Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning (NCT01783080), a na na study. The primary outcome is Paid Work Hours at Week 12.

2. Clinical Question

3. Trial Design

The registry describes a completed, single-group behavioral study of Behavioral Activation for return to work. It records an enrollment of 16 and identifies the sponsor as New York State Psychiatric Institute. The study start is recorded as 2010-06 and primary completion as 2012-12. The phase and allocation are recorded as NA, and masking is recorded as NONE. These entries describe the registry classification; further operational detail is not reported in the registry record.

The intervention was intended to address work dysfunction through employment-related goals. The broader stated aim was to assess a modified Behavioral Activation approach in relation to social adjustment, work functioning, avoidance behavior, and behavioral activation. The registry lists Social Functioning at Week Baseline on the Social Adjustment Scale and Social Functioning at Week 12 on the Social Adjustment Scale as secondary outcomes. It records four outcome measures and two analyses, but the detailed analysis procedures and results are not reported in the registry record.

Because this was not a randomized comparison, the study design does not provide a concurrent randomized control group for separating intervention-associated changes from other influences. The registry does not describe a comparator group, allocation procedure, or masking beyond the entries noted above. It also does not report details of recruitment, eligibility criteria, follow-up completeness, or how participants entered the analysis. These omissions limit interpretation of both the study population and the strength of any causal conclusions.

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 Paid Work Hours at Week 12, measured over Week 12.

The primary endpoint, Paid Work Hours at Week 12, is described as subject-reported paid work hours per week at that time. It is a continuous measure, with the registry specifying a mean as the parameter and standard deviation as the dispersion measure. In practical terms, it is intended to quantify participants’ reported amount of paid work at the week-12 assessment rather than a categorical employment status alone.

Work hours are relevant to the study’s stated focus on occupational functioning and return to work. A continuous measure can retain information about differing amounts of paid work among participants, while a mean describes the group’s average and a standard deviation describes the spread of individual observations around that average. These are general statistical interpretations of the measure; they do not establish that the outcome captures every aspect of work functioning.

The registry record does not report the observed week-12 mean or standard deviation, the number of participants contributing endpoint data, or an estimate of change from baseline. It also does not report a comparator for this primary endpoint. Consequently, the endpoint’s value and precision cannot be assessed from the registry results described in this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a continuous primary endpoint and specifies a mean and standard deviation as its summary measures. It does not report the statistical analysis used to produce an endpoint estimate. The explanations below are general statistical concepts, not claims about analyses performed in this study.

What does a mean describe?

In general, a mean is the arithmetic average of observed values. For paid work hours, it would summarize the average reported weekly hours among the participants included in a particular analysis. A mean alone does not show whether observations were tightly grouped or widely spread, and it can be influenced by unusually high or low observations. The registry record does not report the observed mean or specify the analysis population used to calculate one.

What does a standard deviation describe?

In general, a standard deviation describes the spread of individual values around their mean. It is expressed in the same units as the measure, so it would be expressed in hours for this endpoint. A larger standard deviation indicates more dispersion in the recorded values; it is not the same as uncertainty in the estimated mean. The record specifies standard deviation as the dispersion measure but does not report its observed value.

How would a confidence interval be read?

In general, a confidence interval gives a range of values compatible with an estimate under the analysis assumptions and reflects its statistical precision. A narrower interval indicates greater precision than a wider interval, while an interval does not eliminate the possibility of bias or limitations in measurement. No confidence interval for paid work hours is reported in the registry record, so the endpoint’s precision cannot be evaluated from such an interval.

What can a significance test establish?

In general, a p-value describes how incompatible the observed data are with a specified null hypothesis under the assumptions of a test. It is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of an effect. A p-value requires a clearly defined comparison and analysis. The registry record does not report a primary endpoint p-value, the test used, or a null hypothesis for the endpoint.

Why does the study design matter?

In general, random allocation can make groups comparable in expectation, supporting a treatment-versus-control interpretation when other design and analysis conditions are met. This study is recorded as single-group, with allocation listed as NA, and is not a randomized comparison. A single-group assessment can describe its participants, but it cannot offer the same concurrent control-based separation of intervention effects from other influences. The registry does not report a comparator-based estimate for this endpoint.

