Islamic Trauma Healing: Feasibility Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Islamic Trauma Healing: Feasibility Study (NCT03761732), a na na study. The primary outcome is PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016).

2. Clinical Question

Feasibility was also to be examined through retention, satisfaction and community feedback. The record lists the Patient Health Questionnaire-9 (PHQ-9), Somatic Symptoms Scale-8 (SSS-8) and Quality of Well-being Index as secondary outcomes. It does not report findings for those measures or for the feasibility targets. The clinical question is therefore about the study's intended evaluation, not evidence of a treatment effect. With no comparator and no outcome analyses reported, the record cannot establish whether observed changes, if any, were attributable to the program.

3. Trial Design

This is a completed, single-group feasibility study of Islamic Trauma Healing, sponsored by the University of Washington. The registry lists the intervention as behavioral and describes a PTSD lay-led group treatment program. The brief summary places the study in Somalia and identifies PTSD, depression, somatic symptoms and quality of life as key targets. The status is COMPLETED. The listed start date is 2018-10-15, and the primary completion date is 2019-02-06.

The registry records allocation as NA and the study model as SINGLE GROUP. Masking is listed as NONE, and phase is NA. No randomized allocation or control arm is described. These design features matter when interpreting any before-and-after pattern: without a comparator, a change over time cannot by itself distinguish a program-related change from other explanations. The registry record does not report a statistical analysis plan or an inferential analysis.

The enrollment field reports 28. Separately, the brief summary describes the feasibility study as N = 26. Both figures appear in the record, and no explanation for their difference is reported. It would not be appropriate to assume that they refer to the same analysis population or to reconcile them without further information.

The primary outcome is a continuous PDS-5 score, with the stated timeframe “Last 1 Week.” The registry also lists three secondary measures. While it describes intended assessment of retention, satisfaction and community feedback, details of how those feasibility measures were defined or evaluated are not reported in the registry record. The record gives no account of when outcomes were assessed beyond the primary outcome timeframe, how participants entered or left the study, or how the intervention was delivered in practice.

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 PTSD Scale - Self-Report for DSM-5 (PDS-5; Foa et al., 2016), measured over Last 1 Week.

The primary endpoint is the PTSD Scale - Self-Report for DSM-5 (PDS-5), a self-report measure of PTSD symptom severity. The registry describes a total score based on 20 items, ranging from 0 to 80, with higher scores indicating higher PTSD severity. The timeframe is the “Last 1 Week.” The endpoint is recorded as a mean of a continuous measure, with standard deviation as its dispersion measure.

A symptom scale can express severity in a consistent numerical form, allowing the study to describe the average score and how scores vary among participants. The PDS-5 is relevant to the stated clinical question because reducing PTSD symptoms is one of the study's hypotheses. The score does not, by itself, measure every aspect of feasibility or well-being; those aims are addressed separately in the study description and secondary outcome list.

The registry record does not report PDS-5 means, standard deviations, changes over time, confidence intervals or a statistical test. It also does not report the timing of assessment occasions or a change score. Consequently, the endpoint's definition is available, but its observed values and precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary measure reported as a mean, with standard deviation as the dispersion measure. It does not report a fitted model, an inferential test, or a statistical analysis plan. The explanations below describe general statistical concepts; they should not be read as methods confirmed to have been used in this study.

What does a mean describe?

For a continuous score such as the PDS-5, a mean summarizes the scores in the group as a central value. It can be useful for describing the overall symptom level, but it does not show every participant's score or the shape of the score distribution. The registry gives the scale's possible score range and the direction of interpretation, but no observed mean. Therefore, the mean cannot be interpreted as evidence of a particular symptom level or change in this study.

What does a standard deviation describe?

A standard deviation describes how spread out individual scores are around their mean. A smaller spread indicates that scores are more concentrated around that mean; a larger spread indicates greater variation. It is not the same as the uncertainty in the mean. The registry specifies standard deviation as the dispersion measure for the primary outcome but reports no observed standard deviation.

How is uncertainty different from variation?

In general, a confidence interval expresses uncertainty about an estimated quantity under the statistical model and sampling assumptions used. It is distinct from the standard deviation, which describes variation among scores. An interval's width is influenced by the amount of information and the variability in the data, among other factors. No confidence interval or other uncertainty estimate for the PDS-5 is reported in the registry record. Without one, the precision of any estimated endpoint value cannot be evaluated from this record.

What would a change estimate mean in a single-group study?

