Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education (NCT01022203), a randomized na study. The primary outcome is Psychological Functioning.

2. Clinical Question

The registry frames the study as an evaluation of whether a structured couples treatment can reduce PTSD and improve marital and social functioning, compared with couple-based education. The primary outcome is titled Psychological Functioning. Its description includes Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale and Self-Rated PTSD measured with the PTSD Checklist. For both measures, higher scores indicate more severe PTSD.

The record also lists Relationship Functioning and Emotion Regulation as secondary outcomes. It does not report comparative estimates for those outcomes or for the primary measures. The primary outcome has multiple measures and assessment times, and no single comparison is identified in the posted registry information. The clinical question is therefore clear as a study aim, but the registry record does not establish the direction, size, or precision of any treatment difference.

3. Trial Design

This is a randomized, parallel-group trial with an enrollment of 138. Participants were assigned to Structured Approach Therapy or PTSD Family Education. The registry identifies the study as single-masked, but who was masked is not reported in the registry record. The study phase is listed as NA. The trial status is completed.

Structured Approach Therapy is described as a couple-based behavioral intervention with skills training intended to help couples reduce PTSD. The comparison intervention, PTSD Family Education, teaches couples about PTSD symptoms, related problems, and treatment. Thus, the comparison is between two couple-based approaches, not between a treatment and no intervention.

The primary outcome is Psychological Functioning, measured using clinician-rated PTSD and self-rated PTSD. The stated assessment schedule is pre-treatment, post-treatment (12 weeks), and follow-up (12 weeks after post-treatment). The scale descriptions specify a range of 0-133 for the Clinician Administered PTSD Scale and 17-85 for the PTSD Checklist. Higher scores indicate more severe PTSD on each measure. Outcome data are described as collected from 44 veterans in Structured Approach Therapy and 42 in PTSD Family Education; the registry does not clarify in this description how those numbers relate to all enrolled participants or to each assessment time.

The study began in 2010-08, and primary completion is listed as 2013-12. The sponsor is the VA Office of Research and Development. The registry record does not report further details about the randomization procedure, allocation concealment, masking procedures, intervention duration, or the planned statistical analysis. These details should not be inferred from the design labels alone.

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: Twenty-four subjects (12 couples) were lost or withdrew from the study after providing consent and participating in the pretreatment assessment, but before randomization to one of the two treatment conditions (Structured Approach Therapy or PTSD Family Education).

PreTreatment Assessment

Post Treatment Assessment

Reasons for not completing this period:

Follow-Up Assessment

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Outcome data collected from 44 veterans who participated in Structured Approach Therapy and 42 Veterans who participated in PTSD Family Education.

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: These variables were entered into initial GLMM outcome models with no variable predicting outcome.

6. Primary Endpoint

The registry lists the primary outcome as Psychological Functioning, measured over Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment)..

The primary outcome is titled Psychological Functioning and is described through two PTSD measures: clinician-rated PTSD on the Clinician Administered PTSD Scale and self-rated PTSD on the PTSD Checklist. The record gives a score range of 0-133 for the clinician-rated measure and 17-85 for the self-rated measure. On both measures, higher scores indicate more severe PTSD. The reported unit is units on a scale, with means and standard deviations specified as the summary format.

Using both clinician ratings and participant self-ratings can characterize symptoms from different perspectives. A clinician-rated measure reflects an assessment made by a clinician, while a self-rated measure captures participants’ reported symptoms. This is a general description of the types of measures; the registry does not report how the two measures were combined, prioritized, or interpreted together.

The assessment schedule includes pre-treatment, post-treatment (12 weeks), and follow-up (12 weeks after post-treatment). Repeated measurements can describe how scores change over time and whether differences between groups are present at different assessment points. The registry does not give means, standard deviations, changes from baseline, or between-group estimates for these measures. It also does not identify one assessment time or one scale as the sole primary comparison. The endpoint description therefore explains what was measured, but not what the trial found.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a randomized parallel-group design mean?

