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 Supportive and Supportive-Expressive Treatment for Depression (NCT02728557), a randomized na study. The primary outcome is Hamilton Rating Scale for Depression (HRSD).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02728557 |
| Phase | NA |
| Condition | Major Depressive Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 100 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Haifa |
| Results posted | Yes |
2. Clinical Question
Population
People with major depressive disorder were eligible for the psychotherapy study. The registry record lists an enrollment of 100. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
One arm received supportive-expressive psychotherapy. The study description says this treatment could use an expressive focus, and the arm description identifies it as supportive-expressive therapy. Further details about treatment delivery are not reported in the registry record.
Comparator
The comparison arm received supportive psychotherapy. The registry record describes the trial as comparing supportive and supportive-expressive approaches. It does not report additional details about treatment sessions or how treatment was standardized across participants.
Primary question
The primary measure was the Hamilton Rating Scale for Depression (HRSD), with the outcome described as the slope from baseline to week 16. The clinical question is whether the course of depression severity, as measured by the HRSD, differed between the two psychotherapy arms. The registry record does not report a single numerical estimate of that between-arm comparison, its uncertainty, or a test result.
The study description also says that the research would examine whether benefit from treatment varied by attachment orientation and investigate the role of therapeutic alliance. These are aims described in the record, not reported findings. The registry record does not provide results establishing whether attachment orientation or alliance was associated with outcome, or whether either modified the comparison between therapies.
3. Trial Design
The registry record describes a randomized, double-masked, parallel-group study of supportive psychotherapy and supportive-expressive psychotherapy for major depressive disorder. The listed enrollment is 100, and the study status is completed. The phase is recorded as not applicable. The sponsor is the University of Haifa.
The study description characterizes the treatment protocol as four months, with a year follow-up period. The primary outcome timeframe is the slope from baseline to week 16, so the specified primary measure concerns change over the treatment period rather than a single endpoint score alone. The record also lists the Beck Depression Inventory (BDI) and Outcome Questionnaire (OQ) as secondary outcomes. It records six outcome measures, but does not give enough outcome-specific information to reconstruct all of them.
Random allocation means that assignment to the study arms was intended to be determined by a random process. In a parallel-group design, participants are assigned to an arm and the arms are compared. The registry record labels the study double-masked, but does not report which people were masked, how masking was maintained, or whether it remained intact.
The recorded study dates are a start date of 2016-03-02 and a primary completion date of 2021-02-17. These dates describe the registry record; they do not by themselves establish the timing of every participant’s treatment or follow-up. Details such as the randomization procedure, allocation concealment, treatment frequency, adherence, and analysis population are not reported in the registry record.
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 | Supportive-expressive Psychotherapy | Supportive Psychotherapy |
|---|---|---|
| STARTED | 50 | 50 |
| COMPLETED | 48 | 45 |
| NOT COMPLETED | 2 | 5 |
Reasons for not completing this period:
| Reason | Supportive-expressive Psychotherapy | Supportive Psychotherapy |
|---|---|---|
| Dissatisfaction with assigned treatment | 1 | 3 |
| Dissatisfaction with research tasks | 0 | 1 |
| Scheduling or change in availability | 1 | 1 |
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 | Supportive Psychotherapy | Supportive-expressive Psychotherapy | Total |
|---|---|---|---|---|
| Participants analysed | 50 | 50 | 100 | |
| Age, Continuous | Years | 31.02 (SD 6.9) | 31.5 (SD 9.6) | 31.2 (SD 8.25) |
| Sex: Female, Male: Female | Participants | 29 | 28 | 57 |
| Sex: Female, Male: Male | Participants | 21 | 22 | 43 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Israel | participants | 50 | 50 | 100 |
| HRSD | Unit on a scale | 20.84 (SD 3.588) | 21.00 (SD 3.881) | 20.92 (SD 3.719) |
6. Primary Endpoint
The registry lists the primary outcome as Hamilton Rating Scale for Depression (HRSD), measured over Slope from baseline to week 16..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Hamilton Rating Scale for Depression (HRSD), a clinician-administered measure of depression severity. The registry description says scoring is based on the first 17 items and gives a scale range of 0-52. It describes items covering aspects of depression experienced in the past week, with ratings on a 3-point or 5-point scale depending on the symptom. The record also presents severity categories, including normal, mild, moderate, severe, and very severe.
The listed outcome is the slope from baseline to week 16. A slope describes the direction and rate of change across the measurement period, rather than just the score at a single assessment. Comparing slopes between randomized arms can address whether measured depression severity changed differently over that period. A clinician-administered scale is used to quantify symptom severity in a structured way; it is not, by itself, a complete description of a participant’s experience or functioning.
