Improving Obesity Self-Care Among Mentally Ill Veterans: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Obesity Self-Care Among Mentally Ill Veterans (NCT02642536), a randomized na study. The primary outcome is MOVE! Attendance.

2. Clinical Question

The clinical question concerns attendance in a weight management program, rather than weight change itself. Both groups received the standard MOVE! program and an educational workbook. The distinguishing feature described in the registry record is that MH MOVE incorporated phone-based clinician-led CBT sessions, while enhanced usual care did not include phone calls. The trial therefore compared these two program approaches in the recorded population.

The primary outcome was a mean number of sessions attended at the 16-week timeframe. Attendance can indicate engagement with the program, but the outcome is not itself a direct measure of weight, symptom change, or whether a participant completed the program according to a separate completion definition. Those distinctions matter when interpreting what a difference in attendance could represent. The posted results also include symptom-severity outcomes for depression, anxiety, and PTSD; they address related but distinct questions from the primary attendance outcome.

3. Trial Design

The registry record describes a randomized, triple-masked, parallel-group trial comparing MH MOVE with enhanced usual care. The study status is completed, and enrollment is listed as 44. The phase is recorded as not applicable. The registry dates the study start as 2011-01-01 and primary completion as 2016-12-31. These dates describe the study record and do not establish how long each participant was followed.

Both programs included the standard MOVE! weight management program and a workbook containing education for managing depression, anxiety, and PTSD symptoms. In MH MOVE, the workbook was used during 10 phone-based clinician-led CBT sessions. Enhanced usual care included the workbook but no phone calls. Both interventions are classified as behavioral in the registry record.

The reported primary endpoint was the number of MOVE! sessions attended at 16 weeks. The record describes this as a mean, with standard deviation as the measure of dispersion. Its stated minimum-maximum total score range is 2-12, and the score came from a single item. The primary outcome summaries report 19 participants for MH MOVE and 18 for enhanced usual care.

The record also lists secondary outcomes concerning depression, anxiety, and PTSD symptom severity, with a 16-week timeframe. The registry record lists 11 outcome measures, while six secondary outcome entries are noted as posted. It reports no analysis entries. The trial's original statistical analysis plan, allocation procedures beyond randomization, details of masking, handling of missing observations, and original sample-size justification are not reported in the registry record. The labels randomized, triple masked, and parallel describe the recorded design, but do not by themselves explain how these procedures were implemented.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as MOVE! Attendance, measured over 16 weeks.

The primary endpoint is MOVE! attendance, measured as the number of sessions attended at 16 weeks. The registry record defines the score as a single-item count, with a stated minimum-maximum total score range of 2-12. A higher value represents more sessions attended. The posted summaries report the mean and standard deviation for each group.

Attendance is used to address whether participants engaged with the MOVE! program. It is directly connected to the study's stated purpose of comparing participation in and completion of the program. However, the endpoint is attendance, not a separate indicator of program completion. The record does not define a threshold for completion, so a mean attendance score should not be read as the proportion of participants who completed MOVE!.

The measure also does not directly capture weight change or changes in depression, anxiety, or PTSD symptoms. Those symptom constructs appear among the secondary outcomes, and they ask different questions from attendance. A group mean describes the average attendance score, while the standard deviation describes how spread out individual scores are around that average. Neither statistic alone gives the number of participants who attended a particular number of sessions.

In this trial, the primary comparison is between a program with phone-based clinician-led CBT sessions and one without phone calls, with the standard MOVE! program and workbook included in both. The endpoint can therefore characterize attendance under these two program approaches, but should not be treated as a direct measure of every intended clinical or behavioral outcome.

7. Results Posted in the Registry

• MH MOVE: mean 5.90 versus 5.80 on control; difference 0.10 (95% CI -1.06 to 1.26), standardized effect d = 0.06; z-test p = 0.866.

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.

