Treatment, Pain, and Opioids: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Treatment, Pain, and Opioids (NCT05363176), a randomized na study. The primary outcome is Medical Record Review and Treatment Utilization Form.

2. Clinical Question

3. Trial Design

The registry describes NCT05363176 as a randomized, double-masked, parallel-group trial. It lists an enrollment of 300 and a completed status. The sponsor is the VA Office of Research and Development. The registry labels the phase as not applicable. Further detail about the randomization procedure, concealment, or which people were masked is not reported in the registry record.

The comparison was between two behavioral interventions delivered remotely: Cognitive-Behavioral Therapy for Treatment Seeking and pain treatment education. Each was described as a single telehealth session of approximately 45 minutes. The registry summary frames the study around beliefs that may hinder engagement in psychosocial and other non-pharmacological pain treatment. It does not report additional information about intervention fidelity, providers, or participant adherence to the sessions.

The primary outcome assessed treatment initiation by 6-months post-treatment. Medical-record chart review was used to identify whether a participant attended at least one appointment for a non-pharmacological pain treatment. The registry lists the Pain Treatment Willingness Scale, Medication Beliefs Questionnaire, Beck Hopelessness Scale, Pain Catastrophizing Scale, and Tampa Scale for Kinesiophobia-17 among secondary outcome measures. Numerical results are posted for some secondary measures, while numerical results for the remaining listed measures are not reported in the registry record.

The registry reports primary endpoint counts for 129 participants in the CBT for Treatment Seeking group and 136 in the Pain Treatment Education group. These arm counts are lower than the stated enrollment of 300. Reasons for the difference, including how many participants lacked endpoint data and how missing outcomes were handled, are not reported in the registry record. The analysis population and any exclusions are also not described in sufficient detail to determine how the reported counts relate to all randomized participants.

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

Reasons for not completing this period:

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: Baseline characteristics not assessed in 6 participants because they were lost to follow-up after consent.

6. Primary Endpoint

The registry lists the primary outcome as Medical Record Review and Treatment Utilization Form, measured over 6-months post-treatment.

The primary endpoint is treatment initiation by 6-months post-treatment. It records whether a participant attended at least one appointment for a non-pharmacological pain treatment. The registry says this information was captured through medical-record chart review and a Treatment Utilization Form, with the investigators calculating the percent who initiated treatment by the follow-up.

This endpoint addresses engagement with care rather than a direct measure of pain intensity, function, or the quality of treatment received. A participant counts as having initiated treatment after attending at least one appointment; the endpoint does not, by itself, describe ongoing attendance or treatment completion. The registry gives examples of eligible non-pharmacological treatment as psychosocial interventions and movement-related interventions.

A binary endpoint is useful for comparing the proportion of participants in each group who met a defined event criterion. In this trial, that event is treatment initiation. The posted primary counts are 19 of 129 in the CBT for Treatment Seeking group and 17 of 136 in the Pain Treatment Education group. These counts describe the recorded events and denominators; they do not establish why a participant did or did not initiate treatment.

Medical-record review offers a way to assess documented treatment use, but the registry does not report how records were obtained across participants, how records from outside the health system were handled, or how uncertain records were classified. Those details matter because the endpoint depends on documented attendance. Such ascertainment details are not reported in the registry record.

7. Results Posted in the Registry

• Pain Treatment Education: 12.5% (17/136) versus 14.7% (19/129) on control; risk difference -2.2 percentage points (95% CI -10.5 to 6.0), risk ratio 0.85 (0.46–1.56); unadjusted two-proportion z-test p = 0.597.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Pain Treatment Willingness Scale (PTWS)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Pain Treatment Education: mean 3.61 versus 3.70 on control; difference -0.09 (95% CI -0.40 to 0.22), standardized effect d = -0.08; z-test p = 0.569.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Pain Treatment Education and the control. The interval gives the range of effects that remain compatible with the data.

Medication Beliefs Questionnaire

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Pain Treatment Education: mean 15.97 versus 15.97 on control; difference 0.00 (95% CI -0.69 to 0.69), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Pain Treatment Education and the control. The interval gives the range of effects that remain compatible with the data.

Beck Hopelessness Scale (BHS)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Pain Treatment Education: mean 5.04 versus 4.82 on control; difference 0.22 (95% CI -1.19 to 1.63), standardized effect d = 0.04; z-test p = 0.759.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Pain Treatment Education and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists five secondary outcome measures that cover willingness to pursue pain treatment, medication beliefs, hopelessness, pain catastrophizing, and kinesiophobia. Numerical arm-level results and inferential comparisons are posted for the Pain Treatment Willingness Scale, Medication Beliefs Questionnaire, and Beck Hopelessness Scale. Numerical results for the other listed measures are not reported in the registry record.

