A Study of Cognitive Adaptation Training in Inpatient Forensic Environments: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of Cognitive Adaptation Training in Inpatient Forensic Environments (NCT04294719), a registered phase not stated study. The primary outcome is Clutter Image Rating Scale (CIRS) - Blind-rated.

2. Clinical Question

The study summary frames the project as a mixed-methods feasibility study, combining quantitative measures with qualitative attitudes from participants and care providers. That framing matters: a feasibility study can examine whether an intervention and its measurement procedures can be used in a particular service context, but a feasibility aim alone does not answer whether the intervention changes an outcome. No specific feasibility criteria or thresholds are reported in the registry record.

3. Trial Design

The registry record describes a completed study sponsored by the Centre for Addiction and Mental Health. Its stated focus is modified Cognitive Adaptation Training in inpatient forensic environments, with a population described as inpatient clients with a schizophrenia spectrum illness in a general-security forensic unit. The brief summary calls the project a mixed-methods feasibility study. Enrollment is recorded as 24.

The intervention is listed as Cognitive Adaptation Training (CAT), with the study summary using the term finCAT for its modified inpatient form. The description characterizes CAT as a compensatory cognitive intervention that uses environmental supports and cues to focus on functioning. It also notes prior inpatient adaptations in other settings, but the registry record does not give details of the intervention’s sessions, duration, delivery schedule, or adherence requirements for this study.

The record does not state allocation, and does not describe a like-for-like control comparison. It therefore cannot be characterized from the registry record as a randomized controlled trial. The listed arm description is for “Inpatient Clients”; it gives eligibility and setting information rather than establishing a separate comparator. The role of any comparison condition, if one existed, is not reported in the registry record.

The primary outcome is the blind-rated Clutter Image Rating Scale (CIRS), with the timeframe stated as baseline. The record also lists secondary outcomes covering the Evidence-Based Practice Attitude Scale, the Essen Climate Evaluation Schema, qualitative care-provider attitudes, and qualitative participant attitudes. Some named measures appear more than once in the registry listing. The total number of outcome measures is 20, while the registry record lists 0 analyses.

The study status is COMPLETED. The recorded start date is 2019-12-12, and the primary completion date is 2020-06-20. Those registry dates describe study timing, not the timing of the primary outcome assessment beyond the stated baseline timeframe. Further operational details, including the schedule of assessments and the analysis plan, 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:

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 Clutter Image Rating Scale (CIRS) - Blind-rated, measured over Baseline.

The primary outcome is the Clutter Image Rating Scale (CIRS), rated by blinded assessors. The record describes the CIRS as a visual scale using pictures to quantify clutter in a living space. Although the instrument can cover a kitchen, living room, and bedroom, this project is described as using only the bedroom rating. The scale runs from 1 to 9, with higher ratings indicating more clutter.

Room organization is the feature being assessed. The record says that photos of each participant’s room would be rated by 2 blinded student investigators, and that the mean rating would be used. Blinding is relevant because assessors who do not know the participant’s study allocation or intervention status may be less likely to let that knowledge influence their ratings. The registry record does not report whether blinding was maintained or how disagreements between raters were handled.

A standardized visual rating can make an assessment of room clutter more consistent than an informal description alone. It also turns a visual judgment into a score that can be summarized across participants. That is a general measurement rationale, not evidence that the measure is reliable or sensitive to change in this study population; such performance results are not reported in the registry record.

The registered timeframe for the primary outcome is baseline. Although the outcome description refers to before-and-after room photos, the registry record does not give a post-intervention timeframe or report any CIRS scores. The primary endpoint therefore cannot be interpreted as a reported change in clutter from the information in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is continuous: it is a score on a scale, summarized in the registry as a mean with standard deviation. A mean describes the central value of a group of scores, while a standard deviation describes how spread out individual scores are around that mean. These summaries can help characterize a group, but they do not by themselves show whether a change is attributable to an intervention. No means or standard deviations for CIRS are reported in the registry record.

What does a blind-rated score mean?