In general, a change estimate compares measurements from different assessment occasions, if repeated measurements are collected. The registry's hypothesis refers to symptom reduction, but it does not report assessment occasions or an analysis of change. A within-group change can describe how scores differ over time; without a suitable comparison, it cannot isolate the effect of the intervention from other possible influences. No change estimate is reported in the registry record.

Why does the design affect interpretation?

In general, randomized allocation to an intervention and a control condition can help make groups comparable, subject to the study's conduct and analysis. This record lists a single-group model and allocation as NA; it does not describe a control group. Thus, a treatment-versus-control contrast is not part of the design described in the registry. The absence of a comparator does not prevent descriptive reporting of feasibility or scores, but it limits causal interpretation of changes.

What do the planning assumptions represent?

The registry describes sample-size calculations as planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. It also describes the effect to detect as a stated fraction of the observed effect. These assumptions describe hypothetical planning calculations, not the design of this single-group study, which has no listed two-arm allocation. No numerical planning illustrations or observed effect estimate are reported in the registry record. Such calculations, when reported, are planning aids and should not be described as observed power or as evidence that an effect was found.

In general, a significance level sets a decision threshold for a specified statistical test; it does not give the probability that a hypothesis is true, and it does not describe the size or practical importance of an effect. A normal approximation is a mathematical approach that may be used for some estimates under specified conditions. Whether those conditions are appropriate depends on the data and analysis, which are not reported. Because no test, model, estimate or uncertainty interval is reported, the registry record does not support a reconstruction of the trial's statistical analysis.

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("PTSD Lay-led Group Treatment Program")
n   <- c(26)
m   <- c(8.08)
sp  <- c(5.74)
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  PTSD Lay-led Group Treatment Program  26  8.080  5.740  5.762  10.398

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures and 0 analyses. It names the PDS-5 as the primary measure and lists PHQ-9, SSS-8 and Quality of Well-being Index as secondary outcomes. However, it does not report results for any of these measures. The planned assessment of retention, satisfaction and community feedback is also described without reported findings.

Multiplicity arises in general when several outcomes or statistical tests are considered: the chance of at least one apparently notable result can depend on how many tests are conducted and how they are handled. The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or a plan for interpreting multiple tests. With no analyses posted, it is not possible to determine how multiplicity was addressed in practice.

Missing-data methods are not reported in the registry record. The record does not state how incomplete measures, participant withdrawal, or missing follow-up information were handled. It also does not identify the population included in any outcome analysis. The enrollment figure and the brief-summary figure do not establish how many participants contributed data to a particular endpoint, and the record does not explain their relationship.

These omissions limit interpretation of both the size and reliability of any potential outcome estimates. They do not establish that data were missing or that any particular method was used. Without analysis populations, missing-data procedures and outcome results, the reader cannot assess whether reported estimates—if available elsewhere—represent all enrolled participants or a subset.

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 registry lists one group, titled PTSD Lay-led Group Treatment Program. For serious adverse events, it reports 26 at risk and 0 affected. For other adverse events, it also reports 26 at risk and 0 affected. Deaths are recorded as 0. These are the safety figures in the registry record; they do not provide detail about event types, timing or individual circumstances.

“At risk” is the denominator reported for the relevant safety category. It should not be assumed to equal the number enrolled or the number assessed for the primary endpoint. The registry enrollment field is 28, while the brief summary describes N = 26; the record does not explain the difference. It also does not report additional safety-analysis details or a narrative account of surveillance and reporting.

A recorded 0 affected means that no affected participants are listed in these registry fields. It should not be interpreted as proof that an event was impossible or that the intervention is free of risk. These figures describe what the registry reports, within the limits of the record's information.

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

The record establishes that Islamic Trauma Healing was studied as a behavioral, lay-led group program in a completed single-group feasibility study. It identifies the primary symptom measure, describes the intended secondary measures and feasibility aims, and reports safety counts. Those details are useful for understanding what the study set out to examine.

The record does not report analyzed outcome results. It therefore does not establish whether PDS-5 scores changed, whether depressive or somatic symptoms changed, or whether quality of well-being improved. The stated hypotheses are aims, not findings. The absence of posted outcome analyses also does not establish that no change occurred; the relevant estimates are simply not reported in the registry record.

Because no comparator is listed, the design described cannot provide a direct treatment-versus-control estimate. General statistical reasoning distinguishes a change observed within a group from a causal effect attributable to an intervention. The registry record reports no outcome estimates with which to assess even the within-group pattern, and it supplies no precision estimates such as confidence intervals.