Assessing Depression Symptom Severity

• 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:
  • MH MOVE: mean 6.30 versus 13.40 on control; difference -7.10 (95% CI -11.39 to -2.81), standardized effect d = -1.06; z-test p = 0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for MH MOVE than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Assessing Anxiety Symptom Severity

• 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:
  • MH MOVE: mean 5.50 versus 10.50 on control; difference -5.00 (95% CI -9.26 to -0.74), standardized effect d = -0.76; z-test p = 0.021.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for MH MOVE than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Assessing PTSD Symptom Severity

• 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:
  • MH MOVE: mean 32.10 versus 53.00 on control; difference -20.90 (95% CI -33.41 to -8.39), standardized effect d = -1.07; z-test p = 0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for MH MOVE than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary summaries follow a consistent direction: average depression, anxiety, and PTSD symptom-severity scores are lower in MH MOVE than in enhanced usual care at 16 weeks. Their unadjusted recalculated mean differences are negative, reflecting that direction under the stated comparison convention. The results add context about symptom measures, but they do not alter the interpretation of the primary attendance outcome, which shows similar group means and a confidence interval spanning zero.

Attendance and symptom severity are distinct outcomes. The primary measure reflects participation in MOVE!, while the secondary measures concern reported symptom severity. A pattern in one domain does not establish a pattern in another, and the record does not provide analyses linking individual attendance to symptom scores. It is therefore not possible to infer from these group summaries whether attending more sessions was associated with symptom differences or whether the phone-based sessions explain the observed secondary pattern.

The secondary comparisons carry less evidential weight than a single prespecified primary result because the registry record includes multiple outcomes and reports no multiplicity adjustment or analysis plan. In general, examining multiple outcomes can increase the chance of observing apparently notable differences by chance. The record does not say which outcomes were designated in advance as confirmatory, whether any outcomes were prioritized, or how the investigators intended to interpret multiple tests.

The record lists six secondary outcome entries, while the posted summaries address depression, anxiety, and PTSD symptom severity. The outcome instruments and clinically meaningful thresholds are not described in the registry record. Without those details, the score differences cannot be translated confidently into the practical importance of the changes. The pattern is a description of the posted averages and recalculated comparisons, not a definitive account of treatment effects across all secondary measures.

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

• Assessing Depression Symptom Severity
• Assessing Anxiety Symptom Severity
• Assessing PTSD Symptom Severity
• Assessing Depression Symptom Severity
• Assessing Anxiety Symptom Severity
• Assessing PTSD Symptom Severity

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a numerical score for the number of MOVE! sessions attended. The registry record summarizes it with a mean and standard deviation. A mean is the arithmetic average of the recorded values. The standard deviation describes the degree of variation among individual values around that average. It is not the uncertainty in the estimated mean; the latter depends on both the spread of observations and the number of observations.

What does the mean difference represent?

The comparison is expressed as the MH MOVE mean minus the enhanced usual care mean. The reported estimate is 0.1 sessions. A value of zero would correspond to equal group means; a positive estimate indicates a higher mean in MH MOVE, and a negative estimate indicates a lower mean in MH MOVE. The sign communicates direction, while the size of the estimate communicates the observed separation on the outcome's scale. Since this is a difference between group averages, it does not describe how each individual participant changed or attended.

How should the confidence interval be understood?

A confidence interval expresses uncertainty around an estimated difference. In general, a confidence interval is constructed by a method that, under its assumptions, would cover the underlying quantity at its stated rate over repeated samples. It is not a range containing a known proportion of individual participant outcomes, and it is not a probability statement about the true value after the data have been observed. For the primary comparison, the interval runs from -1.06 to 1.26 sessions. Since it includes zero, the data are compatible with no mean difference as well as with differences in either direction. The width also shows that the estimate does not precisely pin down a single value.

What does the p-value add?

The unadjusted p-value for the primary comparison is 0.866. In general, a p-value measures how unusual data at least as discrepant as those observed would be under a specified null hypothesis and model. It is not the probability that the null hypothesis is true, and it does not measure the clinical importance of a result. Here it is consistent with the confidence interval's inclusion of zero: neither summary indicates a clear difference in mean attendance. The registry record does not report a prespecified statistical analysis plan, so the unadjusted label should not be mistaken for a documented primary analysis procedure.

Why do group sizes and spread matter?

Uncertainty in a mean comparison depends in part on the number of observations and the variability within groups. More variable measurements generally make a difference harder to estimate precisely, while more observations can improve precision under suitable assumptions. The posted primary means are based on 19 and 18 participants, and both groups have a standard deviation of 1.8. These group counts are the available outcome summaries, not proof of the number randomized or the number included in every analysis. The registry record does not explain the relationship between these endpoint counts and overall enrollment of 44.

