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 Women Veterans' Substance Abuse Treatment (NCT00734903), a randomized na study. The primary outcome is Addiction Severity Index Alcohol Composite.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00734903 |
| Phase | NA |
| Condition | Substance Use Disorders |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 66 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Women Veterans with substance use disorder. The registry record lists 66 enrolled participants. It does not report further eligibility details in the information available for this comparison.
Intervention
A Woman's Path to Recovery (WPR), described as a gender-focused approach to addiction recovery.
Comparator
12-Step Facilitation (TSF), described as an evidence-based, non-gender-focused approach to addiction recovery.
Primary question
How do the two approaches compare on the Addiction Severity Index Alcohol Composite, measured at baseline, end of treatment (month 3), and 3-month post-treatment follow-up? The measure is intended to capture alcohol use and associated problems. A treatment-group comparison of the endpoint is not reported in the registry record.
The study is described as a randomized controlled trial of a gender-focused model and a non-gender-focused model. The primary question is therefore a comparative one: whether the alcohol composite scores differ across the listed assessment times between participants assigned to WPR and those assigned to TSF. The registry record does not report a numerical estimate of that difference, its uncertainty, or a statistical test for the comparison.
The record also lists secondary measures covering medical, employment, psychiatric, family and social functioning, psychological symptoms, psychosocial functioning, coping skills, and intention related to Alcoholics Anonymous. Those domains broaden the study’s stated scope, but their results are not reported in the registry record. The listed enrollment and intervention descriptions alone do not establish how the treatments compared on these outcomes.
3. Trial Design
This is a randomized, parallel-group study with single masking, according to the registry record. The record labels the study phase as NA and its status as completed. It identifies the VA Office of Research and Development as the sponsor. The study is titled “Women Veterans' Substance Abuse Treatment,” and its official title describes a randomized controlled trial on women's substance abuse treatment.
The registry lists 66 participants enrolled. Its adverse-event entries show 33 at risk in each group. WPR is the gender-focused behavioral intervention, while TSF is the non-gender-focused behavioral comparator. The record does not identify who was masked, describe how randomization was implemented, or state whether allocation concealment was used; those details are not reported in the registry record.
The listed study start is 2010-10 and the primary completion is 2015-03. The primary endpoint is assessed at baseline, at the end of treatment (month 3), and at 3-month post-treatment follow-up. This repeated schedule makes change over time relevant to the clinical question, but a specific longitudinal analysis method is not reported in the registry record.
The registry lists 11 outcome measures, including the primary alcohol composite and secondary measures across several health and functioning domains. It lists no analyses. The record does not report a statistical analysis plan, a sample-size justification for the trial, or an explanation of how repeated measurements and multiple outcomes were handled. The sample-size calculations displayed with the results are planning illustrations based on an observed effect and stated assumptions, not a substitute for an original design justification.
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: Of 103 screened, 82 were eligible, 21 ineligible. Of 82 eligible, 66 completed baseline and were randomized; 16 did not complete baseline.
Overall Study
| Stage | A Woman's Path to Recovery (WPR) | 12-Step Facilitation (TSF) |
|---|---|---|
| STARTED | 33 | 33 |
| Completed End of Treatment Assessment | 21 | 23 |
| Completed 3-month Followup | 14 | 15 |
| COMPLETED | 30 | 32 |
| NOT COMPLETED | 3 | 1 |
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.
| Characteristic | Unit | A Woman's Path to Recovery (WPR) | 12-Step Facilitation (TSF) | Total |
|---|---|---|---|---|
| Participants analysed | 33 | 33 | 66 | |
| Age, Continuous | years | 46.97 (SD 9.92) | 48.45 (SD 8.13) | 47.72 (SD 9.01) |
| Sex: Female, Male: Female | Participants | 33 | 33 | 66 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 0 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 29 | 30 | 59 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 3 | 5 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 2 | 3 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 | 6 | 12 |
| Race (NIH/OMB): White | Participants | 23 | 22 | 45 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 3 | 5 |
| Region of Enrollment: United States | Participants | 33 | 33 | 66 |
6. Primary Endpoint
The registry lists the primary outcome as Addiction Severity Index Alcohol Composite, measured over Baseline, end of treatment (month 3), 3-month post-treatment follow-up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Addiction Severity Index Alcohol Composite, expressed in units on a scale and described as a mean with standard deviation. It is intended to measure alcohol use and associated problems through a blinded-interviewer-rated composite score. Six questions contribute to the score: four ask about the number of days in the past month, and two use subjective ratings. The record states that higher responses on the individual items indicate worse pathology, while the composite score ranges from 0 (worst outcome) to 1 (best outcome). Those directions should be kept distinct when interpreting item responses and the composite.