The registry record does not report the numerical slopes, arm-specific estimates, uncertainty intervals, or a single between-arm result for this endpoint. It also notes that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, the primary measure and its intended timeframe can be described, but the magnitude and precision of the treatment contrast cannot be read from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and names the HRSD slope from baseline to week 16 as the primary outcome. It does not report one reduced primary comparison or its numerical result. This means the record does not support a quantitative statement about the difference between arms in depression-severity trajectories. In particular, there is no reported arm contrast, confidence interval, or p-value for a single primary comparison in the record.
The outcome specification indicates what investigators intended to assess, not what the observed data established. Although the record lists the primary outcome, the note that it has several categories or time points and was not reduced to one comparison is important: without a clearly specified contrast and corresponding estimate, readers cannot determine the direction, magnitude, or precision of the primary result from this information. The same absence prevents a statistical assessment of whether the data are compatible with a range of possible effects.
There are no numerical results for the listed secondary measures, BDI and OQ, in the record. The record also does not report findings on attachment orientation or therapeutic alliance, despite describing these as research aims. A study aim should not be treated as a finding, and a named outcome should not be interpreted as evidence of an effect without its results.
General statistical interpretation: an estimate describes the observed contrast, while a confidence interval communicates its uncertainty under the statistical model used. A narrow interval would indicate greater precision than a wide interval, but neither can be assessed when the estimate and interval are not reported. A p-value, if reported, would address compatibility with a specified null model; it would not by itself express the size or practical importance of a contrast. These concepts cannot fill in absent trial results.
The registry record reports zero serious adverse events affected and zero other adverse events affected in each arm, with 50 at risk in each arm; deaths are recorded as 0 in each arm. These are descriptive safety counts in the record. They do not establish that no adverse experiences occurred outside the registry’s reported categories or ascertainment, nor do they provide an estimate of comparative safety with precision.
Overall, the posted information allows a description of the design, outcome measure, and recorded adverse-event figures, but not an estimate of comparative treatment outcome. The record’s completed status does not substitute for outcome estimates. The sponsor’s own analysis takes precedence over any simple recalculation when a discrepancy is identified; the registry record does not provide a numerical primary comparison for such a recalculation in the first place.
9. Statistical Methods Explained
The record describes a randomized, parallel-group comparison and a continuous primary outcome summarized as a mean, with standard deviation specified as the dispersion measure. It names the HRSD slope from baseline to week 16 as the primary endpoint. However, the record also says that the primary outcome has several categories or time points and was not reduced to one comparison. The precise statistical analysis used for the primary outcome is not reported in the registry record.
What does a slope comparison represent?
General explanation: a slope expresses how an outcome changes across measurement occasions. A comparison of slopes asks whether the average pattern of change differs between groups over the specified period. Such an analysis can use repeated measurements rather than treating each assessment as independent. The interpretation depends on how time is represented, how within-participant correlation is handled, and which model terms are included. Those details are not reported in the registry record, so it is not possible to identify the exact model or reproduce the primary analysis.
The word “mean” indicates that the outcome is treated as a continuous measure and that a group average is relevant to the reported summary. A standard deviation describes the spread of individual observations around a mean; it is not the uncertainty of the mean or of the difference between arms. A confidence interval for an effect estimate would address uncertainty in the estimated contrast. The registry record does not report the primary arm means, standard deviations, effect estimate, or confidence interval.
What does randomization contribute?
General explanation: random assignment is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics before treatment. It supports a causal comparison when allocation is implemented as planned, outcome data are handled appropriately, and the analysis respects the randomized assignment. Randomization does not ensure that every characteristic will be identical across groups, and it does not remove uncertainty from the observed estimates. The registry record labels allocation as randomized but does not report the randomization sequence, concealment procedure, or analysis population.
The parallel-group structure means the two psychotherapy arms are compared as separate assigned groups, rather than each participant receiving both treatments as a crossover. The record also labels masking as double. General explanation: masking can reduce the influence of expectations on treatment delivery, outcome assessment, or reporting, depending on who is masked. The record does not say who was masked or how masking operated, so its practical scope cannot be determined.
How should the planning illustrations be read?
General explanation: a sample-size planning illustration translates an assumed effect and statistical design into a prospective number of participants needed for a chosen power target. It depends on its assumptions and is not a measure of the probability that a completed study found a real effect. The record describes illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a report of the original trial’s design justification. The sample-size illustrations are not observed power and should not be interpreted as proof that the study was adequately powered.
For a continuous outcome, planning calculations generally depend on the assumed contrast and variability. If the result is not reported, the observed effect needed to interpret an illustration is not available in the registry record. The record also does not report the original sample-size justification, its target effect, or whether any such calculation governed enrollment. These points limit what can be inferred from planning values.
What can be recalculated from the record?