What do the planning assumptions mean?

The registry states that its planning illustration uses the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also describes the target effect as a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial used those design features: the study itself is recorded as single-group. A sample-size calculation is a prospective planning illustration and must not be read as observed power. The underlying observed effect and resulting planning counts are not reported in the registry record.

Why might distributional assumptions matter?

As a general point, continuous measurements can have different distributions. If observations are strongly skewed or vary more than a statistical model assumes, a model based on a simple normal approximation may not describe uncertainty well. Over-dispersion means that variability exceeds what a model expects; accounting for it can affect standard errors and intervals. These are general considerations, not findings about this endpoint. The registry does not report the distribution of work-hour observations, diagnostic checks, or model assumptions used in any analysis.

For this study, the available methodological information supports describing the endpoint’s scale and the single-group design. It does not support reconstruction of an estimate, its standard error, a confidence interval, or a significance test.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Behavioral Activation for Return to Work")
n   <- c(16)
m   <- c(30.3)
sp  <- c(18.8)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Behavioral Activation for Return to Work  16  30.300  18.800  20.282  40.318

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and two analyses. It identifies paid work hours at week 12 as the primary outcome and lists Social Adjustment Scale social-functioning outcomes at baseline and week 12 as secondary outcomes. The record does not give a complete outcome-by-analysis mapping or describe whether the investigators designated additional outcomes as confirmatory, exploratory, or otherwise ordered.

When several outcomes or analyses are examined, the chance of at least one apparently notable result can increase if each is interpreted without considering the full set. General approaches to multiplicity include prespecifying a primary hypothesis, adjusting inference across a defined family of tests, or clearly separating confirmatory from exploratory analyses. Which, if any, approach was used is not reported in the registry record. No multiplicity adjustment or analysis hierarchy is reported.

Missing data are also important for a week-12 endpoint: the number of enrolled participants does not establish how many posted endpoint observations. The registry record does not report the number with observed week-12 work-hour data, reasons for missing observations, or a method for handling missingness. It does not state whether analyses used only participants with observed data, imputation, or another approach.

The analysis population is not reported in the registry record. In particular, the record does not specify whether the primary analysis included all enrolled participants or a subset defined by treatment exposure, follow-up, or outcome availability. These gaps prevent assessment of how missing observations or analysis-population choices may have affected estimates. They should not be filled by assuming a particular statistical plan.

12. Safety Results

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

Other (non-serious) adverse events

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

The registry reports zero participants with serious adverse events in the Behavioral Activation for Return to Work group, with 16 participants at risk. It also reports zero participants with other adverse events, with 16 participants at risk. These entries describe the recorded counts for the categories shown; they do not establish that no adverse experiences of any kind occurred.

The deaths entry is null. A null entry is not the same as a reported count of zero, and the meaning of the missing entry is not explained in the registry record. The record lists no top serious-event terms. Further details about event definitions, collection procedures, follow-up coverage, or severity assessment are not reported in the registry record.

In general, adverse-event counts are interpreted in light of the number of participants monitored and the period and methods of monitoring. A count of zero in a recorded category does not quantify the likelihood of events beyond the observed study experience, and small studies may provide limited information about uncommon events. These are general considerations; the registry does not report additional safety analyses or exposure details that would permit a broader assessment.

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

The record documents a completed single-group study of Behavioral Activation for return to work, with an enrollment of 16 and a primary endpoint defined as self-reported paid work hours per week at week 12. It also describes a rationale focused on occupational and social functioning and lists social-functioning outcomes at baseline and week 12. These details clarify the question and the type of evidence the study was designed to collect.

The numerical primary endpoint result is not reported in the registry record. Therefore, the posted information does not show the average work hours, how much participants’ values varied, or how precise any estimate may be. It cannot establish whether work hours changed from baseline, because a baseline measure or change estimate for the primary endpoint is not reported. Nor can the record support a comparison with usual care, another treatment, or no intervention.