The endpoint is relevant to the stated comparison because the trial examines addiction treatment models and the measure focuses specifically on alcohol-related use and problems. Assessments are listed at baseline, end of treatment (month 3), and 3-month post-treatment follow-up, allowing the study question to concern both the treatment period and follow-up. However, the registry record does not report group means, changes from baseline, between-group estimates, or uncertainty for any of these times.
A breathalyzer was also obtained to verify self-report and coded as positive or negative. The registry description does not state that the breathalyzer result is part of the primary composite, and no breathalyzer results are reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clear comparative question and a primary endpoint, but it does not provide a reported treatment-effect analysis. No group-specific alcohol composite means, between-group contrasts, confidence intervals, or p-values are listed. Consequently, the posted record does not quantify how the groups differed at baseline, end of treatment, or follow-up, nor how precise any such difference might be.
The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. This matters because a repeated-measures endpoint can be summarized in different ways: a contrast at one assessment, a change from baseline, or a pattern across all listed assessments would answer related but not identical questions. The registry does not specify which contrast was intended as the main inferential target or report a model for the repeated observations. No conclusion about relative outcomes can be drawn from the intervention descriptions alone.
The enrollment total and the equal at-risk group counts describe the study’s size and the groups represented in the safety entries. They do not provide evidence about outcome differences, and they are not a substitute for an effect estimate with uncertainty. The record also lists 11 outcome measures and zero analyses. That combination means the listed outcomes cannot be treated as analyzed findings based on this record.
The safety entries list serious events affecting 4 in WPR and 7 in TSF, with 33 at risk in each group. They also list zero other adverse events in each group. These counts are descriptive safety information, not a statistical comparison of treatment effects. The registry record does not provide a comparative safety estimate or the details needed to interpret event timing, recurrence, or attribution.
Planning illustrations based on the observed effect are not estimates of what the trial was designed to detect unless the underlying design assumptions and result calculations are interpreted in that context. The record describes an illustration using a two-sided significance level of 0.05, equal allocation, and a normal approximation; its sample-size values are not given in the information. Such illustrations are not observed power and cannot fill the gap left by the absence of a reported endpoint analysis.
The defensible reading is therefore narrow: this was a completed randomized study comparing two behavioral approaches, with a specified alcohol composite and scheduled assessments, but the registry record does not report the analysis needed to determine the observed between-group result.
9. Statistical Methods Explained
What does the endpoint summary mean?
The registry characterizes the primary measure as a continuous outcome summarized by a mean and standard deviation. In general, a mean describes the central level of a set of scores, while a standard deviation describes how spread out individual scores are around that mean. Neither quantity is reported by treatment group for this endpoint in the registry record, so no actual group summary can be interpreted.
The score’s direction requires attention. The registry says the component item responses indicate worse pathology when higher, but describes the composite scale as ranging from 0 (worst outcome) to 1 (best outcome). A reader should interpret the composite according to its stated scale rather than assume that the direction of each item carries over unchanged to the combined score. The record does not provide the scoring formula or group-level values.
Why do repeated assessments matter?
Baseline, end of treatment (month 3), and 3-month post-treatment follow-up are distinct assessment occasions. A comparison at one occasion answers a different question from a comparison of change over time or an overall longitudinal contrast. In general, repeated measurements from the same participant are related rather than independent; an analysis should account for that within-person relationship when making an inference across visits. The statistical method used for this endpoint is not reported in the registry record.
The record explicitly notes that the primary outcome has several categories or time points and is not reduced to one comparison. No single time-specific estimate or overall repeated-measures result is given. Without a prespecified contrast or a reported model, the endpoint schedule alone cannot establish which treatment comparison was considered primary for inference.
What would uncertainty measures convey?
In general, a confidence interval describes a range of values compatible with the observed data under the method used to calculate it. Its width reflects precision: a narrower interval indicates greater precision under that method, while a wider interval indicates more uncertainty. A confidence interval does not appear for the primary endpoint in the registry record. A p-value, if reported, would address compatibility with a specified null hypothesis under a statistical model; it would not by itself convey the size or clinical importance of a difference. No p-value is reported for the endpoint comparison.