A simple unadjusted recalculation can be made only when the posted summary statistics required for it are available. No primary arm-specific means, standard deviations, or single comparison are reported in the registry record, so a numerical recalculation of the primary contrast is not possible from this information. If a recalculated result differs from the sponsor’s own analysis, the sponsor’s own analysis takes precedence. A recalculation would also be unadjusted and should not be presented as a substitute for a prespecified model that accounts for repeated measurements or other design features.
General explanation: repeated observations from the same participant are usually correlated. Treating them as independent can misstate uncertainty because observations from one person tend to share characteristics. Models for repeated outcomes can represent this correlation, but choices about covariance structure, missing observations, and time effects can affect estimates and standard errors. Those analysis choices are not reported in the registry record.
Likewise, a mean and standard deviation can be useful summaries, but they do not reveal the full distribution of scores. The registry record does not report distributional diagnostics or a transformation. It is therefore not possible to assess from the posted information whether a particular model’s assumptions were evaluated or whether alternative analyses were conducted.
10. Multiplicity, Missing Data and Analysis Populations
The study record lists one primary outcome title and two named secondary outcomes, BDI and OQ. It also records six outcome measures and one analysis. These entries do not provide a complete account of how many statistical hypotheses were tested, which contrasts were prespecified, or how testing was organized across outcome measures, time points, and categories. Multiplicity procedures are not reported in the registry record.
General explanation: when several outcomes, time points, or subgroup questions are examined, the chance of at least one apparently notable finding can increase if each is assessed separately. Methods for controlling multiplicity can adjust interpretation or testing, but their relevance depends on the planned family of hypotheses. The registry record does not describe a correction, a testing hierarchy, or a distinction between confirmatory and exploratory analyses. No conclusion about multiplicity control can therefore be drawn.
The record’s note that the primary outcome has several categories or time points and was not reduced to one comparison further limits interpretation. It does not identify which time points or categories were analyzed, or how a primary contrast was selected. The analysis plan is not reported in the registry record.
Missing-data methods and analysis populations are also not reported in the registry record. There is no information about the amount or pattern of missing outcome data, how missing observations were handled, whether all randomized participants were included in the primary analysis, or whether any per-protocol or other population was used. General explanation: missingness can affect both the estimate and its uncertainty, and different assumptions or methods can lead to different conclusions. Without these details, readers cannot assess the robustness of the outcome analysis to missing data or determine the exact population represented by any outcome estimate.
The registry record does not report interim analyses, a statistical analysis plan, or sample-size justification. Their absence from the record should not be taken as proof that such procedures did or did not occur; the appropriate description is that they are not reported in the registry record.
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 |
|---|---|---|---|
| Supportive-expressive Psychotherapy | 0 | 50 | 0.0% |
| Supportive Psychotherapy | 0 | 50 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Supportive-expressive Psychotherapy | 0 of 50 |
| Supportive Psychotherapy | 0 of 50 |
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 |
|---|---|
| Supportive-expressive Psychotherapy | 0 of 50 |
| Supportive Psychotherapy | 0 of 50 |
The registry record lists 50 participants at risk in the supportive-expressive psychotherapy arm and 50 at risk in the supportive psychotherapy arm. For each arm, it reports 0 participants affected by serious adverse events and 0 affected by other adverse events. Deaths are recorded as 0 in each arm. No serious adverse-event terms are listed.
These figures are counts recorded in the registry, not estimates of comparative risk with reported uncertainty. A zero count means that the registry record reports no affected participants in that category; it does not show that the underlying risk is exactly zero. General explanation: when an event is uncommon, observing no events does not rule out the possibility that the event could occur in a larger population or under different observation conditions.
The registry record does not provide definitions for the adverse-event categories, details of event collection or follow-up, or information about the timing and duration of safety monitoring. It also does not report a statistical comparison of safety between arms. The figures should therefore be read as the recorded counts for the stated at-risk groups, not as comprehensive evidence about all possible harms or as a precise estimate of relative safety.
12. What the Result Does, and Does Not, Mean
The study addresses a clinically relevant statistical question: whether depression-severity trajectories differ between two psychotherapies for people with major depressive disorder. Its randomized, parallel-group design is suitable in principle for a comparative treatment question. The registry record also specifies an outcome measure and timeframe, which helps identify the intended primary assessment.
However, the posted information does not provide a single primary comparison or numerical outcome estimates. It therefore cannot establish the direction or magnitude of any between-arm difference, how precisely that difference was estimated, or whether the observed data are compatible with no difference. The study’s completed status and the fact that a primary endpoint is named do not answer those questions without results.
The record describes interest in attachment orientation and therapeutic alliance. These aims could concern how participant characteristics or therapeutic processes relate to outcome, but the registry record does not report findings for them. It would be inaccurate to infer that either factor predicted outcome or changed the relative results of the treatments.
