This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Transdiagnostic Course for Common Mental Health Problems in Primary Care (NCT04522713), a na na study. The primary outcome is Overall Satisfaction With Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04522713 |
| Phase | NA |
| Condition | Depression, Anxiety |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 91 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Karolinska Institutet |
| Results posted | Yes |
2. Clinical Question
Population
Adults with clinically significant depression or general anxiety symptoms, alongside adults with subclinical symptoms, in a primary-care context. The trial included 91 participants: 70 clinical and 21 subclinical.
Intervention
A transdiagnostic course consisting of 6 weekly structured large-group sessions. Its described content includes behavioral activation, sleep strategies, exposure-based strategies, physical activity, recuperating activities, and psychoeducational material.
Comparator
There was no separate comparator group. This was a prospective single-group study, with no random allocation and no masking. The registry record does not report a like-for-like control comparison.
Primary question
What was the overall satisfaction with the course at the post-course assessment, measured with the Client Satisfaction Questionnaire (CSQ-8)? The preregistered target was a mean score of at least 22. The registry record does not report the observed mean or standard deviation.
3. Trial Design
This was a completed, prospective, single-group feasibility study of a transdiagnostic course for common mental health problems in primary care. The registry record describes the course as intended for patient groups with clinically significant depression or anxiety. It also included participants with subclinical symptoms. Enrollment was 91; the record describes 70 participants as clinical and 21 as subclinical.
Participants were offered 6 weekly structured large-group sessions focused on strategies intended to reduce psychiatric symptoms and increase wellbeing. The listed intervention content includes behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, and psychoeducational material. The course could be held online if necessary due to the COVID-19 pandemic, but the delivery mode actually used is not reported in the registry record.
The design has no randomized allocation, masking, or separate control arm. As a result, the study is suited to describing feasibility-related outcomes and participants’ post-course responses, but it cannot provide a randomized estimate of a treatment contrast. The registry record lists the study as completed. Its primary assessment was scheduled immediately after the course and completed within 45 days; 86 participants completed the CSQ-8 at that assessment.
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: All participants were enrolled in the course.
Overall Study
| Stage | Large-group Transdiagnostic Course |
|---|---|
| STARTED | 91 |
| COMPLETED | 86 |
| NOT COMPLETED | 5 |
Analysis population for the primary outcome, as defined in the registry: The trial included 91 participants: 70 clinical, and 21 subclinical. Of these, 86 (66 + 20) completed the CSQ-8 at the post-course assessment.
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: In this feasibility study, in accordance with the preregistered plan, no distinction between clinical and subclinical participants was done except for the auxilliary preliminary efficacy analyses. All 91 participants were recruited via the same pathway, followed the same protocol, and were considered part of the same cohort.
| Characteristic | Unit | Large-group Transdiagnostic Course |
|---|---|---|
| Participants analysed | 91 | |
| Age, Continuous | years | 38 (SD 12) |
| Sex: Female, Male: Female | Participants | 63 |
| Sex: Female, Male: Male | Participants | 28 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Sweden | participants | 91 |
| University education | Participants | 71 |
| Employment: Working full-time | Participants | 55 |
| Employment: Working part-time (< 90%) | Participants | 11 |
| Employment: Unemployed | Participants | 3 |
| Employment: Retired | Participants | 3 |
| Employment: Student | Participants | 9 |
| Employment: Other | Participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Satisfaction With Treatment, measured over Post-course assessment (immediately after the course, completed within 45 days).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is overall satisfaction with treatment, measured by the mean Client Satisfaction Questionnaire score (CSQ-8) at the post-course assessment. The questionnaire is a sum score based on 8 items, each scored from 1 to 4. Its theoretical range is 8-32, with higher scores indicating higher satisfaction. The preregistered target was a mean score of at least 22. The registry record notes that the original preregistered range of 7-28 was an erratum.
