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 The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse (NCT01987089), a randomized na study. The primary outcome is Change in Insomnia Severity Index - Total Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01987089 |
| Phase | NA |
| Condition | Insomnia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 63 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people experiencing insomnia during recovery from alcoholism. The primary outcome population is described as all randomized participants in either arm who received at least one treatment session. The registry reports enrollment of 63 participants; it does not give further eligibility details in the record.
Intervention
The intervention was Cognitive Behavioral Therapy for Insomnia (CBT-I), described as eight individual sessions with a study clinician. The study summary characterizes CBT-I as a non-pharmacologic approach and describes an eight-week treatment period.
Comparator
The comparator was Quasi Desensitization Therapy (QDT). The registry describes it as a placebo therapy used in prior behavioral insomnia studies, delivered in eight weekly sessions. Details beyond the description in the record are not reported in the registry record.
Primary question
The primary outcome was change in total Insomnia Severity Index (ISI) score, with assessment at 8 weeks, 3 months post-treatment, and 6 months post-treatment. The study also proposed to evaluate whether insomnia improvement was associated with changes in alcoholism and daytime functioning, and to explore whether first-degree family history of alcoholism was associated with insomnia severity or treatment response. The registry record does not report primary outcome estimates or a comparison between arms, so the size and precision of any difference cannot be assessed from these results.
The clinical question is therefore about both the short-term change in insomnia severity and whether changes persist at follow-up. The registry identifies insomnia as the condition under study and describes the intended population as people recovering from alcoholism. It does not establish from the posted results whether participants in either arm experienced a particular amount of change, or whether changes differed between arms. The additional proposed evaluations concern relationships among insomnia, alcoholism, daytime functioning, and family history; they should be distinguished from the primary ISI outcome.
3. Trial Design
This was a randomized, single-masked, parallel-group study with enrollment of 63 participants. The registry lists the phase as NA and the overall status as completed. The sponsor was the VA Office of Research and Development. The recorded study start was 2014-08-15, and primary completion was 2019-05-23.
Participants were assigned to CBT-I or QDT. CBT-I was delivered in eight individual sessions with a study clinician; the first session served as orientation and no active treatment was delivered at that session, according to the arm description. QDT was described as an eight-session weekly intervention presented as a way to address conditioned arousal after waking at night. The record does not identify which party or parties were masked, so the masking designation cannot be interpreted more specifically.
The study summary describes an eight-week CBT-I course and follow-up at 3 and 6 months after treatment. The primary outcome description specifies assessments at 8 weeks, 3 months post-treatment, and 6 months post-treatment. The registry's primary outcome population is all participants randomized to either arm who received at least one treatment session. This definition does not by itself establish how participants who did not receive a session, withdrew, or missed assessments were handled in the statistical analysis.
The summary says the study would evaluate whether improvement in insomnia was associated with improvement in underlying alcoholism and daytime functioning. It also describes an exploratory evaluation of first-degree family history of alcoholism in relation to insomnia severity and treatment response. The registry record does not report the detailed protocol, the planned statistical model, a sample-size justification, interim analyses, or the operational details of randomization and masking. These details should not be inferred from the study design labels.
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
| Stage | Cognitive Behavioral Therapy for Insomnia (CBT-I) | Quasi Desensitization Therapy (QDT) |
|---|---|---|
| STARTED | 31 | 32 |
| COMPLETED | 30 | 28 |
| NOT COMPLETED | 1 | 4 |
Analysis population for the primary outcome, as defined in the registry: All subjects randomized into either treatment arm and received had 1 or more treatment sessions.