Across the secondary outcomes with numerical comparisons, the observed group contrasts are close to zero relative to the uncertainty in those estimates. The posted confidence intervals for the available unadjusted mean differences include zero, and the registry's adjusted analyses do not provide confidence intervals for the adjusted contrasts. Taken together, these results do not show a consistent, precise pattern of group separation across the reported secondary measures.

These measures relate to beliefs and psychological factors that the study rationale identifies as potentially relevant to treatment engagement. They are distinct from the primary endpoint, which records whether a participant attended at least one appointment. The secondary results can offer context about participant-reported beliefs and psychological measures, but they do not directly establish whether participants initiated care or whether that care continued. The primary comparison remains the direct test of the registered treatment-initiation question.

Secondary outcomes generally carry less weight than the primary outcome because they are additional questions and may involve multiple comparisons. When many outcomes are examined, some apparently notable findings can occur by chance even if there is no underlying difference. The registry record does not report whether multiplicity adjustments were planned or applied. Therefore, secondary comparisons should be read as supportive or exploratory evidence, rather than as independent confirmation of the primary result. The incomplete numerical reporting for the listed measures further limits conclusions about the full secondary-outcome pattern.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Pain Treatment Willingness Scale (PTWS)
• Medication Beliefs Questionnaire
• Beck Hopelessness Scale (BHS)
• Pain Catastrophizing Scale (PCS)
• Tampa Scale for Kinesiophobia-17 (TSK-17)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary: each participant is classified according to whether treatment initiation was recorded by the follow-up. The event is attending at least one appointment for non-pharmacological pain treatment. The registry reports the event counts and denominators for each group, as well as an analysis based on logistic regression. The posted comparison is a superiority analysis.

What does logistic regression contribute?

In general, logistic regression models the odds of a binary event. An odds ratio compares the odds between groups; it is not the same quantity as a difference in event proportions. An odds ratio at the null value represents equal odds between groups. The registry reports an odds ratio of 1.167 and a 95% confidence interval from .603 to 2.277. Because the interval includes the null value, the estimate remains compatible with no difference as well as with effects in either direction. The registry record does not specify the covariates, if any, included in this logistic-regression model.

What is the unadjusted risk difference?

A risk difference subtracts the event proportion in one group from the event proportion in the other. The unadjusted recalculation uses only the posted counts and denominators, without covariate adjustment. It expresses the comparison as Pain Treatment Education versus CBT for Treatment Seeking. The risk-difference estimate is close to zero, and the recalculated confidence interval crosses zero. This is a direct summary of the observed group proportions, whereas the registry's odds ratio summarizes a contrast in odds. Different measures can have different numerical scales while describing the same underlying comparison.

The registry also posts a p-value for its logistic-regression analysis, and the recalculation includes an unadjusted p-value. A p-value describes how compatible the observed data are with a specified null model under the assumptions of the test. It does not measure the probability that the null hypothesis is true, the size of an effect, or the practical importance of an estimate. The confidence interval adds information about the range of effect sizes reasonably compatible with the data and model.

How should continuous secondary outcomes be read?

For the posted secondary outcomes with numerical results, the registry gives group means and standard deviations at 6-months post-treatment. A mean is a summary of the observed scores in a group; a standard deviation describes how dispersed individual scores are around that mean. An unadjusted mean difference compares the group means. Its confidence interval describes uncertainty in that difference. These comparisons are not the same as a comparison of change from baseline: the registry entries describe scores at follow-up, and baseline-adjusted analyses are separately reported as ANCOVA.

ANCOVA is a general approach that compares group outcomes while accounting for one or more covariates. The registry names ANCOVA for the posted analyses of the Pain Treatment Willingness Scale, Medication Beliefs Questionnaire, and Beck Hopelessness Scale. For these analyses, it reports an F-value or F-test and a p-value, but does not identify the covariates or give confidence intervals for the adjusted contrasts. The unadjusted mean-difference recalculations and the registry's ANCOVA results therefore answer related but not necessarily identical statistical questions.

Why can dispersion matter?