Satisfaction is a participant-reported outcome relevant to whether a course is acceptable to those who attend it. In a feasibility study, this can help describe participants’ experience of the course, but it is not a direct measure of symptom change or a comparison with another intervention. The registry record does not report the observed mean or standard deviation for the CSQ-8, so the degree to which the target was met cannot be determined from the reported primary outcome information. The 86 completed questionnaires describe the number contributing to that assessment, not the satisfaction score itself.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies overall satisfaction on the CSQ-8 as the primary outcome and states a preregistered target mean of at least 22. It also reports that 86 participants completed the questionnaire at the post-course assessment. However, it does not report the observed mean, standard deviation, confidence interval, or another numerical summary of the score. Consequently, the posted primary-outcome information does not show whether the target was reached or how precisely satisfaction was estimated.
The study enrolled 91 participants, including 70 in the clinical group and 21 in the subclinical group. The record does not provide separate CSQ-8 results for those groups. It therefore cannot establish whether satisfaction differed by symptom status. Nor does the single-group design support an estimate of how participants would have responded under a different course or without the course. A post-course score describes responses among assessed participants; without a control group, it does not isolate the course’s effect from other explanations.
The registry lists 11 outcome measures, including adherence, symptom improvement, adverse events, need for additional clinical intervention, and changes in depression and general anxiety symptoms. The numerical results for those outcomes are not reported in the registry record. Listing an outcome does not itself establish that it was measured successfully or indicate what its result was.
The adverse-event record reports zero serious adverse events among 91 at risk and 8 events in the other adverse-event category among 86 at risk. Those counts are descriptive and do not establish the cause of an event. The registry record does not provide serious-event terms, and it does not describe the other events in the information available for interpretation.
Overall, the record provides the study design, target for satisfaction, assessment completion count, and limited adverse-event counts, but not numerical primary satisfaction results or symptom-change results. The findings therefore cannot be used to quantify a treatment effect or to judge the precision of a satisfaction estimate. Those distinctions matter: a feasibility study’s design and listed outcomes are not substitutes for posted outcome estimates.
9. Statistical Methods Explained
The primary outcome is a continuous score. The registry describes the CSQ-8 endpoint as a mean with standard deviation, measured immediately after the course and completed within 45 days. A mean gives a measure of the average score among those assessed. A standard deviation describes how spread out individual scores are around that mean. The registry record does not report either statistic for the primary endpoint.
What would a confidence interval mean?
General statistical explanation: a confidence interval expresses the uncertainty around an estimated quantity, such as a mean. It helps readers distinguish an estimate that is relatively precise from one that is compatible with a wider range of values. It is not a range containing a fixed proportion of individual participants’ scores, and it does not by itself show whether an outcome is important. No confidence interval for the CSQ-8 mean is reported in the registry record, so its precision cannot be assessed from that measure.
How should the target be read?
The preregistered target was a mean CSQ-8 score of at least 22. This is a stated benchmark for the average score, not a comparison against a control group and not a test of whether the course caused a change. To assess the observed average against that target, the observed mean would need to be reported; the registry record does not report it. A target alone cannot establish whether it was reached.
Why does the design affect interpretation?
General statistical explanation: a single-group study measures outcomes in participants who receive the course but lacks a concurrent comparison group. It can describe the observed scores and events in the enrolled group. It cannot separate a course-related change from other influences over time, such as changes in circumstances or other care. Random allocation and masking are recorded as absent, and there is no separate comparator. These design features limit causal interpretation even if outcome estimates were available.
What do the sample-size illustrations mean?
General statistical explanation: a sample-size calculation estimates how many participants a hypothetical study might need under specified assumptions. The registry’s planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. It is a planning illustration, not the design of this single-group study and not observed power. The record does not report the numerical primary outcome needed to interpret an observed effect for satisfaction. No planning illustration can be read as evidence that the single-group study had a particular probability of detecting an effect.
For continuous outcomes, such as a mean score, planning depends on both the effect being targeted and the variability of the outcome. General statistical explanation: greater variability makes a given difference harder to distinguish from random variation. For count outcomes, extra variation beyond a simple model can also affect uncertainty; this is often called over-dispersion. These are general considerations, not claims about the statistical distribution of outcomes in this study. The registry record does not report a statistical analysis plan that would establish how these issues were handled.
