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 Peer Based Suicide Prevention (NCT04222673), a na na study. The primary outcome is Questionnaire About the Process of Recovery (QPR) Change.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04222673 |
| Phase | NA |
| Condition | Suicide |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Veterans receiving care through the Veterans Health Administration and described in the study record as being at high risk for suicide. The registry lists 17 participants enrolled and identifies suicide as the condition.
Intervention
Peer Specialist Suicide Prevention: support from a trained Peer Specialist, described as a fellow Veteran with related lived experience. The planned intervention lasted 3 months, with meetings of 30-45 minutes primarily in the community, at home, or by telephone.
Comparator
There was no separate comparator group. The study is recorded as a single-group study, with allocation listed as NA. Baseline and post-intervention measurements are identified, but these are not a randomized control comparison.
Primary question
How does the Questionnaire About the Process of Recovery score change from baseline to post intervention at 12 weeks among participants receiving peer specialist support? The registry record gives the endpoint and its measurement schedule, but the numerical outcome results are not reported in the registry record.
This is a pilot evaluation of an intervention intended to supplement existing clinical approaches with peer support. The stated rationale is that patients may have substantial medical and behavioral health needs, and the intervention is intended to support self-respect, meaning, and connection in the local community. Those statements describe the study's rationale and aims; they are not findings about the effect of the intervention.
The primary endpoint is a questionnaire score about recovery-related experiences. A baseline and a post-intervention assessment can describe within-participant change over the intervention period, but without a separate comparison group that change cannot by itself distinguish intervention effects from other influences over time. The registry record does not report numerical scores, the estimated change, or uncertainty around an estimate. It therefore does not permit a quantitative answer to the primary question.
3. Trial Design
NCT04222673, titled “Peer Based Suicide Prevention,” is recorded as completed. The registry lists the sponsor as the VA Office of Research and Development, enrollment of 17, and a single-group model. Allocation is listed as NA and masking as NONE. The record does not describe a randomized comparison, and specifically cautions that the arms are not a like-for-like control comparison. In this study design, the intervention group is not contrasted with a concurrent control arm.
The intervention is named Peer Specialist Suicide Prevention and classified as behavioral. The study description says it adapts and pilot tests support from a trained Peer Specialist. The planned intervention lasts 3 months, overlapping with the typical duration of a VA suicide high risk flag, and meetings are described as 30-45 minutes, primarily in the community, at home, or by telephone. The description of session content is incomplete in the registry record, so further detail about the sessions is not reported in the registry record.
The primary completion date is 2023-12-30, and the study start date is 2021-05-14. These dates and the completed status describe the registry's study record; they do not establish that every participant completed every assessment. The record lists 8 outcome measures and 8 analyses, but does not provide the analysis results or the details needed to determine which participants contributed to each analysis.
The primary endpoint is the Questionnaire About the Process of Recovery score at baseline and post intervention, with the post-intervention time point identified as 12 weeks. The record describes a continuous score and gives its range. It does not report a statistical analysis plan, a sample-size justification for the actual study, or a detailed account of analysis populations. Those items are not reported in the registry record. The planning assumptions available in the record are illustrative and use a hypothetical two-arm framework; they should not be mistaken for the design or analysis of this single-group study.
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: Given the nature of the subject matter (suicide), recruitment for the study was extremely challenging. Therefore, instead of having a pre-pilot and then a formal pilot, we collected data all at once in one pilot. That is why we are reporting the data all together in one group. Also, the 'needs assessment' process was simply informal qualitative discussions with various stakeholders that helped us adapt the programs to the VA. That is why the information is not reported here.
Overall Study
| Stage | Peer Specialist |
|---|---|
| STARTED | 17 |
| COMPLETED | 12 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | Peer Specialist |
|---|---|
| Lost to Follow-up | 5 |
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: Only baseline data for 12 individuals was reported because the 5 who dropped out left very quickly, so quickly that they did not feel like they were even part of the study.
| Characteristic | Unit | Peer Specialist |
|---|---|---|
| Participants analysed | 12 | |
| Age, Continuous | years | 51.2 (SD 17.7) |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 11 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 |
| Race (NIH/OMB): White | Participants | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Questionnaire About the Process of Recovery (QPR) Change, measured over Baseline, post intervention (12 weeks).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the Questionnaire About the Process of Recovery (QPR) score. The QPR contains 15 items addressing connectedness, hope, identity, meaning, and empowerment. Its stated scale range is 0-60, and the registry says higher scores reflect greater connectedness, hope, positive identity, meaning, and empowerment. The registry also states that the measure has demonstrated high internal and convergent validity and sensitivity to change.