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 | Cognitive Behavioral Therapy for Insomnia | Quasi Desensitization Therapy | Total |
|---|---|---|---|---|
| Participants analysed | 31 | 32 | 63 | |
| Age, Continuous | years | 51.6 (SD 10.9) | 51.5 (SD 8.2) | 51.6 (SD 9.5) |
| Sex: Female, Male: Female | Participants | 3 | 2 | 5 |
| Sex: Female, Male: Male | Participants | 28 | 30 | 58 |
| Race/Ethnicity, Customized: African-American | Participants | 23 | 29 | 52 |
| Race/Ethnicity, Customized: Caucasian | Participants | 8 | 3 | 11 |
| Race/Ethnicity, Customized: Hispanic | Participants | 1 | 1 | 2 |
| Insomnia Severity Index total score (ISI) | units on a scale | 19.7 (SD 3.5) | 19.0 (SD 3.7) | 19.3 (SD 3.6) |
| Sleep Onset Latency (SOL, sleep diary) | minutes | 51.6 (SD 41.4) | 49.3 (SD 34.0) | 50.5 (SD 37.7) |
| Wake After Sleep Onset (WASO, sleep diary) | minutes | 44.6 (SD 30.0) | 28.6 (SD 25.5) | 36.7 (SD 28.8) |
| Total Sleep Time (TST, sleep diary) | minutes | 317.0 (SD 90.8) | 345.1 (SD 99.5) | 330.8 (SD 95.5) |
| Percent Days Abstinent (PDA, last 90 days, at screening) | Percent of Days Abstinent | 38.3 (SD 36.0) | 26.9 (SD 29.2) | 32.5 (SD 32.9) |
| Drinks per day (DrPDay, last 90 days, at screening) | Number of Drinks Per Day | 9.1 (SD 9.2) | 8.8 (SD 7.1) | 8.9 (SD 8.1) |
| Penn Alcohol Craving Scale total score (PACS) | units on a scale | 10.8 (SD 7.5) | 8.2 (SD 7.0) | 9.5 (SD 7.3) |
| Days Abstinent from Alcohol before Treatment (Abs) | Number of Days | 86.8 (SD 103.3) | 142.6 (SD 111.6) | 115.2 (SD 110.4) |
| Physical Composite Score (PCS, SF-12 scale) | units on a scale | 42.7 (SD 4.6) | 40.4 (SD 5.3) | 41.7 (SD 5.0) |
| Mental Composite Score (MCS, SF-12 scale) | units on a scale | 44.4 (SD 7.5) | 43.1 (SD 6.4) | 43.9 (SD 6.9) |
| Beck Depression Inventory total score | units on a scale | 19.7 (SD 12.4) | 17.2 (SD 10.7) | 18.5 (SD 11.6) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Insomnia Severity Index - Total Score, measured over 8 weeks, 3 months post-treatment, and 6 months post-treatment.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change in total score on the Insomnia Severity Index (ISI). The registry describes the ISI as a seven-item measure, with each item using a 0-4 Likert scale, and states that the total score can reach 28. It is intended to represent overall insomnia severity and also to assess insomnia subtype, daytime effects, and sleep satisfaction. Participants were to complete it at baseline and subsequent study-related visits.
The registry lists the primary outcome as a least-squares mean with a 95% confidence interval, in units on a scale. It names assessment points of 8 weeks, 3 months post-treatment, and 6 months post-treatment. A change score provides a way to describe how the measured severity shifts over time; comparison between randomized arms would address whether the observed changes differ between assigned interventions. However, the record does not report the least-squares means, their confidence intervals, or an arm contrast.
The registry gives interpretive bands of 0-7 for no clinically significant insomnia, 8-14 for sub-threshold insomnia, 15-21 for clinical insomnia of moderate severity, and 21-28 for clinical insomnia of severe severity. The stated bands overlap at score 21, so that exact value falls in both listed categories. These bands provide context for scale scores but do not substitute for reported group-level outcome estimates or a comparison between arms.
As a continuous measure, the ISI can capture differences in score across its range rather than reducing the outcome to a simple category. That is useful for describing change, but interpretation still depends on the estimates, uncertainty, and analysis population. Those outcome results are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the primary outcome and the planned assessment times, but it does not report numerical primary outcome results. There are no posted least-squares mean estimates, confidence intervals, p-values, or treatment contrasts in the record. Consequently, it is not possible to describe the observed direction or size of change in ISI score, to compare change between CBT-I and QDT, or to determine how precisely any comparison was estimated.
The study is listed as completed, but completion status does not itself communicate the outcome. Nor does the enrollment count reveal whether the primary endpoint changed, whether any difference was compatible with no difference, or whether the data were sufficiently precise to distinguish among plausible effects. Those judgments require the actual outcome estimates and their uncertainty, which are not reported in the registry record.
The primary outcome is described using least-squares means and 95% confidence intervals. In general, a confidence interval expresses the precision of an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while an interval that spans a range of values leaves uncertainty about the size of the underlying effect. These are general interpretations; without the reported estimates and intervals, no such assessment can be made for this trial.
The registry's summary describes additional interests beyond insomnia severity: whether improvement in insomnia is associated with improvement in alcoholism and daytime functioning, and whether first-degree family history of alcoholism relates to severity or response. These are described as evaluations or exploratory aims, not as reported findings. No estimates for these relationships are reported in the registry record, and the record does not establish whether they were analyzed.
