Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients (NCT04020497), a randomized na study. The primary outcome is General Distress by Global Severity Index.

2. Clinical Question

The question is about the added programme, not about Ensemble replacing usual support: both groups were assigned SAU, while the intervention group also received Ensemble. The planned primary measure is a continuous score representing global distress. The stated assessment schedule includes baseline, T1 at 2 months, and T2 at 4 months. The registry record does not give numerical GSI results at any of these assessments, an estimated between-group difference, or a confidence interval. It therefore does not establish from the posted information whether the groups differed, how large any difference was, or how precisely it was estimated.

The trial is registered as randomized, with a parallel-group model. The enrollment figure is 160. Although the brief description says half of participants would receive each assigned approach, the registry record does not report the final number included in the primary-outcome analysis or the allocation sequence details. The question is clinically focused on distress in caregivers, while the secondary outcomes include optimism, mental quality of life, burden, and patient social and occupational functioning. Those additional measures may broaden the questions considered, but no numerical results for them are reported in the registry record.

3. Trial Design

The registry record describes a randomized, single-masked, parallel-group trial, marked completed. It lists enrollment of 160 and the study condition as psychological distress. One group received the five-session Ensemble programme plus support as usual; the comparison group received support as usual alone. The record identifies Institut et Haute Ecole de la Santé la Source as sponsor. The study start is listed as 2019-09-01, and primary completion as 2021-01-01. The phase field is recorded as not applicable.

The primary outcome is general distress measured by the Global Severity Index (GSI) of the Brief Symptom Inventory. The stated time frame is baseline, T1 at 2 months, and T2 at 4 months. This repeated assessment schedule could describe both starting levels and later scores, but the registry record does not specify the planned primary contrast, such as a particular follow-up visit or an overall trajectory across visits. Nor does it describe whether the main analysis was to compare change from baseline, follow-up values adjusted for baseline, or another summary.

Single masking is recorded, but the registry record does not identify who was masked or explain how masking was implemented. The method used to generate or conceal random allocation, the criteria for assigning participants, and the planned handling of deviations from assigned treatment are not reported in the registry record. The record also does not state the intended recruitment setting or detail the eligibility criteria. These omissions limit assessment of how allocation and participant selection might affect interpretation.

The secondary outcome list names optimism level, mental quality of life, burden level, and the patient's social and occupational functioning. Five outcome measures are listed, while the number of posted analyses is zero. The completed status indicates the trial is marked completed in the registry, but completion status alone does not supply analyzed results. Numerical primary and secondary estimates, participant flow through follow-up, and a detailed statistical 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

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 General Distress by Global Severity Index, measured over Baseline, T1 at 2 months, and T2 at 4 months.

The primary endpoint is general distress measured by the Global Severity Index from the Brief Symptom Inventory (BSI). The registry describes the BSI as a 53-item instrument covering physical and psychological symptoms occurring during the preceding 7-day period. Items use a 5-point Likert-type response scale, from “not at all” to “extremely.” The record describes the GSI as a composite measure of global distress and states that a higher score represents more severe global distress. The measure is reported as a score on a scale, with least-squares means and standard errors designated as the summary format.

A global symptom measure can be useful when the research question concerns overall distress rather than one isolated symptom. The BSI description also identifies the Positive Symptom Total and Positive Symptom Distress Index as other global indices, but the primary outcome specified for this trial is the GSI. The record's description of the scale includes a range and a maximum score; its wording is not fully clear about how the stated range relates to the item-level scoring. The registry record does not explain any scoring or transformation procedure beyond the description given.

Assessments are scheduled at baseline, T1 at 2 months, and T2 at 4 months. Repeated assessment can help characterize whether scores change over follow-up, but interpreting that pattern requires the actual estimates and their uncertainty. Those numerical primary-outcome results are not reported in the registry record. The endpoint definition alone does not show whether distress improved, worsened, or differed between assigned groups.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a score rather than a count of events or a binary status. The registry lists least-squares means with standard errors as the summary. General statistical explanation: a mean describes the central level of a continuous measure, while a standard error describes uncertainty in the estimated mean under a statistical model. The standard error should not be interpreted as the range of scores among individual caregivers. The registry record does not provide the numerical means or standard errors, so their size and precision cannot be assessed.

What does a least-squares mean represent?

General statistical explanation: a least-squares mean is a model-based estimate. It may account for variables or repeated observations specified in the analysis model, so it can differ from an unadjusted average calculated directly from participant scores. Its meaning depends on which predictors and assumptions are included, and on the specific comparison requested from the model. The registry record does not report the model formula, covariates, covariance structure, or exact contrast. It is therefore not possible to determine what adjustment the planned summary would make or reproduce its interpretation from the record.

How does the repeated-measure schedule matter?

