The Effect of Logotherapy-Based Intervention on Depression Patients on Depression,Psychological Pain and Meaning of Life: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Effect of Logotherapy-Based Intervention on Depression Patients on Depression,Psychological Pain and Meaning of Life (NCT05702736), a non-randomized na study. The primary outcome is "Beck Depression Inventory" Scores.

2. Clinical Question

The primary endpoint is a continuous score, with higher Beck Depression Inventory totals corresponding to higher depression levels according to the registry description. The central comparison is therefore not simply whether scores changed: it is whether the scores recorded at the specified assessment times differed between groups, interpreted with attention to the nonrandomized design.

The study also identifies psychological pain and meaning of life as outcomes of interest. Its descriptions name the Psychache Scale and Meaning of Life Questionnaire, respectively. However, the registry record does not report numerical findings for those measures either. The study question is clinically and statistically framed around possible group differences, but the posted record does not establish their size, direction, or precision.

3. Trial Design

This was an interventional study with a parallel-group design and nonrandomized allocation. The registry record lists a total enrollment of 32 and describes two groups: an intervention group and a control group. The sponsor was Ege University. The study status is completed; its recorded start date is 2020-03-04 and its primary completion date is 2021-02-04.

The intervention group received logotherapy-based intervention in addition to standard treatment. The study description says interviews were conducted online once a week for eight sessions. The control group received standard treatment alone. The record describes pre-test assessment for both groups and identifies post-test and follow-up assessments for the measures, with the primary Beck Depression Inventory time frame stated as post-test after 8 weeks and follow-up after 3 months.

Nonrandomized allocation is important for interpreting the comparison. Random assignment, when used, is intended to reduce systematic baseline differences between groups. In a nonrandomized study, measured and unmeasured differences may influence both group membership and outcomes. Consequently, a group difference cannot automatically be attributed to the intervention. The registry record does not report the method used to assign participants, baseline characteristics by group, or an adjusted analysis that could clarify how such differences were handled.

The record identifies three outcome measures, while the listed primary outcome is Beck Depression Inventory scores. It does not report numerical outcome results or an outcome-specific analysis. Details of the statistical plan, including any covariate adjustment or handling of repeated assessments, are not reported in the registry record. The study is therefore described by its design and planned assessments, but the registry record does not permit a quantitative appraisal of its findings.

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.

6. Primary Endpoint

The registry lists the primary outcome as "Beck Depression Inventory" Scores, measured over post-test (after 8 weeks) and follow-up test (after 3 months).

The primary endpoint is the mean Beck Depression Inventory score. The registry describes the inventory as measuring depression level across physical, emotional, cognitive, and motivational components. It contains 21 questions, uses a four-point Likert-type scale, and has a total score from 0 to 63. Higher total scores indicate higher depression levels.

The registry description gives four score categories: normal (0-9 points), mild (10-16 points), moderate (17-29 points), and severe (30-63 points). These categories provide a way to describe score ranges, while the primary endpoint is specified as a mean continuous score. A mean can summarize the overall level of scores in a group and can be compared across groups or assessment times, but it does not show how individual participants are distributed across the categories.

The outcome is assessed at post-test after 8 weeks and follow-up after 3 months. Measuring at both times can distinguish an assessment at the end of the intervention period from a later follow-up assessment. The registry record does not report the observed means, standard deviations, group sizes at each assessment, or contrasts between groups. It therefore does not show whether the scores changed, how large any difference was, or how uncertain an estimate would be.

As a general statistical point, a continuous score retains more gradation than a categorical summary because it uses the recorded score values rather than assigning each person only to a band. Interpretation still depends on the quality and completeness of measurement and on the comparison design. The record does not report details of the instrument's administration beyond the description above.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a mean on a continuous scale and gives standard deviation as its dispersion measure. It also identifies two assessment times for that outcome: post-test after 8 weeks and follow-up after 3 months. The record does not report the analysis used to compare groups or assessment times. The explanations below are general statistical context, not a description of an analysis confirmed for this study.

What does a mean summarize?

In general, the mean is the arithmetic average of observed scores. It provides a single summary of the group's score level, while the standard deviation describes how much individual scores vary around that average. Two groups can have similar means but different amounts of variation, or different means with substantial overlap in their individual scores. For that reason, a mean alone does not convey the full distribution of outcomes.

The Beck Depression Inventory score has a stated range of 0 to 63, with higher scores corresponding to higher depression levels. A mean score is interpretable as an average on that scale, but it is not itself a count of participants in each of the four severity bands. If categories are used in addition to the mean, their frequencies would answer a different descriptive question. The registry record does not report those frequencies.