What are the secondary comparisons?

The secondary results compare group means for symptom-severity scores. The posted summaries give a mean difference, confidence interval, and unadjusted p-value for each of the three named constructs. These comparisons use the same general logic as the attendance comparison, but the outcomes have different scales and meanings. A difference in score units cannot be compared directly with a difference in attendance sessions. The record does not describe the instruments, scoring direction, or clinically meaningful thresholds for the symptom outcomes, so the numerical contrasts should not be translated into a claim about clinical importance.

These are unadjusted comparisons. In general, when several outcomes are examined, the chance of at least one apparently notable result can increase if each is assessed independently without accounting for the number of tests. Multiplicity procedures can control or otherwise characterize that issue, but no such procedure is reported in the registry record. The secondary findings consequently merit more caution than a single prespecified primary analysis would, especially because the record lists multiple outcomes and does not give an analysis plan.

What can and cannot be inferred from these calculations?

The comparisons are unadjusted recalculations from posted group summary statistics. They describe the difference in reported group averages with uncertainty estimates and p-values under the calculation's assumptions. They are not a substitute for a full participant-level analysis, which could account for design features or covariates if appropriate and prespecified. The registry record reports no analysis entries, so it does not establish whether the calculations match the investigators' intended analysis or whether other analyses were conducted. The record also does not report how missing data were handled, which participants were included in each analysis, or whether any adjustment for baseline measures was planned.

Randomization is relevant because, when properly implemented, it is intended to make groups comparable on average at baseline. The registry record identifies the trial as randomized, but it does not describe the randomization method or concealment. Likewise, the triple-masked designation does not identify which parties were masked or how masking was maintained. These missing details limit evaluation of possible sources of bias. The numerical comparisons remain useful descriptions of the posted results, but the record does not contain enough methodological detail to independently assess every assumption behind an inferential analysis.

11. Confidence Intervals and Precision

The primary mean difference is 0.1 sessions, with a 95% confidence interval from -1.06 to 1.26. This interval spans zero, so it is compatible with no difference in mean attendance and also with a difference favoring either group in the direction of the score. The point estimate alone is not enough to characterize the result: the interval shows how uncertain that estimate is. It is not a prediction interval for individual attendance, and it does not mean that all values inside the interval are equally plausible.

The two reported standard deviations for attendance are both 1.8. These describe participant-to-participant variation, whereas the confidence interval describes uncertainty about the group difference. Because the outcome summaries include 19 participants in MH MOVE and 18 in enhanced usual care, the estimate comes from a modest set of observations. The registry record does not report why these counts differ from enrollment of 44 or whether missing outcome data affected the comparison.

For the secondary outcomes, the recalculated confidence intervals exclude zero. Their width still matters: each interval includes a range of possible mean differences, rather than identifying a single fixed effect. The record does not provide clinical thresholds for interpreting these scales, so statistical separation from zero alone does not establish how meaningful a difference may be. The secondary comparisons are also unadjusted, and the record does not explain whether they were planned as confirmatory or exploratory analyses.

Overall, the primary estimate is imprecise enough that the posted results do not rule out differences in either direction. Confidence intervals should be read as uncertainty around estimates under the calculation's assumptions, not as proof of equivalence or proof of a meaningful effect. The absence of a reported analysis plan, analysis population, and missing-data approach adds uncertainty beyond what the numerical interval itself captures.

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 planning figures express participants per arm, not total events. They are illustrations based on the observed effect and the stated assumptions: a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect used for each illustration is the stated fraction of the observed effect. These assumptions describe the planning calculations; the trial's original sample-size justification and design assumptions are not reported in the registry record.

For each effect assumption, the 80% power column gives the estimated number of participants per arm needed for an 80% chance of detecting an effect of that size if the assumptions hold and the effect is real. The 90% power column gives the corresponding planning estimate for a 90% chance. Power is a property of a design under assumed conditions, not a guarantee that a study will detect an effect. The entries should be read as hypothetical planning quantities rather than as a target known to have guided this trial.

The rows consider 100%, 75%, and 50% of the observed effect. The columns are estimates for 80% and 90% power. Smaller assumed effects need more participants to distinguish them from random variation, which is why the planning requirement increases as the effect fraction gets smaller. The observed attendance difference is particularly close to zero, so a planning exercise tied to that estimate produces very large requirements. This does not establish that such a design was intended or that the observed effect is the true effect.