Over-dispersion is a general issue for outcomes whose variability exceeds what a chosen model assumes. When it is present and not addressed, standard errors and inferential conclusions may be unreliable. The primary endpoint is described as continuous, and the registry does not report an analysis model or diagnostics indicating whether over-dispersion was relevant. It would be inappropriate to infer that this issue was tested or corrected.
How should the planning calculations be read?
The registry describes sample-size illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The illustrations vary the effect to detect as a stated fraction of the observed effect. In general, such calculations estimate the participants per arm that a hypothetical study would need under those assumptions; they are not an analysis of the trial’s observed power. The registry record does not report a sample-size justification for the original trial. The resulting planning values are not reported in the registry information used for this interpretation.
The assumptions are important: planning results depend on the target effect and the chosen design and statistical assumptions. They do not establish that the completed study achieved a particular level of precision, and they cannot replace a confidence interval for the observed treatment contrast. No time-to-event outcome is identified as the primary endpoint; the record describes the primary measure as a continuous mean.
What analysis information is absent?
The registry lists no analyses. It does not report the statistical model, covariate adjustment, handling of missing observations, analysis population, or multiplicity procedure. These omissions limit interpretation: even a numerical estimate would need an accompanying description of which participants and visits contributed and how the repeated outcome was modeled. Because no endpoint estimates are listed, there is no basis to reconstruct or independently assess a treatment comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures, with the Addiction Severity Index Alcohol Composite designated as primary and several additional measures covering medical, employment, psychiatric, family and social, psychological, psychosocial, coping, and AA-intention domains. Multiple outcomes and repeated assessment times create more than one possible statistical question. In general, testing many outcomes or contrasts without an appropriate plan can increase the chance of a false-positive finding. The registry record does not report a multiplicity strategy, such as which comparisons were prioritized or whether any adjustment was planned.
The primary endpoint is scheduled at baseline, end of treatment (month 3), and 3-month post-treatment follow-up. The record states that the primary outcome was not reduced to one comparison because it has several categories or time points. It does not identify a single time point, change score, or overall trajectory as the main reported contrast. No outcome analysis is listed.
Missing-data methods and analysis populations are also not reported in the registry record. It is therefore not possible to determine whether all randomized participants were included in an analysis, how missing follow-up measurements were handled, or whether any sensitivity analyses were performed. These details matter because incomplete outcome data can affect both the estimate and its precision, especially when follow-up is part of the question.
The available information does not support assumptions about a protocol, prespecified analysis plan, interim analyses, or imputation method. Those details are not reported in the registry record. The absence of an analysis listing is a limit on what can be concluded from the registry entry, not evidence that no analyses were conducted elsewhere.
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 |
|---|---|---|---|
| A Woman's Path to Recovery (WPR) | 4 | 33 | 12.1% |
| 12-Step Facilitation (TSF) | 7 | 33 | 21.2% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| A Woman's Path to Recovery (WPR) | 0 of 33 |
| 12-Step Facilitation (TSF) | 0 of 33 |
Most frequent serious adverse event terms
| Event term | Organ system | A Woman's Path to Recovery (WPR) | 12-Step Facilitation (TSF) |
|---|---|---|---|
| adverse events | Investigations | 4 of 33 | 7 of 33 |
Serious events with the highest arm-level rate: adverse events (21.2%).
The registry safety entries list 33 at risk in each arm. For serious adverse events, the listed affected counts are 4 for A Woman's Path to Recovery and 7 for 12-Step Facilitation. For other adverse events, the listed affected counts are 0 in each arm. The record also identifies “adverse events” as a serious-event term at 21.2%.
These figures should be read as descriptive registry entries. The record does not provide a comparative risk estimate, confidence interval, or statistical test for the difference between groups. It also does not clarify the denominator and context for the 21.2% term listing in the information available for this interpretation. The term label is broad, and the registry entry does not provide enough detail to infer what specific event types it represents.
No death count is reported in the registry record. Details such as event timing, recurrence, severity criteria, relationship to the intervention, and whether counts represent participants or event episodes are not reported. The counts alone therefore do not establish whether an event was caused by treatment or how the groups’ overall safety profiles compare.
12. What the Result Does, and Does Not, Mean
This trial addresses a clinically relevant comparison between a gender-focused addiction recovery approach and a non-gender-focused approach among women Veterans with substance use disorder. Its randomized parallel-group design and stated primary alcohol composite give the registry record a defined comparative question. The listed assessments cover baseline, end of treatment (month 3), and 3-month post-treatment follow-up, while secondary measures extend to other health and functioning domains.