The available safety information is separate from evidence about the primary endpoint. The record lists serious adverse events affecting 7 of 31 participants at risk in the CBT-I arm and 3 of 32 at risk in the QDT arm, with no deaths reported in either arm. These counts describe the safety entries in the registry, not whether the interventions caused the events. The record does not provide the outcome data needed to connect these safety figures to a treatment effect on insomnia.
In short, the registry describes a randomized comparison and an outcome plan, but the posted information does not support an efficacy estimate. The absence of reported primary results is not evidence that the arms had equal outcomes or that one arm performed better. It means the comparative effect and its precision cannot be evaluated from the registry record. Any interpretation should keep the study's stated aims separate from results that are actually reported.
9. Statistical Methods Explained
The registry names the primary outcome summary as a least-squares mean and its uncertainty as a 95% confidence interval. It does not report the fitted model or the numerical estimates. The explanations below describe these statistical ideas generally and should not be read as a description of an unreported analysis plan.
What does a least-squares mean represent?
In general, a least-squares mean is a model-based estimate of an outcome mean. It may account for terms included in a statistical model, so it can differ from a simple arithmetic average of the observed scores. Which terms were included, whether baseline score was included, and how repeated measurements were handled are not reported in the registry record. Therefore, the label alone is not enough to reconstruct the analysis or interpret an adjusted comparison.
The ISI is a continuous score, and its change can be described on the scale's units. A mean summarizes the central level of a group, while a mean change describes the average shift from a reference measurement. A contrast between arms would express the difference between their estimated changes or means, depending on the chosen model and estimand. The registry record gives no numerical estimates or specified contrast, so no such comparison can be stated.
How should a confidence interval be read?
In general, a confidence interval presents a range of values compatible with an estimate under the statistical procedure and its assumptions. It conveys precision: an interval that is more spread out indicates more uncertainty about the effect's magnitude. A 95% confidence interval is a conventional interval level; it does not mean that there is a 95% probability that a fixed effect lies in the particular calculated interval. This explanation is general. The record names 95% confidence intervals for the primary outcome but does not report their endpoints.
A confidence interval should be read alongside the estimate and the outcome's scale. For a change in ISI units, the estimated shift describes the direction and magnitude of the measured change, while the interval indicates how uncertain that estimate is. For an arm comparison, the interval around the contrast would be central to judging the range of differences compatible with the data. Since no estimates or intervals are reported, precision cannot be assessed in this trial.
Why do repeated assessment times matter?
The primary outcome description includes 8 weeks, 3 months post-treatment, and 6 months post-treatment. Repeated assessments can describe the course of an outcome over time, but they also raise analytical questions. A model may account for correlation among measurements from the same participant; separate analyses at each time may instead address distinct time-specific questions. The registry record does not report which approach was used, whether all listed time points were analyzed, or how a primary time point was selected for a treatment comparison.
Change from baseline is also distinct from a difference between treatment arms. A group can show a change over time without that change differing from the other group's change. Randomization supports a comparative design, but an estimate and its uncertainty are still needed to describe the observed contrast. The registry lists the study as randomized and parallel-group, but provides no primary contrast estimate.
What does over-dispersion mean in general?
Over-dispersion is a general concern for some statistical models when the observed variability is greater than the model assumes. If not accommodated, uncertainty estimates can be too small and tests can appear more decisive than warranted. This concept is not evidence that over-dispersion occurred in this study. The primary outcome is continuous, and the registry does not name an over-dispersion model or report a model diagnostic. The concept is relevant only as a general reminder that uncertainty depends on the suitability of the chosen model.
How should planning calculations be understood?
The sample-size assumptions describe planning illustrations based on an observed effect, not the trial's original design justification. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. For outcomes other than time-to-event outcomes, such illustrations are expressed as participants per arm; time-to-event calculations use total events. These are planning scenarios, not observed power and not evidence about the probability that the trial detected an effect.
A planning calculation depends on its assumptions and the effect size used. An illustration based on a fraction of an observed effect asks what sample size would be needed under that scenario; it does not show that the original trial was designed around that effect, nor does it replace the trial's outcome analysis. The registry record does not report the original sample-size justification. No planning illustration can recover the missing primary outcome estimates or their confidence intervals.