General: In a randomized trial, assignment is determined by a random process rather than by a clinician or participant choosing the group. Randomization is intended to make treatment groups comparable on average at the start, including on factors that may be measured or unmeasured. It does not guarantee that every characteristic will be balanced, particularly in a finite study. A parallel-group design assigns participants to one approach or the other and follows the groups over the study period.

The registry identifies this study as randomized and parallel. It does not describe the sequence-generation method, allocation concealment, or the point at which assignment occurred. Those features cannot be inferred from the design labels. The record calls the trial single-masked, but does not identify who was masked or how masking was maintained. Because the interventions are described as different forms of couple-based care, the identity of the masked party would be useful context; it is not reported in the registry record.

How should continuous outcomes be understood?

The primary outcome uses continuous scale scores and specifies means and standard deviations. General: A mean is a summary of the average score, while a standard deviation describes the spread of scores around that average. Means can make group-level comparisons readable, but they do not show the full distribution of participant scores. Standard deviations describe variability, not uncertainty in the estimated group mean. The registry record does not report the actual means or standard deviations for the PTSD measures.

The clinician-rated scale ranges from 0-133, and the self-rated scale ranges from 17-85; higher scores on both indicate more severe PTSD. These ranges provide context for interpreting a score, but do not reveal the observed scores or the size of any group difference. The record does not state a threshold for clinically important change, nor does it report how a change on one measure should be compared with a change on the other.

Why do assessment times matter?

The outcome schedule includes pre-treatment, post-treatment (12 weeks), and follow-up (12 weeks after post-treatment). General: A pre-treatment assessment can establish a starting measurement, while later assessments can describe outcomes after treatment and at follow-up. A comparison may focus on post-treatment scores, change from baseline, or differences in patterns over time. Those approaches answer related but not identical questions. The registry record does not identify which approach was used or which assessment time was the primary inferential comparison.

Repeated observations from the same participant are related. General: Analyses of repeated measurements should account for that within-person relationship rather than treating every measurement as independent. The registry does not report the statistical model, covariance assumptions, handling of baseline scores, or method for estimating effects across time. It is therefore not possible to reconstruct the analysis from the assessment schedule alone.

What would an effect estimate and confidence interval contribute?

General: An effect estimate communicates the direction and size of a contrast between groups. A confidence interval communicates the uncertainty around that estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, but interpretation also depends on the scale and on what differences are meaningful. A p-value, when reported, addresses compatibility of the data with a specified null model; it does not measure the probability that a treatment is effective or the clinical importance of a difference.

No effect estimates, confidence intervals, or p-values for the primary outcome are reported in the registry record. The trial's aim and design do not substitute for those results. Without them, readers cannot assess the estimated magnitude, direction, or precision of a between-group difference.

What are the planning assumptions?

The registry describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The described effect to detect is a stated fraction of the observed effect. These are assumptions for planning calculations, not a report of the trial's statistical analysis or evidence about the observed treatment effect. Numeric planning results are not reported in the registry record.

General: A sample-size illustration asks how many participants per arm would be needed under specified assumptions to detect an effect at a chosen power. Such an illustration is conditional on the effect size, variability, test, allocation, and other assumptions used. When an effect estimated in a completed study is used as the planning basis, the resulting illustration does not establish the power that the completed trial actually had. It is not observed power. The registry does not report the original sample-size justification or its assumptions, so the listed planning description cannot be treated as the trial's original design rationale.

How should variability and event counts be treated?

General: Variation in continuous measurements affects the precision of group comparisons. In count or event data, over-dispersion means that observed variability exceeds what a chosen simple statistical model expects; methods that ignore it may give misleading uncertainty. The posted primary endpoint is continuous, and no over-dispersion analysis is described in the registry record. The adverse-event counts are safety summaries and should not be mistaken for an analysis of the continuous primary outcome.