Even if a within-group change were available, general statistical interpretation would distinguish an observed change from a causal effect. In a single-group study, changes may reflect the intervention, other events, measurement variation, or a combination of influences. A randomized comparator can strengthen causal interpretation, but this record does not describe such a comparison.

The listed serious adverse-event and other adverse-event counts are zero among 16 participants at risk in each category. The deaths field is null, not a reported zero. These figures should be read as registry entries rather than as proof that every possible safety outcome was absent.

The most defensible conclusion is limited: the registry records the study’s design, endpoint, and stated aims, but does not report the numerical primary result or enough methodological detail to assess its precision and analysis. No claim that the intervention did or did not change work hours follows from the information recorded.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of why design and reporting determine what a result can answer. The intervention was aimed at work dysfunction, and the primary endpoint was a continuous measure tied directly to paid work hours. That endpoint can describe occupational activity in a concrete unit, while a mean and standard deviation would communicate average level and variability if those results were reported.

The single-group design places an important boundary on interpretation. It can document outcomes among participants receiving the intervention, but it does not supply a randomized concurrent comparison for estimating a treatment contrast. The registry’s allocation entry is NA, and the study is recorded as single-group. Readers therefore need to distinguish the study’s occupational objective from evidence that would isolate a causal intervention effect.

The record also illustrates the importance of complete results reporting. It identifies four outcome measures and two analyses, yet the numerical results and detailed analysis procedures are not reported in the registry record. Without endpoint estimates and measures of uncertainty, readers cannot evaluate either the magnitude or precision of the primary outcome. Without information on missing observations and analysis populations, they also cannot judge how complete the endpoint data were.

Finally, planning calculations and observed results answer different questions. The registry describes assumptions for a sample-size planning illustration based on an observed effect, but that does not constitute observed power or replace a reported estimate. In this record, the absence of the underlying endpoint result means the planning assumptions do not yield a substantive conclusion about work hours.

The statistical lesson is not a verdict on the intervention. It is that a clearly defined endpoint and a completed study designation do not by themselves provide the estimates needed to assess an outcome. Design, complete outcome reporting, and transparent analysis details all matter.

15. 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 limitation for interpretation is that the registry record does not report the numerical result for paid work hours at week 12. The mean, standard deviation, confidence interval, and test result are not reported in the registry record. Without these, the endpoint’s observed level and precision cannot be assessed.

The study is recorded as single-group rather than a randomized comparison. This limits causal interpretation because there is no randomized comparator described in the registry record. The record also does not report a primary baseline-to-week-12 change estimate for paid work hours, so it is not possible to determine whether the primary endpoint was analyzed as a final value, a change, or another contrast.

The endpoint is subject-reported, but the record does not describe the reporting instrument or process beyond identifying paid work hours per week. It does not report how the measure was verified, how the timing of assessment was managed, or how incomplete reports were handled. The number of participants contributing week-12 endpoint data and the analysis population are also not reported in the registry record.

Other relevant details are absent: full eligibility criteria, participant characteristics, intervention-delivery details, the statistical model, assumptions, multiplicity procedures, and any missing-data method are not reported in the registry record. The study description of the intervention is incomplete, so the intervention cannot be fully characterized from this entry alone. These limitations constrain interpretation without establishing that any particular bias or problem occurred.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning — NCT01783080.
• Registry record last updated 2017-06-19; status last verified 2017-04.
• Results first posted 2017-06-19.
• 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.

19. Record Summary

The registry record identifies NCT01783080 as a completed, single-group behavioral study sponsored by New York State Psychiatric Institute. Enrollment was 16. The study focused on Behavioral Activation for return to work among medication-responsive patients described as chronically depressed and having impaired social functioning. The condition is listed as Persistent Depressive Disorder.

The primary endpoint was subject-reported paid work hours per week at week 12, summarized by a mean and standard deviation. Social Adjustment Scale social-functioning outcomes at baseline and week 12 are listed as secondary outcomes. The registry states that the study aimed to assess social adjustment, work functioning, avoidance behavior, and behavioral activation.

Numerical results for the primary endpoint and detailed analysis, missing-data, and multiplicity methods are not reported in the registry record. The study is not described as a randomized comparison, so the record does not support a randomized treatment-effect estimate.