What can the posted counts establish?
The count of 86 CSQ-8 completions identifies the number contributing to the reported assessment population, while the registry gives 91 as the enrolled population. The reasons for not completing the questionnaire are not reported in the registry record. General statistical explanation: if outcome completion is related to participants’ experiences or scores, the average among completers may not represent all enrolled participants. Without information on missingness or an analysis addressing it, the direction and size of any resulting bias cannot be determined.
The adverse-event counts are also descriptive. A count of observed events records what was reported in the relevant category and risk group; it does not by itself establish attribution, comparative risk, or the chance of events in a wider population. With no comparator group, these counts cannot estimate a between-group safety difference. The registry record does not report further detail that would support a more specific analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 11 outcome measures. The primary measure is overall satisfaction with treatment. Listed secondary outcomes include adherence, clinically significant improvement in depression and general anxiety, problematic lifestyle behaviors, adverse events, need for additional clinical intervention, and changes in mean depression and general anxiety symptoms. The record does not report numerical results for these secondary outcomes.
When a study evaluates multiple outcomes, the chance of at least one apparently unusual finding can increase if each is tested separately without a strategy for multiplicity. General statistical explanation: a prespecified approach may identify a primary outcome, adjust inference across selected comparisons, or distinguish confirmatory from exploratory analyses. The registry record does not report a multiplicity strategy or an analysis plan that would show how the listed outcomes were handled. The number of outcome measures alone does not establish that every outcome was tested or that any finding is statistically significant.
The registry record reports that 86 participants completed the CSQ-8 assessment, compared with enrollment of 91. It does not report why some enrolled participants lack a completed CSQ-8, how missing outcomes were handled, or whether any sensitivity analysis was conducted. It also does not report analysis populations for the primary or secondary outcomes. Thus, the completion count is known, but the approach to missing data and the exact analysis population beyond that count are not described.
These gaps limit interpretation of both estimates and uncertainty. Without outcome values, analysis details, and missing-data methods, readers cannot assess whether results were adjusted for multiple testing, whether analyses followed a prespecified plan, or how incomplete outcome collection affected the conclusions.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Large-group Transdiagnostic Course | 0 | 91 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Large-group Transdiagnostic Course | 0 of 91 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Large-group Transdiagnostic Course | 8 of 86 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Large-group Transdiagnostic Course |
|---|---|---|
| Other | Psychiatric disorders | 6 of 86 |
| Temporary increase in anxiety or stress | Psychiatric disorders | 3 of 86 |
The registry record reports zero serious adverse events among 91 participants at risk. It reports 8 events in the other adverse-event category among 86 participants at risk. These are event-category counts for the study group, not comparisons with another group. No serious adverse-event terms are listed.
The two categories have different risk-group denominators in the record, so each count should be read alongside its own stated number at risk. The registry does not describe the other adverse events in the information, and it does not state whether events were considered related to the course. The counts therefore cannot establish causation or provide a detailed account of event type or severity.
General statistical explanation: observing zero serious events in a study does not prove that the underlying risk is zero. A study’s observed counts describe the enrolled participants and the period captured by its adverse-event reporting. Without a comparator, the record cannot estimate a relative safety difference. The posted counts are informative as recorded observations, but they are not a complete characterization of safety in other populations or settings.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed single-group feasibility study of a transdiagnostic course for adults with depression or anxiety symptoms in primary care, including participants with subclinical symptoms. It identifies post-course satisfaction as the primary outcome, gives a target mean of at least 22 on the CSQ-8, and states that 86 participants completed the questionnaire. Those details describe the question and the assessment, but the observed satisfaction mean and standard deviation are not reported in the registry record.
As a result, the primary outcome information does not establish whether the target was met, nor does it show how precisely satisfaction was estimated. The registry record also lists symptom-change and other secondary outcomes without reporting their numerical results. It is therefore not possible to infer the amount of symptom change, the frequency of clinically significant improvement, or the level of adherence from the outcome list alone.