The primary outcome is scheduled at baseline, T1 at 2 months, and T2 at 4 months. General statistical explanation: when the same participants are measured repeatedly, their observations are usually related rather than independent. An analysis can account for that within-person correlation and can estimate changes over time or differences between groups at selected time points. Different choices answer different questions. For example, comparing groups at one follow-up is not identical to assessing whether their trajectories across follow-up differ. The registry record does not identify the specific repeated-measure model or primary contrast, and does not report results at the listed assessments.

What can randomization contribute?

General statistical explanation: random allocation is intended to reduce systematic differences between groups at the point of assignment, including differences in measured and unmeasured characteristics on average. It does not ensure that every characteristic will be balanced in a particular trial, and it does not prevent missing follow-up data or departures from assigned treatment. The registry records randomized allocation, but does not describe the sequence generation, concealment, or analysis population. Those details are important for judging how allocation was implemented and preserved.

What does uncertainty mean?

General statistical explanation: an estimate is more informative when accompanied by an interval that expresses its uncertainty. A confidence interval gives a range of values compatible with the observed data under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, but precision does not by itself determine clinical importance. A p-value, when reported, addresses compatibility between data and a specified null hypothesis under model assumptions; it does not give the probability that the null hypothesis is true. No primary-outcome confidence interval or test result is reported in the registry record, so neither statistical precision nor evidence against a null comparison can be evaluated.

How should sample-size illustrations be read?

The stated planning illustration uses a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. These are described as planning assumptions, not as the trial's own design justification. General statistical explanation: a sample-size calculation estimates how many participants would be needed under specified assumptions about the effect, variability, allocation, and testing procedure. The result is conditional on those inputs; it is not a measure of whether an observed study result is reliable. Any sample-size values are planning illustrations, not observed power. The registry record does not report the trial's original sample-size justification or the assumptions used when the trial was designed.

The observed effect needed for such an illustration is not numerically reported in the registry information available for this analysis. Thus the stated assumptions do not allow an independent numerical assessment of the illustration. In general, planning for a smaller effect requires more information from participants than planning for a larger effect, all else equal; this is a general statistical relationship, not a claim about this trial's results.

Why is a detailed analysis plan important?

General statistical explanation: specifying the endpoint, time point, model, covariates, analysis population, and missing-data approach in advance helps clarify which estimate is intended and reduces ambiguity when several reasonable analyses are possible. The registry record does not report these details. It also does not report interim analyses or a prespecified strategy for handling multiple outcome comparisons. No such procedures should be inferred from the randomized design or from the listed outcomes.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and secondary outcomes covering optimism, mental quality of life, burden, and patient social and occupational functioning. The primary outcome also has measurements scheduled at baseline, T1 at 2 months, and T2 at 4 months. Considering multiple outcomes or follow-up comparisons can increase the chance of at least one apparently unusual result when many tests are conducted. General statistical explanation: multiplicity procedures can control that risk, while a clearly defined primary comparison can distinguish the main confirmatory question from additional exploratory analyses. The registry record does not report a multiplicity adjustment, a testing hierarchy, or which follow-up contrast was designated for the main inference.

Missing-data methods and the analysis population are not reported in the registry record. It is not stated how many participants contributed GSI data at each assessment, whether any participants discontinued, or how incomplete questionnaires were handled. The record also does not identify whether the intended analysis was based on all randomized participants, participants who received the assigned programme, or another population. These details matter because the number and characteristics of participants with observed follow-up scores can affect the estimate, and different missing-data assumptions can lead to different results.

General statistical explanation: analyzing only participants with complete measurements may be biased if the likelihood of missing data is related to distress or other factors. Model-based methods can use incomplete repeated observations under assumptions, but do not remove the need to examine whether those assumptions are plausible. The registry record does not report a missingness assumption, imputation method, sensitivity analysis, or analysis population. The listed enrollment figure and adverse-event denominators do not establish the number included in the outcome analysis.

The record reports zero analyses. That does not establish that no analyses were performed outside the registry; it means the registry record does not present an analysis count or numerical outcome results for interpretation.

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 lists two groups for adverse events: Ensemble plus SAU and SAU alone. For each group, 80 participants are shown at risk for serious adverse events and 80 at risk for other adverse events. The reported number affected is 0 for serious events and 0 for other events in each group; deaths are reported as 0 in each group. No top serious-event terms are listed.

These figures are counts in the registry record, not a comparison of event rates adjusted for follow-up time or participant characteristics. The record does not describe how adverse events were defined, collected, classified, or assessed for relatedness to the intervention. It also does not state whether every participant was monitored for the same duration or give a detailed safety-monitoring procedure. The timeframe for the adverse-event counts is not specified in the registry record.

Zero reported events means that the registry lists no participants affected in these categories; it does not establish that no events occurred outside the record, that all possible harms were measured, or that the interventions are free of risk. These counts should be read as descriptive registry reporting. They do not substitute for the missing primary-outcome results and do not establish a comparative safety conclusion.