The outcome is a continuous score, described using a mean and standard deviation. Measuring the score at baseline and post intervention, identified as 12 weeks, provides a way to describe participants' recovery-related responses over the intervention period. A change measure can be useful in a pilot study because it focuses on whether scores differ over time in the group that received the intervention. That within-group change is descriptive in a single-group study; it does not isolate the intervention's contribution from other changes that could occur over time.
The registry record identifies the endpoint and measurement schedule but does not report baseline or post-intervention means, a mean change, standard deviations, or an interval estimate. The direction, size, and precision of the observed change are therefore not reported in the registry record. Nor does the record state how incomplete questionnaires or participants without a post-intervention score were handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a relevant longitudinal question: how QPR scores differ between baseline and the post-intervention assessment at 12 weeks among participants in the peer specialist group. It does not, however, report numerical QPR results. There is no baseline mean, post-intervention mean, mean change, standard deviation, confidence interval, or p-value in the record described for this analysis. The direction and magnitude of any change, and the precision with which it was estimated, are not reported in the registry record.
The design also determines what can be inferred. This is a single-group study, with allocation listed as NA and no like-for-like control comparison. A baseline-to-follow-up difference can describe the experience of the observed group over time. Without a concurrent comparison group, it cannot show what would have happened to the same participants over that period without the intervention. Other events or changes during follow-up could also be associated with differences in scores. This is a general limitation of interpreting within-group change, not a claim that any particular outside influence occurred in this study.
The enrollment is 17. That number describes the registered enrollment, but the record does not state how many participants contributed complete QPR measurements at both time points. The effective information available for an endpoint depends on the observations included in its analysis. Because the analysis population and missing-data handling are not reported in the registry record, the enrolled count alone cannot establish the precision of the outcome estimate.
For continuous outcomes, a mean describes the average score in the analyzed group, while a standard deviation describes the spread of individual scores around that mean. A confidence interval, if reported, would communicate uncertainty in an estimate under the assumptions of its statistical method. Those concepts help readers evaluate a result, but no endpoint estimate or interval is reported in the registry record. A p-value, if available, would address compatibility with a specified null hypothesis under a model; it would not by itself establish the size, importance, or causal interpretation of a change. No p-value for the primary endpoint is reported in the registry record.
The stated study aim includes preliminary evaluation of peer specialist support. The record's aims and rationale should not be read as evidence of an observed benefit. With the primary outcome values and analysis details absent, the posted information does not support a quantitative conclusion about change in recovery scores, nor a causal conclusion about the intervention. These omissions do not show that no change occurred; they mean the registry record does not report the numerical evidence needed to describe it.
9. Statistical Methods Explained
What kind of outcome is the QPR?
The QPR is described as a continuous score on a scale from 0-60. In general, a continuous outcome can take a range of values, so analysis often describes its center and spread. The registry identifies the mean as the parameter and the standard deviation as the dispersion measure for the primary outcome. A mean gives an average score in the group being analyzed; a standard deviation describes how dispersed individual scores are around that average. Neither statistic is reported numerically for the primary endpoint in the registry record.
What does a change score represent?
The endpoint title refers to QPR change, and the record identifies baseline and post-intervention measurement, with the latter at 12 weeks. In general, a change score compares a participant's later measurement with their earlier measurement, and a group summary can then describe the average change. Such a summary depends on which observations are included and how the change is calculated. The registry record does not state the specific calculation or analysis model, and it does not report a numerical change estimate.
When a study follows one group, a before-and-after comparison describes how that group's measurements differ over time. It is not equivalent to comparing the intervention group with a concurrent control group. General reasons for caution include natural change over time, events during follow-up, and differences in who has measurements at each time point. The record does not establish that any particular factor affected these participants; these are general considerations when interpreting an uncontrolled before-and-after result.
How should uncertainty be considered?
In general, a confidence interval gives a range of values compatible with the observed data and the assumptions of the method. Its width reflects statistical uncertainty, and its interpretation depends on the analysis model and data. A confidence interval is not reported for the primary QPR result in the registry record. A p-value is also not reported. Even when available, a p-value is not a measure of the size or practical importance of a result and does not remove design limitations.
The enrollment of 17 is relevant to the scale of this pilot, but it is not enough by itself to establish how precise an endpoint estimate is. Precision also depends on the amount and variability of the outcome data and on the analysis. The registry record does not report the QPR variability, analysis sample size, or uncertainty estimate. Consequently, the precision of a primary outcome estimate cannot be assessed from the reported endpoint information.