In general, the amount of variation in an outcome affects how precisely a group mean or contrast can be estimated. Greater dispersion makes individual scores less alike and can make it harder to distinguish a group contrast from sampling variation, all else being equal. For count outcomes, over-dispersion means that variability exceeds what a simple model assumes. The primary outcome is posted as participant event counts, but the registry analysis is logistic regression rather than a count-rate model. Over-dispersion is therefore not the central issue for interpreting this binary endpoint.

The registry supplies standard deviations for the posted continuous secondary measures, so their variability can be considered alongside their group means. The confidence intervals for the unadjusted mean differences reflect both the estimated contrast and its uncertainty. The registry's adjusted analyses provide test statistics but not adjusted confidence intervals, limiting direct comparison of precision across adjusted and unadjusted results.

All recalculated comparisons are simple unadjusted analyses of posted summary statistics. They do not reproduce the registry's regression or ANCOVA models, and they do not account for unreported covariates, missing-data methods, or other features of the original analysis. Since the discrepancy indicator is false, there is no flagged conflict between the posted analysis and the recalculation. Where the registry reports its own analysis, that remains the study's posted analysis; the recalculation is a complementary descriptive check.

11. Confidence Intervals and Precision

Confidence intervals describe uncertainty in an estimated effect under the assumptions of the analysis. They do not give a range that must contain the true effect, and their width is informative: a wider interval leaves more possible values compatible with the observed data than a narrower interval. For the primary endpoint, the registry's odds-ratio interval extends from .603 to 2.277 around an estimate of 1.167. It includes the null value for an odds ratio, indicating that the posted estimate does not precisely distinguish the groups.

The unadjusted risk-difference interval also crosses zero. A risk difference of zero corresponds to equal observed event proportions; an interval spanning zero permits both a lower and a higher event proportion in Pain Treatment Education relative to CBT for Treatment Seeking. The primary event counts are modest relative to the enrollment figure, and the registry does not explain the difference between those denominators and the enrollment total. Without details on missing outcomes and the analysis population, the contribution of incomplete endpoint ascertainment to precision cannot be assessed from the registry record.

The reported intervals for the posted continuous secondary comparisons also include zero. This indicates uncertainty about the direction of those mean differences, rather than a precise estimate of a nonzero contrast. The adjusted ANCOVA entries do not include confidence intervals, so their precision cannot be read directly from the posted adjusted statistics alone.

Confidence intervals should be considered with the endpoint's definition and the analysis method. The primary interval concerns odds of documented treatment initiation, not treatment duration, pain, or function. It also reflects the statistical model used; it does not account for unreported choices such as handling of missing records or model covariates. The interval communicates uncertainty, but cannot fill gaps in the registry's description of data completeness or analysis procedures.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size illustrations are planning calculations based on the observed effect, not the trial's original design assumptions. For these comparisons, the figures are participants per arm, not total events. The calculations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The trial's own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the number of participants per arm the illustration estimates would be needed to have an 80% chance of detecting the specified effect under the listed assumptions, if that effect and model assumptions were correct. The 90% power column uses a higher target chance of detecting that effect and therefore requires more participants per arm. These are planning quantities, not counts observed in the trial.

Rows that plan for 100%, 75%, and 50% of the observed effect show how the required sample size changes when the target effect is smaller. A smaller effect is harder to distinguish from sampling variation, so more participants are required under the same planning assumptions. The observed effect is itself uncertain, particularly when its confidence interval is broad or includes the null value; using it as a planning input does not make it a reliable forecast of a future effect.

This is not observed power. It is an illustration of sample sizes under explicit assumptions, based on the observed effect and the stated planning method. It should not be read as a retrospective measure of the trial's ability to detect an effect, nor as evidence that the trial was or was not adequately designed. The registry's original sample-size justification is not reported.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.147; treatment proportion p₁ = 0.125; average p̄ = 0.136.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.4850 = 0.9506.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.4847 = 0.4080.
4. n = (0.9506 + 0.4080)² / (-0.0223)² = 3,715.7, rounded up to 3,716 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.147286821705426                          # control proportion
p1 <- 0.125                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(5363176)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 3,716 (80% power), 4,974 (90% power)
 75% of observed effect: n per arm = 6,721 (80% power), 8,996 (90% power)
 50% of observed effect: n per arm = 15,376 (80% power), 20,583 (90% power)
power.prop.test: 3715.7 
Simulated power at n = 3,716 per arm: 0.801 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry's own primary analysis is logistic regression, reported as an odds ratio of 1.167 with a 95% confidence interval from .603 to 2.277. The unadjusted recalculation instead uses the posted event counts to estimate a risk difference for Pain Treatment Education relative to CBT for Treatment Seeking. These are different effect measures and use different analysis approaches, so their numerical values should not be compared as though they were estimates on the same scale.