The registry description says room photographs would be rated by 2 blinded student investigators, with their mean rating used. Blinding means keeping assessors unaware of information that could influence their judgment, such as treatment status. In general, blinding can reduce the risk that expectations affect measurement. It does not eliminate all measurement error, and the record does not report how blinding was implemented, whether it was maintained, or how ratings were reconciled.

The CIRS rating uses a visual analogue approach, with the bedroom rating selected for this project. The stated scale range is 1 to 9, and higher ratings indicate more clutter. This direction is essential when interpreting any score: a higher value represents more of the measured feature, not better room organization. The registry record does not report actual scores, so the scale direction cannot be used to infer the observed pattern in this study.

Why is a comparison important?

In general, a comparison helps distinguish changes associated with an intervention from changes that may occur for other reasons, including time, setting, or measurement. A randomized comparison can help balance participant characteristics between groups, though it does not guarantee that every source of bias is removed. Here, allocation is not stated and the record flags that the arms are not a like-for-like control comparison. The registry information therefore does not support treating the study as a randomized comparison or interpreting a between-arm effect.

A before-and-after comparison within participants can describe whether their measurements differ across assessments. But without an appropriate comparison condition, such a difference does not, on its own, show that the intervention caused the change. The record mentions before-and-after room photographs in the outcome description while listing the primary timeframe as baseline. It does not report a post-intervention timeframe, paired scores, or a change analysis.

What can an uncertainty estimate add?

In general, a confidence interval expresses uncertainty around an estimate and indicates which values remain reasonably compatible with the observed data under the chosen model and assumptions. Its width depends on factors including variability and the amount of information in the data. A narrow interval indicates more precise estimation than a wide interval, though precision does not establish that an effect is important or causal. No confidence interval or primary-outcome estimate is reported in the registry record, so precision cannot be assessed.

A p-value, in general, measures how incompatible the observed data are with a specified null hypothesis under the model assumptions. It does not give the probability that a hypothesis is true, and it does not quantify the size or practical importance of an effect. No p-value or inferential test for CIRS is reported. Statistical significance therefore cannot be assessed from the registry record.

How should planning calculations be read?

In general, sample-size planning calculations describe the number of participants that would be required under specified assumptions to detect a chosen effect with a selected error rate and power. They are not observed results and are not the same as achieved or observed power. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of an observed effect. The calculations are planning illustrations, not evidence that this study used those assumptions in its design. The registry record does not report a sample-size justification or a protocol-based target. No specific sample-size planning result is reported in the registry record.

Over-dispersion is a general concern when observed variation exceeds what a statistical model assumes. If ignored, standard errors can be too small and uncertainty can be understated. Whether over-dispersion is relevant depends on the outcome and model; the registry record does not identify a model or report an over-dispersion assessment. For the continuous CIRS outcome, the record names mean and standard deviation summaries but gives no details of a fitted model.

Finally, analysis choices matter. An unadjusted comparison, an adjusted model, a repeated-measures analysis, and an analysis accounting for clustering may answer related but distinct questions. Which approach is suitable depends on the design and data structure. The registry record lists 0 analyses and does not describe an analysis plan, covariate adjustment, clustering, or interim analyses. None should be inferred from the outcome descriptions alone.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Inpatient Clients")
n   <- c(18)
m   <- c(2.28)
sp  <- c(0.575)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Inpatient Clients  18  2.280  0.575  1.994  2.566

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 20 outcome measures, including the Evidence-Based Practice Attitude Scale (EBPAS), the Essen Climate Evaluation Schema (Essen CES), qualitative care-provider attitudes, and qualitative participant attitudes. EBPAS and Essen CES each appear more than once in the listed outcomes. The record does not explain whether repeated entries refer to separate timepoints, subscales, or duplicate registrations. Their meaning should not be guessed.

When a study evaluates many outcomes or performs multiple statistical tests, the chance of at least one apparently unusual finding can increase. In general, multiplicity methods can control that risk, or investigators can identify a primary endpoint in advance and interpret secondary outcomes as exploratory. The registry record names a primary outcome but does not report a multiplicity strategy or analysis plan. It also lists 0 analyses, so there are no registered test results with which to assess how multiplicity was handled.