Finally, statistical significance and clinical interpretation are different questions. A test result, if reported, would address compatibility with a statistical null under specified assumptions; the estimate and interval would describe magnitude and precision. The registry record does not report the test results, the model, or a threshold for a clinically important change. General explanations of these methods therefore cannot be used to infer a result for CBT-I or QDT.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is listed at multiple assessment times, and the registry indicates that the primary outcome has several categories or time points and was not reduced to one comparison in the posted results. When several time points or outcomes are examined, multiplicity can arise because more than one statistical question is being tested. In general, multiple testing can increase the chance of a false-positive finding if each test is interpreted separately without an appropriate plan. The registry record does not report whether any adjustment or hierarchy was planned or used.
The study summary also describes related evaluations of alcoholism, daytime functioning, and first-degree family history of alcoholism. The family-history evaluation is explicitly described as exploratory. The record does not report how these outcomes or associations were analyzed, whether they were prespecified in a detailed statistical plan, or whether multiplicity was addressed. No results for these evaluations are reported in the registry record.
Missing-data handling is not reported in the registry record. The record does not state how missed visits, incomplete ISI questionnaires, withdrawal, or other unavailable measurements were handled. It also does not describe imputation, sensitivity analyses, or assumptions about why data might be missing. These omissions limit the ability to assess whether the reported analysis, if available elsewhere, would represent all randomized participants or only those with particular observed measurements.
The primary outcome population is described as all randomized participants in either treatment arm who received at least one treatment session. That definition is narrower than simply saying all randomized participants, and it does not specify how participants without a treatment session were treated in analyses. The registry record lists no analyses, so it does not establish whether an intention-to-treat analysis, a per-protocol analysis, or another analysis population was used. These details should not be inferred from the outcome population description.
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 |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 7 | 31 | 22.6% |
| Quasi Desensitization Therapy (QDT) | 3 | 32 | 9.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 0 of 31 |
| Quasi Desensitization Therapy (QDT) | 0 of 32 |
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 |
|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 0 of 31 |
| Quasi Desensitization Therapy (QDT) | 0 of 32 |
Most frequent serious adverse event terms
| Event term | Organ system | Cognitive Behavioral Therapy for Insomnia (CBT-I) | Quasi Desensitization Therapy (QDT) |
|---|---|---|---|
| Alcohol detoxification | Nervous system disorders | 4 of 31 | 2 of 32 |
| Cerebrovascular Accident (CVA) | Nervous system disorders | 0 of 31 | 1 of 32 |
| Abdominal Pain | Gastrointestinal disorders | 1 of 31 | 0 of 32 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 1 of 31 | 0 of 32 |
| Residential Psychiatric Treatment | Nervous system disorders | 1 of 31 | 0 of 32 |
Serious events with the highest arm-level rate: alcohol detoxification (12.9%), abdominal pain (3.2%), pneumonia (3.2%), residential psychiatric treatment (3.2%), cerebrovascular accident (cva) (3.1%).
The registry reports serious adverse events by treatment arm. In the CBT-I arm, 7 of 31 participants at risk were reported as affected; in the QDT arm, 3 of 32 participants at risk were reported as affected. Deaths were reported as 0 in each arm. The registry also reports 0 other adverse events affected in each arm. These are counts in the safety record and should not be treated as estimates of the primary insomnia outcome.
The listed serious-event terms include Alcohol detoxification at 12.9%, Abdominal Pain at 3.2%, Pneumonia at 3.2%, Residential Psychiatric Treatment at 3.2%, and Cerebrovascular Accident (CVA) at 3.1%. The registry record does not clarify the denominator or event-counting details for these term percentages in the material. They should therefore be read as reported terms and percentages, not as a basis for deriving additional rates or totals.
These safety figures do not establish that an intervention caused an event. A comparison of counts alone does not account for event context, timing, severity beyond the serious-event classification, or other potential explanations. The record does not report an analysis attributing events to treatment. The figures also do not indicate whether participants experienced improvement or worsening in ISI score; that primary outcome information is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The study's design makes a randomized comparison between CBT-I and QDT, and the registry identifies change in ISI total score as the primary outcome. That design and outcome description clarify the question the study intended to address. They do not, by themselves, show the answer. The registry record does not report the primary outcome estimates, confidence intervals, or an arm comparison.
Accordingly, the posted information cannot establish the direction, magnitude, or precision of change in insomnia severity. It cannot show whether changes differed between arms or whether any change was maintained at follow-up. It also cannot establish whether insomnia improvement was associated with changes in alcoholism or daytime functioning, or whether family history was related to severity or treatment response. Those are stated aims, not reported findings.