Both analyses indicate substantial uncertainty around the comparison: the registry's odds-ratio interval includes the null value, and the recalculated risk-difference interval crosses zero. The recalculation is a simple check based on posted summary counts; it does not reproduce the registry's regression model or any adjustments that may have been used. The registry does not report the logistic model's covariates or other details needed to reconstruct it fully.

The discrepancy indicator is false, so no conflict is flagged between the registry analysis and the recalculation. The registry analysis remains the sponsor-reported result, while the unadjusted result supplies a complementary view of the group counts. Neither result should be interpreted as establishing a treatment effect, and the registry record does not provide enough methodological detail to explain every modeling choice.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary outcome and lists secondary outcomes, but it does not report a multiplicity strategy. Multiplicity arises when analyses address several outcomes or contrasts: the more comparisons made, the greater the possibility of observing an apparently notable result by chance. Methods such as adjustment of significance thresholds or a pre-specified hierarchy can address that issue, but whether any such approach was used is not reported in the registry record. The posted secondary results should therefore be interpreted with caution, especially when considered separately from the primary outcome.

Important details about missing data are also not reported. The enrollment entry is 300, while primary endpoint data are posted for 129 participants in the CBT for Treatment Seeking group and 136 in the Pain Treatment Education group. The registry does not explain the difference, describe missingness by group, state how a missing medical record was classified, or specify whether imputation or another missing-data method was used. The posted counts alone do not establish why participants are absent from the endpoint denominators.

The analysis population is not defined in enough detail to determine whether the reported comparisons include all randomized participants, only participants with available outcome data, or another subset. The registry does not report whether an intention-to-treat principle was used, how exclusions were handled, or whether participants were analyzed according to assigned intervention. Those details affect how the results can be interpreted and reproduced.

The registry names logistic regression for the primary outcome and ANCOVA for several secondary outcomes, but does not provide the full statistical analysis plan, covariates, model diagnostics, or handling of protocol deviations. The methods and adjustment set for the adjusted analyses are therefore not fully described in the registry record. These omissions do not change the posted estimates, but they limit assessment of robustness and the ability to reproduce the sponsor's analyses.

16. 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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hospitalization associated with respiratory issues (2.7%), surgery/procedure (2.0%), musculoskeletal pain (1.3%), hospitalization associated with renal functioning (1.3%), cardiac issues (1.3%).

The registry posts serious adverse event figures separately from the primary treatment-initiation outcome. For CBT for Treatment Seeking, 10 of 151 participants at risk were affected by serious adverse events; for Pain Treatment Education, 12 of 149 at risk were affected. Other adverse events affected 28 of 151 participants in the CBT group and 28 of 149 in the education group. The registry also records one death in the CBT group and zero in the education group.

These are counts with the stated at-risk denominators, not estimates of whether an intervention caused an event. The record does not provide enough detail to assess event timing, attribution, severity criteria, or whether an event was related to treatment. The listed serious-event terms include hospitalization associated with respiratory issues at 2.7%, surgery/procedure at 2.0%, musculoskeletal pain at 1.3%, hospitalization associated with renal functioning at 1.3%, cardiac issues at 1.3%, and fatigue at 0.7%.

Serious adverse event counts and the primary endpoint answer different questions and should not be conflated. These safety figures describe events recorded in the registry; they do not by themselves establish comparative safety or causation.

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

The primary result concerns a specific engagement outcome: documented attendance at at least one non-pharmacological pain-treatment appointment by 6-months post-treatment. The posted counts are similar in scale between groups, and the registry's odds-ratio confidence interval includes the null value. The unadjusted risk-difference interval also crosses zero. The available evidence therefore does not precisely distinguish the groups on this outcome.

That uncertainty is not proof that the interventions are equivalent. A confidence interval spanning the null can include a range of effects, including potentially meaningful differences in either direction. Establishing equivalence or non-inferiority requires a design and analysis that directly address those questions, and such an objective is not reported in the registry record. The posted trial is described as a superiority analysis.

The result also does not address all aspects of pain care. The endpoint counts initiation, not how many sessions a participant attended, whether treatment was sustained, or whether pain, function, medication use, or quality of life changed. The registry's secondary measures provide some information on related beliefs and psychological constructs, but do not substitute for those unmeasured or unreported outcomes.