Missing-data methods are not reported in the registry record. There is no account of missing CIRS ratings, unavailable photographs, incomplete questionnaires, or absent qualitative responses. The reason for any missing assessments, if any, is not reported. No imputation, complete-case approach, or sensitivity analysis is described.

The analysis populations are also not reported. The record does not say which participants were included in any analysis, how participation or intervention exposure was defined, or how deviations from the intended procedures were handled. Enrollment is 24, while the adverse-event group lists 18 participants at risk; the record does not explain this difference. These counts cannot establish an analysis denominator or a missing-data pattern.

The registry record does not describe interim analyses or stopping rules. It also does not give a statistical analysis plan that would clarify which outcomes and models were planned before the data were examined. In the absence of those details and outcome results, the extent to which missingness, multiplicity, or analysis-population choices affect conclusions cannot be evaluated.

12. 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 listing identifies the group as Inpatient Clients. It records 18 participants at risk for serious adverse events and 18 at risk for other adverse events. The reported counts affected are 0 for serious adverse events, 0 for other adverse events, and 0 deaths.

These figures describe the registry entries for the listed group. They should not be read as proof that the intervention has no risks. A zero count in a registry record indicates that no events were recorded in that category for the reported group; it does not establish that no event could occur or that all events were captured. The record does not provide event terms, event definitions, follow-up duration, or additional detail on safety surveillance.

The 18 participants at risk are not the same as the enrollment count of 24. The registry record does not explain the distinction, so it cannot be attributed to a particular reason such as withdrawal or eligibility for safety follow-up. The number at risk should not be substituted for an analysis population or assumed to represent all enrolled participants.

Because the record does not describe a like-for-like control comparison, these counts do not allow a comparative assessment of event rates. They are descriptive safety information for the listed group only. The registry record does not report statistical comparisons, uncertainty intervals, or a causal assessment of adverse events.

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

The record identifies a feasibility study of modified CAT in an inpatient forensic setting, a population with a schizophrenia spectrum diagnosis, and a primary measure focused on bedroom clutter. It also records enrollment of 24 and a completed study status. These details establish the study context and its registered measurement focus, but they are not outcome evidence.

The primary outcome is listed at baseline, and no CIRS results are reported. There is no reported estimate of a mean score, change, treatment contrast, or uncertainty. As a result, the registry record does not show whether bedroom clutter changed, how large any change might have been, or how precisely it was estimated. It also cannot establish whether any observed change, if reported elsewhere, was caused by CAT.

The registry record does not state allocation and flags the absence of a like-for-like control comparison. It is therefore not possible to interpret this information as a randomized trial comparison. The intervention description explains the intended approach—environmental supports and cues to support functioning—but does not demonstrate that the approach changed functioning or another outcome in this study.

The study’s mixed-methods feasibility framing is relevant to what it may have been designed to learn. Feasibility concerns whether study procedures and intervention delivery can be undertaken in a particular service context. Attitudes from care providers and participants may offer contextual insight, but the registry record does not report these qualitative findings or define feasibility thresholds. Those results cannot be inferred from the list of outcomes.

The safety listing reports zero serious adverse events, zero other adverse events, and zero deaths among the group with 18 at risk. These are descriptive entries, not a comparison and not proof that risk is absent. The record does not explain why the safety denominator differs from enrollment.

In general, a study can be informative about how research might be conducted in a specialized setting even when it does not establish an intervention effect. For this record, however, the feasibility findings themselves are not reported. The evidence supports a careful description of the registered design and measures, not a conclusion about effectiveness, clinical benefit, or the absence of harm.

14. Why This Trial Matters Statistically

This study addresses a statistical and measurement challenge: assessing a behavioral and environmental intervention in an inpatient forensic setting. The registry summary describes CAT as using environmental supports and cues to focus on functioning. Applying such an approach in an inpatient context raises practical questions about delivery and outcome measurement that may differ from those in other care settings. The record positions the project as a feasibility study, though it does not report feasibility results or criteria.