How are groups and time points compared?

In general, a group comparison can estimate a difference between group means at a particular assessment. A study with repeated assessments may also compare changes over time or estimate whether the pattern of change differs between groups. These are distinct estimands: a post-test group contrast, a within-group change, and a difference in change do not answer the same question. The registry record does not identify which contrast was used or report estimates for any of them.

Repeated measurements on the same participant are related rather than independent. General methods for repeated data account for that correlation when estimating uncertainty. The specific method, assumptions, and handling of incomplete repeated measurements for this study are not reported in the registry record. It would be inappropriate to infer a particular model or test from the schedule alone.

What does a confidence interval add?

In general, a confidence interval expresses the precision of an estimated quantity under a statistical model. A narrow interval indicates greater precision than a wide interval, while the interval's location indicates which effect sizes are compatible with the data and assumptions. An interval for a difference can include values consistent with effects in either direction or with little difference. Interpretation should consider the estimate and interval, not only whether a significance threshold is crossed. No confidence interval is reported for the primary outcome in this registry record.

A p-value is also a model-based summary, not the probability that a treatment works or that a null hypothesis is true. In general, it reflects how unusual the observed data, or data more extreme, would be under the specified null model. A small p-value alone does not establish that a difference is large, important, unbiased, or reproducible. No p-value for the primary outcome is reported in the registry record.

Why does allocation matter?

In general, randomization makes treatment assignment independent of participant characteristics in expectation, helping balance both measured and unmeasured factors across groups. Nonrandomized allocation does not have that protection. Baseline differences can affect later scores and complicate causal interpretation. Adjustment for measured baseline characteristics can address some observed imbalance, but cannot guarantee control of unmeasured factors. The registry record says allocation was nonrandomized; it does not report the assignment procedure, group-specific baseline results, or any adjusted model.

There are further sources of uncertainty in a comparison, including outcome variability, incomplete follow-up, measurement differences, and model choice. Statistical methods can quantify some uncertainty, but they do not remove bias caused by design or data collection. The available record does not report enough analysis detail to evaluate these issues for the primary endpoint.

What is stated about planning?

The record describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; it says the effect to detect is a stated fraction of the observed effect. Such calculations are planning illustrations, not observed trial outcomes and not observed power. The registry record does not report numerical planning counts or an observed effect estimate alongside these details. Its sample-size justification and the assumptions used for the trial's original design are not reported in the registry record.

These planning concepts cannot replace an estimate from the enrolled participants. A planning calculation concerns a hypothetical future design under specified assumptions; an outcome analysis describes the observed data. Because numerical outcome results and analysis methods are not reported, the record does not support reconstruction of the study's statistical findings.

10. Multiplicity, Missing Data and Analysis Populations

The study description identifies three outcome measures: Beck Depression Inventory, Psychache Scale, and Meaning of Life Questionnaire. The listed primary outcome is Beck Depression Inventory scores, measured at post-test after 8 weeks and follow-up after 3 months. Considering multiple outcomes and assessment times raises multiplicity questions, because testing many contrasts can increase the chance of at least one apparently unusual result under a null model. The registry record does not report a multiplicity strategy, such as a prespecified hierarchy or adjustment method. It also does not report outcome-specific numerical analyses.

Missing data can affect both the estimated group comparison and its uncertainty. In general, the consequences depend on how many observations are missing, why they are missing, and the assumptions used by the analysis. Complete-case analysis, imputation, and likelihood-based approaches make different assumptions and may yield different estimates. The registry record does not report missing outcome counts, reasons for missingness, or methods used to address missing data.

The record lists total enrollment as 32, but does not report how many participants contributed data to each outcome at each assessment. Enrollment alone therefore does not establish the analysis population or the number of observations used in any comparison. Details about inclusion of participants in analyses, exclusions after enrollment, or treatment of participants who did not complete follow-up are not reported in the registry record.

These omissions limit assessment of how robust a result would be even if a numerical result were available. With no reported outcome estimates, analysis populations, missing-data information, or multiplicity plan, the record does not permit evaluation of the statistical handling of these issues.

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

The record establishes that a completed nonrandomized study compared logotherapy-based intervention plus standard treatment with standard treatment alone, and that it identified depression, psychological pain, and meaning of life as outcomes of interest. It also specifies Beck Depression Inventory scores as the primary outcome and names post-test and follow-up assessment times. These details describe the study question and design, not the observed effect.