The findings are specific to Veterans with chronic pain who use prescription opioids and to the two telehealth behavioral sessions described in the registry. The record does not report enough eligibility, implementation, or participant-characteristic detail to assess how closely the enrolled sample represents other populations or settings. Generalization beyond the studied population and interventions is therefore uncertain.

Finally, the distinction between enrollment and reported endpoint denominators, along with unreported missing-data and analysis-population details, limits assessment of how complete the primary comparison is. The result describes the posted data and analysis; it does not establish that either intervention works or does not work, and it is not a basis for individual treatment decisions.

18. Why This Trial Matters Statistically

This trial raises a clear statistical question about engagement: whether a brief telehealth intervention targeting treatment-seeking beliefs differs from pain-treatment education in the likelihood of initiating non-pharmacological pain care. The primary endpoint translates that question into a defined, observable event rather than relying only on stated willingness or intention. It is therefore useful to distinguish actual documented initiation from beliefs that might precede it.

The registry also illustrates why effect measures and uncertainty need to be read together. The sponsor's logistic-regression result is an odds ratio, while the simple recalculation is a risk difference based on the observed counts. Each describes the comparison on a different scale. Both estimates are uncertain, and the intervals do not establish a clear separation. Reporting both the outcome counts and the model-based result helps clarify what was observed and what remains unresolved.

Interpretation also depends on outcome ascertainment. Medical-record review provides a measure of documented attendance, but it may not capture every form of treatment use unless records are complete and accessible. The registry's lack of detail on record coverage, missing data, and the analysis population is therefore statistically important, not merely administrative.

Finally, the secondary measures connect the trial rationale with psychological and belief-related outcomes, but multiple comparisons and incomplete reporting constrain how much they can add to the primary finding. Reading the primary endpoint, secondary outcomes, uncertainty, and missing methodological details together gives a more balanced account than focusing on any single point estimate or p-value.

19. 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 primary endpoint is a narrow measure of treatment engagement: attendance at at least one appointment. It does not capture continuation, intensity, or completion of non-pharmacological treatment. Nor does it directly measure pain or functional outcomes. Its reliance on medical-record review makes the result dependent on documentation and record availability, while the registry does not report how records from different care settings were handled or how incomplete documentation was classified.

The posted primary denominators are smaller than the enrollment figure of 300, but the registry does not explain the difference. Missing-data rates, reasons for missing outcomes, and the approach to missing records are not reported. Because the analysis population is also unspecified, the extent to which the comparison represents all randomized participants is unclear.

The interventions are described as single telehealth sessions of approximately 45 minutes, but further information about content delivery, adherence, provider training, and fidelity is not reported in the registry record. The record also does not state which parties were masked despite labeling the study double masked. These omissions limit assessment of intervention implementation and risk of bias.

Several secondary measures are named, but numerical results are posted for only some of them. The registry does not report a multiplicity strategy, and the adjusted ANCOVA entries omit confidence intervals and covariate details. The primary logistic-regression covariates are likewise not reported. These gaps restrict evaluation of the full analysis and the robustness of adjusted comparisons.

Lastly, the trial concerns Veterans with chronic pain who use prescription opioids, and the registry does not provide extensive participant characteristics or eligibility details. The applicability of the results to other populations, treatment settings, or intervention formats cannot be fully assessed from the registry record.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Treatment, Pain, and Opioids — NCT05363176.
• Registry record last updated 2026-05-29; status last verified 2026-05.
• Results first posted 2026-05-29.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

NCT05363176 is a completed, randomized, double-masked, parallel trial sponsored by the VA Office of Research and Development. It compared one telehealth session of Cognitive-Behavioral Therapy for Treatment Seeking with one telehealth session of pain treatment education among Veterans with chronic pain who use prescription opioids. The registry lists enrollment of 300.

The primary outcome was initiation of non-pharmacological pain treatment by 6-months post-treatment, defined as attending at least one appointment and assessed through medical-record review. The posted event counts are 19 of 129 in the CBT group and 17 of 136 in the education group. The sponsor-reported logistic-regression estimate is an odds ratio of 1.167, with a 95% confidence interval from .603 to 2.277. The interval includes the null value, and the unadjusted recalculation is likewise uncertain.

The record lists secondary measures and serious adverse event counts, but important details about missing data, analysis populations, covariates, and multiplicity are not reported. The results describe the posted treatment-initiation comparison and should be interpreted within those reporting limits.