The design also defines what can be concluded. Because this was a single-group study with no randomized comparator, any observed post-course outcome would describe the participants assessed rather than establish what the course caused. The study cannot separate an effect of the course from other explanations using a comparison that it did not include.
The reported adverse-event counts describe events recorded in the study group. They do not establish whether an event was caused by the course, and they cannot be used as a comparative safety estimate. Overall, the record identifies the study’s aims, design, target, and some descriptive counts, but the absence of numerical primary and secondary outcome results prevents a fuller assessment of the observed outcomes.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how a feasibility question differs from a comparative effectiveness question. Its single-group design evaluates course participation and post-course outcomes without a separate control group. That design can describe experiences and events among enrolled participants, but it does not estimate a treatment contrast.
The primary endpoint is satisfaction, a participant-reported measure that is relevant to acceptability. The preregistered benchmark gives readers a clear reference point for the intended average score. However, without a posted mean and measure of variability, the benchmark cannot be compared with an observed result, and the precision of the estimate cannot be judged. The distinction between a target and an outcome estimate is central to interpreting feasibility studies.
The record also makes assessment completion visible: 86 of 91 participants completed the CSQ-8. That is useful context for understanding who contributed to the primary assessment, while the unreported reasons for incomplete assessments leave uncertainty about missing-data implications. The listed symptom and implementation outcomes indicate the range of questions the study considered, but their results are not reported in the registry record.
Finally, the adverse-event counts illustrate why descriptive safety reporting needs careful framing. Counts can document what was observed in the enrolled group, but without comparative data and further event detail they do not establish causation or generalize to other settings. The study’s statistical value lies in its feasibility-oriented design and stated outcome framework; the lack of posted numerical outcome estimates limits the conclusions readers can draw.
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.
A central limitation is that the registry record does not report the numerical result for the primary CSQ-8 endpoint. Although the target mean is stated and 86 participants completed the assessment, the observed mean and standard deviation are absent. The record therefore does not show whether the target was met or how uncertain the estimate was.
The single-group design has no separate control arm and no randomized allocation. It cannot support a controlled estimate of the course’s effect or distinguish course-related change from other influences. Masking is recorded as absent. The actual course delivery mode is not reported, despite the description allowing online delivery if necessary due to the COVID-19 pandemic.
The registry lists secondary outcomes, but does not report their numerical results, outcome-specific analysis populations, or the statistical analysis plan. Multiplicity handling is not reported. The record also does not describe how missing outcomes were handled or why 86 participants completed the CSQ-8 while enrollment was 91. These omissions limit assessment of potential bias from incomplete outcome data.
The adverse-event information is limited to counts: zero serious adverse events among 91 at risk and 8 events in the other category among 86 at risk. Serious-event terms are not listed, and further descriptions of the other events are not reported in the registry record. Consequently, event type, attribution, and comparative safety cannot be assessed from these counts alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Transdiagnostic Course for Common Mental Health Problems in Primary Care — NCT04522713.
- Registry record last updated 2025-01-31; status last verified 2024-12.
- Results first posted 2025-01-31.
- 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.
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18. Record Summary
NCT04522713 is a completed, prospective, single-group feasibility study titled “A Transdiagnostic Course for Common Mental Health Problems in Primary Care.” It enrolled 91 participants, described as 70 clinical and 21 subclinical, to attend 6 weekly structured large-group sessions. The registry record lists behavioral activation, sleep strategies, exposure-based strategies, physical activity, recuperating activities, and psychoeducation among the intervention content.
The primary outcome was post-course satisfaction measured by the CSQ-8. Its preregistered target mean was at least 22, and 86 participants completed the assessment. The observed mean and standard deviation are not reported in the registry record. Listed secondary outcomes include adherence, symptom improvement, lifestyle behaviors, adverse events, additional clinical intervention, and changes in depression and anxiety symptoms; their numerical results are not reported.
The adverse-event record reports zero serious events among 91 at risk and 8 in the other category among 86 at risk. The study had no randomized comparator, and the registry record does not report a statistical analysis plan, missing-data methods, or multiplicity handling.