The record's enrollment field and brief-summary sample description differ, and the record does not explain why. The number contributing to each outcome analysis is not reported. These limitations preclude treating either enrollment figure as the analyzed sample for the primary endpoint. The safety entries report 0 affected for serious and other adverse events and 0 deaths, with 26 at risk listed for each adverse-event category; these entries should be read as registry reports rather than as proof of no possible risk.

In short, this record supports a description of the study's purpose, intervention, design, measures and recorded safety figures. It does not support a conclusion about symptom benefit, comparative effectiveness, precision of an effect, or the completeness of outcome follow-up.

14. Why This Trial Matters Statistically

Feasibility studies address questions that are distinct from whether an intervention produces a clinical effect. This record describes interest in retention, satisfaction and community feedback alongside symptom and well-being measures. Those aims make the study relevant for understanding whether a lay-led group program could be examined in a community setting, although the registry does not report the feasibility findings needed to judge those aims.

The statistical structure is important: the record describes a single-group study with no listed comparator. This allows the design to be understood as an initial feasibility evaluation rather than a randomized comparison. It also means that any symptom change, if reported elsewhere, would require cautious interpretation as a within-group observation rather than a direct estimate against a control condition.

The endpoint definitions are relatively clear. The PDS-5 is described as a 20-item self-report scale, with scores from 0 to 80 and higher scores indicating greater PTSD severity. The record also names the secondary measures. Yet measure definitions alone do not provide evidence about outcomes. The lack of posted analyses and estimates is central to statistical interpretation: neither effect size nor precision can be assessed from the registry record.

The two enrollment descriptions also illustrate why careful attention to the record's fields matters. The enrollment field says 28, while the brief summary says N = 26; the relationship is not reported. An analysis denominator should not be inferred from either statement. Clear reporting of analysis populations and outcome results would be needed to connect study participation to estimates of symptoms and feasibility.

Statistically, the trial matters as a case where design, outcome definition and reporting boundaries must be kept separate. The stated aims tell readers what investigators intended to evaluate; the recorded design tells readers what comparisons were planned; and the absent analyses limit what can be concluded.

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.

A central limitation for interpretation is that the registry record reports no outcome analyses. It gives no observed PDS-5 mean, standard deviation, change estimate, confidence interval or test result. The same absence applies to the named secondary outcomes and the described feasibility targets. As a result, the record cannot show the magnitude, direction or precision of outcome patterns.

The study is listed as single group, with allocation NA and no masking. No control group is described. This design does not support a direct comparison with an untreated or alternative-treatment group, and any change over time would have limited causal interpretation even if estimates were available. The record does not report whether repeated assessments were conducted or how outcomes were analyzed.

The enrollment field reports 28, while the brief summary states N = 26. The record does not explain the difference, and it does not report outcome-specific analysis populations. It is therefore unclear from the registry which participants, if any, contributed to each endpoint estimate. Missing-data handling and follow-up completeness are also not reported.

The registry identifies 4 outcome measures but reports 0 analyses. It does not describe how multiple outcomes were prioritized or whether multiplicity was considered. The sample-size assumptions describe hypothetical two-arm planning illustrations, but the study is listed as single group; no numerical illustration or observed effect estimate appears in the record. These limitations concern the information available in the registry and should not be taken as evidence about analyses or procedures that may or may not have occurred outside it.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Islamic Trauma Healing: Feasibility Study — NCT03761732.
• Registry record last updated 2023-11-21; status last verified 2023-02.
• Results first posted 2023-11-21.
• 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

NCT03761732, titled “Islamic Trauma Healing: Feasibility Study,” is listed as COMPLETED and sponsored by the University of Washington. The registry describes a behavioral, single-group study of a lay-led Islamic Trauma Healing program for PTSD. The listed start date is 2018-10-15, and the primary completion date is 2019-02-06. Masking is NONE, allocation is NA and phase is NA.

The primary measure is the PDS-5 score for the “Last 1 Week,” described as a 20-item scale ranging from 0 to 80, with higher scores indicating greater PTSD severity. Secondary measures are PHQ-9, SSS-8 and Quality of Well-being Index. The registry reports an enrollment of 28, while its brief summary describes N = 26, without explaining the difference.

The record lists 4 outcome measures and 0 analyses. It reports no outcome estimates or analysis populations. Safety fields list 26 at risk and 0 affected for serious adverse events, 26 at risk and 0 affected for other adverse events, and 0 deaths.