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

The record establishes that a randomized, parallel-group study of Ensemble plus usual support versus usual support alone was marked completed, with enrollment of 160. It identifies general distress measured by the BSI Global Severity Index as the primary outcome and lists assessments at baseline, T1 at 2 months, and T2 at 4 months. These details define the study question and the intended outcome, but are not results of the comparison.

The registry record does not report numerical primary-outcome estimates or analyses. There is no basis in the posted information to say whether distress differed between groups, whether scores changed over time, or how precise an estimated difference might be. The absence of reported estimates does not show that there was no effect, nor does it establish that there was a meaningful effect. It means the registry record does not provide the data needed to evaluate those possibilities.

The same limitation applies to the listed secondary outcomes. Their names describe additional topics, but no numerical results are reported for them. The record's adverse-event counts are descriptive and do not establish that all events were captured or that the groups' safety profiles were equivalent. Likewise, completion status does not establish that all enrolled participants completed follow-up or were included in an analysis.

General statistical explanation: trial results are most interpretable when estimates are presented with uncertainty, the target comparison is clearly defined, and analysis methods and missing-data handling are described. Those elements allow readers to distinguish the size of an estimated difference from its precision and to understand the assumptions behind it. Here, the design and endpoint information can be described, but the lack of reported estimates and analysis details prevents an evidence-based conclusion about the outcome comparison. No medical advice or treatment recommendation follows from this registry information.

13. Why This Trial Matters Statistically

This trial addresses a question about psychological distress among informal caregivers of adult psychiatric patients, a group described in the record as playing an important role in helping patients with severe psychiatric disorders. Its comparison is structured to examine the added programme in the context of usual support: Ensemble is combined with SAU in one arm, while the other arm receives SAU alone. This makes the intended contrast distinct from a comparison against no support.

Statistically, the design pairs randomized allocation with a continuous outcome measured repeatedly. That combination raises important interpretive questions: which follow-up contrast is primary, how within-person correlation is handled, whether baseline values are incorporated, and how missing scores are treated. These are general considerations for repeated-measure trials, not methods confirmed for this study. The registry record does not report the planned model or the exact primary comparison.

The distinction between a defined endpoint and a reported result is especially important. The record gives a recognizable measure, a schedule, a design, and enrollment information, but not the estimates needed to evaluate the outcome. Without group-level values and uncertainty, the size and precision of any difference remain unknown. The listed secondary outcomes also raise multiplicity considerations, yet the registry does not describe a testing strategy or report results for those outcomes.

For readers assessing trial evidence, this record illustrates why registration details and outcome reporting serve different purposes. Design information clarifies what investigators intended to study; numerical results and transparent analysis methods are needed to judge what the data show. The registry information supports the former description, while the latter is not available in the reported analysis record.

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 numerical outcome results are not reported in the registry record. No GSI least-squares means, standard errors, between-group contrasts, confidence intervals, or test results are available. Without them, the primary question cannot be answered from the record. The number of posted analyses is zero, and no numerical results are listed for the secondary outcomes.

Important design and analysis details are also absent. The record identifies single masking but does not say who was masked. It does not describe random-sequence generation or allocation concealment, the planned analysis population, the statistical model, the primary time-point contrast, or the handling of incomplete outcome data. Participant flow and outcome-specific numbers at follow-up are not reported. The enrollment figure does not show how many participants contributed data to the primary analysis.

The registry lists repeated assessments and several secondary outcomes, but does not describe multiplicity control or a prespecified hierarchy of comparisons. The sample-size assumptions describe a planning illustration rather than the trial's design justification; the original sample-size rationale is not reported in the registry record. The record also does not report interim analyses or a missing-data sensitivity analysis. These omissions prevent assessment of how the intended inference was protected against analytic choices or incomplete follow-up.

The endpoint description contains wording about the GSI scale range that is not fully clear, and it does not provide a detailed scoring procedure. Adverse-event counts are listed, but definitions, ascertainment methods, follow-up duration, and attribution procedures are not reported. These limitations do not prove that the study was conducted poorly; they identify what cannot be evaluated from the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients — NCT04020497.
• Registry record last updated 2026-09-25; status last verified 2025-05.
• Results first posted 2026-09-25.
• 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 record describes NCT04020497, a completed randomized, single-masked, parallel-group trial of the five-session Ensemble programme added to support as usual for informal caregivers of psychiatric patients. Enrollment is listed as 160. The primary outcome is general distress measured by the BSI Global Severity Index at baseline, T1 at 2 months, and T2 at 4 months. Secondary outcomes include optimism, mental quality of life, burden, and patient social and occupational functioning.

The record lists 80 participants at risk in each group for serious and other adverse events, with 0 affected in each category and 0 deaths in each group. It reports zero analyses and does not provide numerical primary- or secondary-outcome results. Consequently, the registry record describes the trial design and intended measurements but does not permit interpretation of the comparative distress outcome.