The record lists three analyses but does not identify their specifications, adjustment variables, treatment of repeated assessments, or inferential outputs. A count of analyses alone does not show whether a particular model was suitable or whether its assumptions were checked. The statistical plan, including any interim analyses, is not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome includes two PTSD measures and assessment at pre-treatment, post-treatment (12 weeks), and follow-up (12 weeks after post-treatment). The registry indicates that the primary outcome has several categories or time points and was not reduced to one comparison. It does not specify a single primary scale-and-time contrast. The record also lists Relationship Functioning and Emotion Regulation as secondary outcomes.

General: When several outcomes, measures, or time points are tested, the chance of finding at least one apparently notable result can increase if each test is interpreted separately. A prespecified hierarchy or multiplicity adjustment can help define how evidence across several tests is assessed. The registry does not report whether a hierarchy, adjustment, or other multiplicity strategy was used. The number of listed outcome measures and analyses does not reveal how the tests were grouped or interpreted.

The primary-outcome description reports data collected from 44 veterans in Structured Approach Therapy and 42 in PTSD Family Education, while enrollment was 138. The registry does not explain the relationship between these figures, report assessment-specific completion counts, or state why outcome data may be unavailable for other enrolled participants. Missing-data methods, reasons for missingness, and sensitivity analyses are not reported in the registry record.

The analysis populations are also not described. The registry does not state whether analyses used all randomized participants, only participants with available outcome data, or another defined population. It does not report whether participants were analyzed according to assignment, how deviations from intervention were handled, or whether any imputation was used. These omissions limit interpretation of the listed outcome-data counts and prevent assessment of how missing observations may affect estimates.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists serious adverse events for each group. For Structured Approach Therapy (SAT), the number at risk is 58 and the number affected by serious adverse events is 0. For PTSD Family Education (PFE), the number at risk is 56 and the number affected by serious adverse events is 0. The listed counts for other adverse events are 0 of 58 for SAT and 2 of 56 for PFE. Deaths are not reported for either group.

These are registry counts, not comparative estimates with uncertainty intervals. The record does not give event descriptions for the two other adverse events, their timing, severity, relationship to an intervention, or whether a participant could have experienced more than one event. The listing therefore supports only a description of the reported counts, not an assessment of cause or comparative risk.

A zero count in a group means that no affected participants are listed for that event category in the registry record. It does not prove that an event is impossible or that the true risk is zero. Conversely, the two other adverse events in PFE do not establish that the intervention caused them. The number of deaths is null in the record, which means the death count is not reported; it should not be interpreted as zero. Safety counts also do not answer the primary question about PTSD scores or secondary questions about relationship functioning and emotion regulation.

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

The registry describes a study designed to compare a couple-based PTSD treatment with couple-based education. Its stated purpose was to evaluate Structured Approach Therapy in relation to PTSD and marital and social functioning among Iraqi war Veterans and their partners. The record identifies Psychological Functioning as the primary outcome and lists Relationship Functioning and Emotion Regulation as secondary outcomes.

What the posted registry information does not establish is whether one group had higher or lower PTSD scores, how large any difference was, how precise an estimate might be, or whether any difference was meaningful to participants. Group means, standard deviations, comparative estimates, confidence intervals, and p-values are not reported in the registry record. The outcome covers two PTSD instruments and multiple assessment times, with no single comparison identified. The study's randomized design and stated aim cannot stand in for its missing outcome estimates.

General: A trial result is best interpreted by considering the estimated difference, its uncertainty, the outcome scale, the timing of assessment, and the analysis population. Statistical evidence and clinical importance are related but distinct questions. The registry provides scale ranges and score direction, but not results or a threshold for meaningful change. No conclusion about benefit, lack of benefit, or equivalence between the approaches follows from the available outcome description alone.

The enrollment of 138 and the primary-outcome description of 44 and 42 veterans are relevant context, but the record does not explain the relation between those counts or how missing outcome observations were handled. The safety record lists zero serious adverse events in each group and two other adverse events in the PFE group; deaths are not reported. These counts do not determine the comparative PTSD outcome and do not establish causality.

