaches produced equivalent outcomes, nor as showing that one produced better outcomes.

The record’s enrollment entry is 33, whereas the arm descriptions state that the study would recruit 70 inpatients. That discrepancy is not explained. The information also does not establish how many participants completed each assessment or entered each outcome analysis. Without those details, the amount of information underlying any outcome estimate cannot be judged.

The zero adverse-event counts are limited to the categories recorded in the registry. They do not show that every possible unwanted event was absent, and they do not support a comparative safety conclusion. Likewise, the stated design labels alone do not confirm that allocation was concealed or that masking was maintained in practice.

In general, evidence from a clinical trial is interpreted by combining the estimated effect, its uncertainty, the validity of the design and analysis, and the relevance of the measured outcome. Here, the design and intended outcome are described, but the primary numerical comparison and several analysis details are missing from the registry record. Conclusions should therefore remain limited to what the record documents rather than claims about treatment benefit or lack of benefit.

13. Why This Trial Matters Statistically

This trial is statistically notable because its primary endpoint is not represented by one straightforward score comparison in the registry record. OPHI-II is described through a total score and three subdomains, and the assessment is described as occurring before and after treatment in both groups. These dimensions allow multiple possible summaries and contrasts. A clear prespecified primary comparison is important because different choices can lead to different estimates and interpretations.

The record also illustrates the distinction between a trial’s design labels and the statistical evidence needed to interpret its result. Randomized and double-masked are useful design descriptions, but the record does not specify how assignment was generated or who was masked. In general, those procedural details help readers assess whether selection, performance, or measurement biases might affect a group comparison.

Enrollment information also warrants care. The registry lists enrollment of 33, while the arm descriptions contain a statement about recruiting 70 inpatients. The record does not explain this difference. Clear reporting of recruitment, participant flow, and analysis counts helps readers understand how the evidence relates to the planned study and which participants contribute to each outcome.

Finally, the registry lists eight analyses, but does not explain their relation to the outcomes or report a single primary estimate. Statistical interpretation depends not just on whether analyses were conducted, but on how outcomes and comparisons were specified and how uncertainty was reported. Without the result and analysis details, readers cannot distinguish a precise estimate from an uncertain one or assess the role of multiple comparisons. The case underscores the value of complete outcome reporting alongside design descriptions.

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 interpretation is that the registry record does not report numerical results for the primary OPHI-II outcome or reduce its multiple categories or time points to one comparison. It gives no comparative estimate, confidence interval, or p-value. As a result, the direction, magnitude, and precision of the primary finding cannot be evaluated.

The enrollment information is internally difficult to interpret: the registry lists 33, while the arm descriptions say the study would recruit 70 inpatients. The record does not explain this difference. It does not report participant flow, completion of assessments, or the number included in each analysis. The recorded adverse-event at-risk counts do not substitute for outcome-analysis counts.

Important trial procedures are also absent. The method of random sequence generation and allocation concealment is not reported. Although double masking is recorded, the parties masked and procedures for maintaining masking are not described. The content and delivery of the occupational therapy models, including treatment intensity and fidelity, are not reported in enough detail to assess comparability or reproducibility.

The registry lists eight analyses but does not describe their statistical methods, the primary contrast, multiplicity handling, analysis population, or missing-data approach. The timing and definition of the post-treatment assessment are only partly specified by the 2 weeks timeframe. The record also does not explain the arm-description text that ends incompletely. These reporting gaps limit both independent evaluation of bias and reproduction of the analysis. They do not establish that the study was conducted improperly, but they prevent a detailed appraisal using the registry record alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Development and Validation of the Client Centered Occupational Therapy Service Model — NCT04465422.
• Registry record last updated 2021-03-24; status last verified 2020-06.
• Results first posted 2021-03-02.
• 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

NCT04465422 is a completed randomized, double-masked, parallel-group study sponsored by Taipei City Hospital. The registry records enrollment of 33, a start date of 2020-06-19, and a primary completion date of 2020-07-16. The comparison is occupational therapy based on MOHO theory versus the original occupational therapy model for inpatients with schizophrenia.

The primary outcome is OPHI-II total and subscale scores, described as means and standard deviations, with a 2 weeks timeframe. Occupational Therapy Evaluation Scales Measure is listed as a secondary outcome. The registry lists two outcome measures and eight analyses, but does not report one reduced primary comparison or numerical OPHI-II results. The arm descriptions state a recruitment intention of 70, a difference from the enrollment entry that is not explained. The registry records zero affected participants for serious and other adverse events and zero deaths in both groups.