The selected primary measure makes the measurement target concrete. Rather than relying only on a broad judgment about functioning, the study describes a blind-rated photograph-based assessment of bedroom clutter. A defined scale and blinded assessors can support more standardized measurement in principle. At the same time, a visual rating remains an assessment process whose consistency, sensitivity to change, and relevance to participants’ goals need empirical evaluation. Those measurement properties are not reported in the registry record.

The record also illustrates why design information is essential to interpretation. A registered outcome and intervention do not by themselves establish a comparison capable of estimating an intervention effect. Allocation is unstated, and the record flags that the arms are not a like-for-like control comparison. Without clear comparator details and outcome estimates, statistical methods cannot resolve the fundamental uncertainty about what changed and why.

Mixed-methods work can bring together quantitative measures and perspectives from participants and care providers. Those forms of evidence can address complementary questions: scale scores characterize a measured outcome, while qualitative accounts may describe experience and implementation. The registry lists both types of outcomes, but no analyses or findings are reported. The potential value of that approach should not be confused with evidence that the intended questions were answered.

Finally, the distinction between enrollment, safety denominators, and analyzed populations matters in small or specialized studies. The record states enrollment of 24 and a safety risk count of 18, but does not explain the difference or identify analysis populations. Transparent reporting of these denominators would help readers assess completeness and uncertainty. Here, those details and the primary outcome results are not reported in the registry record.

15. 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 available registry information is that it does not report primary-outcome results. Although CIRS is identified as the primary measure and its timeframe is listed as baseline, there are no scores, change estimates, confidence intervals, or statistical tests. The outcome description refers to before-and-after photographs, but the registry record does not specify a post-intervention timeframe or present follow-up ratings.

The design description is insufficient to support a comparative effect estimate. Allocation is not stated, and the record flags that the arms are not a like-for-like control comparison. The intervention is named, but details such as its delivery schedule, duration, adherence, and fidelity are not reported in the registry record. No protocol or statistical analysis plan is described.

Outcome ascertainment also has unresolved details. The description specifies ratings by 2 blinded student investigators and use of their mean, but the registry record does not explain how blinding was maintained, how rater agreement was evaluated, or how disagreements were addressed. It does not report whether CIRS was assessed consistently across participants or whether the measure’s performance was evaluated in this setting.

The registry lists 20 outcome measures and 0 analyses. Repeated entries for EBPAS and Essen CES are not explained, and no multiplicity strategy is reported. Missing-data handling and analysis populations are not reported either. Consequently, completeness of outcome data and the potential influence of analytic choices cannot be assessed.

Enrollment is 24, whereas the safety listing gives 18 participants at risk. The registry record does not account for this difference. Safety event definitions, follow-up duration, and event details are also absent. These limitations restrict interpretation to the registered study description and the recorded safety counts; they do not support conclusions about treatment effect or broad generalizability.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study of Cognitive Adaptation Training in Inpatient Forensic Environments — NCT04294719.
• Registry record last updated 2023-01-26; status last verified 2022-04.
• Results first posted 2023-01-26.
• 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.

19. Record Summary

The registry record describes a completed mixed-methods feasibility study of modified Cognitive Adaptation Training in inpatient forensic environments, sponsored by the Centre for Addiction and Mental Health. The population is described as inpatient clients with a schizophrenia spectrum illness in a general-security forensic unit. Enrollment is 24.

The primary outcome is a blind-rated bedroom Clutter Image Rating Scale score, with the timeframe listed as baseline. The record describes the scale direction and photo-rating approach but does not report CIRS results, a post-intervention assessment timeframe, or an effect estimate. Allocation is not stated, and a like-for-like control comparison is not described.

The registry lists 20 outcome measures and 0 analyses. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths among 18 participants at risk; the difference between that count and enrollment is not explained. Missing-data methods, analysis populations, multiplicity handling, and the statistical analysis plan are not reported in the registry record. The posted information therefore describes the study and its registered measures, but does not establish an outcome effect.