The curve represents the same kind of planning relationship: as the effect being targeted becomes smaller, the number of participants needed generally rises under the stated assumptions. Read its values as planning estimates under those assumptions, not as a reconstruction of the trial's design. This is not observed power; it is a prospective illustration based on the observed effect, and it cannot tell whether the trial had a high or low probability of success after the results were known.

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, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.100; pooled standard deviation σ = 1.800.
2. n = 2 × (1.96 + 0.842)² × 1.800² / 0.100² = 5,086.1, rounded up to 5,087 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
delta <- 0.100000000000001                      # observed difference in means
sigma <- 1.8                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^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 (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2642536)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 5,087 (80% power), 6,809 (90% power)
 75% of observed effect: n per arm = 9,042 (80% power), 12,105 (90% power)
 50% of observed effect: n per arm = 20,345 (80% power), 27,236 (90% power)
power.t.test: 5087 
Simulated power at n = 5,087 per arm: 0.797 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-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. Multiplicity, Missing Data and Analysis Populations

The registry record lists multiple outcomes, including the primary attendance measure and secondary measures concerning depression, anxiety, and PTSD symptom severity. It does not report a statistical analysis plan, a hierarchy for testing outcomes, or a procedure for controlling multiplicity. These omissions make it difficult to know whether the posted results reflect prespecified analyses or which outcomes were intended to carry confirmatory weight.

Multiplicity matters because the chance of at least one small p-value can rise when several hypotheses are tested. An adjustment can address that issue in different ways, depending on the scientific goals and the planned analysis. No adjustment is reported for the secondary results. Their p-values should therefore be read as unadjusted comparisons, not as results that account for the full set of outcomes or analyses that may have been considered. The record does not report the number of analyses conducted beyond indicating no analysis entries.

Missing-data handling is also not reported in the registry record. The primary endpoint summaries include 19 participants for MH MOVE and 18 for enhanced usual care, while total enrollment is 44. The record does not explain why the outcome counts are lower than enrollment, whether all randomized participants were included in an analysis, or whether missing values were imputed or otherwise handled. It also does not identify the analysis population, such as whether the results follow an intention-to-treat approach.

These are important uncertainties rather than evidence that a particular method was or was not used. The record gives no basis for assuming a specific imputation method, exclusion rule, interim analysis, or covariate adjustment. Consequently, the posted comparisons can be described as unadjusted calculations from the available group summaries, but the registry record does not support a complete reconstruction of the investigators' statistical methods or assessment of the potential impact of missingness and outcome selection.

15. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The serious adverse event summaries report zero affected participants in each group: 0 of 19 at risk in MH MOVE and 0 of 18 at risk in enhanced usual care. The record also reports zero deaths in each group. These are counts within the reported at-risk groups, not estimates of how often an event might occur in a broader population.

Zero recorded events does not establish that no serious adverse events could occur, nor does it show that the programs have identical safety profiles. With no events recorded in these groups, the registry record does not support a comparative estimate of relative risk. The number of participants followed for safety and the duration or completeness of safety monitoring are not described in the registry record.

The adverse-event information is limited to the posted serious-event counts and deaths. The record does not list serious-event terms, and the summary reports zero other affected participants as well. These counts should be interpreted as what was recorded for this trial, not as a guarantee about safety outside the study or as a basis for clinical advice.

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

The primary result describes average MOVE! attendance at 16 weeks in the two randomized groups. The mean was 5.9 sessions in MH MOVE and 5.8 sessions in enhanced usual care, with a mean difference of 0.1 sessions. The confidence interval from -1.06 to 1.26 includes zero, so the posted data do not establish a clear difference in average attendance. At the same time, the interval is not evidence that the programs are equivalent: no equivalence margin or noninferiority framework is reported.

The result concerns the number of sessions attended, not weight loss, long-term participation, program completion under a defined rule, or symptom change. The secondary results address symptom-severity scores and show a different pattern of group averages, but they are unadjusted and lack reported multiplicity procedures. They do not convert the primary attendance comparison into evidence of a difference in attendance.

The trial was randomized according to the registry record, which supports interpreting the group comparison as a randomized comparison in principle. Yet the record does not provide details of sequence generation, concealment, analysis populations, missing-data handling, or the original statistical plan. These omissions constrain how strongly the posted numerical estimates can be interpreted. The endpoint summaries also cover fewer participants than the total enrollment, with no explanation in the record.