General explanation: a treatment contrast is an estimate for the population, outcome, time period, and analysis represented by the study. It is not automatically a statement about every patient, every aspect of depression, or longer-term outcomes. Here, the listed primary timeframe is the slope from baseline to week 16; the study description also refers to a year follow-up, but no numerical follow-up outcome results are reported in the registry record.
The recorded adverse-event counts are reassuring only in the narrow descriptive sense that the registry lists zero affected participants in the stated categories for each arm. They do not establish the absence of all adverse experiences or quantify comparative safety precisely. No medical decision should be based on these registry entries alone.
In short, the registry record establishes what comparison was planned and identifies several relevant measures, but it does not report enough outcome data for a statistical conclusion about comparative effectiveness or the role of alliance and attachment. The distinction between an intended question and an observed, quantified result is central to interpreting this trial record.
13. Why This Trial Matters Statistically
This trial matters statistically because it combines a randomized comparison of two psychotherapies with a question about change in depression severity over time. A slope outcome can represent the pattern of change across repeated assessments, rather than only the score at one occasion. That makes clear reporting of the time points, analysis model, and between-arm contrast especially important.
The record also describes interest in attachment orientation and therapeutic alliance. Questions about whether characteristics or therapeutic processes relate to outcome can require analyses beyond a simple comparison of arm averages. Such analyses need clear definitions of the measures, planned contrasts, and adequate reporting of uncertainty. The registry record does not report these methods or results, so the aims cannot be evaluated quantitatively from the information available.
The case illustrates why registration details and results serve different purposes. Registration can identify the population, arms, outcomes, and intended timeframe. Interpreting the findings additionally requires estimates, uncertainty, analysis populations, missing-data methods, and a transparent account of how multiple outcomes and time points were handled. The record supplies some design context but does not report those outcome-analysis details for the primary comparison.
It also illustrates why a sample-size planning illustration must not be confused with observed power. Planning assumptions describe prospective requirements under an assumed effect and model. They do not establish the precision achieved in the completed study, especially when the observed outcome estimates are not reported.
For clinical researchers and biostatisticians, the key statistical lesson is that a well-defined outcome and randomized design do not replace the need for a reported estimand and its uncertainty. Without a single interpretable result, readers cannot assess how much the arms differed or whether conclusions are robust to analytical choices. Clear reporting would allow the trial’s substantive aims to be evaluated against the evidence rather than inferred from the design description.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation for interpreting the trial record is the lack of a single reported primary comparison. Although the HRSD slope from baseline to week 16 is named, the record says the primary outcome has several categories or time points and was not reduced to one comparison. No arm-specific outcome estimates, contrast, confidence interval, or p-value are reported in the registry record. This prevents assessment of effect size, direction, and precision.
Participant eligibility details and baseline characteristics are not reported in the registry record, limiting assessment of who the findings would represent. The treatment descriptions are brief; session frequency, treatment duration at the participant level, therapist training, treatment fidelity, and adherence are not reported. The record labels the study double-masked, but does not identify who was masked or describe masking procedures.
Important analytical details are also not reported in the registry record. These include the statistical model for the repeated HRSD assessments, the analysis population, handling of missing data, and any adjustment for multiple outcomes or time points. The record does not report the original sample-size justification or interim analyses. Without these details and the numerical results, readers cannot assess how analytic decisions might affect conclusions.
The study description refers to a year follow-up, but numerical follow-up results are not reported in the registry record. It is not possible to determine from the record whether follow-up data were complete or how they were analyzed. The safety information is likewise limited to recorded counts, without detailed event definitions or ascertainment methods.
These limitations concern what can be learned from the registry record; they do not establish that unreported procedures or analyses did not occur. The record’s completed status does not resolve the missing information needed for statistical interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Supportive and Supportive-Expressive Treatment for Depression — NCT02728557.
- Registry record last updated 2025-01-27; status last verified 2024-12.
- Results first posted 2025-01-27.
- 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, double-masked, parallel-group study sponsored by the University of Haifa, with an enrollment of 100. It compares supportive psychotherapy with supportive-expressive psychotherapy for major depressive disorder. The record lists the primary outcome as the HRSD slope from baseline to week 16 and names BDI and OQ as secondary outcomes.
The study description refers to a four month protocol and a year follow-up. The registry dates are 2016-03-02 for study start and 2021-02-17 for primary completion. The record also describes research aims concerning attachment orientation and therapeutic alliance.
A single numerical primary comparison and its uncertainty are not reported in the registry record. Serious and other adverse events affected 0 participants in each arm among 50 at risk in each arm; deaths are recorded as 0 in each arm. The record does not report the analysis plan, missing-data methods, or analysis populations.