What the record does not establish is the observed comparative result. It contains no group-specific endpoint summaries, effect estimate, confidence interval, or p-value for the primary outcome. It also lists zero analyses. The intervention descriptions, enrollment count, and scheduled measurement times cannot show whether scores differed, how large any difference was, or how precisely a difference was estimated.
The safety counts provide limited descriptive information: serious-event affected counts are listed as 4 and 7, while other adverse-event counts are 0 in both groups. Without a reported statistical comparison and fuller event context, these entries do not quantify a treatment-related safety difference. The registry also does not report a death count.
The primary endpoint’s assessment at multiple times means that different summaries could address different aspects of the study question. The record does not state which time-specific or longitudinal contrast should guide interpretation. Nor does it report missing-data methods, analysis populations, or a multiplicity approach for the listed outcome measures.
Accordingly, the registry entry documents the design, population, interventions, endpoint definition, and some safety counts, but it does not provide the outcome analysis needed to judge the comparative endpoint results. Absence of a reported result in this record should not be mistaken for evidence of no difference, or for evidence of a difference.
13. Why This Trial Matters Statistically
This study is statistically notable for the gap between a clearly specified endpoint schedule and the lack of a reported endpoint analysis in the registry record. The primary alcohol composite is measured at baseline, end of treatment (month 3), and 3-month post-treatment follow-up, but the record does not report a single comparison or an overall repeated-measures analysis. That makes the distinction between a study question and an available estimate especially important.
The endpoint itself also requires careful reading because the record describes higher component-item values as worse pathology while the composite scale is described from 0 (worst outcome) to 1 (best outcome). Reporting the score’s construction and direction alongside group estimates would help readers interpret the result accurately. No group-level values or scoring details are reported in the registry record.
The study lists 11 outcomes, which brings multiplicity and prioritization into view. Without reported analyses or a stated multiplicity strategy, the registry does not show which findings, if any, were emphasized or how uncertainty across outcomes was considered. Likewise, missing-data and analysis-population information would be needed to understand which observations support any estimate.
The safety entries illustrate another statistical distinction: counts are not comparative estimates. The serious-event counts and at-risk counts are informative descriptions, but without event context and uncertainty, they cannot by themselves establish the size or precision of a between-group safety difference. Overall, the entry is useful for understanding the trial’s question and recorded design, while its missing analysis details limit statistical interpretation.
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 interpreting this trial from the registry record is that no outcome analyses are listed. The primary endpoint is defined, but treatment-group summaries and comparative estimates are not reported. As a result, the record does not permit assessment of the direction, magnitude, or precision of the primary outcome result.
The primary endpoint is scheduled at multiple times, and the registry says it was not reduced to one comparison. The intended primary contrast and the method for analyzing repeated measurements are not reported. The record also does not provide the scoring formula, so the relationship between component items and the composite’s stated direction cannot be independently evaluated from this description.
Details of the randomized process and the single masking are not reported, including who was masked and how randomization was implemented. Eligibility criteria beyond the description of women Veterans with substance use disorder are not reported. The record does not give a trial-specific sample-size justification, analysis population, missing-data method, or multiplicity plan.
The safety information is limited to affected counts, at-risk counts, and a serious-event term percentage. Event timing, recurrence, attribution, and denominator context for the term percentage are not reported. A death count is also not reported in the registry record. These limitations mean the available safety entries should not be read as a complete comparative safety analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Women Veterans' Substance Abuse Treatment — NCT00734903.
- Registry record last updated 2018-11-05; status last verified 2018-02.
- Results first posted 2018-11-05.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed randomized, parallel-group behavioral study with single masking, enrolling 66 women Veterans with substance use disorder. It compares A Woman's Path to Recovery, a gender-focused approach, with 12-Step Facilitation, a non-gender-focused approach. The primary endpoint is the Addiction Severity Index Alcohol Composite, assessed at baseline, end of treatment (month 3), and 3-month post-treatment follow-up.
The record lists 11 outcome measures and no analyses. It does not report a treatment-group estimate for the primary endpoint, uncertainty around such an estimate, or a statistical analysis plan. Safety entries list serious-event affected counts of 4 and 7, with 33 at risk in each group, and zero other adverse events in each group. The trial’s comparative outcome results are therefore not reported in the registry record.