The record does not establish that one program is clinically superior, nor does it demonstrate that the programs are interchangeable. It reports estimates with uncertainty for a specific endpoint and timeframe in the recorded study population. The secondary symptom summaries are also specific to the posted outcomes and should be treated cautiously in view of multiple outcomes and the absence of a reported adjustment. The findings do not support medical advice or conclusions about people beyond the study population.

17. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between a program's intended mechanism and the outcome used to assess it. MH MOVE added phone-based clinician-led CBT sessions to a standard weight management program and workbook, while enhanced usual care included the standard program and workbook without phone calls. The primary outcome measured attendance, which is relevant to participation but is not itself a direct measure of symptom change, weight change, or completion.

The attendance estimate illustrates why a point estimate and its uncertainty should be considered together. The mean difference is close to zero, while its confidence interval includes differences in either direction. A nonsignificant unadjusted p-value does not prove no effect; conversely, a numerical estimate alone does not establish a meaningful effect. Confidence intervals make the range of compatible values visible and help avoid overinterpreting a single point estimate.

The secondary results also demonstrate why a favorable-looking pattern across several measures should be interpreted in light of multiplicity and prespecification. The registry record does not document a testing hierarchy or adjustment, so those outcomes carry uncertainty beyond their individual intervals and p-values. A record that reports the analysis plan and missing-data approach would allow readers to assess these issues more fully.

Finally, the difference between total enrollment and the endpoint counts underscores the importance of transparent accounting for participants. Without an explanation of the analysis population and missing outcomes, readers cannot determine how the reported summaries relate to all randomized participants. These are general statistical considerations illustrated by the record, not evidence that any particular analysis choice was made.

18. 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 registry record leaves several trial-specific questions unanswered. Although it identifies the study as randomized, triple masked, and parallel, it does not describe the randomization method, allocation concealment, or which people were masked. The labels alone do not allow readers to evaluate whether assignment or masking could have influenced recruitment, care, outcome assessment, or reporting.

The primary endpoint summaries include 19 participants in MH MOVE and 18 in enhanced usual care, whereas overall enrollment is 44. No participant flow or explanation for those counts is reported. The record does not say whether every randomized participant contributed to the posted outcome, how missing observations were addressed, or which analysis population was used. These gaps limit evaluation of possible attrition bias.

The statistical analysis plan, original sample-size justification, any interim analyses, and methods for adjustment are not reported in the registry record. The planning figures based on observed effects are illustrations and do not reveal the study's original design assumptions. The registry also does not report an analysis hierarchy or multiplicity procedure for the multiple secondary outcomes. This makes it difficult to assess whether the secondary comparisons were confirmatory or exploratory.

For the secondary symptom outcomes, the registry record does not identify the instruments, scoring direction beyond the numerical summaries, or thresholds for clinically meaningful differences. The primary attendance measure is described as a single item, but its interpretation as a measure of engagement should not be expanded into a claim about completion or longer-term participation. Finally, the posted summary statistics do not support exploration of participant-level patterns or relationships between attendance and symptom scores.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Improving Obesity Self-Care Among Mentally Ill Veterans — NCT02642536.
• Registry record last updated 2018-02-22; status last verified 2018-01.
• Results first posted 2017-08-07.
• 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.

22. Record Summary

The registry record describes a completed, randomized, triple-masked, parallel-group behavioral trial with enrollment of 44. It compared MH MOVE, which included phone-based clinician-led CBT sessions alongside the standard MOVE! program and workbook, with enhanced usual care, which included the standard program and workbook without phone calls.

The primary outcome was mean MOVE! attendance at 16 weeks. The posted means were 5.9 sessions for MH MOVE and 5.8 for enhanced usual care; the recalculated mean difference was 0.1, with a 95% confidence interval from -1.06 to 1.26 and an unadjusted p-value of 0.866. Secondary summaries addressed depression, anxiety, and PTSD symptom severity. Serious adverse events and deaths were recorded as zero in both groups.

The registry record does not report the original analysis plan, missing-data methods, participant flow, or multiplicity procedures. These omissions limit interpretation of the posted comparisons, particularly the secondary outcomes.