The record's completed status should not be mistaken for a result. Likewise, the enrollment figure and safety counts do not substitute for the primary outcome analysis. Without estimates and their uncertainty, there is no basis in the registry record for declaring that the treatments produced the same or different ISI outcomes. Lack of a reported comparison is not a finding of no difference.
In general, interpreting a clinical-trial result requires attention to the estimated effect, precision, the outcome's meaning, and the analysis population. The ISI provides a measure of insomnia severity on a defined scale, but group-level results are needed to understand the observed change. The registry provides interpretive score bands, although its stated categories overlap at 21. The record does not report enough outcome information to determine where either arm's results fell relative to those bands.
The safety information is also limited to reported counts and terms. It does not establish causality or provide the missing evidence about efficacy. A balanced reading keeps these distinct: the registry describes the study's design and selected safety entries, while its primary comparative results and broader exploratory findings are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because its stated question combines a repeated continuous outcome with a randomized treatment comparison and follow-up after treatment. The primary measure, ISI total score, is described at 8 weeks, 3 months post-treatment, and 6 months post-treatment. That structure raises practical questions about how change over time is summarized, how within-participant measurements are handled, and which comparison is emphasized.
The record makes clear why a study objective and a statistical result must be distinguished. It names a least-squares mean and a 95% confidence interval, but the estimates themselves are not reported. Without those values, readers cannot assess magnitude or precision. This is a useful example of how a registry entry can document an outcome definition and design while leaving the central comparative result unavailable in the record.
The study also has several related aims. The summary describes possible associations between insomnia improvement and alcoholism or daytime functioning, along with an exploratory family-history question. Multiple outcomes and time points require clear analysis priorities and transparent reporting. The registry record does not report a multiplicity strategy or results for these additional questions, so their statistical interpretation remains unresolved.
Finally, the stated planning assumptions illustrate why sample-size calculations should be separated from outcome evidence. A planning illustration based on an observed effect and selected assumptions is not a measure of achieved power and cannot establish whether an effect was detected. In this record, the main statistical lesson is the importance of complete reporting: an interpretable treatment comparison requires the estimate, its uncertainty, and enough information about the analysis population and methods to understand what was estimated.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A central limitation of the registry information is that it does not report numerical results for the primary ISI outcome. The registry identifies the outcome, its scale, and the intended assessment times, but no means, change estimates, confidence intervals, or arm comparisons are reported. The effect's direction, size, and precision therefore cannot be evaluated from the record.
The statistical analysis is also insufficiently described for independent interpretation. The registry names least-squares means but does not report the model specification, adjustment variables, handling of repeated measurements, or a defined contrast. It does not report an analysis population beyond the primary outcome population description. The number and role of any analyses are not detailed in the record.
Missing-data methods, multiplicity procedures, and a detailed statistical plan are not reported in the registry record. This matters because the primary outcome spans several assessment times and the study summary includes additional proposed evaluations. Without these details, the handling of incomplete measurements and the priority given to different comparisons cannot be assessed.
The record gives an enrollment figure and arm-specific safety counts, but these do not resolve the absence of efficacy results. The safety-term percentages are listed without denominator and event-counting details in the information, and the record does not attribute events to treatment. The arm descriptions are also incomplete in the registry material: the CBT-I description ends during its account of intervention components, and the QDT description is partial. As a result, intervention details beyond the stated session format should not be inferred.
The registry's ISI severity bands overlap at score 21, adding ambiguity for a score exactly at that boundary. These limitations do not establish a flaw in the conduct of the trial; they describe what cannot be assessed from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse — NCT01987089.
- Registry record last updated 2020-08-07; status last verified 2020-08.
- Results first posted 2020-08-07.
- 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
The registry record describes a completed, randomized, single-masked, parallel-group study with enrollment of 63 participants. It compares eight-session CBT-I with QDT and identifies change in total ISI score as the primary outcome, assessed at 8 weeks, 3 months post-treatment, and 6 months post-treatment. The primary outcome population is described as randomized participants who received at least one treatment session.
The study summary also describes planned evaluations involving alcoholism, daytime functioning, and first-degree family history of alcoholism. The record lists serious adverse events affecting 7 of 31 participants at risk in the CBT-I arm and 3 of 32 in the QDT arm, with 0 deaths in either arm. Primary outcome estimates, treatment comparisons, analysis methods, missing-data handling, and multiplicity procedures are not reported in the registry record.