What do the planning assumptions mean?
The registry record includes assumptions for a planning illustration: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect for that illustration as a stated fraction of the observed effect. These are planning assumptions, not a description of the actual single-group design. The record's caution about the nonrandomized comparison is particularly important: an equal-allocation, two-arm illustration does not turn this study into a two-arm trial.
The assumptions also do not establish that the actual study was designed around the observed effect or that its analysis followed that hypothetical framework. The record does not report a sample-size justification for the actual study. A sample-size calculation is a planning exercise under specified assumptions; it is not an observed result and should not be described as observed power. No numerical planning result is reported in the registry record. As the observed primary effect itself is not reported, readers also cannot use the record to evaluate the stated effect-based planning premise.
Why does over-dispersion matter in general?
For count outcomes, over-dispersion means that counts vary more than a statistical model assumes. If that extra variation is ignored, estimated uncertainty can be too small. This is a general issue for some count-data analyses, not a description of the QPR endpoint, which the registry identifies as continuous. The record does not report enough detail to assess whether any such methods were used for other outcomes.
What is not documented about the analysis?
The record lists 8 outcome measures and 8 analyses, but does not provide the statistical methods for the primary endpoint, the models for the other analyses, or a prespecified analysis plan. It does not report whether adjustment for baseline values, covariates, or multiple testing was used. These details are not reported in the registry record, so readers should not infer them from the endpoint label, the measure's properties, or the planning assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 8 outcome measures and 8 analyses. It identifies the QPR change as the primary endpoint, but the information available does not describe the other outcomes in sufficient detail to explain their relationship to the primary endpoint. A multiplicity plan—such as a hierarchy of hypotheses or an adjustment to account for multiple statistical tests—is not reported in the registry record.
In general, when several outcomes or hypotheses are tested, the chance of at least one apparently notable result can increase if each is assessed separately without accounting for the number of tests. Whether and how that issue applies depends on the hypotheses, analysis plan, and interpretation. The count of listed measures and analyses alone does not reveal which results were considered confirmatory or exploratory, or whether any adjustment was made. No such details are reported in the registry record.
Missing-data procedures are also not reported. The record gives enrollment of 17 and identifies baseline and post-intervention measurement, but does not say how many participants completed each assessment, whether any QPR responses were incomplete, or how missing values were handled. In general, incomplete follow-up can affect the analyzed sample and the interpretation of a change estimate. The enrollment figure should not be assumed to equal the number analyzed for the primary endpoint.
The record does not define an intention-to-treat, per-protocol, or other analysis population for the primary outcome. It also does not describe exclusions or sensitivity analyses. These items are not reported in the registry record. Without them, readers cannot determine which participants and observations underlie a primary analysis or assess how sensitive it might be to missing data and analytic choices.
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 |
|---|---|---|---|
| Peer Specialist | 0 | 17 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Peer Specialist | 0 of 17 |
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 |
|---|---|
| Peer Specialist | 0 of 17 |
The registry safety figures list 17 participants at risk for serious adverse events and 0 participants affected. For other adverse events, the record likewise lists 17 at risk and 0 affected. Deaths are listed as 0, and no top serious adverse-event terms are listed. These are the event counts recorded in the registry; they do not provide a detailed narrative of safety monitoring or event ascertainment.
In general, “at risk” is the denominator used for the reported event category, while “affected” indicates participants with at least one event in that category. The figures therefore describe what was recorded for the listed categories, rather than proving that no event of any kind occurred. The registry record does not specify the observation window or provide further details about how events were collected and classified. The absence of listed serious-event terms should not be taken as evidence about unlisted outcomes or about events outside the record's reporting.
The group is a single intervention group, not a comparison of safety rates between randomized arms. The figures cannot establish a relative safety difference against a control group. They should be read as the registry's reported counts for this small enrolled cohort, without extending them beyond the categories and information recorded.
12. What the Result Does, and Does Not, Mean
The posted record establishes that a completed single-group pilot evaluated peer specialist support and identified QPR change from baseline to post intervention at 12 weeks as the primary outcome. It also documents the intended intervention period, the enrolled sample, the measure's content, and the registry's safety counts. These details describe the study's focus and design.