The registry record does not report numerical group results, so it does not establish the direction or size of any difference in depression scores, psychological pain, or meaning of life. It also does not report confidence intervals or p-values that would describe statistical precision or compatibility with a null model. The absence of reported results should not be interpreted as proof of no difference; it means the results cannot be evaluated from the registry record.

Even if a group difference were reported, a nonrandomized comparison would require cautious causal interpretation. In general, group differences can arise from baseline characteristics or other factors related to group assignment, not only from the intervention. The record does not report the assignment procedure or the statistical adjustment used to address such factors.

Likewise, a change within one group would not by itself establish that the intervention caused that change. Changes over time can reflect factors shared by both groups or other influences. A comparison between groups, with a clearly defined estimand and suitable analysis, is needed to address the study question; the registry record does not report such an estimate.

The information supports a description of what was planned and how the groups were characterized, but not a conclusion about benefit, lack of benefit, or clinical importance. No medical recommendation follows from the posted record.

12. Why This Trial Matters Statistically

This study raises several important statistical issues for clinical research. First, the nonrandomized allocation means the comparison is vulnerable to differences between groups that existed before intervention. That design feature should shape how any estimated contrast is interpreted. The registry record does not report enough baseline information or analysis detail to assess the extent of this concern.

Second, the primary endpoint is a continuous score measured at more than one time. Researchers and readers need to distinguish a group contrast at post-test from change within a group and from differences in change over time. Each targets a different question. The registry record specifies assessment times but does not report which contrast was analyzed.

Third, the study description names three outcome measures, while one is designated as primary. Clear reporting of the planned outcome hierarchy and approach to multiple comparisons helps readers understand which findings were confirmatory and how uncertainty should be interpreted. The multiplicity strategy is not reported in the registry record.

Finally, transparent reporting of group-level estimates, variability, uncertainty intervals, analysis populations, and missing-data handling is needed to evaluate the evidence quantitatively. The registry record reports total enrollment and describes the measures, but does not report numerical results or these analysis details. As a result, the statistical questions are identifiable, but the posted information does not resolve them.

The trial matters statistically as an example of why design details and complete outcome reporting are essential alongside a study question. Without those elements, readers cannot judge the magnitude or precision of the comparison or how strongly the design supports causal interpretation.

13. 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 most consequential limitation of the available record is that it does not report numerical results for the primary outcome or the other named measures. Group means, standard deviations, contrasts, confidence intervals, and p-values are not reported in the registry record. Consequently, no estimate of the observed outcome difference or its precision can be evaluated.

The nonrandomized allocation is a design limitation for causal interpretation. The record does not explain how participants were assigned to groups, report group-specific baseline characteristics, or describe adjustment for baseline differences. These missing details prevent assessment of whether the groups were comparable before the intervention or whether measured confounding was addressed.

Although the registry describes assessment before treatment and at post-test and follow-up, it does not report the number of participants assessed at each time point, missing-data patterns, reasons for missingness, or methods for handling incomplete outcomes. It also does not identify the analysis population. The total enrollment of 32 does not show how many observations contributed to each analysis.

The record identifies three outcome measures but does not report a multiplicity plan or the statistical model used for repeated measurements. The specific sample-size justification and original design assumptions are not reported in the registry record. The planning assumptions described in the record do not provide an outcome estimate or substitute for an analysis of the enrolled participants.

These limitations concern what can be evaluated from the registry record. They do not establish that the study lacked analyses or that the intervention had no effect; those matters are not reported in the registry record.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: The Effect of Logotherapy-Based Intervention on Depression Patients on Depression,Psychological Pain and Meaning of Life — NCT05702736.
• Registry record last updated 2025-04-08; status last verified 2025-03.
• Results first posted 2025-04-08.
• 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.

17. Record Summary

This completed interventional study, sponsored by Ege University, enrolled 32 participants and used a parallel, nonrandomized comparison. The intervention group received logotherapy-based intervention in addition to standard treatment; the control group received standard treatment alone. The study description says the intervention involved online interviews once a week for eight sessions.

The primary outcome was mean Beck Depression Inventory score, assessed at post-test after 8 weeks and follow-up after 3 months. Psychological pain and meaning of life were also named as outcomes. The record lists the study start as 2020-03-04 and primary completion as 2021-02-04.

Numerical outcome results, analysis methods, missing-data handling, and multiplicity procedures are not reported in the registry record. The posted record therefore describes the study question and design but does not permit quantitative interpretation of its findings.