Accordingly, the registry supports a description of the trial question, interventions, design, measures, and recorded safety counts. It does not support a judgment about which approach performed better or how reliably any difference was estimated.

13. Why This Trial Matters Statistically

This trial raises statistical questions that are common in behavioral and couple-based research. The comparison is between two active approaches with different content: skills training intended to help couples reduce PTSD and education about PTSD symptoms, related problems, and treatment. Interpretation depends on defining the contrast clearly and on reporting outcomes in a way that distinguishes the intervention's possible effects from changes over time or from the effects of receiving couple-based care more generally.

The primary outcome combines clinician-rated and self-rated PTSD measures and spans pre-treatment, post-treatment (12 weeks), and follow-up (12 weeks after post-treatment). This gives the study more than one potentially relevant outcome dimension. A clear prespecified primary contrast and an account of how multiple measures and times were handled are important for interpreting evidence without selecting a result after the fact. Those analysis details are not reported in the registry record.

The registry describes outcome data for 44 veterans in one group and 42 in the other, alongside an enrollment of 138. The absence of an explanation for these counts makes analysis-population and missing-data details particularly important. Without assessment-specific counts and a description of who contributed to each analysis, readers cannot determine how broadly any eventual estimate would apply to enrolled participants.

The record also illustrates why trial design labels do not fully describe statistical rigor. Randomization and parallel assignment are reported, but allocation procedures, masking details, outcome-analysis methods, and interim analyses are not. A completed-trial record that reports those elements alongside estimates and uncertainty would make the statistical evidence easier to evaluate. The current record allows readers to identify the research question and measures, but not to assess the comparative outcome results.

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 it does not report comparative results for the primary or secondary outcomes. There are no group means or standard deviations, no between-group estimates, and no confidence intervals or p-values for Psychological Functioning, Relationship Functioning, or Emotion Regulation. The trial is marked completed, but completion status does not supply outcome evidence.

The primary outcome description includes clinician-rated and self-rated PTSD and several assessment times. The record does not identify one scale-and-time comparison as primary or state how results across the measures were handled. That makes it difficult to know which estimate would answer the principal study question, even if outcome values were otherwise available.

The outcome-data description identifies 44 veterans in Structured Approach Therapy and 42 in PTSD Family Education, compared with enrollment of 138. The record does not explain the difference, give counts at each assessment, describe reasons for missing observations, or identify the analysis population. No missing-data method or sensitivity analysis is reported. These omissions limit assessment of potential attrition-related bias.

Details that could affect interpretation of a randomized trial are also absent: the randomization and allocation-concealment procedures, who was masked, and the statistical model and analysis plan are not reported in the registry record. The record does not describe intervention adherence or deviations. It lists three analyses but does not map them to outcomes or times. Finally, deaths are not reported, and the other adverse events are not described beyond their count. These registry limitations do not establish that such procedures or analyses were absent; they mean the record does not report them.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education — NCT01022203.
• Registry record last updated 2016-11-16; status last verified 2016-10.
• Results first posted 2015-03-09.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT01022203 is a completed randomized, single-masked, parallel-group trial comparing Structured Approach Therapy with PTSD Family Education. Enrollment was 138, and the sponsor was the VA Office of Research and Development. The primary outcome, Psychological Functioning, is described using clinician-rated PTSD and self-rated PTSD measures at pre-treatment, post-treatment (12 weeks), and follow-up (12 weeks after post-treatment).

The registry lists Relationship Functioning and Emotion Regulation as secondary outcomes. Its primary-outcome description reports data collected from 44 veterans in Structured Approach Therapy and 42 in PTSD Family Education. Comparative outcome estimates and analysis details are not reported in the registry record. Safety listings show zero serious adverse events in both groups and two other adverse events in the PTSD Family Education group; deaths are not reported.