The primary endpoint's numerical results are not reported in the registry record. Readers therefore cannot determine whether the average QPR score increased, decreased, or remained similar, how large any change was, or how precisely it was estimated. The study's stated intention to evaluate preliminary effectiveness is not itself an outcome result. The absence of numerical results should not be interpreted as evidence of no change, just as the study rationale should not be interpreted as evidence of improvement.
Even if within-group change were available, the single-group design would limit causal interpretation. A baseline measure is useful for describing participants before the intervention, but it does not provide the concurrent counterfactual that a control group can help estimate. Change over time could reflect the intervention, other experiences, or a combination; the registry record does not separate these possibilities.
The enrollment of 17 and the pilot framing are important when considering how much information the study can contribute, but enrollment alone does not quantify precision. The record does not provide the endpoint estimates, the number analyzed, or an uncertainty interval. It therefore cannot support a numerical judgment about the stability of the result. Nor does it report enough about missing data or the analysis plan to evaluate those aspects of the evidence.
The appropriate reading is limited: the record describes a peer-support intervention and a planned recovery measure, while its numerical primary outcome and key analysis details are not reported in the registry record. The available information cannot establish whether the intervention caused a change or support a treatment recommendation.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between an intervention's rationale, its design, and its results. The record gives a clear primary construct—recovery-related experiences measured with the QPR—and a defined comparison in time, baseline versus post intervention at 12 weeks. But a well-described endpoint does not substitute for reporting the observed scores and their uncertainty.
The single-group structure is central to interpretation. It can support a descriptive account of change in the participants who were measured, but does not supply a concurrent control comparison. This distinction matters because a within-group difference is not automatically an intervention effect. The registry expressly cautions that the arms are not a like-for-like control comparison, and the study model is single group.
The record also illustrates why enrollment, analyzed sample size, and precision should not be conflated. Enrollment is listed as 17, but the number contributing to each endpoint analysis and the dispersion of QPR scores are not reported. Without those details or an interval estimate, the precision of any endpoint result cannot be evaluated. Statistical significance, if reported, would not resolve the design's causal limitations; no primary p-value is reported in the registry record.
Finally, the planning assumptions describe a hypothetical two-arm calculation, while the registered study is single-group. Keeping those purposes separate prevents a planning illustration from being mistaken for the actual design, a sample-size justification, or evidence of observed power. The study remains statistically relevant as a pilot evaluation of peer specialist support, but its posted record does not report the primary numerical outcome needed to quantify what changed.
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.
Several trial-specific limitations follow directly from the registry record. First, the study is single-group, with allocation listed as NA and no like-for-like control comparison. This means that a baseline-to-follow-up difference, if reported, would not by itself distinguish intervention-related change from change that might have occurred over time for other reasons.
Second, the registry does not report numerical results for the primary QPR endpoint. Baseline and post-intervention means, the mean change, standard deviations, and an uncertainty estimate are not reported in the registry record. This prevents readers from assessing direction, magnitude, and precision. The record also does not state how many of the 17 enrolled participants contributed data to the primary analysis.
Third, important analysis details are not reported: the statistical model, handling of missing data, analysis population, and any adjustment for multiple outcomes. The record lists 8 outcome measures and 8 analyses, but does not explain the multiplicity strategy or distinguish confirmatory from exploratory analyses. The available information therefore cannot establish how analytic choices affected any result.
Fourth, the intervention description is incomplete. It states the planned duration and meeting format, but the session-content description is truncated in the registry record. Details beyond those recorded are not reported in the registry record. The study's planning assumptions also use a hypothetical two-arm framework, which is not the registered single-group design and is not a substitute for a reported design justification.
These limitations describe what the registry record does not establish; they do not show that the intervention had no effect or that participants did not complete assessments. Rather, they constrain the conclusions that can be drawn from the posted information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Peer Based Suicide Prevention — NCT04222673.
- Registry record last updated 2025-11-05; status last verified 2025-10.
- Results first posted 2025-04-29.
- 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
NCT04222673, “Peer Based Suicide Prevention,” is recorded as completed and sponsored by the VA Office of Research and Development. The registry lists 17 participants, a single-group model, allocation NA, and masking NONE. The intervention is Peer Specialist Suicide Prevention, described as a 3-month program with meetings of 30-45 minutes primarily in the community, at home, or by telephone.
The primary outcome is change in the Questionnaire About the Process of Recovery score, measured at baseline and post intervention at 12 weeks. The measure addresses connectedness, hope, identity, meaning, and empowerment, with a range of 0-60. Numerical primary results and key analysis details are not reported in the registry record. Safety figures list 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths among 17 at risk in each event category.